diff --git a/data/README.md b/data/README.md new file mode 100644 index 0000000..26da59b --- /dev/null +++ b/data/README.md @@ -0,0 +1,93 @@ +# Data Directory + +Input and reference data for the data-definition-engine. Files are organized by source and study. + +## Directory Structure + +``` +data/ +├── archive/ # Superseded files kept for reference +│ └── protocol/ +│ └── LZZT/ +│ └── usdm/ +│ └── pilot_LLZT_protocol.json # Earlier USDM draft for LZZT pilot +├── metadata_xlsx/ # Excel-based metadata specifications +│ ├── LZZT/ +│ │ ├── CDISCPILOT01-ADaM-2026-02-23.xlsx # ADaM metadata for CDISC Pilot 01 (LZZT) +│ │ └── CDISCPILOT01-SDTM-2026-02-23.xlsx # SDTM metadata for CDISC Pilot 01 (LZZT) +│ └── templates/ +│ └── Define-Excel-Spec.xlsx # Template for the Define-XML Excel spec format +└── soa_workbench/ # Exports from the SOA Workbench tool + └── protocols/ + ├── HCT01797120/ # Study NCT01797120 + │ ├── NCT01797120-latest.json # USDM 4.0 protocol export + │ └── NCT01797120-define-latest.json # Define-JSON export + └── LZZT/ # Study H2Q-MC-LZZT (CDISC Pilot) + ├── H2Q-MC-LZZT-latest.json # USDM 4.0 protocol export + └── H2Q-MC-LZZT-define-latest.json # Define-JSON export +``` + +## Subdirectories + +### `archive/` + +Older or superseded files retained for historical reference. Not used as active inputs. + +### `metadata_xlsx/` + +Excel workbooks containing SDTM and ADaM dataset/variable metadata in the Define-XML Excel spec format. The `templates/` subfolder holds the blank template used as a starting point for new studies. + +### `soa_workbench/` + +JSON exports from the [SOA Workbench](https://soa-workbench.cdisc.org) tool, organized by study identifier. Each study folder contains two file types: + +| Suffix | Format | Description | +|---|---|---| +| `{studyId}-{timestamp}.json` | USDM 4.0 | Protocol-level study definition (schedule of activities, visits, arms) | +| `{studyId}-define-{timestamp}.json` | Define-JSON | Dataset/variable definitions in Define-JSON format | + +Filenames include an ISO 8601 timestamp (`YYYYMMDDTHHMM`) recording when the export was generated. When multiple exports exist for the same study, the most recent timestamp is the current working version. + + +## USDM Version Identification + +There is a new `extensionAttribute` that can be used ot determine the date of USDM JSON generation. Check in tteh `study.versions` class entity: + +```JSON +"extensionAttributes": [ + { + "id": "ExtensionAttribute_44", + "url": "http://www.cdisc.org/usdm/extensions/studyDesignSolution", + "valueExtensionClass": { + "id": "ExtensionClass_1", + "url": "http://www.cdisc.org/usdm/extensions/StudyDesignSolution", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_45", + "url": "tool-name", + "valueString": "SoA Workbench", + "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_46", + "url": "tool-version", + "valueString": "1.4.0", + "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_47", + "url": "usdm-creation-date", + "valueString": "20260618T15:11", + "instanceType": "ExtensionAttribute" + } + ], + "instanceType": "ExtensionClass" + }, + "instanceType": "ExtensionAttribute" + } +] +``` + +This `extensionAttribute` identifies the USDM was generated using the SoA Workbench, version 1.4 on 2026-06-18 at 15:11. + +If raising issues with the USDM JSON file, include all of this information to make support easier. \ No newline at end of file diff --git a/data/protocol/LZZT/usdm/pilot_LLZT_protocol.json b/data/archive/protocol/LZZT/usdm/pilot_LLZT_protocol.json similarity index 100% rename from data/protocol/LZZT/usdm/pilot_LLZT_protocol.json rename to data/archive/protocol/LZZT/usdm/pilot_LLZT_protocol.json diff --git a/data/soa_workbench/protocols/HCT01797120/NCT01797120-define-latest.json b/data/soa_workbench/protocols/HCT01797120/NCT01797120-define-latest.json new file mode 100644 index 0000000..61b2f4e --- /dev/null +++ b/data/soa_workbench/protocols/HCT01797120/NCT01797120-define-latest.json @@ -0,0 +1,11197 @@ +{ + "OID": "MDV.None.Version1.Design1", + "name": "MDV None", + "description": "Data Definitions for None", + "fileOID": "ODM.DEFINE-JSON.None.Version1.Design1", + "creationDateTime": "2026-06-18T15:14:46.008763+00:00", + "odmVersion": "1.3.2", + "fileType": "Snapshot", + "originator": "Define-JSON Processor", + "context": "Other", + "defineVersion": "2.1.0", + "studyOID": "ODM.None.Version1.Design1", + "studyName": null, + "studyDescription": "Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Fulvestrant (Faslodex) plus Everolimus in Post-Menopausal Patients with Hormone-Receptor Positive Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy", + "protocolName": null, + "itemGroups": [ + { + "OID": "IG.DS", + "name": "DS", + "description": "Disposition", + "domain": "DS", + "purpose": "Tabulation", + "structure": "One record per disposition status or protocol milestone per subject", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "DSSEQ" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "EVENTS" + }, + "items": [ + { + "OID": "IT.DS.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.DS.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.DS.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.DS.DSSEQ", + "mandatory": true, + "name": "DSSEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.DS.DSTERM", + "mandatory": true, + "name": "DSTERM", + "description": "Reported Term for the Disposition Event", + "role": "Topic", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_2", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.DS.DSDECOD", + "mandatory": true, + "name": "DSDECOD", + "description": "Standardized Disposition Term", + "role": "Synonym Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_1", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.NCOMPLT" + }, + { + "OID": "IT.DS.DSCAT", + "mandatory": false, + "name": "DSCAT", + "description": "Category for Disposition Event", + "role": "Grouping Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.DSCAT" + }, + { + "OID": "IT.DS.DSSCAT", + "mandatory": false, + "name": "DSSCAT", + "description": "Subcategory for Disposition Event", + "role": "Grouping Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.DSSCAT" + }, + { + "OID": "IT.DS.DSSTDTC", + "mandatory": false, + "name": "DSSTDTC", + "description": "Start Date/Time of Disposition Event", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_3", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.DS.DSSTDY", + "mandatory": false, + "name": "DSSTDY", + "description": "Study Day of Start of Disposition Event", + "role": "Timing", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + } + ], + "implementsConcept": "CONC.BiomedicalConcept_1" + }, + { + "OID": "IG.RS", + "name": "RS", + "description": "Disease Response and Clin Classification", + "domain": "RS", + "purpose": "Tabulation", + "structure": "One record per response assessment or clinical classification assessment per time point per visit per subject per assessor per medical evaluator", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "RSSEQ" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "FINDINGS" + }, + "items": [ + { + "OID": "IT.RS.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.RS.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.RS.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.RS.RSSEQ", + "mandatory": true, + "name": "RSSEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.RS.RSLNKGRP", + "mandatory": false, + "name": "RSLNKGRP", + "description": "Link Group ID", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.RS.RSTESTCD", + "mandatory": true, + "name": "RSTESTCD", + "description": "Assessment Short Name", + "role": "Topic", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.ONCRTSCD" + }, + { + "OID": "IT.RS.RSTEST", + "mandatory": true, + "name": "RSTEST", + "description": "Assessment Name", + "role": "Synonym Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.ONCRTS" + }, + { + "OID": "IT.RS.RSCAT", + "mandatory": false, + "name": "RSCAT", + "description": "Category for Assessment", + "role": "Grouping Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.ONCRSCAT" + }, + { + "OID": "IT.RS.RSORRES", + "mandatory": false, + "name": "RSORRES", + "description": "Result or Finding in Original Units", + "role": "Result Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_15", + "dataType": "text", + "length": 20, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.RS.RSSTRESC", + "mandatory": false, + "name": "RSSTRESC", + "description": "Character Result/Finding in Std Format", + "role": "Result Qualifier", + "dataType": "integer", + "length": 1, + "origin": { + "type": "Derived", + "source": "Sponsor" + }, + "codeList": "CL.ONCRSR" + }, + { + "OID": "IT.RS.RSSTRESN", + "mandatory": false, + "name": "RSSTRESN", + "description": "Numeric Result/Finding in Standard Units", + "role": "Result Qualifier", + "dataType": "integer", + "length": 1, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.RS.RSEVAL", + "mandatory": false, + "name": "RSEVAL", + "description": "Evaluator", + "role": "Record Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.EVAL" + }, + { + "OID": "IT.RS.RSEVALID", + "mandatory": false, + "name": "RSEVALID", + "description": "Evaluator Identifier", + "role": "Variable Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Vendor" + }, + "codeList": "CL.MEDEVAL" + }, + { + "OID": "IT.RS.VISITNUM", + "mandatory": false, + "name": "VISITNUM", + "description": "Visit Number", + "role": "Timing", + "dataType": "integer", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.RS.RSDTC", + "mandatory": false, + "name": "RSDTC", + "description": "Date/Time of Assessment", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_16", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + } + ], + "implementsConcept": "CONC.BiomedicalConcept_5" + }, + { + "OID": "IG.VS", + "name": "VS", + "description": "Vital Signs", + "domain": "VS", + "purpose": "Tabulation", + "structure": "One record per vital sign measurement per time point per visit per subject", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "VSSEQ" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "FINDINGS" + }, + "items": [ + { + "OID": "IT.VS.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.VS.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.VS.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.VS.VSSEQ", + "mandatory": true, + "name": "VSSEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.VS.VSTESTCD", + "mandatory": true, + "name": "VSTESTCD", + "description": "Vital Signs Test Short Name", + "role": "Topic", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.VSTESTCD" + }, + { + "OID": "IT.VS.VSTEST", + "mandatory": true, + "name": "VSTEST", + "description": "Vital Signs Test Name", + "role": "Synonym Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.VSTEST" + }, + { + "OID": "IT.VS.VSPOS", + "mandatory": false, + "name": "VSPOS", + "description": "Vital Signs Position of Subject", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_19", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.POSITION" + }, + { + "OID": "IT.VS.VSORRES", + "mandatory": false, + "name": "VSORRES", + "description": "Result or Finding in Original Units", + "role": "Result Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_17", + "dataType": "integer", + "length": 3, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.VS.VSORRESU", + "mandatory": false, + "name": "VSORRESU", + "description": "Original Units", + "role": "Variable Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_18", + "dataType": "text", + "length": 20, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.VSRESU" + }, + { + "OID": "IT.VS.VSSTRESC", + "mandatory": false, + "name": "VSSTRESC", + "description": "Character Result/Finding in Std Format", + "role": "Result Qualifier", + "dataType": "integer", + "length": 3, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.VS.VSSTRESN", + "mandatory": false, + "name": "VSSTRESN", + "description": "Numeric Result/Finding in Standard Units", + "role": "Result Qualifier", + "dataType": "integer", + "length": 3, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.VS.VSSTRESU", + "mandatory": false, + "name": "VSSTRESU", + "description": "Standard Units", + "role": "Variable Qualifier", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.VSRESU" + }, + { + "OID": "IT.VS.VSLOC", + "mandatory": false, + "name": "VSLOC", + "description": "Location of Vital Signs Measurement", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_20", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.LOC" + }, + { + "OID": "IT.VS.VSLAT", + "mandatory": false, + "name": "VSLAT", + "description": "Laterality", + "role": "Result Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_21", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.LAT" + }, + { + "OID": "IT.VS.VSLOBXFL", + "mandatory": false, + "name": "VSLOBXFL", + "description": "Last Observation Before Exposure Flag", + "role": "Record Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY" + }, + { + "OID": "IT.VS.VISITNUM", + "mandatory": false, + "name": "VISITNUM", + "description": "Visit Number", + "role": "Timing", + "dataType": "integer", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.VS.VSDTC", + "mandatory": false, + "name": "VSDTC", + "description": "Date/Time of Measurements", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_22", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + } + ], + "implementsConcept": "CONC.BiomedicalConcept_7" + }, + { + "OID": "IG.UR", + "name": "UR", + "description": "Urinary System Findings", + "domain": "UR", + "purpose": "Tabulation", + "structure": "One record per finding per location per per visit per subject", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "URSEQ" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "FINDINGS" + }, + "items": [ + { + "OID": "IT.UR.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.UR.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.UR.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.UR.URSEQ", + "mandatory": true, + "name": "URSEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.UR.URTESTCD", + "mandatory": true, + "name": "URTESTCD", + "description": "Short Name of Urinary Test", + "role": "Topic", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.URNSTSCD" + }, + { + "OID": "IT.UR.URTEST", + "mandatory": true, + "name": "URTEST", + "description": "Name of Urinary Test", + "role": "Synonym Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.URNSTS" + }, + { + "OID": "IT.UR.URORRES", + "mandatory": false, + "name": "URORRES", + "description": "Result or Finding in Original Units", + "role": "Result Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.UR.URSTRESC", + "mandatory": false, + "name": "URSTRESC", + "description": "Character Result/Finding in Std Format", + "role": "Result Qualifier", + "dataType": "text", + "length": 2, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.UR.URMETHOD", + "mandatory": false, + "name": "URMETHOD", + "description": "Method of Test or Examination", + "role": "Record Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.METHOD" + }, + { + "OID": "IT.UR.URLOBXFL", + "mandatory": false, + "name": "URLOBXFL", + "description": "Last Observation Before Exposure Flag", + "role": "Record Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY" + }, + { + "OID": "IT.UR.VISITNUM", + "mandatory": false, + "name": "VISITNUM", + "description": "Visit Number", + "role": "Timing", + "dataType": "integer", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.UR.URDTC", + "mandatory": false, + "name": "URDTC", + "description": "Date/Time of Collection", + "role": "Timing", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + } + ], + "implementsConcept": "CONC.BiomedicalConcept_27" + }, + { + "OID": "IG.CM", + "name": "CM", + "description": "Concomitant/Prior Medications", + "domain": "CM", + "purpose": "Tabulation", + "structure": "One record per recorded intervention occurrence or constant-dosing interval per subject", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "CMSEQ" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "INTERVENTIONS" + }, + "items": [ + { + "OID": "IT.CM.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.CM.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.CM.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.CM.CMSEQ", + "mandatory": true, + "name": "CMSEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.CM.CMTRT", + "mandatory": true, + "name": "CMTRT", + "description": "Reported Name of Drug, Med, or Therapy", + "role": "Topic", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_82", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.CM.CMDECOD", + "mandatory": false, + "name": "CMDECOD", + "description": "Standardized Medication Name", + "role": "Synonym Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_83", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.CM.CMCAT", + "mandatory": false, + "name": "CMCAT", + "description": "Category for Medication", + "role": "Grouping Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.CM.CMSCAT", + "mandatory": false, + "name": "CMSCAT", + "description": "Subcategory for Medication", + "role": "Grouping Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.CM.CMPRESP", + "mandatory": false, + "name": "CMPRESP", + "description": "CM Pre-specified", + "role": "Variable Qualifier", + "dataType": "text", + "length": 1, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.NY" + }, + { + "OID": "IT.CM.CMOCCUR", + "mandatory": false, + "name": "CMOCCUR", + "description": "CM Occurrence", + "role": "Record Qualifier", + "dataType": "text", + "length": 1, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY" + }, + { + "OID": "IT.CM.CMINDC", + "mandatory": false, + "name": "CMINDC", + "description": "Indication", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_85", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.CM.CMCLAS", + "mandatory": false, + "name": "CMCLAS", + "description": "Medication Class", + "role": "Variable Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_84", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.CM.CMCLASCD", + "mandatory": false, + "name": "CMCLASCD", + "description": "Medication Class Code", + "role": "Variable Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.CM.CMDOSE", + "mandatory": false, + "name": "CMDOSE", + "description": "Dose per Administration", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_86", + "dataType": "float", + "length": 8, + "displayFormat": "8.3", + "significantDigits": 3, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.CM.CMDOSTXT", + "mandatory": false, + "name": "CMDOSTXT", + "description": "Dose Description", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_87", + "dataType": "text", + "length": 40, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.CM.CMDOSU", + "mandatory": false, + "name": "CMDOSU", + "description": "Dose Units", + "role": "Variable Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_88", + "dataType": "text", + "length": 40, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.UNIT" + }, + { + "OID": "IT.CM.CMDOSFRM", + "mandatory": false, + "name": "CMDOSFRM", + "description": "Dose Form", + "role": "Variable Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_89", + "dataType": "text", + "length": 40, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.FRM" + }, + { + "OID": "IT.CM.CMDOSFRQ", + "mandatory": false, + "name": "CMDOSFRQ", + "description": "Dosing Frequency per Interval", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_90", + "dataType": "text", + "length": 40, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.FREQ" + }, + { + "OID": "IT.CM.CMROUTE", + "mandatory": false, + "name": "CMROUTE", + "description": "Route of Administration", + "role": "Variable Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_91", + "dataType": "text", + "length": 40, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.ROUTE" + }, + { + "OID": "IT.CM.CMSTDTC", + "mandatory": false, + "name": "CMSTDTC", + "description": "Start Date/Time of Medication", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_92", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.CM.CMENDTC", + "mandatory": false, + "name": "CMENDTC", + "description": "End Date/Time of Medication", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_93", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.CM.CMSTRF", + "mandatory": false, + "name": "CMSTRF", + "description": "Start Relative to Reference Period", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_94", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.STENRF" + }, + { + "OID": "IT.CM.CMENRF", + "mandatory": false, + "name": "CMENRF", + "description": "End Relative to Reference Period", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_97", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.STENRF" + }, + { + "OID": "IT.CM.CMSTRTPT", + "mandatory": false, + "name": "CMSTRTPT", + "description": "Start Relative to Reference Time Point", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_95", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.STENRF" + }, + { + "OID": "IT.CM.CMSTTPT", + "mandatory": false, + "name": "CMSTTPT", + "description": "Start Reference Time Point", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_96", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.CM.CMENRTPT", + "mandatory": false, + "name": "CMENRTPT", + "description": "End Relative to Reference Time Point", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_98", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.STENRF" + }, + { + "OID": "IT.CM.CMENTPT", + "mandatory": false, + "name": "CMENTPT", + "description": "End Reference Time Point", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_99", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + } + ], + "implementsConcept": "CONC.BiomedicalConcept_50" + }, + { + "OID": "IG.TS", + "name": "TS", + "description": "Trial Summary", + "domain": "TS", + "purpose": "Tabulation", + "structure": "One record per trial summary parameter value", + "isReferenceData": true, + "keySequence": [ + "STUDYID", + "TSPARMCD", + "TSSEQ" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "TRIAL DESIGN" + }, + "items": [ + { + "OID": "IT.TS.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.TS.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.TS.TSSEQ", + "mandatory": true, + "name": "TSSEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.TS.TSPARMCD", + "mandatory": true, + "name": "TSPARMCD", + "description": "Trial Summary Parameter Short Name", + "role": "Topic", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_236", + "dataType": "text", + "length": null, + "codeList": "CL.TSPARMCD" + }, + { + "OID": "IT.TS.TSPARM", + "mandatory": true, + "name": "TSPARM", + "description": "Trial Summary Parameter", + "role": "Synonym Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_237", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.TSPARM" + }, + { + "OID": "IT.TS.TSVAL", + "mandatory": false, + "name": "TSVAL", + "description": "Parameter Value", + "role": "Result Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_238", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.TS.TSVALCD", + "mandatory": false, + "name": "TSVALCD", + "description": "Parameter Value Code", + "role": "Result Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_239", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.TS.TSVCDREF", + "mandatory": false, + "name": "TSVCDREF", + "description": "Name of the Reference Terminology", + "role": "Result Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_240", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.DICTNAM" + }, + { + "OID": "IT.TS.TSVCDVER", + "mandatory": false, + "name": "TSVCDVER", + "description": "Version of the Reference Terminology", + "role": "Result Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_241", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + } + } + ], + "implementsConcept": "CONC.BiomedicalConcept_51", + "slices": [ + { + "OID": "VL.TS.TSPARMCD", + "name": "VL_TS_TSPARMCD", + "type": "ValueList", + "wasDerivedFrom": "IT.TS.TSPARMCD", + "items": [ + { + "OID": "IT.TS.TSPARMCD.COMPTRT", + "mandatory": false, + "name": "TSPARMCD", + "dataType": "text", + "length": 200, + "origin": { + "type": "Protocol", + "source": "Sponsor" + }, + "applicableWhen": [ + "WC.TS.54cd02f1" + ] + }, + { + "OID": "IT.TS.TSPARMCD.INDIC", + "mandatory": false, + "name": "TSPARMCD", + "dataType": "text", + "length": 200, + "origin": { + "type": "Protocol", + "source": "Sponsor" + }, + "applicableWhen": [ + "WC.TS.9cdae039" + ] + }, + { + "OID": "IT.TS.TSPARMCD.INTTYPE", + "mandatory": false, + "name": "TSPARMCD", + "dataType": "text", + "length": 200, + "origin": { + "type": "Protocol", + "source": "Sponsor" + }, + "applicableWhen": [ + "WC.TS.e3ae16cd" + ] + }, + { + "OID": "IT.TS.TSPARMCD.NARMS", + "mandatory": false, + "name": "TSPARMCD", + "dataType": "text", + "length": 200, + "origin": { + "type": "Protocol", + "source": "Sponsor" + }, + "applicableWhen": [ + "WC.TS.89c0d243" + ] + }, + { + "OID": "IT.TS.TSPARMCD.OBJPRIM", + "mandatory": false, + "name": "TSPARMCD", + "dataType": "text", + "length": 200, + "origin": { + "type": "Protocol", + "source": "Sponsor" + }, + "applicableWhen": [ + "WC.TS.7a056c75" + ] + }, + { + "OID": "IT.TS.TSPARMCD.OBJSEC", + "mandatory": false, + "name": "TSPARMCD", + "dataType": "text", + "length": 200, + "origin": { + "type": "Protocol", + "source": "Sponsor" + }, + "applicableWhen": [ + "WC.TS.36721696" + ] + }, + { + "OID": "IT.TS.TSPARMCD.OUTMSPRI", + "mandatory": false, + "name": "TSPARMCD", + "dataType": "text", + "length": 200, + "origin": { + "type": "Protocol", + "source": "Sponsor" + }, + "applicableWhen": [ + "WC.TS.d8b84608" + ] + }, + { + "OID": "IT.TS.TSPARMCD.OUTMSSEC", + "mandatory": false, + "name": "TSPARMCD", + "dataType": "text", + "length": 200, + "origin": { + "type": "Protocol", + "source": "Sponsor" + }, + "applicableWhen": [ + "WC.TS.1d3cd461" + ] + }, + { + "OID": "IT.TS.TSPARMCD.SPONSOR", + "mandatory": false, + "name": "TSPARMCD", + "dataType": "text", + "length": 200, + "origin": { + "type": "Protocol", + "source": "Sponsor" + }, + "applicableWhen": [ + "WC.TS.51236927" + ] + }, + { + "OID": "IT.TS.TSPARMCD.TITLE", + "mandatory": false, + "name": "TSPARMCD", + "dataType": "text", + "length": 200, + "origin": { + "type": "Protocol", + "source": "Sponsor" + }, + "applicableWhen": [ + "WC.TS.43684533" + ] + }, + { + "OID": "IT.TS.TSPARMCD.TRT", + "mandatory": false, + "name": "TSPARMCD", + "dataType": "text", + "length": 200, + "origin": { + "type": "Protocol", + "source": "Sponsor" + }, + "applicableWhen": [ + "WC.TS.1948fed3" + ] + } + ] + } + ] + }, + { + "OID": "IG.TU", + "name": "TU", + "description": "Tumor/Lesion Identification", + "domain": "TU", + "purpose": "Tabulation", + "structure": "One record per identified tumor per subject per assessor", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "TUSEQ" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "FINDINGS" + }, + "items": [ + { + "OID": "IT.TU.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.TU.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.TU.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.TU.TUSEQ", + "mandatory": true, + "name": "TUSEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.TU.TUREFID", + "mandatory": false, + "name": "TUREFID", + "description": "Reference ID", + "role": "Identifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_285", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.TU.TULNKID", + "mandatory": false, + "name": "TULNKID", + "description": "Link ID", + "role": "Identifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_286", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.TU.TUTESTCD", + "mandatory": true, + "name": "TUTESTCD", + "description": "Tumor/Lesion ID Short Name", + "role": "Topic", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.TUTESTCD" + }, + { + "OID": "IT.TU.TUTEST", + "mandatory": true, + "name": "TUTEST", + "description": "Tumor/Lesion ID Test Name", + "role": "Synonym Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.TUTEST" + }, + { + "OID": "IT.TU.TUORRES", + "mandatory": false, + "name": "TUORRES", + "description": "Tumor/Lesion ID Result", + "role": "Result Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_278", + "dataType": "text", + "length": 24, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.TU.TUSTRESC", + "mandatory": false, + "name": "TUSTRESC", + "description": "Tumor/Lesion ID Result Std. Format", + "role": "Result Qualifier", + "dataType": "text", + "length": 24, + "origin": { + "type": "Derived", + "source": "Sponsor" + }, + "codeList": "CL.TUIDRS" + }, + { + "OID": "IT.TU.TULOC", + "mandatory": false, + "name": "TULOC", + "description": "Location of the Tumor/Lesion", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_279", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.LOC" + }, + { + "OID": "IT.TU.TULAT", + "mandatory": false, + "name": "TULAT", + "description": "Laterality", + "role": "Variable Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_280", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.LAT" + }, + { + "OID": "IT.TU.TUDIR", + "mandatory": false, + "name": "TUDIR", + "description": "Directionality", + "role": "Variable Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_281", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.DIR" + }, + { + "OID": "IT.TU.TUMETHOD", + "mandatory": false, + "name": "TUMETHOD", + "description": "Method of Identification", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_282", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.METHOD" + }, + { + "OID": "IT.TU.TULOBXFL", + "mandatory": false, + "name": "TULOBXFL", + "description": "Last Observation Before Exposure Flag", + "role": "Record Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY" + }, + { + "OID": "IT.TU.TUEVAL", + "mandatory": false, + "name": "TUEVAL", + "description": "Evaluator", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_283", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.EVAL" + }, + { + "OID": "IT.TU.TUEVALID", + "mandatory": false, + "name": "TUEVALID", + "description": "Evaluator Identifier", + "role": "Variable Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_284", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Vendor" + }, + "codeList": "CL.MEDEVAL" + }, + { + "OID": "IT.TU.VISITNUM", + "mandatory": false, + "name": "VISITNUM", + "description": "Visit Number", + "role": "Timing", + "dataType": "integer", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.TU.TUDTC", + "mandatory": false, + "name": "TUDTC", + "description": "Date/Time of Tumor/Lesion Identification", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_287", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Sponsor" + } + } + ], + "implementsConcept": "CONC.BiomedicalConcept_74" + }, + { + "OID": "IG.TA", + "name": "TA", + "description": "Trial Arms", + "domain": "TA", + "purpose": "Tabulation", + "structure": "One record per planned Element per Arm", + "isReferenceData": true, + "keySequence": [ + "STUDYID", + "ARMCD", + "ETCD" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "TRIAL DESIGN" + }, + "items": [ + { + "OID": "IT.TA.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.TA.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.TA.ARMCD", + "mandatory": true, + "name": "ARMCD", + "description": "Planned Arm Code", + "role": "Topic", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.ARMCD" + }, + { + "OID": "IT.TA.ARM", + "mandatory": true, + "name": "ARM", + "description": "Description of Planned Arm", + "role": "Synonym Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.ARM" + }, + { + "OID": "IT.TA.TAETORD", + "mandatory": true, + "name": "TAETORD", + "description": "Planned Order of Element within Arm", + "role": "Timing", + "dataType": "integer", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.TA.ETCD", + "mandatory": true, + "name": "ETCD", + "description": "Element Code", + "role": "Record Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.ETCD" + }, + { + "OID": "IT.TA.ELEMENT", + "mandatory": false, + "name": "ELEMENT", + "description": "Description of Element", + "role": "Synonym Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.ELEMENT" + }, + { + "OID": "IT.TA.TABRANCH", + "mandatory": false, + "name": "TABRANCH", + "description": "Branch", + "role": "Rule", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.TA.TATRANS", + "mandatory": false, + "name": "TATRANS", + "description": "Transition Rule", + "role": "Rule", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.TA.EPOCH", + "mandatory": true, + "name": "EPOCH", + "description": "Epoch", + "role": "Timing", + "dataType": "text", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + }, + "codeList": "CL.EPOCH" + } + ] + }, + { + "OID": "IG.TE", + "name": "TE", + "description": "Trial Elements", + "domain": "TE", + "purpose": "Tabulation", + "structure": "One record per planned Element", + "isReferenceData": true, + "keySequence": [ + "STUDYID", + "ETCD" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "TRIAL DESIGN" + }, + "items": [ + { + "OID": "IT.TE.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.TE.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.TE.ETCD", + "mandatory": true, + "name": "ETCD", + "description": "Element Code", + "role": "Topic", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.ETCD" + }, + { + "OID": "IT.TE.ELEMENT", + "mandatory": true, + "name": "ELEMENT", + "description": "Description of Element", + "role": "Synonym Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.ELEMENT" + }, + { + "OID": "IT.TE.TESTRL", + "mandatory": true, + "name": "TESTRL", + "description": "Rule for Start of Element", + "role": "Rule", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + } + ] + }, + { + "OID": "IG.SV", + "name": "SV", + "description": "Subject Visits", + "domain": "SV", + "purpose": "Tabulation", + "structure": "One record per actual or planned visit per subject", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "VISITNUM" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "SPECIAL-PURPOSE" + }, + "items": [ + { + "OID": "IT.SV.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.SV.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.SV.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.SV.VISITNUM", + "mandatory": true, + "name": "VISITNUM", + "description": "Visit Number", + "role": "Topic", + "dataType": "integer", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.SV.VISIT", + "mandatory": false, + "name": "VISIT", + "description": "Visit Name", + "role": "Synonym Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.SV.SVPRESP", + "mandatory": false, + "name": "SVPRESP", + "description": "Pre-specified", + "role": "Variable Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.NY" + }, + { + "OID": "IT.SV.SVOCCUR", + "mandatory": false, + "name": "SVOCCUR", + "description": "Occurrence", + "role": "Record Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY" + }, + { + "OID": "IT.SV.SVCNTMOD", + "mandatory": false, + "name": "SVCNTMOD", + "description": "Contact Mode", + "role": "Record Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.CNTMODE" + }, + { + "OID": "IT.SV.SVSTDTC", + "mandatory": false, + "name": "SVSTDTC", + "description": "Start Date/Time of Observation", + "role": "Timing", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.SV.SVENDTC", + "mandatory": false, + "name": "SVENDTC", + "description": "End Date/Time of Observation", + "role": "Timing", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + } + ] + }, + { + "OID": "IG.SE", + "name": "SE", + "description": "Subject Elements", + "domain": "SE", + "purpose": "Tabulation", + "structure": "One record per actual Element per subject", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "SESTDTC" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "SPECIAL-PURPOSE" + }, + "items": [ + { + "OID": "IT.SE.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.SE.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.SE.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.SE.SESEQ", + "mandatory": true, + "name": "SESEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.SE.ETCD", + "mandatory": true, + "name": "ETCD", + "description": "Element Code", + "role": "Topic", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.ETCD" + }, + { + "OID": "IT.SE.ELEMENT", + "mandatory": false, + "name": "ELEMENT", + "description": "Description of Element", + "role": "Synonym Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.ELEMENT" + }, + { + "OID": "IT.SE.EPOCH", + "mandatory": false, + "name": "EPOCH", + "description": "Epoch", + "role": "Timing", + "dataType": "text", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + }, + "codeList": "CL.EPOCH" + }, + { + "OID": "IT.SE.SESTDTC", + "mandatory": true, + "name": "SESTDTC", + "description": "Start Date/Time of Element", + "role": "Timing", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.SE.SEENDTC", + "mandatory": false, + "name": "SEENDTC", + "description": "End Date/Time of Element", + "role": "Timing", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + } + ] + } + ], + "conditions": [ + { + "OID": "COND.TS.TSPARMCD.cd7838e7", + "rangeChecks": [ + { + "comparator": "EQ", + "checkValues": [ + "COMPTRT" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" + } + ] + }, + { + "OID": "COND.TS.TSPARMCD.204aa07d", + "rangeChecks": [ + { + "comparator": "EQ", + "checkValues": [ + "INDIC" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" + } + ] + }, + { + "OID": "COND.TS.TSPARMCD.fd076a8d", + "rangeChecks": [ + { + "comparator": "EQ", + "checkValues": [ + "INTTYPE" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" + } + ] + }, + { + "OID": "COND.TS.TSPARMCD.770c1610", + "rangeChecks": [ + { + "comparator": "EQ", + "checkValues": [ + "NARMS" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" + } + ] + }, + { + "OID": "COND.TS.TSPARMCD.eb0c9bb2", + "rangeChecks": [ + { + "comparator": "EQ", + "checkValues": [ + "OBJPRIM" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" + } + ] + }, + { + "OID": "COND.TS.TSPARMCD.5ca3cd0c", + "rangeChecks": [ + { + "comparator": "EQ", + "checkValues": [ + "OBJSEC" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" + } + ] + }, + { + "OID": "COND.TS.TSPARMCD.a724d633", + "rangeChecks": [ + { + "comparator": "EQ", + "checkValues": [ + "OUTMSPRI" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" + } + ] + }, + { + "OID": "COND.TS.TSPARMCD.b313e712", + "rangeChecks": [ + { + "comparator": "EQ", + "checkValues": [ + "OUTMSSEC" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" + } + ] + }, + { + "OID": "COND.TS.TSPARMCD.2e2517d1", + "rangeChecks": [ + { + "comparator": "EQ", + "checkValues": [ + "SPONSOR" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" + } + ] + }, + { + "OID": "COND.TS.TSPARMCD.52dad99f", + "rangeChecks": [ + { + "comparator": "EQ", + "checkValues": [ + "TITLE" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" + } + ] + }, + { + "OID": "COND.TS.TSPARMCD.185bd9b1", + "rangeChecks": [ + { + "comparator": "EQ", + "checkValues": [ + "TRT" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" + } + ] + } + ], + "whereClauses": [ + { + "OID": "WC.TS.54cd02f1", + "conditions": [ + "COND.TS.TSPARMCD.cd7838e7" + ] + }, + { + "OID": "WC.TS.9cdae039", + "conditions": [ + "COND.TS.TSPARMCD.204aa07d" + ] + }, + { + "OID": "WC.TS.e3ae16cd", + "conditions": [ + "COND.TS.TSPARMCD.fd076a8d" + ] + }, + { + "OID": "WC.TS.89c0d243", + "conditions": [ + "COND.TS.TSPARMCD.770c1610" + ] + }, + { + "OID": "WC.TS.7a056c75", + "conditions": [ + "COND.TS.TSPARMCD.eb0c9bb2" + ] + }, + { + "OID": "WC.TS.36721696", + "conditions": [ + "COND.TS.TSPARMCD.5ca3cd0c" + ] + }, + { + "OID": "WC.TS.d8b84608", + "conditions": [ + "COND.TS.TSPARMCD.a724d633" + ] + }, + { + "OID": "WC.TS.1d3cd461", + "conditions": [ + "COND.TS.TSPARMCD.b313e712" + ] + }, + { + "OID": "WC.TS.51236927", + "conditions": [ + "COND.TS.TSPARMCD.2e2517d1" + ] + }, + { + "OID": "WC.TS.43684533", + "conditions": [ + "COND.TS.TSPARMCD.52dad99f" + ] + }, + { + "OID": "WC.TS.1948fed3", + "conditions": [ + "COND.TS.TSPARMCD.185bd9b1" + ] + } + ], + "codeLists": [ + { + "OID": "CL.ARMCD", + "name": "ARM Code", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "Fulvestrant + Everolimus" + }, + { + "codedValue": "Fulvestrant + Placebo" + } + ] + }, + { + "OID": "CL.ARM", + "name": "ARM", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "Fulvestrant + Everolimus" + }, + { + "codedValue": "Fulvestrant + Placebo" + } + ] + }, + { + "OID": "CL.ELEMENT", + "name": "Description of Element", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "Screening Period" + }, + { + "codedValue": "Everolimus Treatment Period" + }, + { + "codedValue": "Placebo Treatment Period" + }, + { + "codedValue": "Follow-Up Period" + } + ] + }, + { + "OID": "CL.ETCD", + "name": "Element Code", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "Screening Period", + "decode": "Screening Period" + }, + { + "codedValue": "Everolimus Treatment Period", + "decode": "Everolimus Treatment Period" + }, + { + "codedValue": "Placebo Treatment Period", + "decode": "Placebo Treatment Period" + }, + { + "codedValue": "Follow-Up Period", + "decode": "Follow-Up Period" + } + ] + }, + { + "OID": "CL.EPOCH", + "name": "Epoch", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C99079", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "Pre-Study Phase", + "coding": { + "code": "C202487", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Induction Phase", + "coding": { + "code": "C101526", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Continuation Phase", + "coding": { + "code": "C123452", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Follow-up Off Therapy", + "coding": { + "code": "C202578", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.a30c10b2", + "name": "DSDECOD Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "INFORMED CONSENT OBTAINED", + "coding": [ + { + "code": "C16735", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "INFORMED CONSENT OBTAINED" + } + ] + } + ] + }, + { + "OID": "CL.360cba0f", + "name": "DSDECOD Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "ELIGIBILITY CRITERIA MET", + "coding": [ + { + "code": "C132447", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "ELIGIBILITY CRITERIA MET" + } + ] + } + ] + }, + { + "OID": "CL.5991b40f", + "name": "VSORRESU Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "mmHg", + "coding": [ + { + "code": "C49670", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "mmHg" + } + ] + } + ] + }, + { + "OID": "CL.cbd6ad98", + "name": "VSORRESU Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "beats/min", + "coding": [ + { + "code": "C49673", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "beats/min" + } + ] + } + ] + }, + { + "OID": "CL.2148028d", + "name": "LBSPEC Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "SERUM OR PLASMA", + "coding": [ + { + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA" + } + ] + } + ] + }, + { + "OID": "CL.64329559", + "name": "LBSPEC Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "URINE", + "coding": [ + { + "code": "C13283", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "URINE" + } + ] + } + ] + }, + { + "OID": "CL.89f4952d", + "name": "TSPARMCD Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "RANDOM", + "coding": [ + { + "code": "C25196", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "RANDOM" + } + ] + } + ] + }, + { + "OID": "CL.37516e43", + "name": "LBORRESU Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "s", + "coding": [ + { + "code": "C42535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "s" + } + ] + } + ] + }, + { + "OID": "CL.1f6d4af1", + "name": "LBSPEC Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "BLOOD", + "coding": [ + { + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD" + } + ] + } + ] + }, + { + "OID": "CL.5ca5bb18", + "name": "LBORRESU Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "RATIO", + "coding": [ + { + "code": "C44256", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "RATIO" + } + ] + } + ] + }, + { + "OID": "CL.f6f992be", + "name": "TUORRES Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "TARGET", + "coding": [ + { + "code": "C94520", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "TARGET" + } + ] + } + ] + }, + { + "OID": "CL.NCOMPLT", + "name": "Completion/Reason for Non-Completion", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66727", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.DSCAT", + "name": "Category of Disposition Event", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C74558", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.DSSCAT", + "name": "Subcategory for Disposition Event", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C170443", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.ONCRTSCD", + "name": "Oncology Response Assessment Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C96782", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.ONCRTS", + "name": "Oncology Response Assessment Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C96781", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.ONCRSCAT", + "name": "Category of Oncology Response Assessment", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C124298", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.ONCRSR", + "name": "Oncology Response Assessment Result", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C96785", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.EVAL", + "name": "Evaluator", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C78735", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.MEDEVAL", + "name": "Medical Evaluator Identifier", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C96777", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.VSTESTCD", + "name": "Vital Signs Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66741", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.VSTEST", + "name": "Vital Signs Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C67153", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.POSITION", + "name": "Position", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C71148", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.VSRESU", + "name": "Units for Vital Signs Results", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66770", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.LOC", + "name": "Anatomical Location", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C74456", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.LAT", + "name": "Laterality", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C99073", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.NY", + "name": "No Yes Response", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66742", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.LBTESTCD", + "name": "Laboratory Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C65047", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.LBTEST", + "name": "Laboratory Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C67154", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.UNIT", + "name": "Unit", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C71620", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.URNSTSCD", + "name": "Urinary System Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C129942", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.URNSTS", + "name": "Urinary System Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C129941", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.METHOD", + "name": "Method", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C85492", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.FRM", + "name": "Dosage Form", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66726", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.FREQ", + "name": "Frequency", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C71113", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.ROUTE", + "name": "Route of Administration Response", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66729", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.STENRF", + "name": "Relation to Reference Period", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66728", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.TSPARMCD", + "name": "Trial Summary Parameter Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66738", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "RANDOM", + "decode": "Trial is Randomized", + "coding": { + "code": "C25196", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.TSPARM", + "name": "Trial Summary Parameter Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C67152", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "Trial is Randomized", + "decode": "Trial is Randomized", + "coding": { + "code": "C25196", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.DICTNAM", + "name": "Dictionary Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66788", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.TUTESTCD", + "name": "Tumor or Lesion Identification Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C96784", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.TUTEST", + "name": "Tumor or Lesion Identification Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C96783", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.TUIDRS", + "name": "Tumor or Lesion Identification Test Results", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C123650", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.DIR", + "name": "Directionality", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C99074", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.CNTMODE", + "name": "Mode of Subject Contact", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C171445", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "IN PERSON", + "decode": "In-Person", + "coding": { + "code": "C175574", + "codeSystem": "nci:ExtCodeID" + } + } + ] + } + ], + "methods": [], + "comments": [], + "standards": [ + { + "OID": "STD.SDTMIG", + "name": "SDTMIG", + "type": "IG", + "version": "3.4", + "status": "FINAL" + }, + { + "OID": "STD.SDTMCT", + "name": "CDISC/NCI", + "type": "CT", + "version": "2026-03-27", + "status": "FINAL", + "publishingSet": "SDTM" + } + ], + "annotatedCRF": [], + "concepts": [ + { + "OID": "CONC.BiomedicalConcept_1", + "name": "Informed Consent", + "label": "Informed Consent", + "aliases": [ + "Informed Consent Obtained" + ], + "href": "/mdr/bc/biomedicalconcepts/C16735", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_1", + "name": "DSDECOD", + "label": "DSDECOD", + "mandatory": true, + "coding": [ + { + "code": "C82977", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term" + } + ], + "codeList": "CL.a30c10b2" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_2", + "name": "DSTERM", + "label": "DSTERM", + "mandatory": true, + "coding": [ + { + "code": "C82571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_3", + "name": "DSSTDTC", + "label": "DSSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C82517", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C16735", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Informed Consent" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_2", + "name": "Eligibility Criteria Met By Subject", + "label": "Eligibility Criteria Met By Subject", + "aliases": [ + "Eligibility Criteria Met" + ], + "href": "/mdr/bc/biomedicalconcepts/C132447", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_4", + "name": "DSDECOD", + "label": "DSDECOD", + "mandatory": true, + "coding": [ + { + "code": "C82977", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term" + } + ], + "codeList": "CL.360cba0f" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_5", + "name": "DSTERM", + "label": "DSTERM", + "mandatory": true, + "coding": [ + { + "code": "C82571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_6", + "name": "DSSTDTC", + "label": "DSSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C82517", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C132447", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Eligibility Criteria Met By Subject" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_3", + "name": "Medical History Yes No Indicator", + "label": "Medical History Yes No Indicator", + "aliases": [ + "MHYN" + ], + "href": "/mdr/bc/biomedicalconcepts/C85522", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_7", + "name": "Medical History Yes No Indicator", + "label": "Medical History Yes No Indicator", + "mandatory": true, + "coding": [ + { + "code": "C85522", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Medical History Yes No Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_8", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C85522", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Medical History Yes No Indicator" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_4", + "name": "Medical History Reported Term [RETIRED]", + "label": "Medical History Reported Term [RETIRED]", + "aliases": [ + "Medical History", + "MHTERM" + ], + "href": "/mdr/bc/biomedicalconcepts/C83118", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_9", + "name": "Medical History Dictionary Derived Term", + "label": "Medical History Dictionary Derived Term", + "mandatory": true, + "coding": [ + { + "code": "C83346", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Dictionary Derived Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_10", + "name": "Medical History Occurrence", + "label": "Medical History Occurrence", + "mandatory": true, + "coding": [ + { + "code": "C83067", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Occurrence" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_11", + "name": "Medical History Pre-specified", + "label": "Medical History Pre-specified", + "mandatory": true, + "coding": [ + { + "code": "C87897", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Pre-specified" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_12", + "name": "Medical History Reported Term", + "label": "Medical History Reported Term", + "mandatory": true, + "coding": [ + { + "code": "C83118", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Reported Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_13", + "name": "Medical History Category", + "label": "Medical History Category", + "mandatory": true, + "coding": [ + { + "code": "C83018", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_14", + "name": "Medical History Subcategory", + "label": "Medical History Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C83143", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Subcategory" + } + ] + } + ], + "coding": [ + { + "code": "C83118", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Reported Term [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_5", + "name": "ECOG - Performance Status", + "label": "ECOG - Performance Status", + "aliases": [ + "ECOG1-Performance Status", + "ECOG101", + "ECOG - Performance Status" + ], + "href": "/mdr/bc/biomedicalconcepts/C102408", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_15", + "name": "RSORRES", + "label": "RSORRES", + "mandatory": false, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Clinical or Research Assessment Answer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_16", + "name": "RSDTC", + "label": "RSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C102408", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "ECOG - Performance Status" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_6", + "name": "Physical Examination Finding", + "label": "Physical Examination Finding", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C83119", + "properties": [], + "coding": [ + { + "code": "C83119", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-04-02", + "decode": "Physical Examination Finding" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_7", + "name": "Systolic Blood Pressure", + "label": "Systolic Blood Pressure", + "aliases": [ + "SYSBP" + ], + "href": "/mdr/bc/biomedicalconcepts/C25298", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_17", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_18", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C49669", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Pressure" + } + ], + "codeList": "CL.5991b40f" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_19", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_20", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_21", + "name": "VSLAT", + "label": "VSLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_22", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C25298", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Systolic Blood Pressure" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_8", + "name": "Diastolic Blood Pressure", + "label": "Diastolic Blood Pressure", + "aliases": [ + "DIABP" + ], + "href": "/mdr/bc/biomedicalconcepts/C25299", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_23", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_24", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C49669", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Pressure" + } + ], + "codeList": "CL.5991b40f" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_25", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_26", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_27", + "name": "VSLAT", + "label": "VSLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_28", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C25299", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Diastolic Blood Pressure" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_9", + "name": "Heart Rate", + "label": "Heart Rate", + "aliases": [ + "HR" + ], + "href": "/mdr/bc/biomedicalconcepts/C49677", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_29", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_30", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C73688", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Count per Minute" + } + ], + "codeList": "CL.cbd6ad98" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_31", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_32", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_33", + "name": "VSLAT", + "label": "VSLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_34", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C49677", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Heart Rate" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_10", + "name": "Body Temperature", + "label": "Body Temperature", + "aliases": [ + "Temperature" + ], + "href": "/mdr/bc/biomedicalconcepts/C174446", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_35", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_36", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C44276", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Temperature" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_37", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_38", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C174446", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Body Temperature" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_11", + "name": "Body Weight", + "label": "Body Weight", + "aliases": [ + "WEIGHT" + ], + "href": "/mdr/bc/biomedicalconcepts/C81328", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_39", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_40", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48208", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Weight" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_41", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C81328", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Body Weight" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_18", + "name": "Alanine Aminotransferase Measurement", + "label": "Alanine Aminotransferase Measurement", + "aliases": [ + "ALT", + "SGPT" + ], + "href": "/mdr/bc/biomedicalconcepts/C64433", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_42", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_43", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67365", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_44", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_45", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_46", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64433", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Alanine Aminotransferase Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_19", + "name": "Aspartate Aminotransferase Measurement", + "label": "Aspartate Aminotransferase Measurement", + "aliases": [ + "AST", + "SGOT" + ], + "href": "/mdr/bc/biomedicalconcepts/C64467", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_47", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_48", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67365", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_49", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_50", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_51", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64467", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Aspartate Aminotransferase Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_20", + "name": "Total Bilirubin Measurement", + "label": "Total Bilirubin Measurement", + "aliases": [ + "Bilirubin", + "Total Bilirubin Level" + ], + "href": "/mdr/bc/biomedicalconcepts/C38037", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_52", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_53", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_54", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_55", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_56", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C38037", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Total Bilirubin Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_21", + "name": "Creatinine Measurement", + "label": "Creatinine Measurement", + "aliases": [ + "Creatinine" + ], + "href": "/mdr/bc/biomedicalconcepts/C64547", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_57", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_58", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_59", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_60", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_61", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64547", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Creatinine Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_22", + "name": "Albumin Measurement", + "label": "Albumin Measurement", + "aliases": [ + "Albumin" + ], + "href": "/mdr/bc/biomedicalconcepts/C64431", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_62", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_63", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_64", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_65", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_66", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64431", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Albumin Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_26", + "name": "pH", + "label": "pH", + "aliases": [ + "PH", + "potential of Hydrogen" + ], + "href": "/mdr/bc/biomedicalconcepts/C45997", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_67", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_68", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.64329559" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_69", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_70", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C45997", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "pH" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_27", + "name": "Color Assessment", + "label": "Color Assessment", + "aliases": [ + "COLOR", + "Color" + ], + "href": "/mdr/bc/biomedicalconcepts/C64546", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_71", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_72", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.64329559" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_73", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64546", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Color Assessment" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_28", + "name": "Specific Gravity", + "label": "Specific Gravity", + "aliases": [ + "SPGRAV" + ], + "href": "/mdr/bc/biomedicalconcepts/C64832", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_74", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_75", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.64329559" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_76", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_77", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64832", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Specific Gravity" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_47", + "name": "Adverse Event Yes No Indicator", + "label": "Adverse Event Yes No Indicator", + "aliases": [ + "AEYN" + ], + "href": "/mdr/bc/biomedicalconcepts/C83347", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_78", + "name": "Adverse Event Yes No Indicator", + "label": "Adverse Event Yes No Indicator", + "mandatory": true, + "coding": [ + { + "code": "C83347", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Yes No Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_79", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C83347", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Yes No Indicator" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_48", + "name": "Adverse Event", + "label": "Adverse Event", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C41331", + "properties": [], + "coding": [ + { + "code": "C41331", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Adverse Event [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_49", + "name": "Concomitant Medication Yes No Indicator", + "label": "Concomitant Medication Yes No Indicator", + "aliases": [ + "CMYN" + ], + "href": "/mdr/bc/biomedicalconcepts/C83056", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_80", + "name": "Concomitant Medication Yes No Indicator", + "label": "Concomitant Medication Yes No Indicator", + "mandatory": true, + "coding": [ + { + "code": "C83056", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Concomitant Medication Yes No Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_81", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C83056", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Concomitant Medication Yes No Indicator" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_50", + "name": "Concomitant Therapy", + "label": "Concomitant Therapy", + "aliases": [ + "Concomitant Medication" + ], + "href": "/mdr/bc/biomedicalconcepts/C53630", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_82", + "name": "CMTRT", + "label": "CMTRT", + "mandatory": true, + "coding": [ + { + "code": "C70902", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Agent" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_83", + "name": "CMDECOD", + "label": "CMDECOD", + "mandatory": false, + "coding": [ + { + "code": "C83345", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dictionary Derived Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_84", + "name": "CMCLAS", + "label": "CMCLAS", + "mandatory": false, + "coding": [ + { + "code": "C83219", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Class" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_85", + "name": "CMINDC", + "label": "CMINDC", + "mandatory": false, + "coding": [ + { + "code": "C83085", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Use Indication" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_86", + "name": "CMDOSE", + "label": "CMDOSE", + "mandatory": false, + "coding": [ + { + "code": "C83221", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_87", + "name": "CMDOSTXT", + "label": "CMDOSTXT", + "mandatory": false, + "coding": [ + { + "code": "C83221", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_88", + "name": "CMDOSU", + "label": "CMDOSU", + "mandatory": false, + "coding": [ + { + "code": "C83034", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_89", + "name": "CMDOSFRM", + "label": "CMDOSFRM", + "mandatory": false, + "coding": [ + { + "code": "C83110", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose Form" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_90", + "name": "CMDOSFRQ", + "label": "CMDOSFRQ", + "mandatory": false, + "coding": [ + { + "code": "C83042", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose Frequency" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_91", + "name": "CMROUTE", + "label": "CMROUTE", + "mandatory": false, + "coding": [ + { + "code": "C83120", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Route of Administration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_92", + "name": "CMSTDTC", + "label": "CMSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83235", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Use Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_93", + "name": "CMENDTC", + "label": "CMENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83225", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Use End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_94", + "name": "CMSTRF", + "label": "CMSTRF", + "mandatory": false, + "coding": [ + { + "code": "C82559", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_95", + "name": "CMSTRTPT", + "label": "CMSTRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82560", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_96", + "name": "CMSTTPT", + "label": "CMSTTPT", + "mandatory": false, + "coding": [ + { + "code": "C82575", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference Start Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_97", + "name": "CMENRF", + "label": "CMENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_98", + "name": "CMENRTPT", + "label": "CMENRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_99", + "name": "CMENTPT", + "label": "CMENTPT", + "mandatory": false, + "coding": [ + { + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End" + } + ] + } + ], + "coding": [ + { + "code": "C53630", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Therapy" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_51", + "name": "Randomization", + "label": "Randomization", + "aliases": [ + "randomization", + "RANDOM", + "Randomized", + "Trial is Randomized", + "randomized" + ], + "href": "/mdr/bc/biomedicalconcepts/C25196", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_236", + "name": "TSPARMCD", + "label": "TSPARMCD", + "mandatory": false, + "coding": [ + { + "code": "C83445", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Code" + } + ], + "codeList": "CL.89f4952d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_237", + "name": "TSPARM", + "label": "TSPARM", + "mandatory": false, + "coding": [ + { + "code": "C49691", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter" + } + ], + "codeList": "CL.89f4952d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_238", + "name": "TSVAL", + "label": "TSVAL", + "mandatory": false, + "coding": [ + { + "code": "C83447", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Value" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_239", + "name": "TSVALCD", + "label": "TSVALCD", + "mandatory": false, + "coding": [ + { + "code": "C117458", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Value Code" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_240", + "name": "TSVCDREF", + "label": "TSVCDREF", + "mandatory": false, + "coding": [ + { + "code": "C117460", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Name of the Reference Terminology" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_241", + "name": "TSVCDVER", + "label": "TSVCDVER", + "mandatory": false, + "coding": [ + { + "code": "C117461", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Version of the Reference Terminology" + } + ] + } + ], + "coding": [ + { + "code": "C25196", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "RANDOM" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_52", + "name": "Prothrombin Time", + "label": "Prothrombin Time", + "aliases": [ + "PT" + ], + "href": "/mdr/bc/biomedicalconcepts/C62656", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_106", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_107", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time" + } + ], + "codeList": "CL.37516e43" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_108", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_109", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ], + "codeList": "CL.360cba0f" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_110", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C62656", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Prothrombin Time" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_53", + "name": "International Normalized Ratio of Prothrombin Time", + "label": "International Normalized Ratio of Prothrombin Time", + "aliases": [ + "INR", + "Prothrombin Intl. Normalized Ratio" + ], + "href": "/mdr/bc/biomedicalconcepts/C64805", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_111", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_112", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time" + } + ], + "codeList": "CL.5ca5bb18" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_113", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_114", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64805", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "International Normalized Ratio of Prothrombin Time" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_54", + "name": "Activated Partial Thromboplastin Time", + "label": "Activated Partial Thromboplastin Time", + "aliases": [ + "APTT" + ], + "href": "/mdr/bc/biomedicalconcepts/C38462", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_115", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_116", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time" + } + ], + "codeList": "CL.37516e43" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_117", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_118", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C38462", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Activated Partial Thromboplastin Time" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_55", + "name": "Glucose Measurement", + "label": "Glucose Measurement", + "aliases": [ + "Glucose" + ], + "href": "/mdr/bc/biomedicalconcepts/C105585", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_242", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_243", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_244", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_245", + "name": "LBMETHOD", + "label": "LBMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_246", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_247", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C105585", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Glucose Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_56", + "name": "Triglyceride Measurement", + "label": "Triglyceride Measurement", + "aliases": [ + "TRIG", + "Triglycerides" + ], + "href": "/mdr/bc/biomedicalconcepts/C64812", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_125", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_126", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_127", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_128", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_129", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64812", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Triglyceride Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_57", + "name": "Cholesterol Measurement", + "label": "Cholesterol Measurement", + "aliases": [ + "CHOL", + "Cholesterol", + "Total Cholesterol" + ], + "href": "/mdr/bc/biomedicalconcepts/C105586", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_248", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_249", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_250", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_251", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_252", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C105586", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Cholesterol Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_58", + "name": "High Density Lipoprotein Cholesterol Measurement", + "label": "High Density Lipoprotein Cholesterol Measurement", + "aliases": [ + "HDL", + "HDL Cholesterol" + ], + "href": "/mdr/bc/biomedicalconcepts/C105587", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_135", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_136", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_137", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_138", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ], + "codeList": "CL.5991b40f" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_139", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C105587", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "High Density Lipoprotein Cholesterol Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_59", + "name": "Low Density Lipoprotein Cholesterol Measurement", + "label": "Low Density Lipoprotein Cholesterol Measurement", + "aliases": [ + "LDL", + "LDL Cholesterol" + ], + "href": "/mdr/bc/biomedicalconcepts/C105588", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_140", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_141", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_142", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_143", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_144", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ], + "codeList": "CL.cbd6ad98" + } + ], + "coding": [ + { + "code": "C105588", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Low Density Lipoprotein Cholesterol Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_60", + "name": "ECOG Clinical Classification Question", + "label": "ECOG Clinical Classification Question", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C101874", + "properties": [], + "coding": [ + { + "code": "C101874", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "ECOG Clinical Classification Question" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_61", + "name": "Leukocyte Count", + "label": "Leukocyte Count", + "aliases": [ + "WBC", + "White Blood Cells" + ], + "href": "/mdr/bc/biomedicalconcepts/C51948", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_145", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_146", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_147", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_148", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_149", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C51948", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Leukocyte Count" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_62", + "name": "Erythrocyte Count", + "label": "Erythrocyte Count", + "aliases": [ + "RBC", + "Red Blood Cells" + ], + "href": "/mdr/bc/biomedicalconcepts/C51946", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_150", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_151", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_152", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_153", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_154", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C51946", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Erythrocyte Count" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_63", + "name": "Platelet Count", + "label": "Platelet Count", + "aliases": [ + "Thrombocytes", + "Platelets", + "Anucleated Thrombocytes" + ], + "href": "/mdr/bc/biomedicalconcepts/C51951", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_155", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_156", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_157", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_158", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_159", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C51951", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Platelet Count" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_64", + "name": "Potassium Measurement", + "label": "Potassium Measurement", + "aliases": [ + "Potassium", + "K" + ], + "href": "/mdr/bc/biomedicalconcepts/C64853", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_253", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_254", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C64567", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Molarity Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_255", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_256", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_257", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64853", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Potassium Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_65", + "name": "Sodium Measurement", + "label": "Sodium Measurement", + "aliases": [ + "Sodium", + "NA" + ], + "href": "/mdr/bc/biomedicalconcepts/C64809", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_258", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_259", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C64567", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Molarity Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_260", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_261", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_262", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64809", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Sodium Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_66", + "name": "Chloride Measurement", + "label": "Chloride Measurement", + "aliases": [ + "Chloride", + "CL" + ], + "href": "/mdr/bc/biomedicalconcepts/C64495", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_170", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_171", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C64567", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Molarity Unit" + } + ], + "codeList": "CL.64329559" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_172", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_173", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_174", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64495", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Chloride Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_67", + "name": "Carbon Dioxide Measurement", + "label": "Carbon Dioxide Measurement", + "aliases": [ + "Carbon Dioxide", + "CO2" + ], + "href": "/mdr/bc/biomedicalconcepts/C64545", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_263", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_264", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C64567", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Molarity Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_265", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_266", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_267", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64545", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Carbon Dioxide Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_68", + "name": "Calcium Measurement", + "label": "Calcium Measurement", + "aliases": [ + "Calcium", + "CA" + ], + "href": "/mdr/bc/biomedicalconcepts/C64488", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_180", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ], + "codeList": "CL.64329559" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_181", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_182", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_183", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_184", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64488", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Calcium Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_69", + "name": "Urea Nitrogen Measurement", + "label": "Urea Nitrogen Measurement", + "aliases": [ + "Urea Nitrogen" + ], + "href": "/mdr/bc/biomedicalconcepts/C125949", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_185", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_186", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_187", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_188", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_189", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C125949", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Urea Nitrogen Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_70", + "name": "Total Protein Measurement", + "label": "Total Protein Measurement", + "aliases": [ + "Protein" + ], + "href": "/mdr/bc/biomedicalconcepts/C64858", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_268", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_269", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_270", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_271", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_272", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64858", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Total Protein Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_71", + "name": "Alkaline Phosphatase Measurement", + "label": "Alkaline Phosphatase Measurement", + "aliases": [ + "Alkaline Phosphatase" + ], + "href": "/mdr/bc/biomedicalconcepts/C64432", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_195", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_196", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67365", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration" + } + ], + "codeList": "CL.64329559" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_197", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_198", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_199", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ], + "codeList": "CL.64329559" + } + ], + "coding": [ + { + "code": "C64432", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Alkaline Phosphatase Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_72", + "name": "Urate Measurement", + "label": "Urate Measurement", + "aliases": [ + "Urate", + "Uric Acid" + ], + "href": "/mdr/bc/biomedicalconcepts/C64814", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_273", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_274", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_275", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_276", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_277", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64814", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Urate Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_73", + "name": "Tumor Size Measurement", + "label": "Tumor Size Measurement", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C106303", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_205", + "name": "Anatomic Site", + "label": "Anatomic Site", + "mandatory": true, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_206", + "name": "Observation Result", + "label": "Observation Result", + "mandatory": true, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Observation Result" + } + ], + "codeList": "CL.37516e43" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_207", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_208", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_209", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_210", + "name": "Specimen Anatomic Site", + "label": "Specimen Anatomic Site", + "mandatory": true, + "coding": [ + { + "code": "C171435", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Specimen Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_211", + "name": "Biospecimen Type", + "label": "Biospecimen Type", + "mandatory": true, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Biospecimen Type" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_212", + "name": "Unit of Length", + "label": "Unit of Length", + "mandatory": true, + "coding": [ + { + "code": "C42578", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Unit of Length" + } + ], + "codeList": "CL.37516e43" + } + ], + "coding": [ + { + "code": "C106303", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Tumor Size Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_74", + "name": "Tumor Identification", + "label": "Tumor Identification", + "aliases": [ + "TUMIDENT" + ], + "href": "/mdr/bc/biomedicalconcepts/C94523", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_278", + "name": "TUORRES", + "label": "TUORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ], + "codeList": "CL.f6f992be" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_279", + "name": "TULOC", + "label": "TULOC", + "mandatory": false, + "coding": [ + { + "code": "C170500", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Result Anatomical Location" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_280", + "name": "TULAT", + "label": "TULAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_281", + "name": "TUDIR", + "label": "TUDIR", + "mandatory": false, + "coding": [ + { + "code": "C54215", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Directionality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_282", + "name": "TUMETHOD", + "label": "TUMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_283", + "name": "TUEVAL", + "label": "TUEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_284", + "name": "TUEVALID", + "label": "TUEVALID", + "mandatory": false, + "coding": [ + { + "code": "C117043", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator Identifier" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_285", + "name": "TUREFID", + "label": "TUREFID", + "mandatory": false, + "coding": [ + { + "code": "C117442", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Identifier Reference Identifier" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_286", + "name": "TULNKID", + "label": "TULNKID", + "mandatory": false, + "coding": [ + { + "code": "C117436", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Identifier Link Identifier" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_287", + "name": "TUDTC", + "label": "TUDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C94523", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Identification" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_75", + "name": "Response in Non-Target Lesion", + "label": "Response in Non-Target Lesion", + "aliases": [ + "NTRGRESP", + "Non-Target Response" + ], + "href": "/mdr/bc/biomedicalconcepts/C94535", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_223", + "name": "RSORRES", + "label": "RSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_224", + "name": "RSEVAL", + "label": "RSEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_225", + "name": "RSEVALID", + "label": "RSEVALID", + "mandatory": false, + "coding": [ + { + "code": "C117043", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator Identifier" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_226", + "name": "RSDTC", + "label": "RSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C94535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-06-27", + "decode": "Response in Non-Target Lesion" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_76", + "name": "Response in Target Lesion", + "label": "Response in Target Lesion", + "aliases": [ + "TRGRESP", + "Target Response" + ], + "href": "/mdr/bc/biomedicalconcepts/C94534", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_227", + "name": "RSORRES", + "label": "RSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_228", + "name": "RSEVAL", + "label": "RSEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_229", + "name": "RSEVALID", + "label": "RSEVALID", + "mandatory": false, + "coding": [ + { + "code": "C117043", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator Identifier" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_230", + "name": "RSDTC", + "label": "RSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C94534", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-06-27", + "decode": "Response in Target Lesion" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_77", + "name": "Overall Response", + "label": "Overall Response", + "aliases": [ + "OVRLRESP" + ], + "href": "/mdr/bc/biomedicalconcepts/C96613", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_231", + "name": "RSLNKGRP", + "label": "RSLNKGRP", + "mandatory": false, + "coding": [ + { + "code": "C117394", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Disease Response Link Group" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_232", + "name": "RSORRES", + "label": "RSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_233", + "name": "RSEVAL", + "label": "RSEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_234", + "name": "RSEVALID", + "label": "RSEVALID", + "mandatory": false, + "coding": [ + { + "code": "C117043", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator Identifier" + } + ], + "codeList": "CL.89f4952d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_235", + "name": "RSDTC", + "label": "RSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ], + "codeList": "CL.89f4952d" + } + ], + "coding": [ + { + "code": "C96613", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-06-27", + "decode": "Overall Response" + } + ] + } + ], + "conceptProperties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_1", + "name": "DSDECOD", + "label": "DSDECOD", + "mandatory": true, + "coding": [ + { + "code": "C82977", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term" + } + ], + "codeList": "CL.a30c10b2" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_2", + "name": "DSTERM", + "label": "DSTERM", + "mandatory": true, + "coding": [ + { + "code": "C82571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_3", + "name": "DSSTDTC", + "label": "DSSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C82517", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_4", + "name": "DSDECOD", + "label": "DSDECOD", + "mandatory": true, + "coding": [ + { + "code": "C82977", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term" + } + ], + "codeList": "CL.360cba0f" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_5", + "name": "DSTERM", + "label": "DSTERM", + "mandatory": true, + "coding": [ + { + "code": "C82571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_6", + "name": "DSSTDTC", + "label": "DSSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C82517", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_7", + "name": "Medical History Yes No Indicator", + "label": "Medical History Yes No Indicator", + "mandatory": true, + "coding": [ + { + "code": "C85522", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Medical History Yes No Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_8", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_9", + "name": "Medical History Dictionary Derived Term", + "label": "Medical History Dictionary Derived Term", + "mandatory": true, + "coding": [ + { + "code": "C83346", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Dictionary Derived Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_10", + "name": "Medical History Occurrence", + "label": "Medical History Occurrence", + "mandatory": true, + "coding": [ + { + "code": "C83067", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Occurrence" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_11", + "name": "Medical History Pre-specified", + "label": "Medical History Pre-specified", + "mandatory": true, + "coding": [ + { + "code": "C87897", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Pre-specified" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_12", + "name": "Medical History Reported Term", + "label": "Medical History Reported Term", + "mandatory": true, + "coding": [ + { + "code": "C83118", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Reported Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_13", + "name": "Medical History Category", + "label": "Medical History Category", + "mandatory": true, + "coding": [ + { + "code": "C83018", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_14", + "name": "Medical History Subcategory", + "label": "Medical History Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C83143", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_15", + "name": "RSORRES", + "label": "RSORRES", + "mandatory": false, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Clinical or Research Assessment Answer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_16", + "name": "RSDTC", + "label": "RSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_17", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_18", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C49669", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Pressure" + } + ], + "codeList": "CL.5991b40f" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_19", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_20", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_21", + "name": "VSLAT", + "label": "VSLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_22", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_23", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_24", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C49669", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Pressure" + } + ], + "codeList": "CL.5991b40f" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_25", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_26", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_27", + "name": "VSLAT", + "label": "VSLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_28", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_29", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_30", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C73688", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Count per Minute" + } + ], + "codeList": "CL.cbd6ad98" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_31", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_32", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_33", + "name": "VSLAT", + "label": "VSLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_34", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_35", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_36", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C44276", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Temperature" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_37", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_38", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_39", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_40", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48208", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Weight" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_41", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_42", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_43", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67365", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_44", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_45", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_46", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_47", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_48", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67365", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_49", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_50", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_51", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_52", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_53", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_54", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_55", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_56", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_57", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_58", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_59", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_60", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_61", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_62", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_63", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_64", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_65", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_66", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_67", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_68", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.64329559" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_69", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_70", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_71", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_72", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.64329559" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_73", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_74", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_75", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.64329559" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_76", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_77", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_78", + "name": "Adverse Event Yes No Indicator", + "label": "Adverse Event Yes No Indicator", + "mandatory": true, + "coding": [ + { + "code": "C83347", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Yes No Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_79", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_80", + "name": "Concomitant Medication Yes No Indicator", + "label": "Concomitant Medication Yes No Indicator", + "mandatory": true, + "coding": [ + { + "code": "C83056", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Concomitant Medication Yes No Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_81", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_82", + "name": "CMTRT", + "label": "CMTRT", + "mandatory": true, + "coding": [ + { + "code": "C70902", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Agent" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_83", + "name": "CMDECOD", + "label": "CMDECOD", + "mandatory": false, + "coding": [ + { + "code": "C83345", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dictionary Derived Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_84", + "name": "CMCLAS", + "label": "CMCLAS", + "mandatory": false, + "coding": [ + { + "code": "C83219", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Class" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_85", + "name": "CMINDC", + "label": "CMINDC", + "mandatory": false, + "coding": [ + { + "code": "C83085", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Use Indication" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_86", + "name": "CMDOSE", + "label": "CMDOSE", + "mandatory": false, + "coding": [ + { + "code": "C83221", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_87", + "name": "CMDOSTXT", + "label": "CMDOSTXT", + "mandatory": false, + "coding": [ + { + "code": "C83221", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_88", + "name": "CMDOSU", + "label": "CMDOSU", + "mandatory": false, + "coding": [ + { + "code": "C83034", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_89", + "name": "CMDOSFRM", + "label": "CMDOSFRM", + "mandatory": false, + "coding": [ + { + "code": "C83110", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose Form" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_90", + "name": "CMDOSFRQ", + "label": "CMDOSFRQ", + "mandatory": false, + "coding": [ + { + "code": "C83042", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose Frequency" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_91", + "name": "CMROUTE", + "label": "CMROUTE", + "mandatory": false, + "coding": [ + { + "code": "C83120", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Route of Administration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_92", + "name": "CMSTDTC", + "label": "CMSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83235", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Use Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_93", + "name": "CMENDTC", + "label": "CMENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83225", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Use End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_94", + "name": "CMSTRF", + "label": "CMSTRF", + "mandatory": false, + "coding": [ + { + "code": "C82559", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_95", + "name": "CMSTRTPT", + "label": "CMSTRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82560", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_96", + "name": "CMSTTPT", + "label": "CMSTTPT", + "mandatory": false, + "coding": [ + { + "code": "C82575", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference Start Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_97", + "name": "CMENRF", + "label": "CMENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_98", + "name": "CMENRTPT", + "label": "CMENRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_99", + "name": "CMENTPT", + "label": "CMENTPT", + "mandatory": false, + "coding": [ + { + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_236", + "name": "TSPARMCD", + "label": "TSPARMCD", + "mandatory": false, + "coding": [ + { + "code": "C83445", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Code" + } + ], + "codeList": "CL.89f4952d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_237", + "name": "TSPARM", + "label": "TSPARM", + "mandatory": false, + "coding": [ + { + "code": "C49691", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter" + } + ], + "codeList": "CL.89f4952d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_238", + "name": "TSVAL", + "label": "TSVAL", + "mandatory": false, + "coding": [ + { + "code": "C83447", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Value" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_239", + "name": "TSVALCD", + "label": "TSVALCD", + "mandatory": false, + "coding": [ + { + "code": "C117458", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Value Code" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_240", + "name": "TSVCDREF", + "label": "TSVCDREF", + "mandatory": false, + "coding": [ + { + "code": "C117460", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Name of the Reference Terminology" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_241", + "name": "TSVCDVER", + "label": "TSVCDVER", + "mandatory": false, + "coding": [ + { + "code": "C117461", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Version of the Reference Terminology" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_106", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_107", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time" + } + ], + "codeList": "CL.37516e43" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_108", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_109", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ], + "codeList": "CL.360cba0f" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_110", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_111", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_112", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time" + } + ], + "codeList": "CL.5ca5bb18" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_113", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_114", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_115", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_116", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time" + } + ], + "codeList": "CL.37516e43" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_117", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_118", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_242", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_243", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_244", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_245", + "name": "LBMETHOD", + "label": "LBMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_246", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_247", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_125", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_126", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_127", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_128", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_129", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_248", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_249", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_250", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_251", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_252", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_135", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_136", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_137", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_138", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ], + "codeList": "CL.5991b40f" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_139", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_140", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_141", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_142", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_143", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_144", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ], + "codeList": "CL.cbd6ad98" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_145", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_146", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_147", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_148", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_149", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_150", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_151", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_152", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_153", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_154", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_155", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_156", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_157", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_158", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_159", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_253", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_254", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C64567", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Molarity Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_255", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_256", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_257", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_258", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_259", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C64567", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Molarity Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_260", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_261", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_262", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_170", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_171", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C64567", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Molarity Unit" + } + ], + "codeList": "CL.64329559" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_172", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_173", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_174", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_263", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_264", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C64567", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Molarity Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_265", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_266", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_267", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_180", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ], + "codeList": "CL.64329559" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_181", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_182", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_183", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_184", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_185", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_186", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_187", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_188", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_189", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_268", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_269", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_270", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_271", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_272", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_195", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_196", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67365", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration" + } + ], + "codeList": "CL.64329559" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_197", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_198", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_199", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ], + "codeList": "CL.64329559" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_273", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_274", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_275", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_276", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_277", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_205", + "name": "Anatomic Site", + "label": "Anatomic Site", + "mandatory": true, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_206", + "name": "Observation Result", + "label": "Observation Result", + "mandatory": true, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Observation Result" + } + ], + "codeList": "CL.37516e43" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_207", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_208", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_209", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_210", + "name": "Specimen Anatomic Site", + "label": "Specimen Anatomic Site", + "mandatory": true, + "coding": [ + { + "code": "C171435", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Specimen Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_211", + "name": "Biospecimen Type", + "label": "Biospecimen Type", + "mandatory": true, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Biospecimen Type" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_212", + "name": "Unit of Length", + "label": "Unit of Length", + "mandatory": true, + "coding": [ + { + "code": "C42578", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Unit of Length" + } + ], + "codeList": "CL.37516e43" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_278", + "name": "TUORRES", + "label": "TUORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ], + "codeList": "CL.f6f992be" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_279", + "name": "TULOC", + "label": "TULOC", + "mandatory": false, + "coding": [ + { + "code": "C170500", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Result Anatomical Location" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_280", + "name": "TULAT", + "label": "TULAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_281", + "name": "TUDIR", + "label": "TUDIR", + "mandatory": false, + "coding": [ + { + "code": "C54215", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Directionality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_282", + "name": "TUMETHOD", + "label": "TUMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_283", + "name": "TUEVAL", + "label": "TUEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_284", + "name": "TUEVALID", + "label": "TUEVALID", + "mandatory": false, + "coding": [ + { + "code": "C117043", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator Identifier" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_285", + "name": "TUREFID", + "label": "TUREFID", + "mandatory": false, + "coding": [ + { + "code": "C117442", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Identifier Reference Identifier" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_286", + "name": "TULNKID", + "label": "TULNKID", + "mandatory": false, + "coding": [ + { + "code": "C117436", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Identifier Link Identifier" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_287", + "name": "TUDTC", + "label": "TUDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_223", + "name": "RSORRES", + "label": "RSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_224", + "name": "RSEVAL", + "label": "RSEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_225", + "name": "RSEVALID", + "label": "RSEVALID", + "mandatory": false, + "coding": [ + { + "code": "C117043", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator Identifier" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_226", + "name": "RSDTC", + "label": "RSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_227", + "name": "RSORRES", + "label": "RSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_228", + "name": "RSEVAL", + "label": "RSEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_229", + "name": "RSEVALID", + "label": "RSEVALID", + "mandatory": false, + "coding": [ + { + "code": "C117043", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator Identifier" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_230", + "name": "RSDTC", + "label": "RSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_231", + "name": "RSLNKGRP", + "label": "RSLNKGRP", + "mandatory": false, + "coding": [ + { + "code": "C117394", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Disease Response Link Group" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_232", + "name": "RSORRES", + "label": "RSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_233", + "name": "RSEVAL", + "label": "RSEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_234", + "name": "RSEVALID", + "label": "RSEVALID", + "mandatory": false, + "coding": [ + { + "code": "C117043", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator Identifier" + } + ], + "codeList": "CL.89f4952d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_235", + "name": "RSDTC", + "label": "RSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ], + "codeList": "CL.89f4952d" + } + ] +} diff --git a/data/soa_workbench/protocols/HCT01797120/NCT01797120-latest.json b/data/soa_workbench/protocols/HCT01797120/NCT01797120-latest.json new file mode 100644 index 0000000..3e42eba --- /dev/null +++ b/data/soa_workbench/protocols/HCT01797120/NCT01797120-latest.json @@ -0,0 +1,11441 @@ +{ + "study": { + "id": null, + "extensionAttributes": [], + "name": "NCT01797120", + "description": "Post-menopausal women with hormone-receptor positive (HR+) metastatic breast cancer resistant to aromatase inhibitor (AI) therapy will be randomized to receive Fulvestrant (Faslodex) with Everolimus or Fulvestrant (Faslodex) with a placebo (no active ingredients).\r\n\r\nFulvestrant has demonstrated activity when used as first, second, or third line endocrine therapy, making it an attractive therapy for combination with other agents. In addition, it is commonly reserved for use following disease progression on AI therapy.\r\n\r\nEverolimus is an orally administered drug that blocks a signaling pathway called \"mTOR\". \"mTOR\" acts as a regulator for many processes in the body, including cell growth. Blocking this pathway may have an effect on cell growth.\r\n\r\nThe combination of a novel class of agents (mTOR inhibitors) and an established standard treatment for metastatic HR+ breast cancer may potentially increase the clinical benefit by targeting multiple different biological pathways.", + "label": "Phase II - Hormone-receptor positive (HR+) metastatic breast cancer resistant to aromatase inhibitor (AI)", + "versions": [ + { + "id": "StudyVersion_1", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_44", + "url": "http://www.cdisc.org/usdm/extensions/studyDesignSolution", + "valueExtensionClass": { + "id": "ExtensionClass_1", + "url": "http://www.cdisc.org/usdm/extensions/StudyDesignSolution", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_45", + "url": "tool-name", + "valueString": "SoA Workbench", + "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_46", + "url": "tool-version", + "valueString": "1.4.0", + "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_47", + "url": "usdm-creation-date", + "valueString": "20260618T15:11", + "instanceType": "ExtensionAttribute" + } + ], + "instanceType": "ExtensionClass" + }, + "instanceType": "ExtensionAttribute" + } + ], + "versionIdentifier": "1", + "rationale": "", + "studyIdentifiers": [ + { + "id": "StudyIdentifier_1", + "extensionAttributes": [], + "text": "PrE0102", + "scopeId": "Organization_1", + "instanceType": "StudyIdentifier" + } + ], + "referenceIdentifiers": [], + "studyDesigns": [ + { + "id": "InterventionalStudyDesign_1", + "extensionAttributes": [], + "name": "Study of Fulvestrant +/\u200b- Everolimus in Post-Menopausal, Hormone-Receptor + Metastatic Breast Ca Resistant to AI (PrE0102)", + "label": "Phase II - Hormone-receptor positive (HR+) metastatic breast cancer resistant to aromatase inhibitor (AI)", + "description": "Post-menopausal women with hormone-receptor positive (HR+) metastatic breast cancer resistant to aromatase inhibitor (AI) therapy will be randomized to receive Fulvestrant (Faslodex) with Everolimus or Fulvestrant (Faslodex) with a placebo (no active ingredients).\r\n\r\nFulvestrant has demonstrated activity when used as first, second, or third line endocrine therapy, making it an attractive therapy for combination with other agents. In addition, it is commonly reserved for use following disease progression on AI therapy.\r\n\r\nEverolimus is an orally administered drug that blocks a signaling pathway called \"mTOR\". \"mTOR\" acts as a regulator for many processes in the body, including cell growth. Blocking this pathway may have an effect on cell growth.\r\n\r\nThe combination of a novel class of agents (mTOR inhibitors) and an established standard treatment for metastatic HR+ breast cancer may potentially increase the clinical benefit by targeting multiple different biological pathways.", + "studyType": null, + "studyPhase": null, + "therapeuticAreas": [], + "characteristics": [], + "encounters": [ + { + "id": "Encounter_1", + "extensionAttributes": [], + "name": "PRE-STUDY", + "label": "Pre-Study", + "description": "Occuring before Randomization and Treatment", + "type": { + "id": "Code_485", + "extensionAttributes": [], + "code": "C25716", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Visit", + "instanceType": "Code" + }, + "previousId": null, + "nextId": "Encounter_2", + "scheduledAtId": "Timing_1", + "environmentalSettings": [ + { + "id": "Code_486", + "extensionAttributes": [], + "code": "C211570", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "CLINIC", + "instanceType": "Code" + } + ], + "contactModes": [ + { + "id": "Code_487", + "extensionAttributes": [], + "code": "C175574", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "IN PERSON", + "instanceType": "Code" + } + ], + "transitionStartRule": { + "id": "TransitionRule_1", + "extensionAttributes": [], + "name": "Start Screening Period", + "label": "Start Screening Period", + "description": "Start of Pre-treatment eligibility window", + "text": "Screening window starts 28 days prior to treatment", + "instanceType": "TransitionRule" + }, + "transitionEndRule": { + "id": "TransitionRule_2", + "extensionAttributes": [], + "name": "End Screening Period", + "label": "End Screening Period", + "description": "End of Screening Window", + "text": "Screening window ends a maximum of 28 days after start", + "instanceType": "TransitionRule" + }, + "notes": [], + "instanceType": "Encounter" + }, + { + "id": "Encounter_2", + "extensionAttributes": [], + "name": "C1D1", + "label": "Cycle 1 Day 1", + "description": "First day of treatment in the first cycle", + "type": { + "id": "Code_488", + "extensionAttributes": [], + "code": "C25716", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Visit", + "instanceType": "Code" + }, + "previousId": "Encounter_1", + "nextId": "Encounter_3", + "scheduledAtId": null, + "environmentalSettings": [ + { + "id": "Code_489", + "extensionAttributes": [], + "code": "C211570", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "CLINIC", + "instanceType": "Code" + } + ], + "contactModes": [ + { + "id": "Code_490", + "extensionAttributes": [], + "code": "C175574", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "IN PERSON", + "instanceType": "Code" + } + ], + "transitionStartRule": { + "id": "TransitionRule_3", + "extensionAttributes": [], + "name": "Start Study Drug Treatment Period", + "label": "Start Study Drug Treatment Period", + "description": "Fulvestrant + Everolimus; continues until Progressive Disease, unacceptable toxicity, or withdrawal", + "text": "Occurs for at least one cycle and continues until Disease Progression in study drug treatment Arm", + "instanceType": "TransitionRule" + }, + "transitionEndRule": null, + "notes": [], + "instanceType": "Encounter" + }, + { + "id": "Encounter_3", + "extensionAttributes": [], + "name": "C1D15", + "label": "Cycle 1 Day 15", + "description": "Second treament in the first cycle on day 15", + "type": { + "id": "Code_491", + "extensionAttributes": [], + "code": "C25716", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Visit", + "instanceType": "Code" + }, + "previousId": "Encounter_2", + "nextId": "Encounter_4", + "scheduledAtId": null, + "environmentalSettings": [ + { + "id": "Code_492", + "extensionAttributes": [], + "code": "C211570", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "CLINIC", + "instanceType": "Code" + } + ], + "contactModes": [ + { + "id": "Code_493", + "extensionAttributes": [], + "code": "C175574", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "IN PERSON", + "instanceType": "Code" + } + ], + "transitionStartRule": null, + "transitionEndRule": null, + "notes": [], + "instanceType": "Encounter" + }, + { + "id": "Encounter_4", + "extensionAttributes": [], + "name": "CXD1", + "label": "Next Cycle Day 1", + "description": "Each subsequent Cycle Day 1", + "type": { + "id": "Code_494", + "extensionAttributes": [], + "code": "C25716", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Visit", + "instanceType": "Code" + }, + "previousId": "Encounter_3", + "nextId": "Encounter_5", + "scheduledAtId": null, + "environmentalSettings": [ + { + "id": "Code_495", + "extensionAttributes": [], + "code": "C18002", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "HOME", + "instanceType": "Code" + } + ], + "contactModes": [ + { + "id": "Code_496", + "extensionAttributes": [], + "code": "C175574", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "IN PERSON", + "instanceType": "Code" + } + ], + "transitionStartRule": null, + "transitionEndRule": null, + "notes": [], + "instanceType": "Encounter" + }, + { + "id": "Encounter_5", + "extensionAttributes": [], + "name": "P12W", + "label": "Every 12 Weeks", + "description": "Assessment carried out every 12 weeks", + "type": { + "id": "Code_497", + "extensionAttributes": [], + "code": "C25716", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Visit", + "instanceType": "Code" + }, + "previousId": "Encounter_4", + "nextId": "Encounter_6", + "scheduledAtId": null, + "environmentalSettings": [ + { + "id": "Code_498", + "extensionAttributes": [], + "code": "C211570", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "CLINIC", + "instanceType": "Code" + } + ], + "contactModes": [ + { + "id": "Code_499", + "extensionAttributes": [], + "code": "C175574", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "IN PERSON", + "instanceType": "Code" + } + ], + "transitionStartRule": null, + "transitionEndRule": null, + "notes": [], + "instanceType": "Encounter" + }, + { + "id": "Encounter_6", + "extensionAttributes": [], + "name": "EOT", + "label": "End of Treatment", + "description": "End of Induction Phase or End of Treatment", + "type": { + "id": "Code_500", + "extensionAttributes": [], + "code": "C25716", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Visit", + "instanceType": "Code" + }, + "previousId": "Encounter_5", + "nextId": "Encounter_7", + "scheduledAtId": null, + "environmentalSettings": [ + { + "id": "Code_501", + "extensionAttributes": [], + "code": "C211570", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "CLINIC", + "instanceType": "Code" + } + ], + "contactModes": [ + { + "id": "Code_502", + "extensionAttributes": [], + "code": "C175574", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "IN PERSON", + "instanceType": "Code" + } + ], + "transitionStartRule": { + "id": "TransitionRule_4", + "extensionAttributes": [], + "name": "End Study Drug Treatment Period", + "label": "End Study Drug Treatment Period", + "description": "Fulvestrant + Everolimus; continues until PD, unacceptable toxicity, or withdrawal", + "text": "Occurs when Progressive Disease, unacceptable toxicity, or withdrawal in study drug treatment Arm", + "instanceType": "TransitionRule" + }, + "transitionEndRule": null, + "notes": [], + "instanceType": "Encounter" + }, + { + "id": "Encounter_7", + "extensionAttributes": [], + "name": "CPHASE", + "label": "Continuation Phase", + "description": null, + "type": { + "id": "Code_503", + "extensionAttributes": [], + "code": "C25716", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Visit", + "instanceType": "Code" + }, + "previousId": "Encounter_6", + "nextId": "Encounter_8", + "scheduledAtId": null, + "environmentalSettings": [ + { + "id": "Code_504", + "extensionAttributes": [], + "code": "C211570", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "CLINIC", + "instanceType": "Code" + } + ], + "contactModes": [ + { + "id": "Code_505", + "extensionAttributes": [], + "code": "C175574", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "IN PERSON", + "instanceType": "Code" + } + ], + "transitionStartRule": null, + "transitionEndRule": null, + "notes": [], + "instanceType": "Encounter" + }, + { + "id": "Encounter_8", + "extensionAttributes": [], + "name": "FU", + "label": "Follow-Up", + "description": "Foolow-up off therapy", + "type": { + "id": "Code_506", + "extensionAttributes": [], + "code": "C25716", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Visit", + "instanceType": "Code" + }, + "previousId": "Encounter_7", + "nextId": null, + "scheduledAtId": null, + "environmentalSettings": [ + { + "id": "Code_507", + "extensionAttributes": [], + "code": "C211570", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "CLINIC", + "instanceType": "Code" + } + ], + "contactModes": [ + { + "id": "Code_508", + "extensionAttributes": [], + "code": "C175574", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "IN PERSON", + "instanceType": "Code" + } + ], + "transitionStartRule": { + "id": "TransitionRule_7", + "extensionAttributes": [], + "name": "Start Follow-up Period", + "label": "Start Follow-up Period", + "description": "Survival and long-term safety data collection", + "text": "Occurs when subject finishes treatment", + "instanceType": "TransitionRule" + }, + "transitionEndRule": { + "id": "TransitionRule_8", + "extensionAttributes": [], + "name": "End Follow-up Period", + "label": "End Follow-up Period", + "description": "Survival and long-term safety data collection", + "text": "Occurs with subject death or End-of-Study", + "instanceType": "TransitionRule" + }, + "notes": [], + "instanceType": "Encounter" + } + ], + "activities": [ + { + "id": "Activity_2", + "extensionAttributes": [], + "name": "ELIGIBILITY ASSESSMENT", + "label": "Eligibility Assessment", + "description": "Determine subject meets eligibility requirements", + "previousId": null, + "nextId": "Activity_1", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_2" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_1", + "extensionAttributes": [], + "name": "INFORMED CONSENT", + "label": "Informed Consent", + "description": "Informed Consent collected", + "previousId": "Activity_2", + "nextId": "Activity_19", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_1" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_19", + "extensionAttributes": [], + "name": "RANDOMIZATION", + "label": "Randomization", + "description": "Randomization", + "previousId": "Activity_1", + "nextId": "Activity_3", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_51" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_3", + "extensionAttributes": [], + "name": "MEDICAL HISTORY", + "label": "Medical History", + "description": "Medical History & Assessment of Baseline Signs and Symptoms", + "previousId": "Activity_19", + "nextId": "Activity_5", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_3", + "BiomedicalConcept_4" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_5", + "extensionAttributes": [], + "name": "PHYSICAL EXAM", + "label": "Physical Examination", + "description": "Physical Examination", + "previousId": "Activity_3", + "nextId": "Activity_18", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_6" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_18", + "extensionAttributes": [], + "name": "CONCOMITANT MEDS", + "label": "Concomitant Medications", + "description": "Concomitant Medications", + "previousId": "Activity_5", + "nextId": "Activity_6", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_49", + "BiomedicalConcept_50" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_6", + "extensionAttributes": [], + "name": "VITAL SIGNS", + "label": "Vital Signs", + "description": "Vital Signs (Blood Pressure, Heart Rate, Temperature) and Weight", + "previousId": "Activity_18", + "nextId": "Activity_4", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_7", + "BiomedicalConcept_8", + "BiomedicalConcept_9", + "BiomedicalConcept_10", + "BiomedicalConcept_11" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_4", + "extensionAttributes": [], + "name": "ECOG PERFORMANCE STATUS", + "label": "ECOG Performance Status", + "description": "ECOG performance status", + "previousId": "Activity_6", + "nextId": "Activity_17", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_5", + "BiomedicalConcept_60" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_17", + "extensionAttributes": [], + "name": "ADVERSE EVENTS ASSESSMENTS", + "label": "Adverse Event Assessment", + "description": "Adverse Event Assessment", + "previousId": "Activity_4", + "nextId": "Activity_22", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_47", + "BiomedicalConcept_48" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_22", + "extensionAttributes": [], + "name": "IMAGING SCANS", + "label": "Imaging Scans", + "description": "Tumor imaging scans", + "previousId": "Activity_17", + "nextId": "Activity_23", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_73", + "BiomedicalConcept_74", + "BiomedicalConcept_75", + "BiomedicalConcept_76", + "BiomedicalConcept_77" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_23", + "extensionAttributes": [], + "name": "PT/INR", + "label": "PT with INR", + "description": "prothrombin time and international normalized ratio", + "previousId": "Activity_22", + "nextId": "Activity_10", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_52", + "BiomedicalConcept_53", + "BiomedicalConcept_54" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_10", + "extensionAttributes": [], + "name": "URINALYSIS", + "label": "Urinalysis Labs", + "description": "Urinalysis Labs", + "previousId": "Activity_23", + "nextId": "Activity_24", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_26", + "BiomedicalConcept_27", + "BiomedicalConcept_28" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_24", + "extensionAttributes": [], + "name": "CBC", + "label": "CBC with differentials, Platelets", + "description": "CBC with differentials, Platelets", + "previousId": "Activity_10", + "nextId": "Activity_8", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_61", + "BiomedicalConcept_62", + "BiomedicalConcept_63" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_8", + "extensionAttributes": [], + "name": "CHEMISTRY LABS", + "label": "Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein, Phosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin, Magnesium, Uric Acid.", + "description": "Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein, Phosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin, Magnesium, Uric Acid.", + "previousId": "Activity_24", + "nextId": "Activity_25", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_18", + "BiomedicalConcept_19", + "BiomedicalConcept_20", + "BiomedicalConcept_21", + "BiomedicalConcept_22", + "BiomedicalConcept_64", + "BiomedicalConcept_65", + "BiomedicalConcept_66", + "BiomedicalConcept_67", + "BiomedicalConcept_68", + "BiomedicalConcept_69", + "BiomedicalConcept_70", + "BiomedicalConcept_71", + "BiomedicalConcept_72" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [ + "BiomedicalConceptSurrogate_1", + "BiomedicalConceptSurrogate_8" + ], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_25", + "extensionAttributes": [], + "name": "GLUCOSE", + "label": "Fasting Glucose", + "description": "Fasting Glucose", + "previousId": "Activity_8", + "nextId": "Activity_26", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_55" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_26", + "extensionAttributes": [], + "name": "LIPID PROFILE", + "label": "Fasting serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)", + "description": "Fasting serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)", + "previousId": "Activity_25", + "nextId": "Activity_27", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_56", + "BiomedicalConcept_57", + "BiomedicalConcept_58", + "BiomedicalConcept_59" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_27", + "extensionAttributes": [], + "name": "HBV-DNA-1", + "label": "HBV-DNA, HbsAg, HBsAb, HBcAb, HCV- RNA-PCR", + "description": "HBV-DNA, HbsAg, HBsAb, HBcAb, HCV- RNA-PCR", + "previousId": "Activity_26", + "nextId": "Activity_28", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [], + "bcCategoryIds": [], + "bcSurrogateIds": [ + "BiomedicalConceptSurrogate_2", + "BiomedicalConceptSurrogate_3", + "BiomedicalConceptSurrogate_4", + "BiomedicalConceptSurrogate_5", + "BiomedicalConceptSurrogate_6" + ], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_28", + "extensionAttributes": [], + "name": "HBV-DNA-2", + "label": "HBV DNA", + "description": "HBV DNA", + "previousId": "Activity_27", + "nextId": "Activity_29", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [], + "bcCategoryIds": [], + "bcSurrogateIds": [ + "BiomedicalConceptSurrogate_2" + ], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_29", + "extensionAttributes": [], + "name": "HCV", + "label": "HCV RNA-PCR", + "description": "HCV RNA-PCR", + "previousId": "Activity_28", + "nextId": "Activity_30", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [], + "bcCategoryIds": [], + "bcSurrogateIds": [ + "BiomedicalConceptSurrogate_6" + ], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_30", + "extensionAttributes": [], + "name": "COMPLIANCE", + "label": "Study Drug Compliance (Pill Diary)", + "description": "Study Drug Compliance (Pill Diary)", + "previousId": "Activity_29", + "nextId": "Activity_31", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [], + "bcCategoryIds": [], + "bcSurrogateIds": [ + "BiomedicalConceptSurrogate_19", + "BiomedicalConceptSurrogate_20", + "BiomedicalConceptSurrogate_21", + "BiomedicalConceptSurrogate_22", + "BiomedicalConceptSurrogate_23", + "BiomedicalConceptSurrogate_24" + ], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_31", + "extensionAttributes": [], + "name": "PFTS", + "label": "PFTs with DLCO as medically indicatedn", + "description": "PFTs with DLCO as medically indicatedn", + "previousId": "Activity_30", + "nextId": "Activity_21", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [], + "bcCategoryIds": [], + "bcSurrogateIds": [ + "BiomedicalConceptSurrogate_7" + ], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_21", + "extensionAttributes": [], + "name": "Survival Follow-up", + "label": "Survival Follow-up", + "description": "Survival Follow-up occurs (every 3 months)", + "previousId": "Activity_31", + "nextId": null, + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + } + ], + "arms": [ + { + "id": "StudyArm_1", + "extensionAttributes": [], + "name": "Fulvestrant + Everolimus", + "label": "Fulvestrant + Everolimus", + "description": "Fulvestrant 500mg IM Q28D (loading D1/D15) + Everolimus 10mg PO QD", + "type": { + "id": "Code_4", + "extensionAttributes": [], + "code": "C174266", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-26", + "decode": "Experimental Arm", + "instanceType": "Code" + }, + "dataOriginDescription": "Data collected from subjects", + "dataOriginType": { + "id": "Code_5", + "extensionAttributes": [], + "code": "C188866", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Data Generated Within Study", + "instanceType": "Code" + }, + "populationIds": [], + "notes": [], + "instanceType": "StudyArm" + }, + { + "id": "StudyArm_2", + "extensionAttributes": [], + "name": "Fulvestrant + Placebo", + "label": "Fulvestrant + Placebo", + "description": "Fulvestrant 500mg IM Q28D (loading D1/D15) + Placebo PO QD", + "type": { + "id": "Code_6", + "extensionAttributes": [], + "code": "C174267", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-26", + "decode": "Active Comparator Arm", + "instanceType": "Code" + }, + "dataOriginDescription": "Data collected from subjects", + "dataOriginType": { + "id": "Code_7", + "extensionAttributes": [], + "code": "C188866", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Data Generated Within Study", + "instanceType": "Code" + }, + "populationIds": [], + "notes": [], + "instanceType": "StudyArm" + } + ], + "studyCells": [ + { + "id": "StudyCell_1", + "extensionAttributes": [], + "armId": "StudyArm_1", + "epochId": "StudyEpoch_1", + "elementIds": [ + "StudyElement_1" + ], + "instanceType": "StudyCell" + }, + { + "id": "StudyCell_2", + "extensionAttributes": [], + "armId": "StudyArm_1", + "epochId": "StudyEpoch_2", + "elementIds": [ + "StudyElement_2" + ], + "instanceType": "StudyCell" + }, + { + "id": "StudyCell_3", + "extensionAttributes": [], + "armId": "StudyArm_1", + "epochId": "StudyEpoch_3", + "elementIds": [ + "StudyElement_4" + ], + "instanceType": "StudyCell" + }, + { + "id": "StudyCell_4", + "extensionAttributes": [], + "armId": "StudyArm_2", + "epochId": "StudyEpoch_1", + "elementIds": [ + "StudyElement_1" + ], + "instanceType": "StudyCell" + }, + { + "id": "StudyCell_5", + "extensionAttributes": [], + "armId": "StudyArm_2", + "epochId": "StudyEpoch_2", + "elementIds": [ + "StudyElement_3" + ], + "instanceType": "StudyCell" + }, + { + "id": "StudyCell_6", + "extensionAttributes": [], + "armId": "StudyArm_2", + "epochId": "StudyEpoch_3", + "elementIds": [ + "StudyElement_4" + ], + "instanceType": "StudyCell" + } + ], + "rationale": "", + "epochs": [ + { + "id": "StudyEpoch_1", + "extensionAttributes": [], + "name": "Pre-Study Phase", + "label": "Pre-Study Phase", + "description": "Eligibility assessment, up to 28 days prior to C1D1", + "type": { + "id": "Code_1", + "extensionAttributes": [], + "code": "C202487", + "codeSystem": "https://library.cdisc.org", + "codeSystemVersion": "sdtmct-2025-09-26", + "decode": "SCREENING", + "instanceType": "Code" + }, + "previousId": null, + "nextId": "StudyEpoch_2", + "notes": [], + "instanceType": "StudyEpoch" + }, + { + "id": "StudyEpoch_2", + "extensionAttributes": [], + "name": "Induction Phase", + "label": "Induction Phase", + "description": "From C1D1 until disease progression or discontinuation", + "type": { + "id": "Code_2", + "extensionAttributes": [], + "code": "C101526", + "codeSystem": "https://library.cdisc.org", + "codeSystemVersion": "sdtmct-2025-09-26", + "decode": "TREATMENT", + "instanceType": "Code" + }, + "previousId": "StudyEpoch_1", + "nextId": "StudyEpoch_4", + "notes": [], + "instanceType": "StudyEpoch" + }, + { + "id": "StudyEpoch_4", + "extensionAttributes": [], + "name": "Continuation Phase", + "label": "Continuation Phase", + "description": "Continuation Phase (until progression or unacceptable toxicity", + "type": { + "id": "Code_813", + "extensionAttributes": [], + "code": "C123452", + "codeSystem": "https://library.cdisc.org", + "codeSystemVersion": "sdtmct-2025-09-26", + "decode": "CONTINUATION TREATMENT", + "instanceType": "Code" + }, + "previousId": "StudyEpoch_2", + "nextId": "StudyEpoch_3", + "notes": [], + "instanceType": "StudyEpoch" + }, + { + "id": "StudyEpoch_3", + "extensionAttributes": [], + "name": "Follow-up Off Therapy", + "label": "Follow-up, off therapy", + "description": "Post-EOT survival and safety follow-up", + "type": { + "id": "Code_3", + "extensionAttributes": [], + "code": "C202578", + "codeSystem": "https://library.cdisc.org", + "codeSystemVersion": "sdtmct-2025-09-26", + "decode": "FOLLOW-UP", + "instanceType": "Code" + }, + "previousId": "StudyEpoch_4", + "nextId": null, + "notes": [], + "instanceType": "StudyEpoch" + } + ], + "elements": [ + { + "id": "StudyElement_1", + "extensionAttributes": [], + "name": "Screening Period", + "label": "Screening Period", + "description": "Pre-treatment eligibility window", + "transitionStartRule": { + "id": "TransitionRule_1", + "extensionAttributes": [], + "name": "Start Screening Period", + "label": "Start Screening Period", + "description": "Start of Pre-treatment eligibility window", + "text": "Screening window starts 28 days prior to treatment", + "instanceType": "TransitionRule" + }, + "transitionEndRule": { + "id": "TransitionRule_2", + "extensionAttributes": [], + "name": "End Screening Period", + "label": "End Screening Period", + "description": "End of Screening Window", + "text": "Screening window ends a maximum of 28 days after start", + "instanceType": "TransitionRule" + }, + "studyInterventionIds": [], + "notes": [], + "instanceType": "StudyElement" + }, + { + "id": "StudyElement_2", + "extensionAttributes": [], + "name": "Everolimus Treatment Period", + "label": "Everolimus Treatment Period", + "description": "Fulvestrant + Everolimus; continues until PD, unacceptable toxicity, or withdrawal", + "transitionStartRule": { + "id": "TransitionRule_3", + "extensionAttributes": [], + "name": "Start Study Drug Treatment Period", + "label": "Start Study Drug Treatment Period", + "description": "Fulvestrant + Everolimus; continues until Progressive Disease, unacceptable toxicity, or withdrawal", + "text": "Occurs for at least one cycle and continues until Disease Progression in study drug treatment Arm", + "instanceType": "TransitionRule" + }, + "transitionEndRule": { + "id": "TransitionRule_4", + "extensionAttributes": [], + "name": "End Study Drug Treatment Period", + "label": "End Study Drug Treatment Period", + "description": "Fulvestrant + Everolimus; continues until PD, unacceptable toxicity, or withdrawal", + "text": "Occurs when Progressive Disease, unacceptable toxicity, or withdrawal in study drug treatment Arm", + "instanceType": "TransitionRule" + }, + "studyInterventionIds": [], + "notes": [], + "instanceType": "StudyElement" + }, + { + "id": "StudyElement_3", + "extensionAttributes": [], + "name": "Placebo Treatment Period", + "label": "Placebo Treatment Period", + "description": "Fulvestrant + Placebo; continues until PD, unacceptable toxicity, or withdrawal", + "transitionStartRule": { + "id": "TransitionRule_5", + "extensionAttributes": [], + "name": "Start Placebo Treatment Period", + "label": "Start Placebo Treatment Period", + "description": "Fulvestrant + Placebo; continues until PD, unacceptable toxicity, or withdrawal", + "text": "Occurs for at least one treament cycle with Placebo and continues until Disease Progression in Placebo Arm", + "instanceType": "TransitionRule" + }, + "transitionEndRule": { + "id": "TransitionRule_6", + "extensionAttributes": [], + "name": "End Placebo Treament Period", + "label": "End Placebo Treament Period", + "description": "Fulvestrant + Placebo; continues until PD, unacceptable toxicity, or withdrawal", + "text": "Occurs when Progressive Disease, unacceptable toxicity, or withdrawal in Placebo Arm", + "instanceType": "TransitionRule" + }, + "studyInterventionIds": [], + "notes": [], + "instanceType": "StudyElement" + }, + { + "id": "StudyElement_4", + "extensionAttributes": [], + "name": "Follow-Up Period", + "label": "Follow-Up Period", + "description": "Survival and long-term safety data collection", + "transitionStartRule": { + "id": "TransitionRule_7", + "extensionAttributes": [], + "name": "Start Follow-up Period", + "label": "Start Follow-up Period", + "description": "Survival and long-term safety data collection", + "text": "Occurs when subject finishes treatment", + "instanceType": "TransitionRule" + }, + "transitionEndRule": { + "id": "TransitionRule_8", + "extensionAttributes": [], + "name": "End Follow-up Period", + "label": "End Follow-up Period", + "description": "Survival and long-term safety data collection", + "text": "Occurs with subject death or End-of-Study", + "instanceType": "TransitionRule" + }, + "studyInterventionIds": [], + "notes": [], + "instanceType": "StudyElement" + } + ], + "estimands": [ + { + "id": "Estimand_1", + "extensionAttributes": [], + "name": "Estimand for Progression-Free Survival (PFS)", + "label": "Primary Estimand", + "description": "Comparison of PFS between fulvestrant plus everolimus versus fulvestrant plus placebo in AI-resistant HR+ metastatic breast cancer. Constructed retrospectively per ICH E9(R1); this protocol predates the 2019 addendum.", + "populationSummary": "Post-menopausal women with HR+ (ER/PR+, HER2-negative) stage IV or inoperable locally advanced breast cancer that is resistant to aromatase inhibitor therapy; ECOG PS 0-1; no prior mTOR inhibitor; up to one prior systemic chemotherapy for metastatic disease. Randomized 1:1; approximately 120 eligible patients.", + "analysisPopulationId": "", + "variableOfInterestId": "Endpoint_1", + "interventionIds": [ + "StudyIntervention_1", + "StudyIntervention_2" + ], + "intercurrentEvents": [ + { + "id": "IntercurrentEvent_1", + "extensionAttributes": [], + "name": "Death before documented progression", + "label": "Death before documented progression", + "description": null, + "text": "Patient dies from any cause before radiological disease progression has been documented per RECIST v1.1.", + "strategy": "Composite: death is included as a PFS event (composite endpoint definition per \u00a76.1.6). The time-to-event variable captures whichever occurs first: progression or death.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_2", + "extensionAttributes": [], + "name": "Discontinuation of everolimus due to toxicity", + "label": "Discontinuation of everolimus due to toxicity", + "description": null, + "text": "Patient permanently discontinues everolimus or placebo due to an adverse event but continues on fulvestrant monotherapy.", + "strategy": "Treatment-policy: patient remains on study and continues fulvestrant alone per \u00a75.5. Follow-up for progression and survival continues. PFS events occurring after everolimus discontinuation are included in the primary analysis regardless of treatment status.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_3", + "extensionAttributes": [], + "name": "Withdrawal of consent or loss to follow-up", + "label": "Withdrawal of consent or loss to follow-up", + "description": null, + "text": "Patient withdraws consent or is lost to follow-up before a PFS event is documented.", + "strategy": "Hypothetical (censoring): patient is censored at the date of last tumor assessment. The estimand implicitly assumes non-informative censoring \u2014 that censored patients would have experienced events at the same rate as those who remained in follow-up.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_4", + "extensionAttributes": [], + "name": "Initiation of prohibited anti-cancer therapy before progression", + "label": "Initiation of prohibited anti-cancer therapy before progression", + "description": null, + "text": "Patient receives a prohibited anti-cancer agent before disease progression is documented.", + "strategy": "Treatment-policy: protocol prohibits new anti-cancer agents before progression (\u00a75.3.4). If such a violation occurred, the patient would remain in the analysis with events counted as observed. No censoring at time of prohibited therapy initiation is specified.", + "notes": [], + "instanceType": "IntercurrentEvent" + } + ], + "notes": [], + "instanceType": "Estimand" + }, + { + "id": "Estimand_2", + "extensionAttributes": [], + "name": "Estimand for Overall Survival (OS)", + "label": "Secondary Estimand \u2014 OS", + "description": "Comparison of overall survival between treatment arms. Descriptive; no pre-specified alpha or power.", + "populationSummary": "All randomized eligible patients (same as PFS estimand population).", + "analysisPopulationId": "", + "variableOfInterestId": "Endpoint_2", + "interventionIds": [ + "StudyIntervention_1", + "StudyIntervention_2" + ], + "intercurrentEvents": [ + { + "id": "IntercurrentEvent_5", + "extensionAttributes": [], + "name": "Discontinuation of study treatment (any reason)", + "label": "Discontinuation of study treatment (any reason)", + "description": null, + "text": "Patient permanently discontinues all study treatment due to disease progression, toxicity, or other reasons.", + "strategy": "Treatment-policy: all patients who discontinue treatment are followed for survival per \u00a75.5. Deaths after treatment cessation are counted as OS events regardless of reason for discontinuation.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_6", + "extensionAttributes": [], + "name": "Initiation of subsequent anti-cancer therapy after progression", + "label": "Initiation of subsequent anti-cancer therapy after progression", + "description": null, + "text": "Patient initiates a new anti-cancer regimen after disease progression on study treatment.", + "strategy": "Treatment-policy: OS reflects real-world outcome including the effect of any subsequent therapies. No censoring or adjustment for post-progression treatment is specified.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_7", + "extensionAttributes": [], + "name": "Withdrawal of consent or loss to follow-up", + "label": "Withdrawal of consent or loss to follow-up", + "description": null, + "text": "Patient withdraws consent or cannot be contacted for survival follow-up.", + "strategy": "Hypothetical (censoring): patient is censored at date of last known alive contact. Non-informative censoring assumed.", + "notes": [], + "instanceType": "IntercurrentEvent" + } + ], + "notes": [], + "instanceType": "Estimand" + }, + { + "id": "Estimand_3", + "extensionAttributes": [], + "name": "Estimand for Time to Progression (TTP)", + "label": "Secondary Estimand \u2014 TTP", + "description": "Comparison of time to disease progression, excluding deaths as events. Descriptive.", + "populationSummary": "All randomized eligible patients (same as PFS estimand population).", + "analysisPopulationId": "", + "variableOfInterestId": "Endpoint_3", + "interventionIds": [ + "StudyIntervention_1", + "StudyIntervention_2" + ], + "intercurrentEvents": [ + { + "id": "IntercurrentEvent_8", + "extensionAttributes": [], + "name": "Death before documented progression", + "label": "Death before documented progression", + "description": null, + "text": "Patient dies from any cause before radiological disease progression has been documented per RECIST v1.1.", + "strategy": "Hypothetical (censoring): death without prior progression results in censoring at time of death. This reflects the hypothetical question 'what would the time to progression have been if the patient had not died?' \u2014 the key mechanistic distinction from the PFS estimand.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_9", + "extensionAttributes": [], + "name": "Discontinuation of study treatment", + "label": "Discontinuation of study treatment (any reason)", + "description": null, + "text": "Patient permanently discontinues study treatment before disease progression.", + "strategy": "Treatment-policy: follow-up for progression continues after treatment discontinuation per \u00a75.5. TTP events occurring after treatment cessation are included.", + "notes": [], + "instanceType": "IntercurrentEvent" + } + ], + "notes": [], + "instanceType": "Estimand" + }, + { + "id": "Estimand_4", + "extensionAttributes": [], + "name": "Estimand for Objective Response Rate (ORR)", + "label": "Secondary Estimand \u2014 ORR", + "description": "Between-arm comparison of the proportion of patients achieving confirmed CR or PR in patients with measurable disease. Descriptive.", + "populationSummary": "Subset of randomized eligible patients with at least one measurable lesion at baseline per RECIST v1.1.", + "analysisPopulationId": "", + "variableOfInterestId": "Endpoint_4", + "interventionIds": [ + "StudyIntervention_1", + "StudyIntervention_2" + ], + "intercurrentEvents": [ + { + "id": "IntercurrentEvent_10", + "extensionAttributes": [], + "name": "Death or progression before first response assessment", + "label": "Death or progression before first response assessment", + "description": null, + "text": "Patient dies or has documented progression before achieving CR or PR at any post-baseline tumor assessment.", + "strategy": "Composite: patients who die or progress without ever achieving a confirmed CR or PR are counted as non-responders in the ORR denominator.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_11", + "extensionAttributes": [], + "name": "Treatment discontinuation before response assessment", + "label": "Treatment discontinuation before response assessment", + "description": null, + "text": "Patient discontinues all study treatment before a post-baseline tumor assessment confirming CR or PR.", + "strategy": "Treatment-policy: patients who discontinue without a prior confirmed response are counted as non-responders. No censoring at time of treatment discontinuation.", + "notes": [], + "instanceType": "IntercurrentEvent" + } + ], + "notes": [], + "instanceType": "Estimand" + }, + { + "id": "Estimand_5", + "extensionAttributes": [], + "name": "Estimand for Clinical Benefit Rate (CBR)", + "label": "Secondary Estimand \u2014 CBR", + "description": "Between-arm comparison of the proportion of patients with CR, PR, or SD maintained for at least 6 months. Descriptive.", + "populationSummary": "All randomized eligible patients including those with measurable and non-measurable disease.", + "analysisPopulationId": "", + "variableOfInterestId": "Endpoint_5", + "interventionIds": [ + "StudyIntervention_1", + "StudyIntervention_2" + ], + "intercurrentEvents": [ + { + "id": "IntercurrentEvent_12", + "extensionAttributes": [], + "name": "Death or progression before 6-month stable disease threshold", + "label": "Death or progression before 6-month stable disease threshold", + "description": null, + "text": "Patient dies or has documented progression before 6 months of confirmed stable disease, partial response, or complete response.", + "strategy": "Composite: patients who do not achieve and maintain CR, PR, or SD for at least 6 months are counted as not deriving clinical benefit, regardless of cause.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_13", + "extensionAttributes": [], + "name": "Treatment discontinuation before 6-month landmark", + "label": "Treatment discontinuation before 6-month landmark", + "description": null, + "text": "Patient discontinues study treatment before the 6-month landmark required for SD to qualify as clinical benefit.", + "strategy": "Treatment-policy: patients who discontinue and lack tumor assessment confirming \u22656 months of SD are counted as non-responders for CBR.", + "notes": [], + "instanceType": "IntercurrentEvent" + } + ], + "notes": [], + "instanceType": "Estimand" + }, + { + "id": "Estimand_6", + "extensionAttributes": [], + "name": "Estimand for Safety and Tolerability", + "label": "Secondary Estimand \u2014 Safety", + "description": "Descriptive characterization of the incidence and severity of adverse events in the safety-evaluable population. No formal hypothesis test.", + "populationSummary": "All patients who received at least one dose of any study treatment. Approximately 65 patients per arm.", + "analysisPopulationId": "", + "variableOfInterestId": "Endpoint_6", + "interventionIds": [ + "StudyIntervention_1", + "StudyIntervention_2" + ], + "intercurrentEvents": [ + { + "id": "IntercurrentEvent_14", + "extensionAttributes": [], + "name": "Treatment discontinuation", + "label": "Treatment discontinuation", + "description": null, + "text": "Patient permanently discontinues study treatment. AE collection continues for 30 days after last dose of any study drug per \u00a75.5.", + "strategy": "While-on-treatment: TEAEs are collected only during the treatment period and the 30-day post-treatment follow-up window. Adverse events occurring beyond this window are not captured as TEAEs in the primary safety analysis.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_15", + "extensionAttributes": [], + "name": "Dose reduction or interruption of everolimus", + "label": "Dose reduction or interruption of everolimus", + "description": null, + "text": "Patient undergoes dose modification (reduction or temporary interruption) of everolimus or placebo per protocol dose-modification rules.", + "strategy": "Treatment-policy: AEs that prompt dose modification are recorded regardless of the modification. Events are attributed to the randomized treatment arm and included in the safety summary as observed.", + "notes": [], + "instanceType": "IntercurrentEvent" + } + ], + "notes": [], + "instanceType": "Estimand" + } + ], + "indications": [ + { + "id": "Indication_1", + "extensionAttributes": [], + "name": "Hormone Receptor-Positive Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy", + "label": "HR+ AI-Resistant Metastatic Breast Cancer", + "description": "Post-menopausal women with hormone-receptor positive (ER/PR+, HER2-negative) stage IV or inoperable locally advanced breast cancer that is resistant to aromatase inhibitor therapy, defined as relapse while receiving adjuvant AI or progressive disease while receiving an AI for metastatic disease.", + "isRareDisease": false, + "codes": [ + { + "id": "Code_7947", + "extensionAttributes": [], + "code": "C9246", + "codeSystem": "http://ncithesaurus.nci.nih.gov", + "codeSystemVersion": "24.04e", + "decode": "Hormone Receptor-Positive Breast Carcinoma", + "instanceType": "Code" + }, + { + "id": "Code_7948", + "extensionAttributes": [], + "code": "C7771", + "codeSystem": "http://ncithesaurus.nci.nih.gov", + "codeSystemVersion": "24.04e", + "decode": "Metastatic Breast Carcinoma", + "instanceType": "Code" + } + ], + "notes": [], + "instanceType": "Indication" + } + ], + "studyInterventionIds": [ + "StudyIntervention_1", + "StudyIntervention_2" + ], + "objectives": [ + { + "id": "Objective_1", + "extensionAttributes": [], + "name": "Primary Objective", + "label": "Primary Objective", + "description": "To assess progression-free survival in post-menopausal patients with hormone-receptor positive metastatic breast cancer that is resistant to aromatase inhibitor therapy treated with fulvestrant and everolimus compared to fulvestrant alone.", + "text": "", + "dictionaryId": null, + "notes": [], + "level": { + "id": "Code_2355", + "extensionAttributes": [], + "code": "C85826", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "C85826", + "instanceType": "Code" + }, + "endpoints": [ + { + "id": "Endpoint_1", + "extensionAttributes": [], + "name": "Progression-Free Survival (PFS)", + "label": "Progression-Free Survival (PFS)", + "description": "Time from randomization to documented disease progression or death, whichever occurs first. Subjects who have neither progressed nor died are censored at the date of last tumor assessment. Disease progression assessed per RECIST v1.1.", + "text": "", + "dictionaryId": null, + "notes": [], + "purpose": "To demonstrate that the addition of everolimus to fulvestrant improves PFS compared to fulvestrant plus placebo (hypothesized median PFS improvement from 5.4 to 9.2 months; HR \u2248 0.59).", + "level": { + "id": "Code_2356", + "extensionAttributes": [], + "code": "C94496", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "C94496", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + } + ], + "instanceType": "Objective" + }, + { + "id": "Objective_2", + "extensionAttributes": [], + "name": "Secondary Objective", + "label": "Secondary Objective", + "description": "To describe the safety profile, objective response rate, time to progression, and overall survival in this patient population.", + "text": "", + "dictionaryId": null, + "notes": [], + "level": { + "id": "Code_2357", + "extensionAttributes": [], + "code": "C85827", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "C85827", + "instanceType": "Code" + }, + "endpoints": [ + { + "id": "Endpoint_2", + "extensionAttributes": [], + "name": "Overall Survival (OS)", + "label": "Overall Survival (OS)", + "description": "Time from randomization until death from any cause. Subjects alive at the time of analysis are censored at the date of last follow-up.", + "text": "", + "dictionaryId": null, + "notes": [], + "purpose": "To characterize overall survival in the two treatment arms.", + "level": { + "id": "Code_2358", + "extensionAttributes": [], + "code": "C139173", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "C139173", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + }, + { + "id": "Endpoint_3", + "extensionAttributes": [], + "name": "Time to Progression (TTP)", + "label": "Time to Progression (TTP)", + "description": "Time from randomization until objective disease progression per RECIST v1.1. Unlike PFS, deaths without prior progression are not counted as events (subjects are censored at time of death).", + "text": "", + "dictionaryId": null, + "notes": [], + "purpose": "To estimate and compare median time to disease progression between treatment arms.", + "level": { + "id": "Code_2359", + "extensionAttributes": [], + "code": "C139173", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "C139173", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + }, + { + "id": "Endpoint_4", + "extensionAttributes": [], + "name": "Objective Response Rate (ORR)", + "label": "Objective Response Rate (ORR)", + "description": "Proportion of patients with a confirmed complete response (CR) or partial response (PR) per RECIST v1.1. Assessed in patients with measurable disease at baseline.", + "text": "", + "dictionaryId": null, + "notes": [], + "purpose": "To compare the proportion of patients achieving an objective tumor response between treatment arms.", + "level": { + "id": "Code_2360", + "extensionAttributes": [], + "code": "C139173", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "C139173", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + }, + { + "id": "Endpoint_5", + "extensionAttributes": [], + "name": "Clinical Benefit Rate (CBR)", + "label": "Clinical Benefit Rate (CBR)", + "description": "Proportion of patients with stable disease (SD) for \u22656 months, partial response (PR), or complete response (CR) \u2014 i.e., CR + PR + SD \u2265 6 months \u2014 per RECIST v1.1.", + "text": "", + "dictionaryId": null, + "notes": [], + "purpose": "To compare the proportion of patients deriving clinical benefit (response or prolonged stable disease) between treatment arms.", + "level": { + "id": "Code_2361", + "extensionAttributes": [], + "code": "C139173", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "C139173", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + }, + { + "id": "Endpoint_6", + "extensionAttributes": [], + "name": "Safety and Tolerability", + "label": "Safety and Tolerability", + "description": "Incidence, severity (CTCAE v4.0 grade), and type of adverse events, including overall toxicity, grade 3\u20134 toxicities, serious adverse events (SAEs), and second primary cancers. Assessed in all patients who received at least one dose of study treatment.", + "text": "", + "dictionaryId": null, + "notes": [], + "purpose": "To characterize and compare the safety profile of fulvestrant plus everolimus versus fulvestrant plus placebo.", + "level": { + "id": "Code_2362", + "extensionAttributes": [], + "code": "C139173", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "C139173", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + } + ], + "instanceType": "Objective" + } + ], + "population": { + "id": "StudyDesignPopulation_1", + "extensionAttributes": [], + "name": "Population_1", + "label": null, + "description": null, + "includesHealthySubjects": false, + "plannedEnrollmentNumber": null, + "plannedCompletionNumber": null, + "plannedSex": [], + "criterionIds": [], + "plannedAge": null, + "notes": [], + "cohorts": [], + "instanceType": "StudyDesignPopulation" + }, + "scheduleTimelines": [ + { + "id": "ScheduleTimeline_1", + "extensionAttributes": [], + "name": "Main Timeline", + "label": "Main Timeline", + "description": "The main timeline for the study", + "mainTimeline": true, + "entryCondition": null, + "entryId": "ScheduledActivityInstance_1", + "exits": [], + "timings": [ + { + "id": "Timing_1", + "extensionAttributes": [], + "name": "SCREENING", + "label": "Screening", + "description": "Timing for screening", + "type": null, + "value": null, + "valueLabel": null, + "relativeToFrom": null, + "relativeFromScheduledInstanceId": null, + "relativeToScheduledInstanceId": null, + "windowLower": null, + "windowUpper": null, + "windowLabel": null, + "instanceType": "Timing" + } + ], + "instances": [ + { + "id": "ScheduledActivityInstance_1", + "extensionAttributes": [], + "name": "SCR", + "label": "Screening", + "description": "Screening", + "defaultConditionId": "ScheduledActivityInstance_2", + "epochId": "StudyEpoch_1", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [], + "encounterId": "Encounter_1" + }, + { + "id": "ScheduledActivityInstance_2", + "extensionAttributes": [], + "name": "C1D1", + "label": "C1D1", + "description": "Treatment cycle 1 day1", + "defaultConditionId": "ScheduledActivityInstance_3", + "epochId": "StudyEpoch_2", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [], + "encounterId": "Encounter_2" + }, + { + "id": "ScheduledActivityInstance_3", + "extensionAttributes": [], + "name": "C1D15", + "label": "C1D15", + "description": "Treatment cycle 1 day 15", + "defaultConditionId": "ScheduledActivityInstance_4", + "epochId": "StudyEpoch_2", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [], + "encounterId": "Encounter_3" + }, + { + "id": "ScheduledActivityInstance_6", + "extensionAttributes": [], + "name": "P12W", + "label": "Every 12 Weeks", + "description": "Every 12 weeks assessment", + "defaultConditionId": "ScheduledActivityInstance_7", + "epochId": "StudyEpoch_2", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [], + "encounterId": "Encounter_5" + }, + { + "id": "ScheduledActivityInstance_7", + "extensionAttributes": [], + "name": "EOT", + "label": "EOT", + "description": "End of treatment", + "defaultConditionId": "ScheduledActivityInstance_8", + "epochId": "StudyEpoch_2", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [], + "encounterId": "Encounter_6" + }, + { + "id": "ScheduledActivityInstance_8", + "extensionAttributes": [], + "name": "FU", + "label": "FU", + "description": "Follow-up", + "defaultConditionId": null, + "epochId": "StudyEpoch_3", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [], + "encounterId": "Encounter_8" + }, + { + "id": "ScheduledActivityInstance_9", + "extensionAttributes": [], + "name": "CxD1", + "label": "Cycle x Day 1", + "description": "Day 1 Each Subsequent Cycle", + "defaultConditionId": "ScheduledActivityInstance_9", + "epochId": "StudyEpoch_2", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [], + "encounterId": "Encounter_4" + }, + { + "id": "ScheduledActivityInstance_10", + "extensionAttributes": [], + "name": "RANDOMIZE", + "label": "Randomization", + "description": "Randomization", + "defaultConditionId": "ScheduledActivityInstance_2", + "epochId": "StudyEpoch_1", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [], + "encounterId": null + }, + { + "id": "ScheduledActivityInstance_11", + "extensionAttributes": [], + "name": "CPHASE", + "label": "Continuation Phase", + "description": "Occurs until progression or unacceptable toxicity", + "defaultConditionId": "ScheduledActivityInstance_11", + "epochId": "StudyEpoch_4", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [], + "encounterId": "Encounter_7" + } + ], + "plannedDuration": null, + "instanceType": "ScheduleTimeline" + } + ], + "biospecimenRetentions": [], + "documentVersionIds": [], + "eligibilityCriteria": [], + "analysisPopulations": [], + "notes": [], + "subTypes": [], + "model": { + "id": "Code_StudyDesignModel", + "extensionAttributes": [], + "code": "", + "codeSystem": "", + "codeSystemVersion": "", + "decode": "", + "instanceType": "Code" + }, + "intentTypes": [], + "blindingSchema": null, + "instanceType": "InterventionalStudyDesign" + } + ], + "titles": [ + { + "id": "StudyTitle_1", + "extensionAttributes": [], + "text": "Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Fulvestrant (Faslodex) plus Everolimus in Post-Menopausal Patients with Hormone-Receptor Positive Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy", + "type": { + "id": "Code_8497", + "extensionAttributes": [], + "code": "C207616", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Official Study Title", + "instanceType": "Code" + }, + "instanceType": "StudyTitle" + } + ], + "documentVersionIds": [], + "dateValues": [], + "amendments": [], + "organizations": [ + { + "id": "Organization_1", + "extensionAttributes": [], + "name": "PrECOG, LLC", + "label": "PrECOG", + "identifier": "", + "identifierScheme": "", + "type": { + "id": "Code_7949", + "extensionAttributes": [], + "code": "C70793", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Clinical Study Sponsor", + "instanceType": "Code" + }, + "legalAddress": { + "id": "Address_1", + "extensionAttributes": [], + "text": "PrECOG, LLC, 1818 Market Street, Suite 1100, Philadelphia, PA 19103", + "lines": [ + "1818 Market Street", + "Suite 1100" + ], + "city": "Philadelphia", + "district": null, + "state": "PA", + "postalCode": "19103", + "country": { + "id": "Code_7950", + "extensionAttributes": [], + "code": "840", + "codeSystem": "ISO 3166 1 Numeric Code", + "codeSystemVersion": "2026", + "decode": "United States of America", + "instanceType": "Code" + }, + "instanceType": "Address" + }, + "managedSites": [], + "instanceType": "Organization" + }, + { + "id": "Organization_2", + "extensionAttributes": [], + "name": "Novartis Pharmaceuticals Corporation", + "label": "Novartis", + "identifier": "", + "identifierScheme": "", + "type": { + "id": "Code_7951", + "extensionAttributes": [], + "code": "C25392", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Manufacturer", + "instanceType": "Code" + }, + "legalAddress": { + "id": "Address_2", + "extensionAttributes": [], + "text": null, + "lines": [], + "city": null, + "district": null, + "state": null, + "postalCode": null, + "country": { + "id": "Code_7952", + "extensionAttributes": [], + "code": "840", + "codeSystem": "ISO 3166 1 Numeric Code", + "codeSystemVersion": "2026", + "decode": "United States of America", + "instanceType": "Code" + }, + "instanceType": "Address" + }, + "managedSites": [], + "instanceType": "Organization" + }, + { + "id": "Organization_3", + "extensionAttributes": [], + "name": "clinicaltrials.gov", + "label": "clinicaltrials.gov", + "identifier": "", + "identifierScheme": "", + "type": { + "id": "Code_9956", + "extensionAttributes": [], + "code": "C188863", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Regulatory Agency", + "instanceType": "Code" + }, + "legalAddress": { + "id": "Address_3", + "extensionAttributes": [], + "text": "National Library of Medicine\n8600 Rockville Pike, Bethesda, MD 20894", + "lines": [ + "National Library of Medicine", + "8600 Rockville Pike" + ], + "city": "Bethesda", + "district": null, + "state": "MD", + "postalCode": "20894", + "country": { + "id": "Code_9957", + "extensionAttributes": [], + "code": "840", + "codeSystem": "ISO 3166 1 Numeric Code", + "codeSystemVersion": "2026", + "decode": "United States of America", + "instanceType": "Code" + }, + "instanceType": "Address" + }, + "managedSites": [], + "instanceType": "Organization" + }, + { + "id": "Organization_4", + "extensionAttributes": [], + "name": "VendorLab1", + "label": "Vendor1", + "identifier": "", + "identifierScheme": "", + "type": { + "id": "Code_9958", + "extensionAttributes": [], + "code": "C37984", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Laboratory", + "instanceType": "Code" + }, + "legalAddress": { + "id": "Address_4", + "extensionAttributes": [], + "text": null, + "lines": [], + "city": null, + "district": null, + "state": null, + "postalCode": null, + "country": { + "id": "Code_9959", + "extensionAttributes": [], + "code": "840", + "codeSystem": "ISO 3166 1 Numeric Code", + "codeSystemVersion": "2026", + "decode": "United States of America", + "instanceType": "Code" + }, + "instanceType": "Address" + }, + "managedSites": [], + "instanceType": "Organization" + }, + { + "id": "Organization_5", + "extensionAttributes": [], + "name": "VendorLab2", + "label": "Vendor2", + "identifier": "", + "identifierScheme": "", + "type": { + "id": "Code_9961", + "extensionAttributes": [], + "code": "C37984", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Laboratory", + "instanceType": "Code" + }, + "legalAddress": { + "id": "Address_5", + "extensionAttributes": [], + "text": null, + "lines": [], + "city": null, + "district": null, + "state": null, + "postalCode": null, + "country": { + "id": "Code_9962", + "extensionAttributes": [], + "code": "840", + "codeSystem": "ISO 3166 1 Numeric Code", + "codeSystemVersion": "2026", + "decode": "United States of America", + "instanceType": "Code" + }, + "instanceType": "Address" + }, + "managedSites": [], + "instanceType": "Organization" + } + ], + "roles": [ + { + "id": "StudyRole_1", + "extensionAttributes": [], + "name": "Clinical Study Sponsor", + "label": "Clinical Study Sponsor", + "description": "PrECOG, LLC serves as the clinical study sponsor and coordinating group for this investigator-initiated trial.", + "code": { + "id": "Code_8489", + "extensionAttributes": [], + "code": "C70793", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Clinical Study Sponsor", + "instanceType": "Code" + }, + "organizationIds": [ + "Organization_1" + ], + "appliesToIds": [], + "assignedPersons": [], + "masking": null, + "notes": [], + "instanceType": "StudyRole" + }, + { + "id": "StudyRole_2", + "extensionAttributes": [], + "name": "Study Chair", + "label": "Study Chair", + "description": null, + "code": { + "id": "Code_9716", + "extensionAttributes": [], + "code": "C19924", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Principal Investigator", + "instanceType": "Code" + }, + "organizationIds": [ + "Organization_1" + ], + "appliesToIds": [], + "assignedPersons": [ + { + "id": "Person_1", + "extensionAttributes": [], + "name": "Noah Kornblum", + "label": null, + "description": null, + "personName": { + "id": "PersonName_1", + "extensionAttributes": [], + "text": null, + "familyName": "Kornblum", + "givenNames": [ + "Noah" + ], + "prefixes": [ + "Dr." + ], + "suffixes": [ + "MD" + ], + "instanceType": "PersonName" + }, + "jobTitle": "Study Chair", + "instanceType": "AssignedPerson" + } + ], + "masking": null, + "notes": [], + "instanceType": "StudyRole" + }, + { + "id": "StudyRole_3", + "extensionAttributes": [], + "name": "Study Co-Chair", + "label": "Study Co-Chair", + "description": null, + "code": { + "id": "Code_9717", + "extensionAttributes": [], + "code": "C25936", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Investigator", + "instanceType": "Code" + }, + "organizationIds": [ + "Organization_1" + ], + "appliesToIds": [], + "assignedPersons": [ + { + "id": "Person_2", + "extensionAttributes": [], + "name": "Joseph A. Sparano", + "label": null, + "description": null, + "personName": { + "id": "PersonName_2", + "extensionAttributes": [], + "text": null, + "familyName": "Sparano", + "givenNames": [ + "Joseph", + "A." + ], + "prefixes": [ + "Dr." + ], + "suffixes": [ + "MD" + ], + "instanceType": "PersonName" + }, + "jobTitle": "Study Co-Chair", + "instanceType": "AssignedPerson" + } + ], + "masking": null, + "notes": [], + "instanceType": "StudyRole" + }, + { + "id": "StudyRole_4", + "extensionAttributes": [], + "name": "Medical Monitor", + "label": "Medical Monitor", + "description": null, + "code": { + "id": "Code_9718", + "extensionAttributes": [], + "code": "C51876", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Sponsor Medical Expert", + "instanceType": "Code" + }, + "organizationIds": [ + "Organization_1" + ], + "appliesToIds": [], + "assignedPersons": [ + { + "id": "Person_3", + "extensionAttributes": [], + "name": "Katherine M. Smith", + "label": null, + "description": null, + "personName": { + "id": "PersonName_3", + "extensionAttributes": [], + "text": null, + "familyName": "Smith", + "givenNames": [ + "Katherine", + "M." + ], + "prefixes": [ + "Dr." + ], + "suffixes": [ + "MD" + ], + "instanceType": "PersonName" + }, + "jobTitle": "Medical Monitor", + "instanceType": "AssignedPerson" + } + ], + "masking": null, + "notes": [], + "instanceType": "StudyRole" + }, + { + "id": "StudyRole_5", + "extensionAttributes": [], + "name": "Study Statistician", + "label": "Study Statistician", + "description": null, + "code": { + "id": "Code_9719", + "extensionAttributes": [], + "code": "C51877", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Statistician", + "instanceType": "Code" + }, + "organizationIds": [ + "Organization_1" + ], + "appliesToIds": [], + "assignedPersons": [ + { + "id": "Person_4", + "extensionAttributes": [], + "name": "Judi Manola", + "label": null, + "description": null, + "personName": { + "id": "PersonName_4", + "extensionAttributes": [], + "text": null, + "familyName": "Manola", + "givenNames": [ + "Judi" + ], + "prefixes": [], + "suffixes": [ + "MS" + ], + "instanceType": "PersonName" + }, + "jobTitle": "Study Statistician", + "instanceType": "AssignedPerson" + } + ], + "masking": null, + "notes": [], + "instanceType": "StudyRole" + }, + { + "id": "StudyRole_6", + "extensionAttributes": [], + "name": "Study Contact", + "label": "Study Contact", + "description": null, + "code": { + "id": "Code_9720", + "extensionAttributes": [], + "code": "C51851", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Project Coordinator", + "instanceType": "Code" + }, + "organizationIds": [ + "Organization_1" + ], + "appliesToIds": [], + "assignedPersons": [ + { + "id": "Person_5", + "extensionAttributes": [], + "name": "Carolyn Andrews", + "label": null, + "description": null, + "personName": { + "id": "PersonName_5", + "extensionAttributes": [], + "text": null, + "familyName": "Andrews", + "givenNames": [ + "Carolyn" + ], + "prefixes": [], + "suffixes": [ + "RN" + ], + "instanceType": "PersonName" + }, + "jobTitle": "PrECOG Study Contact", + "instanceType": "AssignedPerson" + } + ], + "masking": null, + "notes": [], + "instanceType": "StudyRole" + }, + { + "id": "StudyRole_7", + "extensionAttributes": [], + "name": "Investigational Product Manufacturer", + "label": "Investigational Product Manufacturer", + "description": "Novartis Pharmaceuticals Corporation supplies everolimus and matching placebo for the study.", + "code": { + "id": "Code_9714", + "extensionAttributes": [], + "code": "C25392", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Manufacturer", + "instanceType": "Code" + }, + "organizationIds": [ + "Organization_2" + ], + "appliesToIds": [], + "assignedPersons": [], + "masking": null, + "notes": [], + "instanceType": "StudyRole" + }, + { + "id": "StudyRole_8", + "extensionAttributes": [], + "name": "Pharmacovigilance Group", + "label": "Pharmacovigilance Group", + "description": "Novartis Pharmaceuticals Drug Safety and Epidemiology Department (DS&E). Receives SAE notifications from PrECOG within 24 hours of awareness date.", + "code": { + "id": "Code_9715", + "extensionAttributes": [], + "code": "C215673", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Pharmacovigilance Group", + "instanceType": "Code" + }, + "organizationIds": [ + "Organization_2" + ], + "appliesToIds": [], + "assignedPersons": [], + "masking": null, + "notes": [], + "instanceType": "StudyRole" + }, + { + "id": "StudyRole_9", + "extensionAttributes": [], + "name": "Primary Data Manager", + "label": "Primary Data Manager", + "description": null, + "code": { + "id": "Code_9963", + "extensionAttributes": [], + "code": "C51851", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Project Coordinator", + "instanceType": "Code" + }, + "organizationIds": [ + "Organization_1" + ], + "appliesToIds": [], + "assignedPersons": [ + { + "id": "Person_6", + "extensionAttributes": [], + "name": "Valerie S", + "label": null, + "description": null, + "personName": { + "id": "PersonName_6", + "extensionAttributes": [], + "text": null, + "familyName": "G", + "givenNames": [ + "Valerie" + ], + "prefixes": [], + "suffixes": [], + "instanceType": "PersonName" + }, + "jobTitle": "Primary Data Manager", + "instanceType": "AssignedPerson" + } + ], + "masking": null, + "notes": [], + "instanceType": "StudyRole" + }, + { + "id": "StudyRole_10", + "extensionAttributes": [], + "name": "Secondary Data Manager", + "label": "Secondary Data Manager", + "description": null, + "code": { + "id": "Code_9964", + "extensionAttributes": [], + "code": "C51851", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Project Coordinator", + "instanceType": "Code" + }, + "organizationIds": [ + "Organization_1" + ], + "appliesToIds": [], + "assignedPersons": [ + { + "id": "Person_7", + "extensionAttributes": [], + "name": "Patrick G", + "label": null, + "description": null, + "personName": { + "id": "PersonName_7", + "extensionAttributes": [], + "text": null, + "familyName": "G", + "givenNames": [ + "Patrick" + ], + "prefixes": [], + "suffixes": [], + "instanceType": "PersonName" + }, + "jobTitle": "Secondary Data Manager", + "instanceType": "AssignedPerson" + } + ], + "masking": null, + "notes": [], + "instanceType": "StudyRole" + }, + { + "id": "StudyRole_11", + "extensionAttributes": [], + "name": "Data Acquisition Lead", + "label": "Data Acquisition Lead", + "description": null, + "code": { + "id": "Code_9965", + "extensionAttributes": [], + "code": "C51851", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Project Coordinator", + "instanceType": "Code" + }, + "organizationIds": [ + "Organization_4" + ], + "appliesToIds": [], + "assignedPersons": [ + { + "id": "Person_8", + "extensionAttributes": [], + "name": "Eva J", + "label": null, + "description": null, + "personName": { + "id": "PersonName_8", + "extensionAttributes": [], + "text": null, + "familyName": "J", + "givenNames": [ + "Eva" + ], + "prefixes": [], + "suffixes": [], + "instanceType": "PersonName" + }, + "jobTitle": "Data Acquisition Lead", + "instanceType": "AssignedPerson" + } + ], + "masking": null, + "notes": [], + "instanceType": "StudyRole" + }, + { + "id": "StudyRole_12", + "extensionAttributes": [], + "name": "Data Acquisition Lead", + "label": "Data Acquisition Lead", + "description": null, + "code": { + "id": "Code_9966", + "extensionAttributes": [], + "code": "C51851", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Project Coordinator", + "instanceType": "Code" + }, + "organizationIds": [ + "Organization_5" + ], + "appliesToIds": [], + "assignedPersons": [ + { + "id": "Person_9", + "extensionAttributes": [], + "name": "Melissa T", + "label": null, + "description": null, + "personName": { + "id": "PersonName_9", + "extensionAttributes": [], + "text": null, + "familyName": "T", + "givenNames": [ + "Melissa" + ], + "prefixes": [], + "suffixes": [], + "instanceType": "PersonName" + }, + "jobTitle": "Data Acquisition Lead", + "instanceType": "AssignedPerson" + } + ], + "masking": null, + "notes": [], + "instanceType": "StudyRole" + } + ], + "studyInterventions": [ + { + "id": "StudyIntervention_1", + "extensionAttributes": [], + "name": "Fulvestrant + Everolimus (Arm A)", + "label": "Fulvestrant + Everolimus (Arm A)", + "description": "Fulvestrant 500 mg IM on Day 1 of each 28-day cycle (Day 1 and 15 of Cycle 1 only) plus Everolimus 10 mg orally once daily.", + "role": { + "id": "Code_7943", + "extensionAttributes": [], + "code": "C41161", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Experimental Intervention", + "instanceType": "Code" + }, + "type": { + "id": "Code_7944", + "extensionAttributes": [], + "code": "C54696", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-26", + "decode": "Combination Product", + "instanceType": "Code" + }, + "minimumResponseDuration": null, + "codes": [], + "administrations": [], + "notes": [], + "instanceType": "StudyIntervention" + }, + { + "id": "StudyIntervention_2", + "extensionAttributes": [], + "name": "Fulvestrant + Placebo (Arm B)", + "label": "Fulvestrant + Placebo (Arm B)", + "description": "Fulvestrant 500 mg IM on Day 1 of each 28-day cycle (Day 1 and 15 of Cycle 1 only) plus matching oral placebo once daily.", + "role": { + "id": "Code_7945", + "extensionAttributes": [], + "code": "C68609", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Active Comparator", + "instanceType": "Code" + }, + "type": { + "id": "Code_7946", + "extensionAttributes": [], + "code": "C54696", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-26", + "decode": "Combination Product", + "instanceType": "Code" + }, + "minimumResponseDuration": null, + "codes": [], + "administrations": [], + "notes": [], + "instanceType": "StudyIntervention" + } + ], + "businessTherapeuticAreas": [], + "biomedicalConcepts": [ + { + "id": "BiomedicalConcept_1", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_1", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/CONSENT", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Informed Consent", + "label": "Informed Consent", + "synonyms": [ + "Informed Consent Obtained" + ], + "reference": "/mdr/bc/biomedicalconcepts/C16735", + "properties": [ + { + "id": "BiomedicalConceptProperty_1", + "extensionAttributes": [], + "name": "DSDECOD", + "label": "DSDECOD", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_927", + "instanceType": "ResponseCode", + "name": "INFORMED CONSENT OBTAINED", + "label": "INFORMED CONSENT OBTAINED", + "isEnabled": true, + "code": { + "id": "Code_9455", + "extensionAttributes": [], + "code": "C16735", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "INFORMED CONSENT OBTAINED", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9057", + "standardCode": { + "id": "Code_9721", + "extensionAttributes": [], + "code": "C82977", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_2", + "extensionAttributes": [], + "name": "DSTERM", + "label": "DSTERM", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9058", + "standardCode": { + "id": "Code_9722", + "extensionAttributes": [], + "code": "C82571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_3", + "extensionAttributes": [], + "name": "DSSTDTC", + "label": "DSSTDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9059", + "standardCode": { + "id": "Code_9723", + "extensionAttributes": [], + "code": "C82517", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_1", + "extensionAttributes": [], + "standardCode": { + "id": "Code_8", + "extensionAttributes": [], + "code": "C16735", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Informed Consent", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_2", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_2", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/ELIGMET", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Eligibility Criteria Met By Subject", + "label": "Eligibility Criteria Met By Subject", + "synonyms": [ + "Eligibility Criteria Met" + ], + "reference": "/mdr/bc/biomedicalconcepts/C132447", + "properties": [ + { + "id": "BiomedicalConceptProperty_4", + "extensionAttributes": [], + "name": "DSDECOD", + "label": "DSDECOD", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_928", + "instanceType": "ResponseCode", + "name": "ELIGIBILITY CRITERIA MET", + "label": "ELIGIBILITY CRITERIA MET", + "isEnabled": true, + "code": { + "id": "Code_9459", + "extensionAttributes": [], + "code": "C132447", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "ELIGIBILITY CRITERIA MET", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9060", + "standardCode": { + "id": "Code_9724", + "extensionAttributes": [], + "code": "C82977", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_5", + "extensionAttributes": [], + "name": "DSTERM", + "label": "DSTERM", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9061", + "standardCode": { + "id": "Code_9725", + "extensionAttributes": [], + "code": "C82571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_6", + "extensionAttributes": [], + "name": "DSSTDTC", + "label": "DSSTDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9062", + "standardCode": { + "id": "Code_9726", + "extensionAttributes": [], + "code": "C82517", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_6", + "extensionAttributes": [], + "standardCode": { + "id": "Code_13", + "extensionAttributes": [], + "code": "C132447", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Eligibility Criteria Met By Subject", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_3", + "extensionAttributes": [], + "name": "Medical History Yes No Indicator", + "label": "Medical History Yes No Indicator", + "synonyms": [ + "MHYN" + ], + "reference": "/mdr/bc/biomedicalconcepts/C85522", + "properties": [ + { + "id": "BiomedicalConceptProperty_7", + "extensionAttributes": [], + "name": "Medical History Yes No Indicator", + "label": "Medical History Yes No Indicator", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9063", + "standardCode": { + "id": "Code_9727", + "extensionAttributes": [], + "code": "C85522", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Medical History Yes No Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_8", + "extensionAttributes": [], + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9064", + "standardCode": { + "id": "Code_9728", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_11", + "extensionAttributes": [], + "standardCode": { + "id": "Code_18", + "extensionAttributes": [], + "code": "C85522", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Medical History Yes No Indicator", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_4", + "extensionAttributes": [], + "name": "Medical History Reported Term [RETIRED]", + "label": "Medical History Reported Term [RETIRED]", + "synonyms": [ + "Medical History", + "MHTERM" + ], + "reference": "/mdr/bc/biomedicalconcepts/C83118", + "properties": [ + { + "id": "BiomedicalConceptProperty_9", + "extensionAttributes": [], + "name": "Medical History Dictionary Derived Term", + "label": "Medical History Dictionary Derived Term", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9065", + "standardCode": { + "id": "Code_9729", + "extensionAttributes": [], + "code": "C83346", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Dictionary Derived Term", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_10", + "extensionAttributes": [], + "name": "Medical History Occurrence", + "label": "Medical History Occurrence", + "isRequired": true, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_9066", + "standardCode": { + "id": "Code_9730", + "extensionAttributes": [], + "code": "C83067", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Occurrence", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_11", + "extensionAttributes": [], + "name": "Medical History Pre-specified", + "label": "Medical History Pre-specified", + "isRequired": true, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_9067", + "standardCode": { + "id": "Code_9731", + "extensionAttributes": [], + "code": "C87897", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Pre-specified", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_12", + "extensionAttributes": [], + "name": "Medical History Reported Term", + "label": "Medical History Reported Term", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9068", + "standardCode": { + "id": "Code_9732", + "extensionAttributes": [], + "code": "C83118", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Reported Term", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_13", + "extensionAttributes": [], + "name": "Medical History Category", + "label": "Medical History Category", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9069", + "standardCode": { + "id": "Code_9733", + "extensionAttributes": [], + "code": "C83018", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Category", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_14", + "extensionAttributes": [], + "name": "Medical History Subcategory", + "label": "Medical History Subcategory", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9070", + "standardCode": { + "id": "Code_9734", + "extensionAttributes": [], + "code": "C83143", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Subcategory", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_12", + "extensionAttributes": [], + "standardCode": { + "id": "Code_19", + "extensionAttributes": [], + "code": "C83118", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Reported Term [RETIRED]", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_5", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_3", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/ECOG101", + "instanceType": "ExtensionAttribute" + } + ], + "name": "ECOG - Performance Status", + "label": "ECOG - Performance Status", + "synonyms": [ + "ECOG1-Performance Status", + "ECOG101", + "ECOG - Performance Status" + ], + "reference": "/mdr/bc/biomedicalconcepts/C102408", + "properties": [ + { + "id": "BiomedicalConceptProperty_15", + "extensionAttributes": [], + "name": "RSORRES", + "label": "RSORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9071", + "standardCode": { + "id": "Code_9735", + "extensionAttributes": [], + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Clinical or Research Assessment Answer", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_16", + "extensionAttributes": [], + "name": "RSDTC", + "label": "RSDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9072", + "standardCode": { + "id": "Code_9736", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_13", + "extensionAttributes": [], + "standardCode": { + "id": "Code_20", + "extensionAttributes": [], + "code": "C102408", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "ECOG - Performance Status", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_6", + "extensionAttributes": [], + "name": "Physical Examination Finding", + "label": "Physical Examination Finding", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/C83119", + "properties": [], + "code": { + "id": "AliasCode_21", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28", + "extensionAttributes": [], + "code": "C83119", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-04-02", + "decode": "Physical Examination Finding", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_7", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_4", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/SYSBP", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Systolic Blood Pressure", + "label": "Systolic Blood Pressure", + "synonyms": [ + "SYSBP" + ], + "reference": "/mdr/bc/biomedicalconcepts/C25298", + "properties": [ + { + "id": "BiomedicalConceptProperty_17", + "extensionAttributes": [], + "name": "VSORRES", + "label": "VSORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_9073", + "standardCode": { + "id": "Code_9737", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_18", + "extensionAttributes": [], + "name": "VSORRESU", + "label": "VSORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_929", + "instanceType": "ResponseCode", + "name": "mmHg", + "label": "mmHg", + "isEnabled": true, + "code": { + "id": "Code_9474", + "extensionAttributes": [], + "code": "C49670", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "mmHg", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9074", + "standardCode": { + "id": "Code_9738", + "extensionAttributes": [], + "code": "C49669", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Pressure", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_19", + "extensionAttributes": [], + "name": "VSPOS", + "label": "VSPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9075", + "standardCode": { + "id": "Code_9739", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_20", + "extensionAttributes": [], + "name": "VSLOC", + "label": "VSLOC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9076", + "standardCode": { + "id": "Code_9740", + "extensionAttributes": [], + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_21", + "extensionAttributes": [], + "name": "VSLAT", + "label": "VSLAT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9077", + "standardCode": { + "id": "Code_9741", + "extensionAttributes": [], + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_22", + "extensionAttributes": [], + "name": "VSDTC", + "label": "VSDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9078", + "standardCode": { + "id": "Code_9742", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_22", + "extensionAttributes": [], + "standardCode": { + "id": "Code_29", + "extensionAttributes": [], + "code": "C25298", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Systolic Blood Pressure", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_8", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_5", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/DIABP", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Diastolic Blood Pressure", + "label": "Diastolic Blood Pressure", + "synonyms": [ + "DIABP" + ], + "reference": "/mdr/bc/biomedicalconcepts/C25299", + "properties": [ + { + "id": "BiomedicalConceptProperty_23", + "extensionAttributes": [], + "name": "VSORRES", + "label": "VSORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_9079", + "standardCode": { + "id": "Code_9743", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_24", + "extensionAttributes": [], + "name": "VSORRESU", + "label": "VSORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_930", + "instanceType": "ResponseCode", + "name": "mmHg", + "label": "mmHg", + "isEnabled": true, + "code": { + "id": "Code_9481", + "extensionAttributes": [], + "code": "C49670", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "mmHg", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9080", + "standardCode": { + "id": "Code_9744", + "extensionAttributes": [], + "code": "C49669", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Pressure", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_25", + "extensionAttributes": [], + "name": "VSPOS", + "label": "VSPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9081", + "standardCode": { + "id": "Code_9745", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_26", + "extensionAttributes": [], + "name": "VSLOC", + "label": "VSLOC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9082", + "standardCode": { + "id": "Code_9746", + "extensionAttributes": [], + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_27", + "extensionAttributes": [], + "name": "VSLAT", + "label": "VSLAT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9083", + "standardCode": { + "id": "Code_9747", + "extensionAttributes": [], + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_28", + "extensionAttributes": [], + "name": "VSDTC", + "label": "VSDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9084", + "standardCode": { + "id": "Code_9748", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_34", + "extensionAttributes": [], + "standardCode": { + "id": "Code_41", + "extensionAttributes": [], + "code": "C25299", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Diastolic Blood Pressure", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_9", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_6", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/HR", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Heart Rate", + "label": "Heart Rate", + "synonyms": [ + "HR" + ], + "reference": "/mdr/bc/biomedicalconcepts/C49677", + "properties": [ + { + "id": "BiomedicalConceptProperty_29", + "extensionAttributes": [], + "name": "VSORRES", + "label": "VSORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_9085", + "standardCode": { + "id": "Code_9749", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_30", + "extensionAttributes": [], + "name": "VSORRESU", + "label": "VSORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_931", + "instanceType": "ResponseCode", + "name": "beats/min", + "label": "beats/min", + "isEnabled": true, + "code": { + "id": "Code_9488", + "extensionAttributes": [], + "code": "C49673", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "beats/min", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9086", + "standardCode": { + "id": "Code_9750", + "extensionAttributes": [], + "code": "C73688", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Count per Minute", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_31", + "extensionAttributes": [], + "name": "VSPOS", + "label": "VSPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9087", + "standardCode": { + "id": "Code_9751", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_32", + "extensionAttributes": [], + "name": "VSLOC", + "label": "VSLOC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9088", + "standardCode": { + "id": "Code_9752", + "extensionAttributes": [], + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_33", + "extensionAttributes": [], + "name": "VSLAT", + "label": "VSLAT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9089", + "standardCode": { + "id": "Code_9753", + "extensionAttributes": [], + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_34", + "extensionAttributes": [], + "name": "VSDTC", + "label": "VSDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9090", + "standardCode": { + "id": "Code_9754", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_46", + "extensionAttributes": [], + "standardCode": { + "id": "Code_53", + "extensionAttributes": [], + "code": "C49677", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Heart Rate", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_10", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_7", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/TEMP", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Body Temperature", + "label": "Body Temperature", + "synonyms": [ + "Temperature" + ], + "reference": "/mdr/bc/biomedicalconcepts/C174446", + "properties": [ + { + "id": "BiomedicalConceptProperty_35", + "extensionAttributes": [], + "name": "VSORRES", + "label": "VSORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_9091", + "standardCode": { + "id": "Code_9755", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_36", + "extensionAttributes": [], + "name": "VSORRESU", + "label": "VSORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9092", + "standardCode": { + "id": "Code_9756", + "extensionAttributes": [], + "code": "C44276", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Temperature", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_37", + "extensionAttributes": [], + "name": "VSLOC", + "label": "VSLOC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9093", + "standardCode": { + "id": "Code_9757", + "extensionAttributes": [], + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_38", + "extensionAttributes": [], + "name": "VSDTC", + "label": "VSDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9094", + "standardCode": { + "id": "Code_9758", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_5688", + "extensionAttributes": [], + "standardCode": { + "id": "Code_5767", + "extensionAttributes": [], + "code": "C174446", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Body Temperature", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_11", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_8", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/WEIGHT", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Body Weight", + "label": "Body Weight", + "synonyms": [ + "WEIGHT" + ], + "reference": "/mdr/bc/biomedicalconcepts/C81328", + "properties": [ + { + "id": "BiomedicalConceptProperty_39", + "extensionAttributes": [], + "name": "VSORRES", + "label": "VSORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_9095", + "standardCode": { + "id": "Code_9759", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_40", + "extensionAttributes": [], + "name": "VSORRESU", + "label": "VSORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9096", + "standardCode": { + "id": "Code_9760", + "extensionAttributes": [], + "code": "C48208", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Weight", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_41", + "extensionAttributes": [], + "name": "VSDTC", + "label": "VSDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9097", + "standardCode": { + "id": "Code_9761", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_9354", + "extensionAttributes": [], + "standardCode": { + "id": "Code_10029", + "extensionAttributes": [], + "code": "C81328", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Body Weight", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_18", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_9", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/ALTSERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Alanine Aminotransferase Measurement", + "label": "Alanine Aminotransferase Measurement", + "synonyms": [ + "ALT", + "SGPT" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64433", + "properties": [ + { + "id": "BiomedicalConceptProperty_42", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_9098", + "standardCode": { + "id": "Code_9762", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_43", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9099", + "standardCode": { + "id": "Code_9763", + "extensionAttributes": [], + "code": "C67365", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_44", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_932", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_9503", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9100", + "standardCode": { + "id": "Code_9764", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_45", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_9101", + "standardCode": { + "id": "Code_9765", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_46", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9102", + "standardCode": { + "id": "Code_9766", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_9355", + "extensionAttributes": [], + "standardCode": { + "id": "Code_10030", + "extensionAttributes": [], + "code": "C64433", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Alanine Aminotransferase Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_19", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_10", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/ASTSERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Aspartate Aminotransferase Measurement", + "label": "Aspartate Aminotransferase Measurement", + "synonyms": [ + "AST", + "SGOT" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64467", + "properties": [ + { + "id": "BiomedicalConceptProperty_47", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_9103", + "standardCode": { + "id": "Code_9767", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_48", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9104", + "standardCode": { + "id": "Code_9768", + "extensionAttributes": [], + "code": "C67365", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_49", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_933", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_9509", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9105", + "standardCode": { + "id": "Code_9769", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_50", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_9106", + "standardCode": { + "id": "Code_9770", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_51", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9107", + "standardCode": { + "id": "Code_9771", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_767", + "extensionAttributes": [], + "standardCode": { + "id": "Code_807", + "extensionAttributes": [], + "code": "C64467", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Aspartate Aminotransferase Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_20", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_11", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/BILISERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Total Bilirubin Measurement", + "label": "Total Bilirubin Measurement", + "synonyms": [ + "Bilirubin", + "Total Bilirubin Level" + ], + "reference": "/mdr/bc/biomedicalconcepts/C38037", + "properties": [ + { + "id": "BiomedicalConceptProperty_52", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9108", + "standardCode": { + "id": "Code_9772", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_53", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9109", + "standardCode": { + "id": "Code_9773", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_54", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_934", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_9515", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9110", + "standardCode": { + "id": "Code_9774", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_55", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_9111", + "standardCode": { + "id": "Code_9775", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_56", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9112", + "standardCode": { + "id": "Code_9776", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_768", + "extensionAttributes": [], + "standardCode": { + "id": "Code_808", + "extensionAttributes": [], + "code": "C38037", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Total Bilirubin Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_21", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_12", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/CREATSERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Creatinine Measurement", + "label": "Creatinine Measurement", + "synonyms": [ + "Creatinine" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64547", + "properties": [ + { + "id": "BiomedicalConceptProperty_57", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9113", + "standardCode": { + "id": "Code_9777", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_58", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9114", + "standardCode": { + "id": "Code_9778", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_59", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_935", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_9521", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9115", + "standardCode": { + "id": "Code_9779", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_60", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_9116", + "standardCode": { + "id": "Code_9780", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_61", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9117", + "standardCode": { + "id": "Code_9781", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_5689", + "extensionAttributes": [], + "standardCode": { + "id": "Code_5768", + "extensionAttributes": [], + "code": "C64547", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Creatinine Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_22", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_13", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/ALBSERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Albumin Measurement", + "label": "Albumin Measurement", + "synonyms": [ + "Albumin" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64431", + "properties": [ + { + "id": "BiomedicalConceptProperty_62", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9118", + "standardCode": { + "id": "Code_9782", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_63", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9119", + "standardCode": { + "id": "Code_9783", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_64", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_936", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_9527", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9120", + "standardCode": { + "id": "Code_9784", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_65", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_9121", + "standardCode": { + "id": "Code_9785", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_66", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9122", + "standardCode": { + "id": "Code_9786", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_5690", + "extensionAttributes": [], + "standardCode": { + "id": "Code_5769", + "extensionAttributes": [], + "code": "C64431", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Albumin Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_26", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_14", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/PHURIN", + "instanceType": "ExtensionAttribute" + } + ], + "name": "pH", + "label": "pH", + "synonyms": [ + "PH", + "potential of Hydrogen" + ], + "reference": "/mdr/bc/biomedicalconcepts/C45997", + "properties": [ + { + "id": "BiomedicalConceptProperty_67", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_9123", + "standardCode": { + "id": "Code_9787", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_68", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_937", + "instanceType": "ResponseCode", + "name": "URINE", + "label": "URINE", + "isEnabled": true, + "code": { + "id": "Code_9532", + "extensionAttributes": [], + "code": "C13283", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "URINE", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9124", + "standardCode": { + "id": "Code_9788", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_69", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_9125", + "standardCode": { + "id": "Code_9789", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_70", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9126", + "standardCode": { + "id": "Code_9790", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_5691", + "extensionAttributes": [], + "standardCode": { + "id": "Code_5770", + "extensionAttributes": [], + "code": "C45997", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "pH", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_27", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_15", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/COLORURIN", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Color Assessment", + "label": "Color Assessment", + "synonyms": [ + "COLOR", + "Color" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64546", + "properties": [ + { + "id": "BiomedicalConceptProperty_71", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9127", + "standardCode": { + "id": "Code_9791", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_72", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_938", + "instanceType": "ResponseCode", + "name": "URINE", + "label": "URINE", + "isEnabled": true, + "code": { + "id": "Code_9537", + "extensionAttributes": [], + "code": "C13283", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "URINE", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9128", + "standardCode": { + "id": "Code_9792", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_73", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9129", + "standardCode": { + "id": "Code_9793", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_9356", + "extensionAttributes": [], + "standardCode": { + "id": "Code_10031", + "extensionAttributes": [], + "code": "C64546", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Color Assessment", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_28", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_16", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/SPGRAVURIN", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Specific Gravity", + "label": "Specific Gravity", + "synonyms": [ + "SPGRAV" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64832", + "properties": [ + { + "id": "BiomedicalConceptProperty_74", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_9130", + "standardCode": { + "id": "Code_9794", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_75", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_939", + "instanceType": "ResponseCode", + "name": "URINE", + "label": "URINE", + "isEnabled": true, + "code": { + "id": "Code_9541", + "extensionAttributes": [], + "code": "C13283", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "URINE", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9131", + "standardCode": { + "id": "Code_9795", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_76", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_9132", + "standardCode": { + "id": "Code_9796", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_77", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9133", + "standardCode": { + "id": "Code_9797", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_5692", + "extensionAttributes": [], + "standardCode": { + "id": "Code_5771", + "extensionAttributes": [], + "code": "C64832", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Specific Gravity", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_47", + "extensionAttributes": [], + "name": "Adverse Event Yes No Indicator", + "label": "Adverse Event Yes No Indicator", + "synonyms": [ + "AEYN" + ], + "reference": "/mdr/bc/biomedicalconcepts/C83347", + "properties": [ + { + "id": "BiomedicalConceptProperty_78", + "extensionAttributes": [], + "name": "Adverse Event Yes No Indicator", + "label": "Adverse Event Yes No Indicator", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9134", + "standardCode": { + "id": "Code_9798", + "extensionAttributes": [], + "code": "C83347", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Yes No Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_79", + "extensionAttributes": [], + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9135", + "standardCode": { + "id": "Code_9799", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_5693", + "extensionAttributes": [], + "standardCode": { + "id": "Code_5772", + "extensionAttributes": [], + "code": "C83347", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Yes No Indicator", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_48", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_17", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/ADVEVENT", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Adverse Event", + "label": "Adverse Event", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/C41331", + "properties": [], + "code": { + "id": "AliasCode_773", + "extensionAttributes": [], + "standardCode": { + "id": "Code_813", + "extensionAttributes": [], + "code": "C41331", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Adverse Event [RETIRED]", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_49", + "extensionAttributes": [], + "name": "Concomitant Medication Yes No Indicator", + "label": "Concomitant Medication Yes No Indicator", + "synonyms": [ + "CMYN" + ], + "reference": "/mdr/bc/biomedicalconcepts/C83056", + "properties": [ + { + "id": "BiomedicalConceptProperty_80", + "extensionAttributes": [], + "name": "Concomitant Medication Yes No Indicator", + "label": "Concomitant Medication Yes No Indicator", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9136", + "standardCode": { + "id": "Code_9800", + "extensionAttributes": [], + "code": "C83056", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Concomitant Medication Yes No Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_81", + "extensionAttributes": [], + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9137", + "standardCode": { + "id": "Code_9801", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_5694", + "extensionAttributes": [], + "standardCode": { + "id": "Code_5773", + "extensionAttributes": [], + "code": "C83056", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Concomitant Medication Yes No Indicator", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_50", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_18", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/CMFREE", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Concomitant Therapy", + "label": "Concomitant Therapy", + "synonyms": [ + "Concomitant Medication" + ], + "reference": "/mdr/bc/biomedicalconcepts/C53630", + "properties": [ + { + "id": "BiomedicalConceptProperty_82", + "extensionAttributes": [], + "name": "CMTRT", + "label": "CMTRT", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9138", + "standardCode": { + "id": "Code_9802", + "extensionAttributes": [], + "code": "C70902", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Agent", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_83", + "extensionAttributes": [], + "name": "CMDECOD", + "label": "CMDECOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9139", + "standardCode": { + "id": "Code_9803", + "extensionAttributes": [], + "code": "C83345", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dictionary Derived Term", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_84", + "extensionAttributes": [], + "name": "CMCLAS", + "label": "CMCLAS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9140", + "standardCode": { + "id": "Code_9804", + "extensionAttributes": [], + "code": "C83219", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Class", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_85", + "extensionAttributes": [], + "name": "CMINDC", + "label": "CMINDC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9141", + "standardCode": { + "id": "Code_9805", + "extensionAttributes": [], + "code": "C83085", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Use Indication", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_86", + "extensionAttributes": [], + "name": "CMDOSE", + "label": "CMDOSE", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9142", + "standardCode": { + "id": "Code_9806", + "extensionAttributes": [], + "code": "C83221", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_87", + "extensionAttributes": [], + "name": "CMDOSTXT", + "label": "CMDOSTXT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9143", + "standardCode": { + "id": "Code_9807", + "extensionAttributes": [], + "code": "C83221", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_88", + "extensionAttributes": [], + "name": "CMDOSU", + "label": "CMDOSU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9144", + "standardCode": { + "id": "Code_9808", + "extensionAttributes": [], + "code": "C83034", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose Unit", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_89", + "extensionAttributes": [], + "name": "CMDOSFRM", + "label": "CMDOSFRM", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9145", + "standardCode": { + "id": "Code_9809", + "extensionAttributes": [], + "code": "C83110", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose Form", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_90", + "extensionAttributes": [], + "name": "CMDOSFRQ", + "label": "CMDOSFRQ", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9146", + "standardCode": { + "id": "Code_9810", + "extensionAttributes": [], + "code": "C83042", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose Frequency", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_91", + "extensionAttributes": [], + "name": "CMROUTE", + "label": "CMROUTE", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9147", + "standardCode": { + "id": "Code_9811", + "extensionAttributes": [], + "code": "C83120", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Route of Administration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_92", + "extensionAttributes": [], + "name": "CMSTDTC", + "label": "CMSTDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9148", + "standardCode": { + "id": "Code_9812", + "extensionAttributes": [], + "code": "C83235", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Use Start Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_93", + "extensionAttributes": [], + "name": "CMENDTC", + "label": "CMENDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9149", + "standardCode": { + "id": "Code_9813", + "extensionAttributes": [], + "code": "C83225", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Use End Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_94", + "extensionAttributes": [], + "name": "CMSTRF", + "label": "CMSTRF", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9150", + "standardCode": { + "id": "Code_9814", + "extensionAttributes": [], + "code": "C82559", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Period", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_95", + "extensionAttributes": [], + "name": "CMSTRTPT", + "label": "CMSTRTPT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9151", + "standardCode": { + "id": "Code_9815", + "extensionAttributes": [], + "code": "C82560", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Time Point", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_96", + "extensionAttributes": [], + "name": "CMSTTPT", + "label": "CMSTTPT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9152", + "standardCode": { + "id": "Code_9816", + "extensionAttributes": [], + "code": "C82575", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference Start Time Point", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_97", + "extensionAttributes": [], + "name": "CMENRF", + "label": "CMENRF", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9153", + "standardCode": { + "id": "Code_9817", + "extensionAttributes": [], + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_98", + "extensionAttributes": [], + "name": "CMENRTPT", + "label": "CMENRTPT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9154", + "standardCode": { + "id": "Code_9818", + "extensionAttributes": [], + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_99", + "extensionAttributes": [], + "name": "CMENTPT", + "label": "CMENTPT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9155", + "standardCode": { + "id": "Code_9819", + "extensionAttributes": [], + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_775", + "extensionAttributes": [], + "standardCode": { + "id": "Code_815", + "extensionAttributes": [], + "code": "C53630", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Therapy", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_51", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_19", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/RANDOM", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Randomization", + "label": "Randomization", + "synonyms": [ + "randomization", + "RANDOM", + "Randomized", + "Trial is Randomized", + "randomized" + ], + "reference": "/mdr/bc/biomedicalconcepts/C25196", + "properties": [ + { + "id": "BiomedicalConceptProperty_236", + "extensionAttributes": [], + "name": "TSPARMCD", + "label": "TSPARMCD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_947", + "instanceType": "ResponseCode", + "name": "RANDOM", + "label": "RANDOM", + "isEnabled": true, + "code": { + "id": "Code_9968", + "extensionAttributes": [], + "code": "C25196", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "RANDOM", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9292", + "standardCode": { + "id": "Code_9967", + "extensionAttributes": [], + "code": "C83445", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Code", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_237", + "extensionAttributes": [], + "name": "TSPARM", + "label": "TSPARM", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_948", + "instanceType": "ResponseCode", + "name": "Trial is Randomized", + "label": "Trial is Randomized", + "isEnabled": true, + "code": { + "id": "Code_9970", + "extensionAttributes": [], + "code": "C25196", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial is Randomized", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9294", + "standardCode": { + "id": "Code_9969", + "extensionAttributes": [], + "code": "C49691", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_238", + "extensionAttributes": [], + "name": "TSVAL", + "label": "TSVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_9296", + "standardCode": { + "id": "Code_9971", + "extensionAttributes": [], + "code": "C83447", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Value", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_239", + "extensionAttributes": [], + "name": "TSVALCD", + "label": "TSVALCD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9297", + "standardCode": { + "id": "Code_9972", + "extensionAttributes": [], + "code": "C117458", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Value Code", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_240", + "extensionAttributes": [], + "name": "TSVCDREF", + "label": "TSVCDREF", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9298", + "standardCode": { + "id": "Code_9973", + "extensionAttributes": [], + "code": "C117460", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Name of the Reference Terminology", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_241", + "extensionAttributes": [], + "name": "TSVCDVER", + "label": "TSVCDVER", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9299", + "standardCode": { + "id": "Code_9974", + "extensionAttributes": [], + "code": "C117461", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Version of the Reference Terminology", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_8606", + "extensionAttributes": [], + "standardCode": { + "id": "Code_9210", + "extensionAttributes": [], + "code": "C25196", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "RANDOM", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_52", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_20", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/PTBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Prothrombin Time", + "label": "Prothrombin Time", + "synonyms": [ + "PT" + ], + "reference": "/mdr/bc/biomedicalconcepts/C62656", + "properties": [ + { + "id": "BiomedicalConceptProperty_106", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_9162", + "standardCode": { + "id": "Code_9826", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_107", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_940", + "instanceType": "ResponseCode", + "name": "s", + "label": "s", + "isEnabled": true, + "code": { + "id": "Code_9574", + "extensionAttributes": [], + "code": "C42535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "s", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9163", + "standardCode": { + "id": "Code_9827", + "extensionAttributes": [], + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_108", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_941", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_9576", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9164", + "standardCode": { + "id": "Code_9828", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_109", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [ + { + "id": "ResponseCode_878", + "instanceType": "ResponseCode", + "name": "ELIGIBILITY CRITERIA MET", + "label": "ELIGIBILITY CRITERIA MET", + "isEnabled": true, + "code": { + "id": "Code_9066", + "extensionAttributes": [], + "code": "C132447", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "ELIGIBILITY CRITERIA MET", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9165", + "standardCode": { + "id": "Code_9829", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_110", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9166", + "standardCode": { + "id": "Code_9830", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_5695", + "extensionAttributes": [], + "standardCode": { + "id": "Code_5774", + "extensionAttributes": [], + "code": "C62656", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Prothrombin Time", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_53", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_21", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/INRBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "International Normalized Ratio of Prothrombin Time", + "label": "International Normalized Ratio of Prothrombin Time", + "synonyms": [ + "INR", + "Prothrombin Intl. Normalized Ratio" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64805", + "properties": [ + { + "id": "BiomedicalConceptProperty_111", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [ + { + "id": "ResponseCode_796", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_8079", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9167", + "standardCode": { + "id": "Code_9831", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_112", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_694", + "instanceType": "ResponseCode", + "name": "RATIO", + "label": "RATIO", + "isEnabled": true, + "code": { + "id": "Code_6863", + "extensionAttributes": [], + "code": "C44256", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "RATIO", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9168", + "standardCode": { + "id": "Code_9832", + "extensionAttributes": [], + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_113", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_695", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_6865", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9169", + "standardCode": { + "id": "Code_9833", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_114", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9170", + "standardCode": { + "id": "Code_9834", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_5696", + "extensionAttributes": [], + "standardCode": { + "id": "Code_5775", + "extensionAttributes": [], + "code": "C64805", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "International Normalized Ratio of Prothrombin Time", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_54", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_22", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/APTTBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Activated Partial Thromboplastin Time", + "label": "Activated Partial Thromboplastin Time", + "synonyms": [ + "APTT" + ], + "reference": "/mdr/bc/biomedicalconcepts/C38462", + "properties": [ + { + "id": "BiomedicalConceptProperty_115", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_9171", + "standardCode": { + "id": "Code_9835", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_116", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_942", + "instanceType": "ResponseCode", + "name": "s", + "label": "s", + "isEnabled": true, + "code": { + "id": "Code_9585", + "extensionAttributes": [], + "code": "C42535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "s", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9172", + "standardCode": { + "id": "Code_9836", + "extensionAttributes": [], + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_117", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_943", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_9587", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9173", + "standardCode": { + "id": "Code_9837", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_118", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9174", + "standardCode": { + "id": "Code_9838", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_776", + "extensionAttributes": [], + "standardCode": { + "id": "Code_816", + "extensionAttributes": [], + "code": "C38462", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Activated Partial Thromboplastin Time", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_55", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_23", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/GLUCBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Glucose Measurement", + "label": "Glucose Measurement", + "synonyms": [ + "Glucose" + ], + "reference": "/mdr/bc/biomedicalconcepts/C105585", + "properties": [ + { + "id": "BiomedicalConceptProperty_242", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9300", + "standardCode": { + "id": "Code_9975", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_243", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9301", + "standardCode": { + "id": "Code_9976", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_244", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_949", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_9978", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9302", + "standardCode": { + "id": "Code_9977", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_245", + "extensionAttributes": [], + "name": "LBMETHOD", + "label": "LBMETHOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9304", + "standardCode": { + "id": "Code_9979", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_246", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_9305", + "standardCode": { + "id": "Code_9980", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_247", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9306", + "standardCode": { + "id": "Code_9981", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_777", + "extensionAttributes": [], + "standardCode": { + "id": "Code_817", + "extensionAttributes": [], + "code": "C105585", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Glucose Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_56", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_24", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/TRIGSERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Triglyceride Measurement", + "label": "Triglyceride Measurement", + "synonyms": [ + "TRIG", + "Triglycerides" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64812", + "properties": [ + { + "id": "BiomedicalConceptProperty_125", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_9181", + "standardCode": { + "id": "Code_9845", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_126", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9182", + "standardCode": { + "id": "Code_9846", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_127", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_944", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_9598", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9183", + "standardCode": { + "id": "Code_9847", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_128", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_9184", + "standardCode": { + "id": "Code_9848", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_129", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9185", + "standardCode": { + "id": "Code_9849", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_778", + "extensionAttributes": [], + "standardCode": { + "id": "Code_818", + "extensionAttributes": [], + "code": "C64812", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Triglyceride Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_57", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_25", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/CHOLSERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Cholesterol Measurement", + "label": "Cholesterol Measurement", + "synonyms": [ + "CHOL", + "Cholesterol", + "Total Cholesterol" + ], + "reference": "/mdr/bc/biomedicalconcepts/C105586", + "properties": [ + { + "id": "BiomedicalConceptProperty_248", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_9307", + "standardCode": { + "id": "Code_9982", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_249", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9308", + "standardCode": { + "id": "Code_9983", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_250", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_950", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_9985", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9309", + "standardCode": { + "id": "Code_9984", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_251", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_9311", + "standardCode": { + "id": "Code_9986", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_252", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9312", + "standardCode": { + "id": "Code_9987", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_534", + "extensionAttributes": [], + "standardCode": { + "id": "Code_574", + "extensionAttributes": [], + "code": "C105586", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Cholesterol Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_58", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_26", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/HDLSERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "High Density Lipoprotein Cholesterol Measurement", + "label": "High Density Lipoprotein Cholesterol Measurement", + "synonyms": [ + "HDL", + "HDL Cholesterol" + ], + "reference": "/mdr/bc/biomedicalconcepts/C105587", + "properties": [ + { + "id": "BiomedicalConceptProperty_135", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_9191", + "standardCode": { + "id": "Code_9855", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_136", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9192", + "standardCode": { + "id": "Code_9856", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_137", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_868", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_8647", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9193", + "standardCode": { + "id": "Code_9857", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_138", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [ + { + "id": "ResponseCode_884", + "instanceType": "ResponseCode", + "name": "mmHg", + "label": "mmHg", + "isEnabled": true, + "code": { + "id": "Code_9101", + "extensionAttributes": [], + "code": "C49670", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "mmHg", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9194", + "standardCode": { + "id": "Code_9858", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_139", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9195", + "standardCode": { + "id": "Code_9859", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_5697", + "extensionAttributes": [], + "standardCode": { + "id": "Code_5776", + "extensionAttributes": [], + "code": "C105587", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "High Density Lipoprotein Cholesterol Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_59", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_27", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/LDLSERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Low Density Lipoprotein Cholesterol Measurement", + "label": "Low Density Lipoprotein Cholesterol Measurement", + "synonyms": [ + "LDL", + "LDL Cholesterol" + ], + "reference": "/mdr/bc/biomedicalconcepts/C105588", + "properties": [ + { + "id": "BiomedicalConceptProperty_140", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_9196", + "standardCode": { + "id": "Code_9860", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_141", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9197", + "standardCode": { + "id": "Code_9861", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_142", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_869", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_8653", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9198", + "standardCode": { + "id": "Code_9862", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_143", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_9199", + "standardCode": { + "id": "Code_9863", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_144", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [ + { + "id": "ResponseCode_885", + "instanceType": "ResponseCode", + "name": "beats/min", + "label": "beats/min", + "isEnabled": true, + "code": { + "id": "Code_9108", + "extensionAttributes": [], + "code": "C49673", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "beats/min", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9200", + "standardCode": { + "id": "Code_9864", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_7397", + "extensionAttributes": [], + "standardCode": { + "id": "Code_7476", + "extensionAttributes": [], + "code": "C105588", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Low Density Lipoprotein Cholesterol Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_60", + "extensionAttributes": [], + "name": "ECOG Clinical Classification Question", + "label": "ECOG Clinical Classification Question", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/C101874", + "properties": [], + "code": { + "id": "AliasCode_779", + "extensionAttributes": [], + "standardCode": { + "id": "Code_819", + "extensionAttributes": [], + "code": "C101874", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "ECOG Clinical Classification Question", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_61", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_28", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/WBCBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Leukocyte Count", + "label": "Leukocyte Count", + "synonyms": [ + "WBC", + "White Blood Cells" + ], + "reference": "/mdr/bc/biomedicalconcepts/C51948", + "properties": [ + { + "id": "BiomedicalConceptProperty_145", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_9201", + "standardCode": { + "id": "Code_9865", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_146", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9202", + "standardCode": { + "id": "Code_9866", + "extensionAttributes": [], + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_147", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_870", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_8659", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9203", + "standardCode": { + "id": "Code_9867", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_148", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_9204", + "standardCode": { + "id": "Code_9868", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_149", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9205", + "standardCode": { + "id": "Code_9869", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_5698", + "extensionAttributes": [], + "standardCode": { + "id": "Code_5777", + "extensionAttributes": [], + "code": "C51948", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Leukocyte Count", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_62", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_29", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/RBCBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Erythrocyte Count", + "label": "Erythrocyte Count", + "synonyms": [ + "RBC", + "Red Blood Cells" + ], + "reference": "/mdr/bc/biomedicalconcepts/C51946", + "properties": [ + { + "id": "BiomedicalConceptProperty_150", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_9206", + "standardCode": { + "id": "Code_9870", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_151", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9207", + "standardCode": { + "id": "Code_9871", + "extensionAttributes": [], + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_152", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_871", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_8665", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9208", + "standardCode": { + "id": "Code_9872", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_153", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_9209", + "standardCode": { + "id": "Code_9873", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_154", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9210", + "standardCode": { + "id": "Code_9874", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_780", + "extensionAttributes": [], + "standardCode": { + "id": "Code_820", + "extensionAttributes": [], + "code": "C51946", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Erythrocyte Count", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_63", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_30", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/PLATBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Platelet Count", + "label": "Platelet Count", + "synonyms": [ + "Thrombocytes", + "Platelets", + "Anucleated Thrombocytes" + ], + "reference": "/mdr/bc/biomedicalconcepts/C51951", + "properties": [ + { + "id": "BiomedicalConceptProperty_155", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_9211", + "standardCode": { + "id": "Code_9875", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_156", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9212", + "standardCode": { + "id": "Code_9876", + "extensionAttributes": [], + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_157", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_872", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_8671", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9213", + "standardCode": { + "id": "Code_9877", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_158", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [ + { + "id": "ResponseCode_886", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_9123", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9214", + "standardCode": { + "id": "Code_9878", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_159", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9215", + "standardCode": { + "id": "Code_9879", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_5699", + "extensionAttributes": [], + "standardCode": { + "id": "Code_5778", + "extensionAttributes": [], + "code": "C51951", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Platelet Count", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_64", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_31", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/KBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Potassium Measurement", + "label": "Potassium Measurement", + "synonyms": [ + "Potassium", + "K" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64853", + "properties": [ + { + "id": "BiomedicalConceptProperty_253", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_9313", + "standardCode": { + "id": "Code_9988", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_254", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9314", + "standardCode": { + "id": "Code_9989", + "extensionAttributes": [], + "code": "C64567", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Molarity Unit", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_255", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_951", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_9991", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9315", + "standardCode": { + "id": "Code_9990", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_256", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_9317", + "standardCode": { + "id": "Code_9992", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_257", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9318", + "standardCode": { + "id": "Code_9993", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_5700", + "extensionAttributes": [], + "standardCode": { + "id": "Code_5779", + "extensionAttributes": [], + "code": "C64853", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Potassium Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_65", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_32", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/SODIUMBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Sodium Measurement", + "label": "Sodium Measurement", + "synonyms": [ + "Sodium", + "NA" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64809", + "properties": [ + { + "id": "BiomedicalConceptProperty_258", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_9319", + "standardCode": { + "id": "Code_9994", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_259", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9320", + "standardCode": { + "id": "Code_9995", + "extensionAttributes": [], + "code": "C64567", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Molarity Unit", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_260", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_952", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_9997", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9321", + "standardCode": { + "id": "Code_9996", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_261", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_9323", + "standardCode": { + "id": "Code_9998", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_262", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9324", + "standardCode": { + "id": "Code_9999", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_5701", + "extensionAttributes": [], + "standardCode": { + "id": "Code_5780", + "extensionAttributes": [], + "code": "C64809", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Sodium Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_66", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_33", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/CLBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Chloride Measurement", + "label": "Chloride Measurement", + "synonyms": [ + "Chloride", + "CL" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64495", + "properties": [ + { + "id": "BiomedicalConceptProperty_170", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_9226", + "standardCode": { + "id": "Code_9890", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_171", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_634", + "instanceType": "ResponseCode", + "name": "URINE", + "label": "URINE", + "isEnabled": true, + "code": { + "id": "Code_6447", + "extensionAttributes": [], + "code": "C13283", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "URINE", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9227", + "standardCode": { + "id": "Code_9891", + "extensionAttributes": [], + "code": "C64567", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Molarity Unit", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_172", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_779", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_7665", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9228", + "standardCode": { + "id": "Code_9892", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_173", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [ + { + "id": "ResponseCode_888", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_9140", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9229", + "standardCode": { + "id": "Code_9893", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_174", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9230", + "standardCode": { + "id": "Code_9894", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_5702", + "extensionAttributes": [], + "standardCode": { + "id": "Code_5781", + "extensionAttributes": [], + "code": "C64495", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Chloride Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_67", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_34", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/CO2BLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Carbon Dioxide Measurement", + "label": "Carbon Dioxide Measurement", + "synonyms": [ + "Carbon Dioxide", + "CO2" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64545", + "properties": [ + { + "id": "BiomedicalConceptProperty_263", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_9325", + "standardCode": { + "id": "Code_10000", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_264", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9326", + "standardCode": { + "id": "Code_10001", + "extensionAttributes": [], + "code": "C64567", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Molarity Unit", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_265", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_953", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_10003", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9327", + "standardCode": { + "id": "Code_10002", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_266", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_9329", + "standardCode": { + "id": "Code_10004", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_267", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9330", + "standardCode": { + "id": "Code_10005", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_5703", + "extensionAttributes": [], + "standardCode": { + "id": "Code_5782", + "extensionAttributes": [], + "code": "C64545", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Carbon Dioxide Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_68", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_35", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/CABLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Calcium Measurement", + "label": "Calcium Measurement", + "synonyms": [ + "Calcium", + "CA" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64488", + "properties": [ + { + "id": "BiomedicalConceptProperty_180", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_584", + "instanceType": "ResponseCode", + "name": "URINE", + "label": "URINE", + "isEnabled": true, + "code": { + "id": "Code_5996", + "extensionAttributes": [], + "code": "C13283", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "URINE", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9236", + "standardCode": { + "id": "Code_9900", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_181", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9237", + "standardCode": { + "id": "Code_9901", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_182", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_945", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_9654", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9238", + "standardCode": { + "id": "Code_9902", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_183", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_9239", + "standardCode": { + "id": "Code_9903", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_184", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9240", + "standardCode": { + "id": "Code_9904", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_5704", + "extensionAttributes": [], + "standardCode": { + "id": "Code_5783", + "extensionAttributes": [], + "code": "C64488", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Calcium Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_69", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_36", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/UREANSERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Urea Nitrogen Measurement", + "label": "Urea Nitrogen Measurement", + "synonyms": [ + "Urea Nitrogen" + ], + "reference": "/mdr/bc/biomedicalconcepts/C125949", + "properties": [ + { + "id": "BiomedicalConceptProperty_185", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_9241", + "standardCode": { + "id": "Code_9905", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_186", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9242", + "standardCode": { + "id": "Code_9906", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_187", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_946", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_9660", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9243", + "standardCode": { + "id": "Code_9907", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_188", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_9244", + "standardCode": { + "id": "Code_9908", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_189", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9245", + "standardCode": { + "id": "Code_9909", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_5705", + "extensionAttributes": [], + "standardCode": { + "id": "Code_5784", + "extensionAttributes": [], + "code": "C125949", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Urea Nitrogen Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_70", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_37", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/PROTSERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Total Protein Measurement", + "label": "Total Protein Measurement", + "synonyms": [ + "Protein" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64858", + "properties": [ + { + "id": "BiomedicalConceptProperty_268", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_9331", + "standardCode": { + "id": "Code_10006", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_269", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9332", + "standardCode": { + "id": "Code_10007", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_270", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_954", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_10009", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9333", + "standardCode": { + "id": "Code_10008", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_271", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_9335", + "standardCode": { + "id": "Code_10010", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_272", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9336", + "standardCode": { + "id": "Code_10011", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_5706", + "extensionAttributes": [], + "standardCode": { + "id": "Code_5785", + "extensionAttributes": [], + "code": "C64858", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Total Protein Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_71", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_38", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/ALPSERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Alkaline Phosphatase Measurement", + "label": "Alkaline Phosphatase Measurement", + "synonyms": [ + "Alkaline Phosphatase" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64432", + "properties": [ + { + "id": "BiomedicalConceptProperty_195", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_9251", + "standardCode": { + "id": "Code_9915", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_196", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_893", + "instanceType": "ResponseCode", + "name": "URINE", + "label": "URINE", + "isEnabled": true, + "code": { + "id": "Code_9168", + "extensionAttributes": [], + "code": "C13283", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "URINE", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9252", + "standardCode": { + "id": "Code_9916", + "extensionAttributes": [], + "code": "C67365", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_197", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_874", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_8713", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9253", + "standardCode": { + "id": "Code_9917", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_198", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_9254", + "standardCode": { + "id": "Code_9918", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_199", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [ + { + "id": "ResponseCode_894", + "instanceType": "ResponseCode", + "name": "URINE", + "label": "URINE", + "isEnabled": true, + "code": { + "id": "Code_9172", + "extensionAttributes": [], + "code": "C13283", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "URINE", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9255", + "standardCode": { + "id": "Code_9919", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_5707", + "extensionAttributes": [], + "standardCode": { + "id": "Code_5786", + "extensionAttributes": [], + "code": "C64432", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Alkaline Phosphatase Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_72", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_39", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/URATESERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Urate Measurement", + "label": "Urate Measurement", + "synonyms": [ + "Urate", + "Uric Acid" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64814", + "properties": [ + { + "id": "BiomedicalConceptProperty_273", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9337", + "standardCode": { + "id": "Code_10012", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_274", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9338", + "standardCode": { + "id": "Code_10013", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_275", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_955", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_10015", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9339", + "standardCode": { + "id": "Code_10014", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_276", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_9341", + "standardCode": { + "id": "Code_10016", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_277", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9342", + "standardCode": { + "id": "Code_10017", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_717", + "extensionAttributes": [], + "standardCode": { + "id": "Code_757", + "extensionAttributes": [], + "code": "C64814", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Urate Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_73", + "extensionAttributes": [], + "name": "Tumor Size Measurement", + "label": "Tumor Size Measurement", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/C106303", + "properties": [ + { + "id": "BiomedicalConceptProperty_205", + "extensionAttributes": [], + "name": "Anatomic Site", + "label": "Anatomic Site", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9261", + "standardCode": { + "id": "Code_9925", + "extensionAttributes": [], + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Anatomic Site", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_206", + "extensionAttributes": [], + "name": "Observation Result", + "label": "Observation Result", + "isRequired": true, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [ + { + "id": "ResponseCode_637", + "instanceType": "ResponseCode", + "name": "s", + "label": "s", + "isEnabled": true, + "code": { + "id": "Code_6485", + "extensionAttributes": [], + "code": "C42535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "s", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9262", + "standardCode": { + "id": "Code_9926", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_207", + "extensionAttributes": [], + "name": "Category", + "label": "Category", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9263", + "standardCode": { + "id": "Code_9927", + "extensionAttributes": [], + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Category", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_208", + "extensionAttributes": [], + "name": "Subcategory", + "label": "Subcategory", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9264", + "standardCode": { + "id": "Code_9928", + "extensionAttributes": [], + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Subcategory", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_209", + "extensionAttributes": [], + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9265", + "standardCode": { + "id": "Code_9929", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_210", + "extensionAttributes": [], + "name": "Specimen Anatomic Site", + "label": "Specimen Anatomic Site", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9266", + "standardCode": { + "id": "Code_9930", + "extensionAttributes": [], + "code": "C171435", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Specimen Anatomic Site", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_211", + "extensionAttributes": [], + "name": "Biospecimen Type", + "label": "Biospecimen Type", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9267", + "standardCode": { + "id": "Code_9931", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_212", + "extensionAttributes": [], + "name": "Unit of Length", + "label": "Unit of Length", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_812", + "instanceType": "ResponseCode", + "name": "s", + "label": "s", + "isEnabled": true, + "code": { + "id": "Code_8196", + "extensionAttributes": [], + "code": "C42535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "s", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9268", + "standardCode": { + "id": "Code_9932", + "extensionAttributes": [], + "code": "C42578", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Unit of Length", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_5708", + "extensionAttributes": [], + "standardCode": { + "id": "Code_5787", + "extensionAttributes": [], + "code": "C106303", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Tumor Size Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_74", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_40", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/TUMERGE", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Tumor Identification", + "label": "Tumor Identification", + "synonyms": [ + "TUMIDENT" + ], + "reference": "/mdr/bc/biomedicalconcepts/C94523", + "properties": [ + { + "id": "BiomedicalConceptProperty_278", + "extensionAttributes": [], + "name": "TUORRES", + "label": "TUORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_956", + "instanceType": "ResponseCode", + "name": "TARGET", + "label": "TARGET", + "isEnabled": true, + "code": { + "id": "Code_10019", + "extensionAttributes": [], + "code": "C94520", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "TARGET", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9343", + "standardCode": { + "id": "Code_10018", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_279", + "extensionAttributes": [], + "name": "TULOC", + "label": "TULOC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9345", + "standardCode": { + "id": "Code_10020", + "extensionAttributes": [], + "code": "C170500", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Result Anatomical Location", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_280", + "extensionAttributes": [], + "name": "TULAT", + "label": "TULAT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9346", + "standardCode": { + "id": "Code_10021", + "extensionAttributes": [], + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_281", + "extensionAttributes": [], + "name": "TUDIR", + "label": "TUDIR", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9347", + "standardCode": { + "id": "Code_10022", + "extensionAttributes": [], + "code": "C54215", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Directionality", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_282", + "extensionAttributes": [], + "name": "TUMETHOD", + "label": "TUMETHOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9348", + "standardCode": { + "id": "Code_10023", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_283", + "extensionAttributes": [], + "name": "TUEVAL", + "label": "TUEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9349", + "standardCode": { + "id": "Code_10024", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_284", + "extensionAttributes": [], + "name": "TUEVALID", + "label": "TUEVALID", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9350", + "standardCode": { + "id": "Code_10025", + "extensionAttributes": [], + "code": "C117043", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator Identifier", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_285", + "extensionAttributes": [], + "name": "TUREFID", + "label": "TUREFID", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9351", + "standardCode": { + "id": "Code_10026", + "extensionAttributes": [], + "code": "C117442", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Identifier Reference Identifier", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_286", + "extensionAttributes": [], + "name": "TULNKID", + "label": "TULNKID", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9352", + "standardCode": { + "id": "Code_10027", + "extensionAttributes": [], + "code": "C117436", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Identifier Link Identifier", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_287", + "extensionAttributes": [], + "name": "TUDTC", + "label": "TUDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9353", + "standardCode": { + "id": "Code_10028", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_5709", + "extensionAttributes": [], + "standardCode": { + "id": "Code_5788", + "extensionAttributes": [], + "code": "C94523", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Identification", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_75", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_41", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/NTRGRESP", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Response in Non-Target Lesion", + "label": "Response in Non-Target Lesion", + "synonyms": [ + "NTRGRESP", + "Non-Target Response" + ], + "reference": "/mdr/bc/biomedicalconcepts/C94535", + "properties": [ + { + "id": "BiomedicalConceptProperty_223", + "extensionAttributes": [], + "name": "RSORRES", + "label": "RSORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9279", + "standardCode": { + "id": "Code_9943", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_224", + "extensionAttributes": [], + "name": "RSEVAL", + "label": "RSEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9280", + "standardCode": { + "id": "Code_9944", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_225", + "extensionAttributes": [], + "name": "RSEVALID", + "label": "RSEVALID", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9281", + "standardCode": { + "id": "Code_9945", + "extensionAttributes": [], + "code": "C117043", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator Identifier", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_226", + "extensionAttributes": [], + "name": "RSDTC", + "label": "RSDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9282", + "standardCode": { + "id": "Code_9946", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_5710", + "extensionAttributes": [], + "standardCode": { + "id": "Code_5789", + "extensionAttributes": [], + "code": "C94535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-06-27", + "decode": "Response in Non-Target Lesion", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_76", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_42", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/TRGRESP", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Response in Target Lesion", + "label": "Response in Target Lesion", + "synonyms": [ + "TRGRESP", + "Target Response" + ], + "reference": "/mdr/bc/biomedicalconcepts/C94534", + "properties": [ + { + "id": "BiomedicalConceptProperty_227", + "extensionAttributes": [], + "name": "RSORRES", + "label": "RSORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9283", + "standardCode": { + "id": "Code_9947", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_228", + "extensionAttributes": [], + "name": "RSEVAL", + "label": "RSEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9284", + "standardCode": { + "id": "Code_9948", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_229", + "extensionAttributes": [], + "name": "RSEVALID", + "label": "RSEVALID", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9285", + "standardCode": { + "id": "Code_9949", + "extensionAttributes": [], + "code": "C117043", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator Identifier", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_230", + "extensionAttributes": [], + "name": "RSDTC", + "label": "RSDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_9286", + "standardCode": { + "id": "Code_9950", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_5711", + "extensionAttributes": [], + "standardCode": { + "id": "Code_5790", + "extensionAttributes": [], + "code": "C94534", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-06-27", + "decode": "Response in Target Lesion", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_77", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_43", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/OVRLRESP", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Overall Response", + "label": "Overall Response", + "synonyms": [ + "OVRLRESP" + ], + "reference": "/mdr/bc/biomedicalconcepts/C96613", + "properties": [ + { + "id": "BiomedicalConceptProperty_231", + "extensionAttributes": [], + "name": "RSLNKGRP", + "label": "RSLNKGRP", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9287", + "standardCode": { + "id": "Code_9951", + "extensionAttributes": [], + "code": "C117394", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Disease Response Link Group", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_232", + "extensionAttributes": [], + "name": "RSORRES", + "label": "RSORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9288", + "standardCode": { + "id": "Code_9952", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_233", + "extensionAttributes": [], + "name": "RSEVAL", + "label": "RSEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_9289", + "standardCode": { + "id": "Code_9953", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_234", + "extensionAttributes": [], + "name": "RSEVALID", + "label": "RSEVALID", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_897", + "instanceType": "ResponseCode", + "name": "RANDOM", + "label": "RANDOM", + "isEnabled": true, + "code": { + "id": "Code_9210", + "extensionAttributes": [], + "code": "C25196", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "RANDOM", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9290", + "standardCode": { + "id": "Code_9954", + "extensionAttributes": [], + "code": "C117043", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator Identifier", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_235", + "extensionAttributes": [], + "name": "RSDTC", + "label": "RSDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [ + { + "id": "ResponseCode_898", + "instanceType": "ResponseCode", + "name": "Trial is Randomized", + "label": "Trial is Randomized", + "isEnabled": true, + "code": { + "id": "Code_9212", + "extensionAttributes": [], + "code": "C25196", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial is Randomized", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_9291", + "standardCode": { + "id": "Code_9955", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_763", + "extensionAttributes": [], + "standardCode": { + "id": "Code_803", + "extensionAttributes": [], + "code": "C96613", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-06-27", + "decode": "Overall Response", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + } + ], + "bcSurrogates": [ + { + "id": "BiomedicalConceptSurrogate_1", + "extensionAttributes": [], + "name": "Magnesium Measurement", + "label": "Magnesium Measurement (C64840)", + "description": "A quantitative measurement of the amount of magnesium present in a sample.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C64840", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_2", + "extensionAttributes": [], + "name": "Hepatitis B DNA Measurement", + "label": "Hepatitis B DNA Measurement (C103404)", + "description": "A measurement of the Hepatitis B virus DNA in a biological specimen", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103404", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_3", + "extensionAttributes": [], + "name": "Hepatitis B Surface Antigen", + "label": "Hepatitis B Virus Surface Antigen Measurement (C64850)", + "description": "A measurement of the surface antigen reaction of a biological specimen to the Hepatitis B virus.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C64850", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_4", + "extensionAttributes": [], + "name": "HBsAb+", + "label": "Hepatitis B Surface Antibody Positive (C153243)", + "description": "An indication that antibodies that recognize a hepatitis B virus surface protein have been detected in a sample.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C153243", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_5", + "extensionAttributes": [], + "name": "HBsAb-", + "label": "Hepatitis B Surface Antibody Negative (C153244)", + "description": "An indication that antibodies that recognize a hepatitis B virus surface protein have not been detected in a sample.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C153244", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_6", + "extensionAttributes": [], + "name": "HCV RNA Positive", + "label": "HCV RNA Positive (C162042)", + "description": "An indication that hepatitis C RNA has been detected in a sample.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C162042", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_7", + "extensionAttributes": [], + "name": "PFTs with DLCO", + "label": "Pulmonary function tests (PFTs) that include DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide) (C38081)", + "description": "A broad range of tests that are performed to assess how well lungs inhale and exhale air and how efficiently they transfer oxygen into the blood.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C38081", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_8", + "extensionAttributes": [], + "name": "Dietary Phosphorus Measurement", + "label": "Dietary Phosphorus Measurement (C184481)", + "description": "A determination of the phosphorus in a nutritional product or meal, or a portion thereof.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C184481", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_19", + "extensionAttributes": [], + "name": "Adherence", + "label": "Adherence (C25729)", + "description": "The act of abiding by a stated treatment plan or protocol.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C25729", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_20", + "extensionAttributes": [], + "name": "Patient Compliance", + "label": "Patient Compliance (C39490)", + "description": "The extent to which a patient conforms to medical advice regarding prescribed regimen, lifestyle, dietary changes, follow-up schedule and other recommendations.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C39490", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_21", + "extensionAttributes": [], + "name": "Compliance Monitoring", + "label": "Compliance Monitoring (C62737)", + "description": "The act of continuously assessing whether an individual is adhering to their treatment plan.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C62737", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_22", + "extensionAttributes": [], + "name": "Non-Compliance With Study Drug", + "label": "Non-Compliance With Study Drug (C49631)", + "description": "An indication that a subject has not agreed with or followed the instructions related to the study medication. (NCI)", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C49631", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_23", + "extensionAttributes": [], + "name": "Non-Compliance with Study Product", + "label": "Non-Compliance with Study Product (C210354)", + "description": "An indication that a subject has not agreed with or followed the instructions related to the study product.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C210354", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_24", + "extensionAttributes": [], + "name": "Trial Compliance", + "label": "Trial Compliance (C142734)", + "description": "Adherence to clinical trial-related requirements, good clinical practice (GCP) requirements, and the applicable regulatory requirements. (ICH)", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C142734", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + } + ], + "bcCategories": [], + "eligibilityCriterionItems": [], + "narrativeContentItems": [], + "abbreviations": [], + "administrableProducts": [], + "medicalDevices": [], + "productOrganizationRoles": [], + "dictionaries": [], + "conditions": [], + "notes": [], + "instanceType": "StudyVersion" + } + ], + "documentedBy": [], + "instanceType": "Study" + }, + "usdmVersion": "4.0", + "systemName": "SOA Workbench", + "systemVersion": "1.4.0" +} diff --git a/data/soa_workbench/protocols/LZZT/H2Q-MC-LZZT-define-latest.json b/data/soa_workbench/protocols/LZZT/H2Q-MC-LZZT-define-latest.json new file mode 100644 index 0000000..dda9aec --- /dev/null +++ b/data/soa_workbench/protocols/LZZT/H2Q-MC-LZZT-define-latest.json @@ -0,0 +1,33559 @@ +{ + "OID": "MDV.LZZT - Pilot.Version1.Design1", + "name": "MDV LZZT - Pilot", + "description": "Data Definitions for LZZT - Pilot", + "fileOID": "ODM.DEFINE-JSON.LZZT - Pilot.Version1.Design1", + "creationDateTime": "2026-06-18T15:21:31.605476+00:00", + "odmVersion": "1.3.2", + "fileType": "Snapshot", + "originator": "Define-JSON Processor", + "context": "Other", + "defineVersion": "2.1.0", + "studyOID": "ODM.LZZT - Pilot.Version1.Design1", + "studyName": "LZZT - Pilot", + "studyDescription": "Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer's Disease", + "protocolName": "LZZT - Pilot", + "itemGroups": [ + { + "OID": "IG.DS", + "name": "DS", + "description": "Disposition", + "domain": "DS", + "purpose": "Tabulation", + "structure": "One record per disposition status or protocol milestone per subject", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "DSSEQ" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "EVENTS" + }, + "items": [ + { + "OID": "IT.DS.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.DS.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.DS.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.DS.DSSEQ", + "mandatory": true, + "name": "DSSEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.DS.DSTERM", + "mandatory": true, + "name": "DSTERM", + "description": "Reported Term for the Disposition Event", + "role": "Topic", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_2", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.DS.DSDECOD", + "mandatory": true, + "name": "DSDECOD", + "description": "Standardized Disposition Term", + "role": "Synonym Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_1", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.NCOMPLT" + }, + { + "OID": "IT.DS.DSCAT", + "mandatory": false, + "name": "DSCAT", + "description": "Category for Disposition Event", + "role": "Grouping Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.DSCAT" + }, + { + "OID": "IT.DS.DSSCAT", + "mandatory": false, + "name": "DSSCAT", + "description": "Subcategory for Disposition Event", + "role": "Grouping Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.DSSCAT" + }, + { + "OID": "IT.DS.DSSTDTC", + "mandatory": false, + "name": "DSSTDTC", + "description": "Start Date/Time of Disposition Event", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_3", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.DS.DSSTDY", + "mandatory": false, + "name": "DSSTDY", + "description": "Study Day of Start of Disposition Event", + "role": "Timing", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + } + ], + "implementsConcept": "CONC.BiomedicalConcept_1" + }, + { + "OID": "IG.IE", + "name": "IE", + "description": "Inclusion/Exclusion Criteria Not Met", + "domain": "IE", + "purpose": "Tabulation", + "structure": "One record per inclusion/exclusion criterion not met per subject", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "IESEQ" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "FINDINGS" + }, + "items": [ + { + "OID": "IT.IE.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.IE.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.IE.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.IE.IESEQ", + "mandatory": true, + "name": "IESEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.IE.IETESTCD", + "mandatory": true, + "name": "IETESTCD", + "description": "Inclusion/Exclusion Criterion Short Name", + "role": "Topic", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.IE.IETEST", + "mandatory": true, + "name": "IETEST", + "description": "Inclusion/Exclusion Criterion", + "role": "Synonym Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.IE.IECAT", + "mandatory": true, + "name": "IECAT", + "description": "Inclusion/Exclusion Category", + "role": "Grouping Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.IECAT" + }, + { + "OID": "IT.IE.IEORRES", + "mandatory": true, + "name": "IEORRES", + "description": "I/E Criterion Original Result", + "role": "Result Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_5", + "dataType": "text", + "length": 1, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY" + }, + { + "OID": "IT.IE.IESTRESC", + "mandatory": true, + "name": "IESTRESC", + "description": "I/E Criterion Result in Std Format", + "role": "Result Qualifier", + "dataType": "text", + "length": 1, + "origin": { + "type": "Derived", + "source": "Sponsor" + }, + "codeList": "CL.NY" + }, + { + "OID": "IT.IE.IEDTC", + "mandatory": false, + "name": "IEDTC", + "description": "Date/Time of Collection", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_6", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + } + ], + "implementsConcept": "CONC.BiomedicalConcept_2" + }, + { + "OID": "IG.SC", + "name": "SC", + "description": "Subject Characteristics", + "domain": "SC", + "purpose": "Tabulation", + "structure": "One record per characteristic per visit per subject.", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "SCSEQ" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "FINDINGS" + }, + "items": [ + { + "OID": "IT.SC.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.SC.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.SC.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.SC.SCSEQ", + "mandatory": true, + "name": "SCSEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.SC.SCTESTCD", + "mandatory": true, + "name": "SCTESTCD", + "description": "Subject Characteristic Short Name", + "role": "Topic", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.SCTESTCD" + }, + { + "OID": "IT.SC.SCTEST", + "mandatory": true, + "name": "SCTEST", + "description": "Subject Characteristic", + "role": "Synonym Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.SCTEST" + }, + { + "OID": "IT.SC.SCORRES", + "mandatory": false, + "name": "SCORRES", + "description": "Result or Finding in Original Units", + "role": "Result Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_26", + "dataType": "text", + "length": 100, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.SC.SCORRESU", + "mandatory": false, + "name": "SCORRESU", + "description": "Original Units", + "role": "Variable Qualifier", + "dataType": "text", + "length": 5, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.UNIT" + }, + { + "OID": "IT.SC.SCSTRESC", + "mandatory": false, + "name": "SCSTRESC", + "description": "Character Result/Finding in Std Format", + "role": "Result Qualifier", + "dataType": "text", + "length": 100, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.SC.SCSTRESN", + "mandatory": false, + "name": "SCSTRESN", + "description": "Numeric Result/Finding in Standard Units", + "role": "Result Qualifier", + "dataType": "text", + "length": 100, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.SC.SCSTRESU", + "mandatory": false, + "name": "SCSTRESU", + "description": "Standard Units", + "role": "Variable Qualifier", + "dataType": "text", + "length": 5, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.UNIT" + }, + { + "OID": "IT.SC.SCDTC", + "mandatory": false, + "name": "SCDTC", + "description": "Date/Time of Collection", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_27", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + } + ], + "implementsConcept": "CONC.BiomedicalConcept_11" + }, + { + "OID": "IG.MH", + "name": "MH", + "description": "Medical History", + "domain": "MH", + "purpose": "Tabulation", + "structure": "One record per medical history event per subject", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "MHSEQ" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "EVENTS" + }, + "items": [ + { + "OID": "IT.MH.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.MH.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.MH.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.MH.MHSEQ", + "mandatory": true, + "name": "MHSEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.MH.MHTERM", + "mandatory": true, + "name": "MHTERM", + "description": "Reported Term for the Medical History", + "role": "Topic", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_31", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.MH.MHDECOD", + "mandatory": false, + "name": "MHDECOD", + "description": "Dictionary-Derived Term", + "role": "Synonym Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_32", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.MH.MHCAT", + "mandatory": false, + "name": "MHCAT", + "description": "Category for Medical History", + "role": "Grouping Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.MH.MHSCAT", + "mandatory": false, + "name": "MHSCAT", + "description": "Subcategory for Medical History", + "role": "Grouping Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.MH.MHPRESP", + "mandatory": false, + "name": "MHPRESP", + "description": "Medical History Event Pre-Specified", + "role": "Variable Qualifier", + "dataType": "text", + "length": 1, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.NY" + }, + { + "OID": "IT.MH.MHOCCUR", + "mandatory": false, + "name": "MHOCCUR", + "description": "Medical History Occurrence", + "role": "Record Qualifier", + "dataType": "text", + "length": 1, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY" + }, + { + "OID": "IT.MH.MHSTDTC", + "mandatory": false, + "name": "MHSTDTC", + "description": "Start Date/Time of Medical History Event", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_33", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.MH.MHENDTC", + "mandatory": false, + "name": "MHENDTC", + "description": "End Date/Time of Medical History Event", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_34", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.MH.MHENRF", + "mandatory": false, + "name": "MHENRF", + "description": "End Relative to Reference Period", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_35", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.STENRF" + }, + { + "OID": "IT.MH.MHENRTPT", + "mandatory": false, + "name": "MHENRTPT", + "description": "End Relative to Reference Time Point", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_36", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.STENRF" + }, + { + "OID": "IT.MH.MHENTPT", + "mandatory": false, + "name": "MHENTPT", + "description": "End Reference Time Point", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_37", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + } + ], + "implementsConcept": "CONC.BiomedicalConcept_14" + }, + { + "OID": "IG.SU", + "name": "SU", + "description": "Substance Use", + "domain": "SU", + "purpose": "Tabulation", + "structure": "One record per substance type per reported occurrence per subject", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "SUSEQ" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "INTERVENTIONS" + }, + "items": [ + { + "OID": "IT.SU.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.SU.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.SU.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.SU.SUSEQ", + "mandatory": true, + "name": "SUSEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.SU.SUTRT", + "mandatory": true, + "name": "SUTRT", + "description": "Reported Name of Substance", + "role": "Topic", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_38", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.SU.SUCAT", + "mandatory": false, + "name": "SUCAT", + "description": "Category for Substance Use", + "role": "Grouping Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.SU.SUSCAT", + "mandatory": false, + "name": "SUSCAT", + "description": "Subcategory for Substance Use", + "role": "Grouping Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.SU.SUPRESP", + "mandatory": false, + "name": "SUPRESP", + "description": "SU Pre-Specified", + "role": "Variable Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_39", + "dataType": "text", + "length": 1, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.NY_Y" + }, + { + "OID": "IT.SU.SUOCCUR", + "mandatory": false, + "name": "SUOCCUR", + "description": "SU Occurrence", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_40", + "dataType": "text", + "length": 1, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY_NY" + }, + { + "OID": "IT.SU.SUDOSE", + "mandatory": false, + "name": "SUDOSE", + "description": "Substance Use Consumption", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_41", + "dataType": "float", + "length": 12, + "displayFormat": "12.4", + "significantDigits": 4, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.SU.SUDOSTXT", + "mandatory": false, + "name": "SUDOSTXT", + "description": "Substance Use Consumption Text", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_42", + "dataType": "text", + "length": 40, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.SU.SUDOSU", + "mandatory": false, + "name": "SUDOSU", + "description": "Consumption Units", + "role": "Variable Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_43", + "dataType": "text", + "length": 40, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.UNIT" + }, + { + "OID": "IT.SU.SUDOSFRQ", + "mandatory": false, + "name": "SUDOSFRQ", + "description": "Use Frequency Per Interval", + "role": "Variable Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_44", + "dataType": "text", + "length": 40, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.FREQ" + }, + { + "OID": "IT.SU.SUSTDTC", + "mandatory": false, + "name": "SUSTDTC", + "description": "Start Date/Time of Substance Use", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_45", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.SU.SUENDTC", + "mandatory": false, + "name": "SUENDTC", + "description": "End Date/Time of Substance Use", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_46", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.SU.SUDUR", + "mandatory": false, + "name": "SUDUR", + "description": "Duration of Substance Use", + "role": "Timing", + "dataType": "durationDatetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.SU.SUSTRF", + "mandatory": false, + "name": "SUSTRF", + "description": "Start Relative to Reference Period", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_47", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.STENRF" + }, + { + "OID": "IT.SU.SUENRF", + "mandatory": false, + "name": "SUENRF", + "description": "End Relative to Reference Period", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_50", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.STENRF" + }, + { + "OID": "IT.SU.SUSTRTPT", + "mandatory": false, + "name": "SUSTRTPT", + "description": "Start Relative to Reference Time Point", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_48", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.STENRF" + }, + { + "OID": "IT.SU.SUSTTPT", + "mandatory": false, + "name": "SUSTTPT", + "description": "Start Reference Time Point", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_49", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.SU.SUENRTPT", + "mandatory": false, + "name": "SUENRTPT", + "description": "End Relative to Reference Time Point", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_51", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.STENRF" + }, + { + "OID": "IT.SU.SUENTPT", + "mandatory": false, + "name": "SUENTPT", + "description": "End Reference Time Point", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_52", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + } + ], + "implementsConcept": "CONC.BiomedicalConcept_15" + }, + { + "OID": "IG.PR", + "name": "PR", + "description": "Procedures", + "domain": "PR", + "purpose": "Tabulation", + "structure": "One record per recorded procedure per occurrence per subject", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "PRSEQ" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "INTERVENTIONS" + }, + "items": [ + { + "OID": "IT.PR.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.PR.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.PR.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.PR.PRSEQ", + "mandatory": true, + "name": "PRSEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.PR.PRTRT", + "mandatory": true, + "name": "PRTRT", + "description": "Reported Name of Procedure", + "role": "Topic", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_84", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.PR.PRDECOD", + "mandatory": false, + "name": "PRDECOD", + "description": "Standardized Procedure Name", + "role": "Synonym Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_85", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.PROCEDUR" + }, + { + "OID": "IT.PR.PRCAT", + "mandatory": false, + "name": "PRCAT", + "description": "Category", + "role": "Grouping Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.PR.PRSCAT", + "mandatory": false, + "name": "PRSCAT", + "description": "Subcategory", + "role": "Grouping Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.PR.PRPRESP", + "mandatory": false, + "name": "PRPRESP", + "description": "Pre-specified", + "role": "Variable Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_86", + "dataType": "text", + "length": 1, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.NY_Y" + }, + { + "OID": "IT.PR.PROCCUR", + "mandatory": false, + "name": "PROCCUR", + "description": "Occurrence", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_87", + "dataType": "text", + "length": 1, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY_NY" + }, + { + "OID": "IT.PR.PRLOC", + "mandatory": false, + "name": "PRLOC", + "description": "Location of Procedure", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_88", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.LOC" + }, + { + "OID": "IT.PR.PRSTDTC", + "mandatory": false, + "name": "PRSTDTC", + "description": "Start Date/Time of Procedure", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_89", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.PR.PRENDTC", + "mandatory": false, + "name": "PRENDTC", + "description": "End Date/Time of Procedure", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_90", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + } + ], + "implementsConcept": "CONC.BiomedicalConcept_18" + }, + { + "OID": "IG.VS", + "name": "VS", + "description": "Vital Signs", + "domain": "VS", + "purpose": "Tabulation", + "structure": "One record per vital sign measurement per time point per visit per subject", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "VSSEQ" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "FINDINGS" + }, + "items": [ + { + "OID": "IT.VS.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.VS.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.VS.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.VS.VSSEQ", + "mandatory": true, + "name": "VSSEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.VS.VSTESTCD", + "mandatory": true, + "name": "VSTESTCD", + "description": "Vital Signs Test Short Name", + "role": "Topic", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.VSTESTCD" + }, + { + "OID": "IT.VS.VSTEST", + "mandatory": true, + "name": "VSTEST", + "description": "Vital Signs Test Name", + "role": "Synonym Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.VSTEST" + }, + { + "OID": "IT.VS.VSPOS", + "mandatory": false, + "name": "VSPOS", + "description": "Vital Signs Position of Subject", + "role": "Record Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.POSITION" + }, + { + "OID": "IT.VS.VSORRES", + "mandatory": false, + "name": "VSORRES", + "description": "Result or Finding in Original Units", + "role": "Result Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_94", + "dataType": "float", + "length": 8, + "displayFormat": "8.3", + "significantDigits": 3, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.VS.VSORRESU", + "mandatory": false, + "name": "VSORRESU", + "description": "Original Units", + "role": "Variable Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_95", + "dataType": "text", + "length": 20, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.VSRESU" + }, + { + "OID": "IT.VS.VSSTRESC", + "mandatory": false, + "name": "VSSTRESC", + "description": "Character Result/Finding in Std Format", + "role": "Result Qualifier", + "dataType": "float", + "length": 8, + "displayFormat": "8.3", + "significantDigits": 3, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.VS.VSSTRESN", + "mandatory": false, + "name": "VSSTRESN", + "description": "Numeric Result/Finding in Standard Units", + "role": "Result Qualifier", + "dataType": "float", + "length": 8, + "displayFormat": "8.3", + "significantDigits": 3, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.VS.VSSTRESU", + "mandatory": false, + "name": "VSSTRESU", + "description": "Standard Units", + "role": "Variable Qualifier", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.VSRESU" + }, + { + "OID": "IT.VS.VSLOC", + "mandatory": false, + "name": "VSLOC", + "description": "Location of Vital Signs Measurement", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_96", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.LOC" + }, + { + "OID": "IT.VS.VSLAT", + "mandatory": false, + "name": "VSLAT", + "description": "Laterality", + "role": "Result Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.LAT" + }, + { + "OID": "IT.VS.VSLOBXFL", + "mandatory": false, + "name": "VSLOBXFL", + "description": "Last Observation Before Exposure Flag", + "role": "Record Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY" + }, + { + "OID": "IT.VS.VISITNUM", + "mandatory": false, + "name": "VISITNUM", + "description": "Visit Number", + "role": "Timing", + "dataType": "integer", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.VS.VSDTC", + "mandatory": false, + "name": "VSDTC", + "description": "Date/Time of Measurements", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_97", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + } + ], + "implementsConcept": "CONC.BiomedicalConcept_20" + }, + { + "OID": "IG.EG", + "name": "EG", + "description": "ECG Test Results", + "domain": "EG", + "purpose": "Tabulation", + "structure": "One record per ECG observation per replicate per time point or one record per ECG observation per beat per visit per subject", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "EGSEQ" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "FINDINGS" + }, + "items": [ + { + "OID": "IT.EG.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.EG.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.EG.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.EG.EGSEQ", + "mandatory": true, + "name": "EGSEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.EG.EGTESTCD", + "mandatory": true, + "name": "EGTESTCD", + "description": "ECG Test or Examination Short Name", + "role": "Topic", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.EGTESTCD" + }, + { + "OID": "IT.EG.EGTEST", + "mandatory": true, + "name": "EGTEST", + "description": "ECG Test or Examination Name", + "role": "Synonym Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.EGTEST" + }, + { + "OID": "IT.EG.EGCAT", + "mandatory": false, + "name": "EGCAT", + "description": "Category for ECG", + "role": "Grouping Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.EG.EGPOS", + "mandatory": false, + "name": "EGPOS", + "description": "ECG Position of Subject", + "role": "Record Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.POSITION" + }, + { + "OID": "IT.EG.EGORRES", + "mandatory": false, + "name": "EGORRES", + "description": "Result or Finding in Original Units", + "role": "Result Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_116", + "dataType": "text", + "length": 20, + "origin": { + "type": "Collected", + "source": "Vendor" + } + }, + { + "OID": "IT.EG.EGORRESU", + "mandatory": false, + "name": "EGORRESU", + "description": "Original Units", + "role": "Variable Qualifier", + "dataType": "text", + "length": 20, + "origin": { + "type": "Collected", + "source": "Vendor" + }, + "codeList": "CL.UNIT" + }, + { + "OID": "IT.EG.EGSTRESC", + "mandatory": false, + "name": "EGSTRESC", + "description": "Character Result/Finding in Std Format", + "role": "Result Qualifier", + "dataType": "text", + "length": 20, + "origin": { + "type": "Derived", + "source": "Vendor" + }, + "codeList": "CL.EGSTRESC" + }, + { + "OID": "IT.EG.EGSTRESN", + "mandatory": false, + "name": "EGSTRESN", + "description": "Numeric Result/Finding in Standard Units", + "role": "Result Qualifier", + "dataType": "float", + "length": 8, + "displayFormat": "8.3", + "significantDigits": 3, + "origin": { + "type": "Derived", + "source": "Vendor" + } + }, + { + "OID": "IT.EG.EGSTRESU", + "mandatory": false, + "name": "EGSTRESU", + "description": "Standard Units", + "role": "Variable Qualifier", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Vendor" + }, + "codeList": "CL.UNIT" + }, + { + "OID": "IT.EG.EGMETHOD", + "mandatory": false, + "name": "EGMETHOD", + "description": "Method of Test or Examination", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_117", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.EGMETHOD" + }, + { + "OID": "IT.EG.EGLOBXFL", + "mandatory": false, + "name": "EGLOBXFL", + "description": "Last Observation Before Exposure Flag", + "role": "Record Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY" + }, + { + "OID": "IT.EG.EGEVAL", + "mandatory": false, + "name": "EGEVAL", + "description": "Evaluator", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_118", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.EVAL" + }, + { + "OID": "IT.EG.EGCLSIG", + "mandatory": false, + "name": "EGCLSIG", + "description": "Clinically Significant, Collected", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_119", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY_NY" + }, + { + "OID": "IT.EG.VISITNUM", + "mandatory": false, + "name": "VISITNUM", + "description": "Visit Number", + "role": "Timing", + "dataType": "integer", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.EG.EGDTC", + "mandatory": false, + "name": "EGDTC", + "description": "Date/Time of ECG", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_120", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + } + ], + "implementsConcept": "CONC.BiomedicalConcept_27" + }, + { + "OID": "IG.CM", + "name": "CM", + "description": "Concomitant/Prior Medications", + "domain": "CM", + "purpose": "Tabulation", + "structure": "One record per recorded intervention occurrence or constant-dosing interval per subject", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "CMSEQ" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "INTERVENTIONS" + }, + "items": [ + { + "OID": "IT.CM.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.CM.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.CM.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.CM.CMSEQ", + "mandatory": true, + "name": "CMSEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.CM.CMTRT", + "mandatory": true, + "name": "CMTRT", + "description": "Reported Name of Drug, Med, or Therapy", + "role": "Topic", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_266", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.CM.CMDECOD", + "mandatory": false, + "name": "CMDECOD", + "description": "Standardized Medication Name", + "role": "Synonym Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_267", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.CM.CMCAT", + "mandatory": false, + "name": "CMCAT", + "description": "Category for Medication", + "role": "Grouping Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.CM.CMSCAT", + "mandatory": false, + "name": "CMSCAT", + "description": "Subcategory for Medication", + "role": "Grouping Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.CM.CMPRESP", + "mandatory": false, + "name": "CMPRESP", + "description": "CM Pre-specified", + "role": "Variable Qualifier", + "dataType": "text", + "length": 1, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.NY" + }, + { + "OID": "IT.CM.CMOCCUR", + "mandatory": false, + "name": "CMOCCUR", + "description": "CM Occurrence", + "role": "Record Qualifier", + "dataType": "text", + "length": 1, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY" + }, + { + "OID": "IT.CM.CMINDC", + "mandatory": false, + "name": "CMINDC", + "description": "Indication", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_269", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.CM.CMCLAS", + "mandatory": false, + "name": "CMCLAS", + "description": "Medication Class", + "role": "Variable Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_268", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.CM.CMCLASCD", + "mandatory": false, + "name": "CMCLASCD", + "description": "Medication Class Code", + "role": "Variable Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.CM.CMDOSE", + "mandatory": false, + "name": "CMDOSE", + "description": "Dose per Administration", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_270", + "dataType": "float", + "length": 8, + "displayFormat": "8.3", + "significantDigits": 3, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.CM.CMDOSTXT", + "mandatory": false, + "name": "CMDOSTXT", + "description": "Dose Description", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_271", + "dataType": "text", + "length": 40, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.CM.CMDOSU", + "mandatory": false, + "name": "CMDOSU", + "description": "Dose Units", + "role": "Variable Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_272", + "dataType": "text", + "length": 40, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.UNIT" + }, + { + "OID": "IT.CM.CMDOSFRM", + "mandatory": false, + "name": "CMDOSFRM", + "description": "Dose Form", + "role": "Variable Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_273", + "dataType": "text", + "length": 40, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.FRM" + }, + { + "OID": "IT.CM.CMDOSFRQ", + "mandatory": false, + "name": "CMDOSFRQ", + "description": "Dosing Frequency per Interval", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_274", + "dataType": "text", + "length": 40, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.FREQ" + }, + { + "OID": "IT.CM.CMROUTE", + "mandatory": false, + "name": "CMROUTE", + "description": "Route of Administration", + "role": "Variable Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_275", + "dataType": "text", + "length": 40, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.ROUTE" + }, + { + "OID": "IT.CM.CMSTDTC", + "mandatory": false, + "name": "CMSTDTC", + "description": "Start Date/Time of Medication", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_276", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.CM.CMENDTC", + "mandatory": false, + "name": "CMENDTC", + "description": "End Date/Time of Medication", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_277", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.CM.CMSTRF", + "mandatory": false, + "name": "CMSTRF", + "description": "Start Relative to Reference Period", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_278", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.STENRF" + }, + { + "OID": "IT.CM.CMENRF", + "mandatory": false, + "name": "CMENRF", + "description": "End Relative to Reference Period", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_281", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.STENRF" + }, + { + "OID": "IT.CM.CMSTRTPT", + "mandatory": false, + "name": "CMSTRTPT", + "description": "Start Relative to Reference Time Point", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_279", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.STENRF" + }, + { + "OID": "IT.CM.CMSTTPT", + "mandatory": false, + "name": "CMSTTPT", + "description": "Start Reference Time Point", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_280", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.CM.CMENRTPT", + "mandatory": false, + "name": "CMENRTPT", + "description": "End Relative to Reference Time Point", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_282", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.STENRF" + }, + { + "OID": "IT.CM.CMENTPT", + "mandatory": false, + "name": "CMENTPT", + "description": "End Reference Time Point", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_283", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + } + ], + "implementsConcept": "CONC.BiomedicalConcept_55" + }, + { + "OID": "IG.MB", + "name": "MB", + "description": "Microbiology Specimen", + "domain": "MB", + "purpose": "Tabulation", + "structure": "One record per microbiology specimen finding per time point per visit per subject", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "MBSEQ" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "FINDINGS" + }, + "items": [ + { + "OID": "IT.MB.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.MB.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.MB.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.MB.MBSEQ", + "mandatory": true, + "name": "MBSEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.MB.MBTESTCD", + "mandatory": true, + "name": "MBTESTCD", + "description": "Microbiology Test or Finding Short Name", + "role": "Topic", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.MBTESTCD" + }, + { + "OID": "IT.MB.MBTEST", + "mandatory": true, + "name": "MBTEST", + "description": "Microbiology Test or Finding Name", + "role": "Synonym Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.MBTEST" + }, + { + "OID": "IT.MB.MBTSTDTL", + "mandatory": false, + "name": "MBTSTDTL", + "description": "Measurement, Test or Examination Detail", + "role": "Variable Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_494", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.MBFTSDTL" + }, + { + "OID": "IT.MB.MBORRES", + "mandatory": false, + "name": "MBORRES", + "description": "Result or Finding in Original Units", + "role": "Result Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_495", + "dataType": "text", + "length": 20, + "origin": { + "type": "Collected", + "source": "Vendor" + } + }, + { + "OID": "IT.MB.MBSTRESC", + "mandatory": false, + "name": "MBSTRESC", + "description": "Result or Finding in Standard Format", + "role": "Result Qualifier", + "dataType": "text", + "length": 20, + "origin": { + "type": "Derived", + "source": "Vendor" + } + }, + { + "OID": "IT.MB.MBSPEC", + "mandatory": false, + "name": "MBSPEC", + "description": "Specimen Material Type", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_496", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.SPECTYPE" + }, + { + "OID": "IT.MB.MBMETHOD", + "mandatory": false, + "name": "MBMETHOD", + "description": "Method of Test or Examination", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_497", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.METHOD" + }, + { + "OID": "IT.MB.VISITNUM", + "mandatory": false, + "name": "VISITNUM", + "description": "Visit Number", + "role": "Timing", + "dataType": "integer", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.MB.MBDTC", + "mandatory": false, + "name": "MBDTC", + "description": "Date/Time of Collection", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_498", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + } + ], + "implementsConcept": "CONC.BiomedicalConcept_99" + }, + { + "OID": "IG.UR", + "name": "UR", + "description": "Urinary System Findings", + "domain": "UR", + "purpose": "Tabulation", + "structure": "One record per finding per location per per visit per subject", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "URSEQ" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "FINDINGS" + }, + "items": [ + { + "OID": "IT.UR.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.UR.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.UR.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.UR.URSEQ", + "mandatory": true, + "name": "URSEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.UR.URTESTCD", + "mandatory": true, + "name": "URTESTCD", + "description": "Short Name of Urinary Test", + "role": "Topic", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.URNSTSCD" + }, + { + "OID": "IT.UR.URTEST", + "mandatory": true, + "name": "URTEST", + "description": "Name of Urinary Test", + "role": "Synonym Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.URNSTS" + }, + { + "OID": "IT.UR.URORRES", + "mandatory": false, + "name": "URORRES", + "description": "Result or Finding in Original Units", + "role": "Result Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.UR.URSTRESC", + "mandatory": false, + "name": "URSTRESC", + "description": "Character Result/Finding in Std Format", + "role": "Result Qualifier", + "dataType": "text", + "length": 2, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.UR.URMETHOD", + "mandatory": false, + "name": "URMETHOD", + "description": "Method of Test or Examination", + "role": "Record Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.METHOD" + }, + { + "OID": "IT.UR.URLOBXFL", + "mandatory": false, + "name": "URLOBXFL", + "description": "Last Observation Before Exposure Flag", + "role": "Record Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY" + }, + { + "OID": "IT.UR.VISITNUM", + "mandatory": false, + "name": "VISITNUM", + "description": "Visit Number", + "role": "Timing", + "dataType": "integer", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.UR.URDTC", + "mandatory": false, + "name": "URDTC", + "description": "Date/Time of Collection", + "role": "Timing", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + } + ], + "implementsConcept": "CONC.BiomedicalConcept_101" + }, + { + "OID": "IG.EC", + "name": "EC", + "description": "Exposure as Collected", + "domain": "EC", + "purpose": "Tabulation", + "structure": "One record per protocol-specified study treatment, collected-dosing interval, per subject, per mood", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "ECSEQ" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "INTERVENTIONS" + }, + "items": [ + { + "OID": "IT.EC.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.EC.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.EC.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.EC.ECSEQ", + "mandatory": true, + "name": "ECSEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.EC.ECREFID", + "mandatory": false, + "name": "ECREFID", + "description": "Reference ID", + "role": "Identifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_554", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.EC.ECTRT", + "mandatory": true, + "name": "ECTRT", + "description": "Name of Treatment", + "role": "Topic", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_553", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.EC.ECDOSE", + "mandatory": false, + "name": "ECDOSE", + "description": "Dose", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_555", + "dataType": "integer", + "length": 20, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.EC.ECDOSTXT", + "mandatory": false, + "name": "ECDOSTXT", + "description": "Dose Description", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_556", + "dataType": "text", + "length": 100, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.EC.ECDOSU", + "mandatory": false, + "name": "ECDOSU", + "description": "Dose Units", + "role": "Variable Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_557", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.UNIT" + }, + { + "OID": "IT.EC.ECDOSFRM", + "mandatory": false, + "name": "ECDOSFRM", + "description": "Dose Form", + "role": "Variable Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_558", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.FRM" + }, + { + "OID": "IT.EC.ECDOSFRQ", + "mandatory": false, + "name": "ECDOSFRQ", + "description": "Dosing Frequency per Interval", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_559", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.FREQ" + }, + { + "OID": "IT.EC.ECDOSRGM", + "mandatory": false, + "name": "ECDOSRGM", + "description": "Intended Dose Regimen", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_560", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.EC.ECROUTE", + "mandatory": false, + "name": "ECROUTE", + "description": "Route of Administration", + "role": "Variable Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_561", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.ROUTE" + }, + { + "OID": "IT.EC.ECLOC", + "mandatory": false, + "name": "ECLOC", + "description": "Location of Dose Administration", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_562", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.LOC" + }, + { + "OID": "IT.EC.ECLAT", + "mandatory": false, + "name": "ECLAT", + "description": "Laterality", + "role": "Variable Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_563", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.LAT" + }, + { + "OID": "IT.EC.ECDIR", + "mandatory": false, + "name": "ECDIR", + "description": "Directionality", + "role": "Variable Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_564", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.DIR" + }, + { + "OID": "IT.EC.ECSTDTC", + "mandatory": false, + "name": "ECSTDTC", + "description": "Start Date/Time of Treatment", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_565", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.EC.ECENDTC", + "mandatory": false, + "name": "ECENDTC", + "description": "End Date/Time of Treatment", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_566", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + } + ], + "implementsConcept": "CONC.BiomedicalConcept_112" + }, + { + "OID": "IG.QS", + "name": "QS", + "description": "Questionnaires", + "domain": "QS", + "purpose": "Tabulation", + "structure": "One record per questionnaire per question per time point per visit per subject", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "QSSEQ" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "FINDINGS" + }, + "items": [ + { + "OID": "IT.QS.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.QS.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.QS.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.QS.QSSEQ", + "mandatory": true, + "name": "QSSEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.QS.QSTESTCD", + "mandatory": true, + "name": "QSTESTCD", + "description": "Question Short Name", + "role": "Topic", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.QS.QSTEST", + "mandatory": true, + "name": "QSTEST", + "description": "Question Name", + "role": "Synonym Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.QS.QSCAT", + "mandatory": true, + "name": "QSCAT", + "description": "Category of Question", + "role": "Grouping Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.QSCAT" + }, + { + "OID": "IT.QS.QSORRES", + "mandatory": false, + "name": "QSORRES", + "description": "Finding in Original Units", + "role": "Result Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_570", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.QS.QSSTRESC", + "mandatory": false, + "name": "QSSTRESC", + "description": "Character Result/Finding in Std Format", + "role": "Result Qualifier", + "dataType": "integer", + "length": 1, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.QS.QSSTRESN", + "mandatory": false, + "name": "QSSTRESN", + "description": "Numeric Finding in Standard Units", + "role": "Result Qualifier", + "dataType": "integer", + "length": 1, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.QS.QSLOBXFL", + "mandatory": false, + "name": "QSLOBXFL", + "description": "Last Observation Before Exposure Flag", + "role": "Record Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY" + }, + { + "OID": "IT.QS.VISITNUM", + "mandatory": false, + "name": "VISITNUM", + "description": "Visit Number", + "role": "Timing", + "dataType": "integer", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.QS.QSDTC", + "mandatory": false, + "name": "QSDTC", + "description": "Date/Time of Finding", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_571", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + } + ], + "implementsConcept": "CONC.BiomedicalConcept_114" + }, + { + "OID": "IG.AE", + "name": "AE", + "description": "Adverse Events", + "domain": "AE", + "purpose": "Tabulation", + "structure": "One record per adverse event per subject", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "AESEQ" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "EVENTS" + }, + "items": [ + { + "OID": "IT.AE.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.AE.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.AE.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.AE.AESEQ", + "mandatory": true, + "name": "AESEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.AE.AETERM", + "mandatory": true, + "name": "AETERM", + "description": "Reported Term for the Adverse Event", + "role": "Topic", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_584", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.AE.AELLT", + "mandatory": false, + "name": "AELLT", + "description": "Lowest Level Term", + "role": "Variable Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.AE.AELLTCD", + "mandatory": false, + "name": "AELLTCD", + "description": "Lowest Level Term Code", + "role": "Variable Qualifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.AE.AEDECOD", + "mandatory": true, + "name": "AEDECOD", + "description": "Dictionary-Derived Term", + "role": "Synonym Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_585", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.AE.AEPTCD", + "mandatory": false, + "name": "AEPTCD", + "description": "Preferred Term Code", + "role": "Variable Qualifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.AE.AEHLT", + "mandatory": false, + "name": "AEHLT", + "description": "High Level Term", + "role": "Variable Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.AE.AEHLTCD", + "mandatory": false, + "name": "AEHLTCD", + "description": "High Level Term Code", + "role": "Variable Qualifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.AE.AEHLGT", + "mandatory": false, + "name": "AEHLGT", + "description": "High Level Group Term", + "role": "Variable Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.AE.AEHLGTCD", + "mandatory": false, + "name": "AEHLGTCD", + "description": "High Level Group Term Code", + "role": "Variable Qualifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.AE.AECAT", + "mandatory": false, + "name": "AECAT", + "description": "Category for Adverse Event", + "role": "Grouping Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.AE.AESCAT", + "mandatory": false, + "name": "AESCAT", + "description": "Subcategory for Adverse Event", + "role": "Grouping Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.AE.AEPRESP", + "mandatory": false, + "name": "AEPRESP", + "description": "Pre-Specified Adverse Event", + "role": "Variable Qualifier", + "dataType": "text", + "length": 1, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.NY" + }, + { + "OID": "IT.AE.AEBODSYS", + "mandatory": false, + "name": "AEBODSYS", + "description": "Body System or Organ Class", + "role": "Record Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.AE.AEBDSYCD", + "mandatory": false, + "name": "AEBDSYCD", + "description": "Body System or Organ Class Code", + "role": "Variable Qualifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.AE.AESOC", + "mandatory": false, + "name": "AESOC", + "description": "Primary System Organ Class", + "role": "Variable Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.AE.AESOCCD", + "mandatory": false, + "name": "AESOCCD", + "description": "Primary System Organ Class Code", + "role": "Variable Qualifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.AE.AELOC", + "mandatory": false, + "name": "AELOC", + "description": "Location of Event", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_586", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.LOC" + }, + { + "OID": "IT.AE.AESEV", + "mandatory": false, + "name": "AESEV", + "description": "Severity/Intensity", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_587", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.AESEV" + }, + { + "OID": "IT.AE.AESER", + "mandatory": false, + "name": "AESER", + "description": "Serious Event", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_588", + "dataType": "text", + "length": 1, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY_NY" + }, + { + "OID": "IT.AE.AEACN", + "mandatory": false, + "name": "AEACN", + "description": "Action Taken with Study Treatment", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_589", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.ACN" + }, + { + "OID": "IT.AE.AEACNOTH", + "mandatory": false, + "name": "AEACNOTH", + "description": "Other Action Taken", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_590", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.AE.AEREL", + "mandatory": false, + "name": "AEREL", + "description": "Causality", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_591", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.AE.AERELNST", + "mandatory": false, + "name": "AERELNST", + "description": "Relationship to Non-Study Treatment", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_592", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.AE.AEPATT", + "mandatory": false, + "name": "AEPATT", + "description": "Pattern of Adverse Event", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_593", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.AE.AEOUT", + "mandatory": false, + "name": "AEOUT", + "description": "Outcome of Adverse Event", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_594", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.OUT" + }, + { + "OID": "IT.AE.AESCAN", + "mandatory": false, + "name": "AESCAN", + "description": "Involves Cancer", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_595", + "dataType": "text", + "length": 1, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY_NY" + }, + { + "OID": "IT.AE.AESCONG", + "mandatory": false, + "name": "AESCONG", + "description": "Congenital Anomaly or Birth Defect", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_596", + "dataType": "text", + "length": 1, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY_NY" + }, + { + "OID": "IT.AE.AESDISAB", + "mandatory": false, + "name": "AESDISAB", + "description": "Persist or Signif Disability/Incapacity", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_597", + "dataType": "text", + "length": 1, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY_NY" + }, + { + "OID": "IT.AE.AESDTH", + "mandatory": false, + "name": "AESDTH", + "description": "Results in Death", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_598", + "dataType": "text", + "length": 1, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY_NY" + }, + { + "OID": "IT.AE.AESHOSP", + "mandatory": false, + "name": "AESHOSP", + "description": "Requires or Prolongs Hospitalization", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_599", + "dataType": "text", + "length": 1, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY_NY" + }, + { + "OID": "IT.AE.AESLIFE", + "mandatory": false, + "name": "AESLIFE", + "description": "Is Life Threatening", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_600", + "dataType": "text", + "length": 1, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY_NY" + }, + { + "OID": "IT.AE.AESOD", + "mandatory": false, + "name": "AESOD", + "description": "Occurred with Overdose", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_601", + "dataType": "text", + "length": 1, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY_NY" + }, + { + "OID": "IT.AE.AESMIE", + "mandatory": false, + "name": "AESMIE", + "description": "Other Medically Important Serious Event", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_602", + "dataType": "text", + "length": 1, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY_NY" + }, + { + "OID": "IT.AE.AECONTRT", + "mandatory": false, + "name": "AECONTRT", + "description": "Concomitant or Additional Trtmnt Given", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_603", + "dataType": "text", + "length": 1, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY_NY" + }, + { + "OID": "IT.AE.AETOXGR", + "mandatory": false, + "name": "AETOXGR", + "description": "Standard Toxicity Grade", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_604", + "dataType": "text", + "length": 1, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.AE.AESTDTC", + "mandatory": false, + "name": "AESTDTC", + "description": "Start Date/Time of Adverse Event", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_605", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.AE.AEENDTC", + "mandatory": false, + "name": "AEENDTC", + "description": "End Date/Time of Adverse Event", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_606", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.AE.AEENRF", + "mandatory": false, + "name": "AEENRF", + "description": "End Relative to Reference Period", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_607", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.STENRF" + }, + { + "OID": "IT.AE.AEENRTPT", + "mandatory": false, + "name": "AEENRTPT", + "description": "End Relative to Reference Time Point", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_608", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.STENRF" + }, + { + "OID": "IT.AE.AEENTPT", + "mandatory": false, + "name": "AEENTPT", + "description": "End Reference Time Point", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_609", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + } + ], + "implementsConcept": "CONC.BiomedicalConcept_135" + }, + { + "OID": "IG.MK", + "name": "MK", + "description": "Musculoskeletal System Findings", + "domain": "MK", + "purpose": "Tabulation", + "structure": "One record per assessment per visit per subject", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "MKSEQ" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "FINDINGS" + }, + "items": [ + { + "OID": "IT.MK.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.MK.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.MK.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.MK.MKSEQ", + "mandatory": true, + "name": "MKSEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.MK.MKTESTCD", + "mandatory": true, + "name": "MKTESTCD", + "description": "Short Name of Musculoskeletal Test", + "role": "Topic", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.MUSCTSCD" + }, + { + "OID": "IT.MK.MKTEST", + "mandatory": true, + "name": "MKTEST", + "description": "Name of Musculoskeletal Test", + "role": "Synonym Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.MUSCTS" + }, + { + "OID": "IT.MK.MKORRES", + "mandatory": false, + "name": "MKORRES", + "description": "Result or Finding in Original Units", + "role": "Result Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_652", + "dataType": "float", + "length": 8, + "displayFormat": "8.3", + "significantDigits": 3, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.MK.MKORRESU", + "mandatory": false, + "name": "MKORRESU", + "description": "Original Units", + "role": "Variable Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_653", + "dataType": "text", + "length": 20, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.UNIT" + }, + { + "OID": "IT.MK.MKSTRESC", + "mandatory": false, + "name": "MKSTRESC", + "description": "Character Result/Finding in Std Format", + "role": "Result Qualifier", + "dataType": "float", + "length": 8, + "displayFormat": "8.3", + "significantDigits": 3, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.MK.MKSTRESN", + "mandatory": false, + "name": "MKSTRESN", + "description": "Numeric Result/Finding in Standard Units", + "role": "Result Qualifier", + "dataType": "float", + "length": 8, + "displayFormat": "8.3", + "significantDigits": 3, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.MK.MKSTRESU", + "mandatory": false, + "name": "MKSTRESU", + "description": "Standard Units", + "role": "Variable Qualifier", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.UNIT" + }, + { + "OID": "IT.MK.MKLOC", + "mandatory": false, + "name": "MKLOC", + "description": "Location Used for the Measurement", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_654", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.LOC" + }, + { + "OID": "IT.MK.MKLAT", + "mandatory": false, + "name": "MKLAT", + "description": "Laterality", + "role": "Variable Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_655", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.LAT" + }, + { + "OID": "IT.MK.MKMETHOD", + "mandatory": false, + "name": "MKMETHOD", + "description": "Method of Test or Examination", + "role": "Record Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_656", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.METHOD" + }, + { + "OID": "IT.MK.MKLOBXFL", + "mandatory": false, + "name": "MKLOBXFL", + "description": "Last Observation Before Exposure Flag", + "role": "Record Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY" + }, + { + "OID": "IT.MK.VISITNUM", + "mandatory": false, + "name": "VISITNUM", + "description": "Visit Number", + "role": "Timing", + "dataType": "integer", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.MK.MKDTC", + "mandatory": false, + "name": "MKDTC", + "description": "Date/Time of Collection", + "role": "Timing", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_657", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + } + ], + "implementsConcept": "CONC.BiomedicalConcept_160" + }, + { + "OID": "IG.TS", + "name": "TS", + "description": "Trial Summary", + "domain": "TS", + "purpose": "Tabulation", + "structure": "One record per trial summary parameter value", + "isReferenceData": true, + "keySequence": [ + "STUDYID", + "TSPARMCD", + "TSSEQ" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "TRIAL DESIGN" + }, + "items": [ + { + "OID": "IT.TS.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.TS.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.TS.TSSEQ", + "mandatory": true, + "name": "TSSEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.TS.TSPARMCD", + "mandatory": true, + "name": "TSPARMCD", + "description": "Trial Summary Parameter Short Name", + "role": "Topic", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_850", + "dataType": "text", + "length": null, + "codeList": "CL.TSPARMCD" + }, + { + "OID": "IT.TS.TSPARM", + "mandatory": true, + "name": "TSPARM", + "description": "Trial Summary Parameter", + "role": "Synonym Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_851", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.TSPARM" + }, + { + "OID": "IT.TS.TSVAL", + "mandatory": false, + "name": "TSVAL", + "description": "Parameter Value", + "role": "Result Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_852", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.TS.TSVALCD", + "mandatory": false, + "name": "TSVALCD", + "description": "Parameter Value Code", + "role": "Result Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_853", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.TS.TSVCDREF", + "mandatory": false, + "name": "TSVCDREF", + "description": "Name of the Reference Terminology", + "role": "Result Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_854", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.DICTNAM" + }, + { + "OID": "IT.TS.TSVCDVER", + "mandatory": false, + "name": "TSVCDVER", + "description": "Version of the Reference Terminology", + "role": "Result Qualifier", + "conceptProperty": "CONCPROP.BiomedicalConceptProperty_855", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + } + } + ], + "implementsConcept": "CONC.BiomedicalConcept_162", + "slices": [ + { + "OID": "VL.TS.TSPARMCD", + "name": "VL_TS_TSPARMCD", + "type": "ValueList", + "wasDerivedFrom": "IT.TS.TSPARMCD", + "items": [ + { + "OID": "IT.TS.TSPARMCD.COMPTRT", + "mandatory": false, + "name": "TSPARMCD", + "dataType": "text", + "length": 200, + "origin": { + "type": "Protocol", + "source": "Sponsor" + }, + "applicableWhen": [ + "WC.TS.54cd02f1" + ] + }, + { + "OID": "IT.TS.TSPARMCD.CRMDUR", + "mandatory": false, + "name": "TSPARMCD", + "dataType": "text", + "length": 200, + "origin": { + "type": "Protocol", + "source": "Sponsor" + }, + "applicableWhen": [ + "WC.TS.f9fa8745" + ] + }, + { + "OID": "IT.TS.TSPARMCD.INDIC", + "mandatory": false, + "name": "TSPARMCD", + "dataType": "text", + "length": 200, + "origin": { + "type": "Protocol", + "source": "Sponsor" + }, + "applicableWhen": [ + "WC.TS.9cdae039" + ] + }, + { + "OID": "IT.TS.TSPARMCD.INTTYPE", + "mandatory": false, + "name": "TSPARMCD", + "dataType": "text", + "length": 200, + "origin": { + "type": "Protocol", + "source": "Sponsor" + }, + "applicableWhen": [ + "WC.TS.e3ae16cd" + ] + }, + { + "OID": "IT.TS.TSPARMCD.NARMS", + "mandatory": false, + "name": "TSPARMCD", + "dataType": "text", + "length": 200, + "origin": { + "type": "Protocol", + "source": "Sponsor" + }, + "applicableWhen": [ + "WC.TS.89c0d243" + ] + }, + { + "OID": "IT.TS.TSPARMCD.OBJPRIM", + "mandatory": false, + "name": "TSPARMCD", + "dataType": "text", + "length": 200, + "origin": { + "type": "Protocol", + "source": "Sponsor" + }, + "applicableWhen": [ + "WC.TS.7a056c75" + ] + }, + { + "OID": "IT.TS.TSPARMCD.OBJSEC", + "mandatory": false, + "name": "TSPARMCD", + "dataType": "text", + "length": 200, + "origin": { + "type": "Protocol", + "source": "Sponsor" + }, + "applicableWhen": [ + "WC.TS.36721696" + ] + }, + { + "OID": "IT.TS.TSPARMCD.OUTMSPRI", + "mandatory": false, + "name": "TSPARMCD", + "dataType": "text", + "length": 200, + "origin": { + "type": "Protocol", + "source": "Sponsor" + }, + "applicableWhen": [ + "WC.TS.d8b84608" + ] + }, + { + "OID": "IT.TS.TSPARMCD.OUTMSSEC", + "mandatory": false, + "name": "TSPARMCD", + "dataType": "text", + "length": 200, + "origin": { + "type": "Protocol", + "source": "Sponsor" + }, + "applicableWhen": [ + "WC.TS.1d3cd461" + ] + }, + { + "OID": "IT.TS.TSPARMCD.SPONSOR", + "mandatory": false, + "name": "TSPARMCD", + "dataType": "text", + "length": 200, + "origin": { + "type": "Protocol", + "source": "Sponsor" + }, + "applicableWhen": [ + "WC.TS.51236927" + ] + }, + { + "OID": "IT.TS.TSPARMCD.TITLE", + "mandatory": false, + "name": "TSPARMCD", + "dataType": "text", + "length": 200, + "origin": { + "type": "Protocol", + "source": "Sponsor" + }, + "applicableWhen": [ + "WC.TS.43684533" + ] + }, + { + "OID": "IT.TS.TSPARMCD.TRT", + "mandatory": false, + "name": "TSPARMCD", + "dataType": "text", + "length": 200, + "origin": { + "type": "Protocol", + "source": "Sponsor" + }, + "applicableWhen": [ + "WC.TS.1948fed3" + ] + } + ] + } + ] + }, + { + "OID": "IG.FT", + "name": "FT", + "description": "Functional Tests", + "domain": "FT", + "purpose": "Tabulation", + "structure": "One record per Functional Test finding per time point per visit per subject", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "FTSEQ" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "FINDINGS" + }, + "items": [ + { + "OID": "IT.FT.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.FT.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.FT.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.FT.FTSEQ", + "mandatory": true, + "name": "FTSEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.FT.FTTESTCD", + "mandatory": true, + "name": "FTTESTCD", + "description": "Short Name of Test", + "role": "Topic", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.FT.FTTEST", + "mandatory": true, + "name": "FTTEST", + "description": "Name of Test", + "role": "Synonym Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.FT.FTCAT", + "mandatory": true, + "name": "FTCAT", + "description": "Category", + "role": "Grouping Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.FTCAT" + }, + { + "OID": "IT.FT.FTSCAT", + "mandatory": false, + "name": "FTSCAT", + "description": "Subcategory", + "role": "Grouping Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.FT.FTORRES", + "mandatory": false, + "name": "FTORRES", + "description": "Result or Finding in Original Units", + "role": "Result Qualifier", + "dataType": "float", + "length": 4, + "displayFormat": "5.2", + "significantDigits": 2, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.FT.FTORRESU", + "mandatory": false, + "name": "FTORRESU", + "description": "Original Units", + "role": "Variable Qualifier", + "dataType": "text", + "length": 1, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.UNIT" + }, + { + "OID": "IT.FT.FTSTRESC", + "mandatory": false, + "name": "FTSTRESC", + "description": "Result or Finding in Standard Format", + "role": "Result Qualifier", + "dataType": "float", + "length": 4, + "displayFormat": "5.2", + "significantDigits": 2, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.FT.FTSTRESN", + "mandatory": false, + "name": "FTSTRESN", + "description": "Numeric Result/Finding in Standard Units", + "role": "Result Qualifier", + "dataType": "float", + "length": 4, + "displayFormat": "5.2", + "significantDigits": 2, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.FT.FTSTRESU", + "mandatory": false, + "name": "FTSTRESU", + "description": "Standard Units", + "role": "Variable Qualifier", + "dataType": "text", + "length": 1, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.UNIT" + }, + { + "OID": "IT.FT.FTSTAT", + "mandatory": false, + "name": "FTSTAT", + "description": "Completion Status", + "role": "Record Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.ND" + }, + { + "OID": "IT.FT.FTREASND", + "mandatory": false, + "name": "FTREASND", + "description": "Reason Not Done", + "role": "Record Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.FT.FTLOBXFL", + "mandatory": false, + "name": "FTLOBXFL", + "description": "Last Observation Before Exposure Flag", + "role": "Record Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY" + }, + { + "OID": "IT.FT.VISITNUM", + "mandatory": false, + "name": "VISITNUM", + "description": "Visit Number", + "role": "Timing", + "dataType": "integer", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.FT.FTDTC", + "mandatory": false, + "name": "FTDTC", + "description": "Date/Time of Test", + "role": "Timing", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + } + ], + "implementsConcept": "CONC.BiomedicalConcept_172" + }, + { + "OID": "IG.TA", + "name": "TA", + "description": "Trial Arms", + "domain": "TA", + "purpose": "Tabulation", + "structure": "One record per planned Element per Arm", + "isReferenceData": true, + "keySequence": [ + "STUDYID", + "ARMCD", + "ETCD" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "TRIAL DESIGN" + }, + "items": [ + { + "OID": "IT.TA.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.TA.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.TA.ARMCD", + "mandatory": true, + "name": "ARMCD", + "description": "Planned Arm Code", + "role": "Topic", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.ARMCD" + }, + { + "OID": "IT.TA.ARM", + "mandatory": true, + "name": "ARM", + "description": "Description of Planned Arm", + "role": "Synonym Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.ARM" + }, + { + "OID": "IT.TA.TAETORD", + "mandatory": true, + "name": "TAETORD", + "description": "Planned Order of Element within Arm", + "role": "Timing", + "dataType": "integer", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.TA.ETCD", + "mandatory": true, + "name": "ETCD", + "description": "Element Code", + "role": "Record Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.ETCD" + }, + { + "OID": "IT.TA.ELEMENT", + "mandatory": false, + "name": "ELEMENT", + "description": "Description of Element", + "role": "Synonym Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.ELEMENT" + }, + { + "OID": "IT.TA.TABRANCH", + "mandatory": false, + "name": "TABRANCH", + "description": "Branch", + "role": "Rule", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.TA.TATRANS", + "mandatory": false, + "name": "TATRANS", + "description": "Transition Rule", + "role": "Rule", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.TA.EPOCH", + "mandatory": true, + "name": "EPOCH", + "description": "Epoch", + "role": "Timing", + "dataType": "text", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + }, + "codeList": "CL.EPOCH" + } + ] + }, + { + "OID": "IG.TE", + "name": "TE", + "description": "Trial Elements", + "domain": "TE", + "purpose": "Tabulation", + "structure": "One record per planned Element", + "isReferenceData": true, + "keySequence": [ + "STUDYID", + "ETCD" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "TRIAL DESIGN" + }, + "items": [ + { + "OID": "IT.TE.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.TE.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.TE.ETCD", + "mandatory": true, + "name": "ETCD", + "description": "Element Code", + "role": "Topic", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.ETCD" + }, + { + "OID": "IT.TE.ELEMENT", + "mandatory": true, + "name": "ELEMENT", + "description": "Description of Element", + "role": "Synonym Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.ELEMENT" + }, + { + "OID": "IT.TE.TESTRL", + "mandatory": true, + "name": "TESTRL", + "description": "Rule for Start of Element", + "role": "Rule", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + } + ] + }, + { + "OID": "IG.SV", + "name": "SV", + "description": "Subject Visits", + "domain": "SV", + "purpose": "Tabulation", + "structure": "One record per actual or planned visit per subject", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "VISITNUM" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "SPECIAL-PURPOSE" + }, + "items": [ + { + "OID": "IT.SV.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.SV.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.SV.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.SV.VISITNUM", + "mandatory": true, + "name": "VISITNUM", + "description": "Visit Number", + "role": "Topic", + "dataType": "integer", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.SV.VISIT", + "mandatory": false, + "name": "VISIT", + "description": "Visit Name", + "role": "Synonym Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.SV.SVPRESP", + "mandatory": false, + "name": "SVPRESP", + "description": "Pre-specified", + "role": "Variable Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.NY" + }, + { + "OID": "IT.SV.SVOCCUR", + "mandatory": false, + "name": "SVOCCUR", + "description": "Occurrence", + "role": "Record Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY" + }, + { + "OID": "IT.SV.SVCNTMOD", + "mandatory": false, + "name": "SVCNTMOD", + "description": "Contact Mode", + "role": "Record Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.CNTMODE" + }, + { + "OID": "IT.SV.SVSTDTC", + "mandatory": false, + "name": "SVSTDTC", + "description": "Start Date/Time of Observation", + "role": "Timing", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.SV.SVENDTC", + "mandatory": false, + "name": "SVENDTC", + "description": "End Date/Time of Observation", + "role": "Timing", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + } + ] + }, + { + "OID": "IG.SE", + "name": "SE", + "description": "Subject Elements", + "domain": "SE", + "purpose": "Tabulation", + "structure": "One record per actual Element per subject", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "SESTDTC" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "SPECIAL-PURPOSE" + }, + "items": [ + { + "OID": "IT.SE.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.SE.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.SE.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.SE.SESEQ", + "mandatory": true, + "name": "SESEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, + { + "OID": "IT.SE.ETCD", + "mandatory": true, + "name": "ETCD", + "description": "Element Code", + "role": "Topic", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.ETCD" + }, + { + "OID": "IT.SE.ELEMENT", + "mandatory": false, + "name": "ELEMENT", + "description": "Description of Element", + "role": "Synonym Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.ELEMENT" + }, + { + "OID": "IT.SE.EPOCH", + "mandatory": false, + "name": "EPOCH", + "description": "Epoch", + "role": "Timing", + "dataType": "text", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + }, + "codeList": "CL.EPOCH" + }, + { + "OID": "IT.SE.SESTDTC", + "mandatory": true, + "name": "SESTDTC", + "description": "Start Date/Time of Element", + "role": "Timing", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.SE.SEENDTC", + "mandatory": false, + "name": "SEENDTC", + "description": "End Date/Time of Element", + "role": "Timing", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + } + ] + } + ], + "conditions": [ + { + "OID": "COND.TS.TSPARMCD.cd7838e7", + "rangeChecks": [ + { + "comparator": "EQ", + "checkValues": [ + "COMPTRT" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" + } + ] + }, + { + "OID": "COND.TS.TSPARMCD.ceb735c9", + "rangeChecks": [ + { + "comparator": "EQ", + "checkValues": [ + "CRMDUR" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" + } + ] + }, + { + "OID": "COND.TS.TSPARMCD.204aa07d", + "rangeChecks": [ + { + "comparator": "EQ", + "checkValues": [ + "INDIC" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" + } + ] + }, + { + "OID": "COND.TS.TSPARMCD.fd076a8d", + "rangeChecks": [ + { + "comparator": "EQ", + "checkValues": [ + "INTTYPE" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" + } + ] + }, + { + "OID": "COND.TS.TSPARMCD.770c1610", + "rangeChecks": [ + { + "comparator": "EQ", + "checkValues": [ + "NARMS" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" + } + ] + }, + { + "OID": "COND.TS.TSPARMCD.eb0c9bb2", + "rangeChecks": [ + { + "comparator": "EQ", + "checkValues": [ + "OBJPRIM" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" + } + ] + }, + { + "OID": "COND.TS.TSPARMCD.5ca3cd0c", + "rangeChecks": [ + { + "comparator": "EQ", + "checkValues": [ + "OBJSEC" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" + } + ] + }, + { + "OID": "COND.TS.TSPARMCD.a724d633", + "rangeChecks": [ + { + "comparator": "EQ", + "checkValues": [ + "OUTMSPRI" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" + } + ] + }, + { + "OID": "COND.TS.TSPARMCD.b313e712", + "rangeChecks": [ + { + "comparator": "EQ", + "checkValues": [ + "OUTMSSEC" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" + } + ] + }, + { + "OID": "COND.TS.TSPARMCD.2e2517d1", + "rangeChecks": [ + { + "comparator": "EQ", + "checkValues": [ + "SPONSOR" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" + } + ] + }, + { + "OID": "COND.TS.TSPARMCD.52dad99f", + "rangeChecks": [ + { + "comparator": "EQ", + "checkValues": [ + "TITLE" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" + } + ] + }, + { + "OID": "COND.TS.TSPARMCD.185bd9b1", + "rangeChecks": [ + { + "comparator": "EQ", + "checkValues": [ + "TRT" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" + } + ] + } + ], + "whereClauses": [ + { + "OID": "WC.TS.54cd02f1", + "conditions": [ + "COND.TS.TSPARMCD.cd7838e7" + ] + }, + { + "OID": "WC.TS.f9fa8745", + "conditions": [ + "COND.TS.TSPARMCD.ceb735c9" + ] + }, + { + "OID": "WC.TS.9cdae039", + "conditions": [ + "COND.TS.TSPARMCD.204aa07d" + ] + }, + { + "OID": "WC.TS.e3ae16cd", + "conditions": [ + "COND.TS.TSPARMCD.fd076a8d" + ] + }, + { + "OID": "WC.TS.89c0d243", + "conditions": [ + "COND.TS.TSPARMCD.770c1610" + ] + }, + { + "OID": "WC.TS.7a056c75", + "conditions": [ + "COND.TS.TSPARMCD.eb0c9bb2" + ] + }, + { + "OID": "WC.TS.36721696", + "conditions": [ + "COND.TS.TSPARMCD.5ca3cd0c" + ] + }, + { + "OID": "WC.TS.d8b84608", + "conditions": [ + "COND.TS.TSPARMCD.a724d633" + ] + }, + { + "OID": "WC.TS.1d3cd461", + "conditions": [ + "COND.TS.TSPARMCD.b313e712" + ] + }, + { + "OID": "WC.TS.51236927", + "conditions": [ + "COND.TS.TSPARMCD.2e2517d1" + ] + }, + { + "OID": "WC.TS.43684533", + "conditions": [ + "COND.TS.TSPARMCD.52dad99f" + ] + }, + { + "OID": "WC.TS.1948fed3", + "conditions": [ + "COND.TS.TSPARMCD.185bd9b1" + ] + } + ], + "codeLists": [ + { + "OID": "CL.ARMCD", + "name": "ARM Code", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "Placebo" + }, + { + "codedValue": "Xanomeline Low Dose" + }, + { + "codedValue": "Xanomeline High Dose" + } + ] + }, + { + "OID": "CL.ARM", + "name": "ARM", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "Placebo" + }, + { + "codedValue": "Xanomeline Low Dose" + }, + { + "codedValue": "Xanomeline High Dose" + } + ] + }, + { + "OID": "CL.ELEMENT", + "name": "Description of Element", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "Screening" + }, + { + "codedValue": "Placebo" + }, + { + "codedValue": "Low" + }, + { + "codedValue": "High - Start" + }, + { + "codedValue": "High - Middle" + }, + { + "codedValue": "High - End" + }, + { + "codedValue": "Follow up" + } + ] + }, + { + "OID": "CL.ETCD", + "name": "Element Code", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "EL1", + "decode": "Screening" + }, + { + "codedValue": "EL2", + "decode": "Placebo" + }, + { + "codedValue": "EL3", + "decode": "Low" + }, + { + "codedValue": "EL4", + "decode": "High - Start" + }, + { + "codedValue": "EL5", + "decode": "High - Middle" + }, + { + "codedValue": "EL6", + "decode": "High - End" + }, + { + "codedValue": "EL7", + "decode": "Follow up" + } + ] + }, + { + "OID": "CL.EPOCH", + "name": "Epoch", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C99079", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "Screening", + "coding": { + "code": "C202487", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Treatment 1", + "coding": { + "code": "C101526", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Treatment 2", + "coding": { + "code": "C101526", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Treatment 3", + "coding": { + "code": "C101526", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Follow-up", + "coding": { + "code": "C202578", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.a30c10b2", + "name": "DSDECOD Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "INFORMED CONSENT OBTAINED", + "coding": [ + { + "code": "C16735", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "INFORMED CONSENT OBTAINED" + } + ] + } + ] + }, + { + "OID": "CL.e1a1b71c", + "name": "DSDECOD Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "RANDOMIZED", + "coding": [ + { + "code": "C114209", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "RANDOMIZED" + } + ] + } + ] + }, + { + "OID": "CL.bf247815", + "name": "SCORRESU Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "YEARS", + "coding": [ + { + "code": "C29848", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "YEARS" + } + ] + } + ] + }, + { + "OID": "CL.82acb719", + "name": "PRDECOD Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "X-RAY", + "coding": [ + { + "code": "C38101", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "X-RAY" + } + ] + } + ] + }, + { + "OID": "CL.cbd6ad98", + "name": "VSORRESU Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "beats/min", + "coding": [ + { + "code": "C49673", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "beats/min" + } + ] + } + ] + }, + { + "OID": "CL.b63f6642", + "name": "VSORRESU Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "breaths/min", + "coding": [ + { + "code": "C49674", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "breaths/min" + } + ] + } + ] + }, + { + "OID": "CL.04edb9f9", + "name": "EGORRESU Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "deg", + "coding": [ + { + "code": "C68667", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "deg" + } + ] + } + ] + }, + { + "OID": "CL.2e4119e7", + "name": "PRDECOD Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "CT SCAN", + "coding": [ + { + "code": "C17204", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "CT SCAN" + } + ] + } + ] + }, + { + "OID": "CL.3edf8d8c", + "name": "PRLOC Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "CHEST", + "coding": [ + { + "code": "C25389", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "CHEST" + } + ] + } + ] + }, + { + "OID": "CL.d03f062b", + "name": "PRDECOD Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "MRI", + "coding": [ + { + "code": "C16809", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "MRI" + } + ] + } + ] + }, + { + "OID": "CL.e2fce626", + "name": "PRLOC Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "BRAIN", + "coding": [ + { + "code": "C12439", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "BRAIN" + } + ] + } + ] + }, + { + "OID": "CL.1f6d4af1", + "name": "LBSPEC Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "BLOOD", + "coding": [ + { + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD" + } + ] + } + ] + }, + { + "OID": "CL.8d13b90f", + "name": "LBSPEC Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "ERYTHROCYTES", + "coding": [ + { + "code": "C12521", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "ERYTHROCYTES" + } + ] + } + ] + }, + { + "OID": "CL.d00a60ac", + "name": "LBORRESU Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "fL", + "coding": [ + { + "code": "C64780", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "fL" + } + ] + } + ] + }, + { + "OID": "CL.d121315c", + "name": "LBORRESU Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "10^9/L", + "coding": [ + { + "code": "C67255", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "10^9/L" + } + ] + } + ] + }, + { + "OID": "CL.b454d520", + "name": "LBORRESU Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "10^6/L", + "coding": [ + { + "code": "C67452", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "10^6/L" + } + ] + } + ] + }, + { + "OID": "CL.2148028d", + "name": "LBSPEC Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "SERUM OR PLASMA", + "coding": [ + { + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA" + } + ] + } + ] + }, + { + "OID": "CL.b0ec3282", + "name": "MBTSTDTL Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "DETECTION", + "coding": [ + { + "code": "C174330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "DETECTION" + } + ] + } + ] + }, + { + "OID": "CL.64500426", + "name": "MBSPEC Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "SERUM", + "coding": [ + { + "code": "C13325", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM" + } + ] + } + ] + }, + { + "OID": "CL.928af9cb", + "name": "MBMETHOD Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "LINE PROBE ASSAY", + "coding": [ + { + "code": "C102656", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "LINE PROBE ASSAY" + } + ] + } + ] + }, + { + "OID": "CL.64329559", + "name": "LBSPEC Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "URINE", + "coding": [ + { + "code": "C13283", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "URINE" + } + ] + } + ] + }, + { + "OID": "CL.65d42172", + "name": "LBSPEC Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "STOOL", + "coding": [ + { + "code": "C13234", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "STOOL" + } + ] + } + ] + }, + { + "OID": "CL.d7c5855c", + "name": "QSEVAL Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "CAREGIVER", + "coding": [ + { + "code": "C17445", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "CAREGIVER" + } + ] + } + ] + }, + { + "OID": "CL.fc6fa4d8", + "name": "DSDECOD Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "SITE TRANSFER", + "coding": [ + { + "code": "C186208", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SITE TRANSFER" + } + ] + } + ] + }, + { + "OID": "CL.6e594ef0", + "name": "DSDECOD Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY", + "coding": [ + { + "code": "C170610", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY" + } + ] + } + ] + }, + { + "OID": "CL.5991b40f", + "name": "VSORRESU Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "mmHg", + "coding": [ + { + "code": "C49670", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "mmHg" + } + ] + } + ] + }, + { + "OID": "CL.b57d3f41", + "name": "TSPARMCD Response Codes", + "dataType": "text", + "isNonStandard": true, + "codeListItems": [ + { + "codedValue": "EGCTMON", + "coding": [ + { + "code": "C119561", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "EGCTMON" + } + ] + } + ] + }, + { + "OID": "CL.NCOMPLT", + "name": "Completion/Reason for Non-Completion", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66727", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.DSCAT", + "name": "Category of Disposition Event", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C74558", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.DSSCAT", + "name": "Subcategory for Disposition Event", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C170443", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.IECAT", + "name": "Category of Inclusion/Exclusion", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66797", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.NY", + "name": "No Yes Response", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66742", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.AGEU", + "name": "Age Unit", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66781", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.SEX", + "name": "Sex", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66731", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.SCTESTCD", + "name": "Subject Characteristic Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C74559", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.SCTEST", + "name": "Subject Characteristic Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C103330", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.UNIT", + "name": "Unit", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C71620", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.STENRF", + "name": "Relation to Reference Period", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66728", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.NY_Y", + "name": "No Yes Response (Subset Y)", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66742", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.NY_NY", + "name": "No Yes Response (Subset NY)", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66742", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.FREQ", + "name": "Frequency", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C71113", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.PROCEDUR", + "name": "Procedure", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C101858", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "CT SCAN", + "decode": "CAT Scan", + "coding": { + "code": "C17204", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "MRI", + "decode": "Magnetic Resonance Imaging", + "coding": { + "code": "C16809", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "X-RAY", + "decode": "Static X-Ray", + "coding": { + "code": "C38101", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.LOC", + "name": "Anatomical Location", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C74456", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "BRAIN", + "decode": "Nervous System, Brain", + "coding": { + "code": "C12439", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "CHEST", + "decode": "Chest", + "coding": { + "code": "C25389", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "BLOOD", + "decode": "Peripheral Blood", + "coding": { + "code": "C12434", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.VSTESTCD", + "name": "Vital Signs Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66741", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.VSTEST", + "name": "Vital Signs Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C67153", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.POSITION", + "name": "Position", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C71148", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.VSRESU", + "name": "Units for Vital Signs Results", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66770", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.LAT", + "name": "Laterality", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C99073", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.EGTESTCD", + "name": "ECG Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C71153", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.EGTEST", + "name": "ECG Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C71152", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.EGSTRESC", + "name": "ECG Result", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C71150", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.EGMETHOD", + "name": "ECG Test Method", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C71151", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.EVAL", + "name": "Evaluator", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C78735", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "CAREGIVER", + "decode": "Caregiver", + "coding": { + "code": "C17445", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.FRM", + "name": "Dosage Form", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66726", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.ROUTE", + "name": "Route of Administration Response", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66729", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.LBTESTCD", + "name": "Laboratory Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C65047", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.LBTEST", + "name": "Laboratory Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C67154", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.MBTESTCD", + "name": "Microbiology Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C120527", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.MBTEST", + "name": "Microbiology Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C120528", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.MBFTSDTL", + "name": "Microbiology Findings Test Details", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C174225", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "DETECTION", + "decode": "", + "coding": { + "code": "C174330", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.SPECTYPE", + "name": "Specimen Type", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C78734", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "SERUM", + "decode": "Sera", + "coding": { + "code": "C13325", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.METHOD", + "name": "Method", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C85492", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "LINE PROBE ASSAY", + "decode": "LiPA", + "coding": { + "code": "C102656", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.URNSTSCD", + "name": "Urinary System Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C129942", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.URNSTS", + "name": "Urinary System Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C129941", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.DIR", + "name": "Directionality", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C99074", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.QSCAT", + "name": "Category of Questionnaire", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C100129", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.AESEV", + "name": "Severity/Intensity Scale for Adverse Events", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66769", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.ACN", + "name": "Action Taken with Study Treatment", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66767", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.OUT", + "name": "Outcome of Event", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66768", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.MUSCTSCD", + "name": "Musculoskeletal System Finding Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C127269", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.MUSCTS", + "name": "Musculoskeletal System Finding Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C127270", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.TSPARMCD", + "name": "Trial Summary Parameter Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66738", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "EGCTMON", + "decode": "ECG Continuous Monitoring", + "coding": { + "code": "C119561", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.TSPARM", + "name": "Trial Summary Parameter Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C67152", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "ECG Continuous Monitoring", + "decode": "ECG Continuous Monitoring", + "coding": { + "code": "C119561", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.DICTNAM", + "name": "Dictionary Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66788", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.FTCAT", + "name": "Category of Functional Test", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C115304", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.ND", + "name": "Not Done", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66789", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.CNTMODE", + "name": "Mode of Subject Contact", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C171445", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "IN PERSON", + "decode": "In-Person", + "coding": { + "code": "C175574", + "codeSystem": "nci:ExtCodeID" + } + } + ] + } + ], + "methods": [], + "comments": [], + "standards": [ + { + "OID": "STD.SDTMIG", + "name": "SDTMIG", + "type": "IG", + "version": "3.4", + "status": "FINAL" + }, + { + "OID": "STD.SDTMCT", + "name": "CDISC/NCI", + "type": "CT", + "version": "2026-03-27", + "status": "FINAL", + "publishingSet": "SDTM" + } + ], + "annotatedCRF": [], + "concepts": [ + { + "OID": "CONC.BiomedicalConcept_1", + "name": "Informed Consent", + "label": null, + "aliases": [ + "Informed Consent Obtained" + ], + "href": "/mdr/bc/biomedicalconcepts/C16735", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_1", + "name": "DSDECOD", + "label": "DSDECOD", + "mandatory": true, + "coding": [ + { + "code": "C82977", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term" + } + ], + "codeList": "CL.a30c10b2" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_2", + "name": "DSTERM", + "label": "DSTERM", + "mandatory": true, + "coding": [ + { + "code": "C82571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_3", + "name": "DSSTDTC", + "label": "DSSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C82517", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C16735", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Informed Consent" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_2", + "name": "Inclusion Criteria", + "label": "Inclusion Criteria", + "aliases": [ + "Inclusion" + ], + "href": "/mdr/bc/biomedicalconcepts/C25532", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_4", + "name": "TIVERS", + "label": "TIVERS", + "mandatory": false, + "coding": [ + { + "code": "C83444", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Trial Inclusion Exclusion Criteria Version" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_5", + "name": "IEORRES", + "label": "IEORRES", + "mandatory": false, + "coding": [ + { + "code": "C181043", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Clinical Findings Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_6", + "name": "IEDTC", + "label": "IEDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C25532", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Inclusion Criteria" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_3", + "name": "Inclusion Exclusion Criteria Yes No Indicator", + "label": "Inclusion Exclusion Criteria Yes No Indicator", + "aliases": [ + "Inclusion Exclusion Criteria Yes No Indicator", + "IEYN" + ], + "href": "/mdr/bc/biomedicalconcepts/C83063", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_7", + "name": "Inclusion Exclusion Criteria Yes No Indicator", + "label": "Inclusion Exclusion Criteria Yes No Indicator", + "mandatory": true, + "coding": [ + { + "code": "C83063", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Inclusion Exclusion Criteria Yes No Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_8", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C83063", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Inclusion Exclusion Criteria Yes No Indicator" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_4", + "name": "Exclusion Criteria", + "label": "Exclusion Criteria", + "aliases": [ + "Exclusion" + ], + "href": "/mdr/bc/biomedicalconcepts/C25370", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_9", + "name": "TIVERS", + "label": "TIVERS", + "mandatory": false, + "coding": [ + { + "code": "C83444", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Trial Inclusion Exclusion Criteria Version" + } + ], + "codeList": "CL.a30c10b2" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_10", + "name": "IEORRES", + "label": "IEORRES", + "mandatory": false, + "coding": [ + { + "code": "C181043", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Clinical Findings Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_11", + "name": "IEDTC", + "label": "IEDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C25370", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Exclusion Criteria" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_5", + "name": "Subject is Randomized", + "label": "Subject is Randomized", + "aliases": [ + "Randomized" + ], + "href": "/mdr/bc/biomedicalconcepts/C114209", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_12", + "name": "DSDECOD", + "label": "DSDECOD", + "mandatory": true, + "coding": [ + { + "code": "C82977", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term" + } + ], + "codeList": "CL.e1a1b71c" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_13", + "name": "DSTERM", + "label": "DSTERM", + "mandatory": true, + "coding": [ + { + "code": "C82571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_14", + "name": "DSSTDTC", + "label": "DSSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C82517", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C114209", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Subject is Randomized" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_6", + "name": "Race", + "label": "Race", + "aliases": [ + "Racial Group" + ], + "href": "/mdr/bc/biomedicalconcepts/C17049", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_15", + "name": "RACE", + "label": "RACE", + "mandatory": false, + "coding": [ + { + "code": "C17049", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Race" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_16", + "name": "DMDTC", + "label": "DMDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C17049", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-04-01", + "decode": "Race" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_7", + "name": "Ethnic Group", + "label": "Ethnic Group", + "aliases": [ + "Ethnicity", + "Ethnic Origin" + ], + "href": "/mdr/bc/biomedicalconcepts/C16564", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_17", + "name": "ETHNIC", + "label": "ETHNIC", + "mandatory": false, + "coding": [ + { + "code": "C16564", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Ethnic Group" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_18", + "name": "DMDTC", + "label": "DMDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C16564", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-04-01", + "decode": "Ethnic Group" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_8", + "name": "Subject Age", + "label": "Subject Age", + "aliases": [ + "Age" + ], + "href": "/mdr/bc/biomedicalconcepts/C69260", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_19", + "name": "AGE", + "label": "AGE", + "mandatory": false, + "coding": [ + { + "code": "C170981", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Numeric Age for Data Tabulation" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_20", + "name": "AGEU", + "label": "AGEU", + "mandatory": false, + "coding": [ + { + "code": "C50400", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Age Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_21", + "name": "DMDTC", + "label": "DMDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C69260", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-04-01", + "decode": "Subject Age" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_9", + "name": "Birth Date and Time", + "label": "Birth Date and Time", + "aliases": [ + "BRTHDTC", + "Date/Time of Birth" + ], + "href": "/mdr/bc/biomedicalconcepts/C83217", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_22", + "name": "BRTHDTC", + "label": "BRTHDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_23", + "name": "DMDTC", + "label": "DMDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C83217", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Birth Date and Time" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_10", + "name": "Sex", + "label": null, + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C28421", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_24", + "name": "SEX", + "label": "SEX", + "mandatory": false, + "coding": [ + { + "code": "C28421", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-04-01", + "decode": "Sex" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_25", + "name": "DMDTC", + "label": "DMDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-04-01", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C28421", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-04-01", + "decode": "Sex" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_11", + "name": "Education Level", + "label": "Education Level", + "aliases": [ + "EDULEVEL", + "Education Level Completed", + "Education" + ], + "href": "/mdr/bc/biomedicalconcepts/C17953", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_26", + "name": "SCORRES", + "label": "SCORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_27", + "name": "SCDTC", + "label": "SCDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C17953", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Education Level" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_12", + "name": "Number of Years of Education", + "label": "Number of Years of Education", + "aliases": [ + "EDUYRNUM", + "Education" + ], + "href": "/mdr/bc/biomedicalconcepts/C122393", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_28", + "name": "SCORRES", + "label": "SCORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ], + "codeList": "CL.e1a1b71c" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_29", + "name": "SCORRESU", + "label": "SCORRESU", + "mandatory": false, + "coding": [ + { + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time" + } + ], + "codeList": "CL.bf247815" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_30", + "name": "SCDTC", + "label": "SCDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ], + "codeList": "CL.e1a1b71c" + } + ], + "coding": [ + { + "code": "C122393", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Number of Years of Education" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_14", + "name": "Solicited Medical History", + "label": "Solicited Medical History", + "aliases": [ + "Medical History", + "Medical History Collection" + ], + "href": "/mdr/bc/biomedicalconcepts/C200145", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_31", + "name": "MHTERM", + "label": "MHTERM", + "mandatory": true, + "coding": [ + { + "code": "C83118", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Reported Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_32", + "name": "MHDECOD", + "label": "MHDECOD", + "mandatory": false, + "coding": [ + { + "code": "C83346", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Dictionary Derived Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_33", + "name": "MHSTDTC", + "label": "MHSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83338", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Event Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_34", + "name": "MHENDTC", + "label": "MHENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Event End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_35", + "name": "MHENRF", + "label": "MHENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_36", + "name": "MHENRTPT", + "label": "MHENRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "End Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_37", + "name": "MHENTPT", + "label": "MHENTPT", + "mandatory": false, + "coding": [ + { + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Reference End Time Point End" + } + ] + } + ], + "coding": [ + { + "code": "C200145", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Solicited Medical History" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_15", + "name": "Alcohol Use History", + "label": "Alcohol Use History", + "aliases": [ + "Alcohol History", + "Alcohol Use" + ], + "href": "/mdr/bc/biomedicalconcepts/C81229", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_38", + "name": "SUTRT", + "label": "SUTRT", + "mandatory": true, + "coding": [ + { + "code": "C83092", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Reported Name" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_39", + "name": "SUPRESP", + "label": "SUPRESP", + "mandatory": false, + "coding": [ + { + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Prespecified Event or Intervention Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_40", + "name": "SUOCCUR", + "label": "SUOCCUR", + "mandatory": false, + "coding": [ + { + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Occurrence Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_41", + "name": "SUDOSE", + "label": "SUDOSE", + "mandatory": false, + "coding": [ + { + "code": "C83416", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_42", + "name": "SUDOSTXT", + "label": "SUDOSTXT", + "mandatory": false, + "coding": [ + { + "code": "C83041", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Description" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_43", + "name": "SUDOSU", + "label": "SUDOSU", + "mandatory": false, + "coding": [ + { + "code": "C83038", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_44", + "name": "SUDOSFRQ", + "label": "SUDOSFRQ", + "mandatory": false, + "coding": [ + { + "code": "C83044", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Frequency" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_45", + "name": "SUSTDTC", + "label": "SUSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83431", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_46", + "name": "SUENDTC", + "label": "SUENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83419", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_47", + "name": "SUSTRF", + "label": "SUSTRF", + "mandatory": false, + "coding": [ + { + "code": "C82559", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_48", + "name": "SUSTRTPT", + "label": "SUSTRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82560", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_49", + "name": "SUSTTPT", + "label": "SUSTTPT", + "mandatory": false, + "coding": [ + { + "code": "C82575", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference Start Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_50", + "name": "SUENRF", + "label": "SUENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_51", + "name": "SUENRTPT", + "label": "SUENRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_52", + "name": "SUENTPT", + "label": "SUENTPT", + "mandatory": false, + "coding": [ + { + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End" + } + ] + } + ], + "coding": [ + { + "code": "C81229", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Alcohol Use History" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_16", + "name": "Caffeine Use History", + "label": "Caffeine Use History", + "aliases": [ + "Caffeine History", + "Caffeine Use" + ], + "href": "/mdr/bc/biomedicalconcepts/C201990", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_53", + "name": "SUTRT", + "label": "SUTRT", + "mandatory": true, + "coding": [ + { + "code": "C83092", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Reported Name" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_54", + "name": "SUPRESP", + "label": "SUPRESP", + "mandatory": false, + "coding": [ + { + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Prespecified Event or Intervention Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_55", + "name": "SUOCCUR", + "label": "SUOCCUR", + "mandatory": false, + "coding": [ + { + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Occurrence Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_56", + "name": "SUDOSE", + "label": "SUDOSE", + "mandatory": false, + "coding": [ + { + "code": "C83416", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_57", + "name": "SUDOSTXT", + "label": "SUDOSTXT", + "mandatory": false, + "coding": [ + { + "code": "C83041", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Description" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_58", + "name": "SUDOSU", + "label": "SUDOSU", + "mandatory": false, + "coding": [ + { + "code": "C83038", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_59", + "name": "SUDOSFRQ", + "label": "SUDOSFRQ", + "mandatory": false, + "coding": [ + { + "code": "C83044", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Frequency" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_60", + "name": "SUSTDTC", + "label": "SUSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83431", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_61", + "name": "SUENDTC", + "label": "SUENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83419", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_62", + "name": "SUSTRF", + "label": "SUSTRF", + "mandatory": false, + "coding": [ + { + "code": "C82559", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_63", + "name": "SUSTRTPT", + "label": "SUSTRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82560", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_64", + "name": "SUSTTPT", + "label": "SUSTTPT", + "mandatory": false, + "coding": [ + { + "code": "C82575", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference Start Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_65", + "name": "SUENRF", + "label": "SUENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_66", + "name": "SUENRTPT", + "label": "SUENRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point" + } + ], + "codeList": "CL.bf247815" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_67", + "name": "SUENTPT", + "label": "SUENTPT", + "mandatory": false, + "coding": [ + { + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End" + } + ] + } + ], + "coding": [ + { + "code": "C201990", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Caffeine Use History" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_17", + "name": "History of Tobacco Use", + "label": "History of Tobacco Use", + "aliases": [ + "Tobacco Use", + "Tobacco Use History" + ], + "href": "/mdr/bc/biomedicalconcepts/C181760", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_68", + "name": "SUTRT", + "label": "SUTRT", + "mandatory": true, + "coding": [ + { + "code": "C83092", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Reported Name" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_69", + "name": "SUPRESP", + "label": "SUPRESP", + "mandatory": false, + "coding": [ + { + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Prespecified Event or Intervention Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_70", + "name": "SUOCCUR", + "label": "SUOCCUR", + "mandatory": false, + "coding": [ + { + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Occurrence Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_71", + "name": "SUDOSE", + "label": "SUDOSE", + "mandatory": false, + "coding": [ + { + "code": "C83416", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_72", + "name": "SUDOSTXT", + "label": "SUDOSTXT", + "mandatory": false, + "coding": [ + { + "code": "C83041", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Description" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_73", + "name": "SUDOSU", + "label": "SUDOSU", + "mandatory": false, + "coding": [ + { + "code": "C83038", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_74", + "name": "SUDOSFRQ", + "label": "SUDOSFRQ", + "mandatory": false, + "coding": [ + { + "code": "C83044", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Frequency" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_75", + "name": "SUSTDTC", + "label": "SUSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83431", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_76", + "name": "SUENDTC", + "label": "SUENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83419", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_77", + "name": "SUDUR", + "label": "SUDUR", + "mandatory": false, + "coding": [ + { + "code": "C83419", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_78", + "name": "SUSTRF", + "label": "SUSTRF", + "mandatory": false, + "coding": [ + { + "code": "C82559", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_79", + "name": "SUSTRTPT", + "label": "SUSTRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82560", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_80", + "name": "SUSTTPT", + "label": "SUSTTPT", + "mandatory": false, + "coding": [ + { + "code": "C82575", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference Start Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_81", + "name": "SUENRF", + "label": "SUENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_82", + "name": "SUENRTPT", + "label": "SUENRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_83", + "name": "SUENTPT", + "label": "SUENTPT", + "mandatory": false, + "coding": [ + { + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End" + } + ] + } + ], + "coding": [ + { + "code": "C181760", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "History of Tobacco Use" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_18", + "name": "X-Ray Imaging", + "label": "X-Ray Imaging", + "aliases": [ + "Conventional X-Ray", + "Medical Imaging", + "X-Ray", + "Static X-Ray" + ], + "href": "/mdr/bc/biomedicalconcepts/C38101", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_84", + "name": "PRTRT", + "label": "PRTRT", + "mandatory": true, + "coding": [ + { + "code": "C117511", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Name of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_85", + "name": "PRDECOD", + "label": "PRDECOD", + "mandatory": true, + "coding": [ + { + "code": "C117512", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Standardized Name of Procedure" + } + ], + "codeList": "CL.82acb719" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_86", + "name": "PRPRESP", + "label": "PRPRESP", + "mandatory": false, + "coding": [ + { + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Prespecified Event or Intervention Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_87", + "name": "PROCCUR", + "label": "PROCCUR", + "mandatory": false, + "coding": [ + { + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Occurrence Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_88", + "name": "PRLOC", + "label": "PRLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_89", + "name": "PRSTDTC", + "label": "PRSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C117529", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Start Date and Time of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_90", + "name": "PRENDTC", + "label": "PRENDTC", + "mandatory": false, + "coding": [ + { + "code": "C117530", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "End Date and Time of Procedure" + } + ] + } + ], + "coding": [ + { + "code": "C38101", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "X-RAY" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_19", + "name": "Subject is Randomized", + "label": null, + "aliases": [ + "Randomized" + ], + "href": "/mdr/bc/biomedicalconcepts/C114209", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_91", + "name": "DSDECOD", + "label": "DSDECOD", + "mandatory": true, + "coding": [ + { + "code": "C82977", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term" + } + ], + "codeList": "CL.e1a1b71c" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_92", + "name": "DSTERM", + "label": "DSTERM", + "mandatory": true, + "coding": [ + { + "code": "C82571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_93", + "name": "DSSTDTC", + "label": "DSSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C82517", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C114209", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Subject is Randomized" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_20", + "name": "Body Temperature", + "label": "Body Temperature", + "aliases": [ + "Temperature" + ], + "href": "/mdr/bc/biomedicalconcepts/C174446", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_94", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_95", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C44276", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Temperature" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_96", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_97", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C174446", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "VSTESTCD" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_21", + "name": "Body Weight", + "label": "Body Weight", + "aliases": [ + "WEIGHT" + ], + "href": "/mdr/bc/biomedicalconcepts/C81328", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_98", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_99", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48208", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Weight" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_100", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C81328", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Body Weight" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_22", + "name": "Body Height", + "label": "Body Height", + "aliases": [ + "HEIGHT" + ], + "href": "/mdr/bc/biomedicalconcepts/C164634", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_101", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_102", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C168688", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Height" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_103", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C164634", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Body Height" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_23", + "name": "Pulse Rate", + "label": "Pulse Rate", + "aliases": [ + "Pulse" + ], + "href": "/mdr/bc/biomedicalconcepts/C49676", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_104", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_105", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C73688", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Count per Minute" + } + ], + "codeList": "CL.cbd6ad98" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_106", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_107", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_108", + "name": "VSLAT", + "label": "VSLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_109", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C49676", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "VSTESTCD" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_24", + "name": "Respiratory Rate", + "label": "Respiratory Rate", + "aliases": [ + "RESP", + "RESPRATE" + ], + "href": "/mdr/bc/biomedicalconcepts/C49678", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_110", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_111", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C73688", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Count per Minute" + } + ], + "codeList": "CL.b63f6642" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_112", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C49678", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "VSTESTCD" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_25", + "name": "Body Mass Index", + "label": "Body Mass Index", + "aliases": [ + "BMI", + "Quetelet Index" + ], + "href": "/mdr/bc/biomedicalconcepts/C16358", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_113", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_114", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C42575", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Mass Density" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_115", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C16358", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Body Mass Index" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_26", + "name": "Blood Pressure", + "label": "Blood Pressure", + "aliases": [ + "BP" + ], + "href": "/mdr/bc/biomedicalconcepts/C54706", + "properties": [], + "coding": [ + { + "code": "C54706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Blood Pressure" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_27", + "name": "Electrocardiogram Analysis", + "label": "Electrocardiogram Analysis", + "aliases": [ + "ECG Analysis", + "EKG Analysis", + "Electrocardiogram Interpretation", + "ECG Interpretation", + "EKG Interpretation" + ], + "href": "/mdr/bc/biomedicalconcepts/C181655", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_116", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C125009", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Clinical Interpretation" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_117", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_118", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_119", + "name": "EGCLSIG", + "label": "EGCLSIG", + "mandatory": false, + "coding": [ + { + "code": "C93532", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Clinically Significant Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_120", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C181655", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Electrocardiogram Analysis" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_28", + "name": "Atrioventricular Conduction ECG Assessment", + "label": "Atrioventricular Conduction ECG Assessment", + "aliases": [ + "AVCOND", + "Atrioventricular Conduction" + ], + "href": "/mdr/bc/biomedicalconcepts/C111131", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_121", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_122", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_123", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_124", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_125", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C111131", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-17", + "decode": "Atrioventricular Conduction ECG Assessment" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_29", + "name": "Axis and Voltage ECG Assessment", + "label": "Axis and Voltage ECG Assessment", + "aliases": [ + "AXISVOLT", + "Axis and Voltage" + ], + "href": "/mdr/bc/biomedicalconcepts/C111132", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_126", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_127", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_128", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_129", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_130", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C111132", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-17", + "decode": "Axis and Voltage ECG Assessment" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_30", + "name": "Chamber Hypertrophy or Enlargement ECG Assessment", + "label": "Chamber Hypertrophy or Enlargement ECG Assessment", + "aliases": [ + "CHYPTENL", + "Chamber Hypertrophy or Enlargement" + ], + "href": "/mdr/bc/biomedicalconcepts/C111155", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_131", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_132", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_133", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_134", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_135", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C111155", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-17", + "decode": "Chamber Hypertrophy or Enlargement ECG Assessment" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_31", + "name": "ECG Technical Quality", + "label": "ECG Technical Quality", + "aliases": [ + "TECHQUAL" + ], + "href": "/mdr/bc/biomedicalconcepts/C117807", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_136", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C114120", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "ECG Recording Quality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_137", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_138", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_139", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C117807", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "ECG Technical Quality" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_32", + "name": "Intraventricular and Intraatrial Conduction ECG Assessment", + "label": "Intraventricular and Intraatrial Conduction ECG Assessment", + "aliases": [ + "IVTIACD", + "Intraventricular-Intraatrial Conduction" + ], + "href": "/mdr/bc/biomedicalconcepts/C111238", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_140", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_141", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_142", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_143", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_144", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C111238", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-17", + "decode": "Intraventricular and Intraatrial Conduction ECG Assessment" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_33", + "name": "Myocardial Infarction ECG Assessment", + "label": "Myocardial Infarction ECG Assessment", + "aliases": [ + "MI", + "Myocardial Infarction" + ], + "href": "/mdr/bc/biomedicalconcepts/C111280", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_145", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_146", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_147", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_148", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + } + ], + "coding": [ + { + "code": "C111280", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-17", + "decode": "Myocardial Infarction ECG Assessment" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_34", + "name": "Pacemaker ECG Assessment", + "label": "Pacemaker ECG Assessment", + "aliases": [ + "PACEMAKR", + "Pacemaker" + ], + "href": "/mdr/bc/biomedicalconcepts/C111285", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_149", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_150", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_151", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_152", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_153", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C111285", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-17", + "decode": "Pacemaker ECG Assessment" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_35", + "name": "Rhythm Not Otherwise Specified ECG Assessment", + "label": "Rhythm Not Otherwise Specified ECG Assessment", + "aliases": [ + "RHYNOS", + "Rhythm Not Otherwise Specified" + ], + "href": "/mdr/bc/biomedicalconcepts/C111307", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_154", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_155", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_156", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_157", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_158", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C111307", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-17", + "decode": "Rhythm Not Otherwise Specified ECG Assessment" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_36", + "name": "ST Segment, T wave, and U wave ECG Assessment", + "label": "ST Segment, T wave, and U wave ECG Assessment", + "aliases": [ + "STSTWUW", + "ST Segment, T wave, and U wave" + ], + "href": "/mdr/bc/biomedicalconcepts/C111363", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_159", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_160", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_161", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_162", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_163", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C111363", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-17", + "decode": "ST Segment, T wave, and U wave ECG Assessment" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_37", + "name": "Sinus Node Rhythm and Arrhythmia ECG Assessment", + "label": "Sinus Node Rhythm and Arrhythmia ECG Assessment", + "aliases": [ + "SNRARRY", + "Sinus Node Rhythms and Arrhythmias" + ], + "href": "/mdr/bc/biomedicalconcepts/C111312", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_164", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_165", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_166", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_167", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ], + "codeList": "CL.cbd6ad98" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_168", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C111312", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-17", + "decode": "Sinus Node Rhythm and Arrhythmia ECG Assessment" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_38", + "name": "Supraventricular Arrhythmia ECG Assessment", + "label": "Supraventricular Arrhythmia ECG Assessment", + "aliases": [ + "SPRARRY", + "Supraventricular Arrhythmias" + ], + "href": "/mdr/bc/biomedicalconcepts/C111320", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_169", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_170", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_171", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_172", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_173", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ], + "codeList": "CL.b63f6642" + } + ], + "coding": [ + { + "code": "C111320", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-17", + "decode": "Supraventricular Arrhythmia ECG Assessment" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_39", + "name": "Supraventricular Tachyarrhythmia ECG Assessment", + "label": "Supraventricular Tachyarrhythmia ECG Assessment", + "aliases": [ + "SPRTARRY", + "Supraventricular Tachyarrhythmias" + ], + "href": "/mdr/bc/biomedicalconcepts/C111321", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_174", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_175", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_176", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_177", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_178", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C111321", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-17", + "decode": "Supraventricular Tachyarrhythmia ECG Assessment" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_40", + "name": "Aggregate PR Interval", + "label": "Aggregate PR Interval", + "aliases": [ + "PR Interval Aggregate", + "PQ Interval Aggregate", + "PRAG", + "PQAG" + ], + "href": "/mdr/bc/biomedicalconcepts/C117773", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_179", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C25330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Duration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_180", + "name": "EGORRESU", + "label": "EGORRESU", + "mandatory": false, + "coding": [ + { + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_181", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_182", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ], + "codeList": "CL.82acb719" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_183", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_184", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_185", + "name": "EGENDTC", + "label": "EGENDTC", + "mandatory": false, + "coding": [ + { + "code": "C82516", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation End Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C117773", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Aggregate PR Interval" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_41", + "name": "Aggregate QRS Duration", + "label": "Aggregate QRS Duration", + "aliases": [ + "QRS Aggregate Duration", + "QRSAG" + ], + "href": "/mdr/bc/biomedicalconcepts/C117779", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_186", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C25330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Duration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_187", + "name": "EGORRESU", + "label": "EGORRESU", + "mandatory": false, + "coding": [ + { + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_188", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ], + "codeList": "CL.e1a1b71c" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_189", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_190", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_191", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_192", + "name": "EGENDTC", + "label": "EGENDTC", + "mandatory": false, + "coding": [ + { + "code": "C82516", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation End Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C117779", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Aggregate QRS Duration" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_42", + "name": "Aggregate QT Interval", + "label": "Aggregate QT Interval", + "aliases": [ + "QT Interval Aggregate", + "QTAG" + ], + "href": "/mdr/bc/biomedicalconcepts/C117783", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_193", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C25330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Duration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_194", + "name": "EGORRESU", + "label": "EGORRESU", + "mandatory": false, + "coding": [ + { + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_195", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_196", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_197", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_198", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_199", + "name": "EGENDTC", + "label": "EGENDTC", + "mandatory": false, + "coding": [ + { + "code": "C82516", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation End Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C117783", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Aggregate QT Interval" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_43", + "name": "Aggregate QTCB Interval", + "label": "Aggregate QTCB Interval", + "aliases": [ + "QTCB Interval Aggregate", + "QTCBAG" + ], + "href": "/mdr/bc/biomedicalconcepts/C117784", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_200", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C25330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Duration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_201", + "name": "EGORRESU", + "label": "EGORRESU", + "mandatory": false, + "coding": [ + { + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_202", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_203", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_204", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_205", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_206", + "name": "EGENDTC", + "label": "EGENDTC", + "mandatory": false, + "coding": [ + { + "code": "C82516", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation End Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C117784", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Aggregate QTCB Interval" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_44", + "name": "Aggregate QTCF Interval", + "label": "Aggregate QTCF Interval", + "aliases": [ + "QTCF Interval Aggregate", + "QTCFAG" + ], + "href": "/mdr/bc/biomedicalconcepts/C117786", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_207", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C25330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Duration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_208", + "name": "EGORRESU", + "label": "EGORRESU", + "mandatory": false, + "coding": [ + { + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_209", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_210", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_211", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_212", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_213", + "name": "EGENDTC", + "label": "EGENDTC", + "mandatory": false, + "coding": [ + { + "code": "C82516", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation End Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C117786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Aggregate QTCF Interval" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_45", + "name": "Aggregate RR Interval", + "label": "Aggregate RR Interval", + "aliases": [ + "RR Interval Aggregate", + "RRAG" + ], + "href": "/mdr/bc/biomedicalconcepts/C117791", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_214", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C25330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Duration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_215", + "name": "EGORRESU", + "label": "EGORRESU", + "mandatory": false, + "coding": [ + { + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_216", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_217", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ], + "codeList": "CL.cbd6ad98" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_218", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_219", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_220", + "name": "EGENDTC", + "label": "EGENDTC", + "mandatory": false, + "coding": [ + { + "code": "C82516", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation End Date Time" + } + ], + "codeList": "CL.b63f6642" + } + ], + "coding": [ + { + "code": "C117791", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Aggregate RR Interval" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_46", + "name": "Mean Heart Rate by Electrocardiogram", + "label": "Mean Heart Rate by Electrocardiogram", + "aliases": [ + "ECG Mean Heart Rate", + "EKG Mean Heart Rate", + "EGHRMN" + ], + "href": "/mdr/bc/biomedicalconcepts/C119259", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_221", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_222", + "name": "EGORRESU", + "label": "EGORRESU", + "mandatory": false, + "coding": [ + { + "code": "C73688", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Count per Minute" + } + ], + "codeList": "CL.cbd6ad98" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_223", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_224", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_225", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_226", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ], + "codeList": "CL.b63f6642" + } + ], + "coding": [ + { + "code": "C119259", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Mean Heart Rate by Electrocardiogram" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_47", + "name": "QRS Axis", + "label": "QRS Axis", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C118165", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_227", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_228", + "name": "EGORRESU", + "label": "EGORRESU", + "mandatory": false, + "coding": [ + { + "code": "C68667", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Degree Unit of Plane Angle" + } + ], + "codeList": "CL.04edb9f9" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_229", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_230", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_231", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_232", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C118165", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "QRS Axis" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_48", + "name": "QTc Correction Method Unspecified, Aggregate", + "label": "QTc Correction Method Unspecified, Aggregate", + "aliases": [ + "QTCUNSAG" + ], + "href": "/mdr/bc/biomedicalconcepts/C174285", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_233", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C25330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Duration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_234", + "name": "EGORRESU", + "label": "EGORRESU", + "mandatory": false, + "coding": [ + { + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_235", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_236", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_237", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_238", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_239", + "name": "EGENDTC", + "label": "EGENDTC", + "mandatory": false, + "coding": [ + { + "code": "C82516", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation End Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C174285", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "QTc Correction Method Unspecified, Aggregate" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_49", + "name": "Ventricular Arrhythmia ECG Assessment", + "label": "Ventricular Arrhythmia ECG Assessment", + "aliases": [ + "VTARRY", + "Ventricular Arrhythmias" + ], + "href": "/mdr/bc/biomedicalconcepts/C111330", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_240", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_241", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_242", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_243", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_244", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C111330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-17", + "decode": "Ventricular Arrhythmia ECG Assessment" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_50", + "name": "Ventricular Tachyarrhythmia ECG Assessment", + "label": "Ventricular Tachyarrhythmia ECG Assessment", + "aliases": [ + "VTTARRY", + "Ventricular Tachyarrhythmias" + ], + "href": "/mdr/bc/biomedicalconcepts/C111331", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_245", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_246", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_247", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_248", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_249", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C111331", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-17", + "decode": "Ventricular Tachyarrhythmia ECG Assessment" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_51", + "name": "Computed Tomography", + "label": "Computed Tomography", + "aliases": [ + "CAT Scan", + "Computed Axial Tomography", + "Computed Tomography", + "Computerized Tomography", + "CT" + ], + "href": "/mdr/bc/biomedicalconcepts/C17204", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_250", + "name": "PRTRT", + "label": "PRTRT", + "mandatory": true, + "coding": [ + { + "code": "C117511", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Reported Name of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_251", + "name": "PRDECOD", + "label": "PRDECOD", + "mandatory": true, + "coding": [ + { + "code": "C117512", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Standardized Name of Procedure" + } + ], + "codeList": "CL.2e4119e7" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_252", + "name": "PRPRESP", + "label": "PRPRESP", + "mandatory": false, + "coding": [ + { + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Prespecified Event or Intervention Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_253", + "name": "PROCCUR", + "label": "PROCCUR", + "mandatory": false, + "coding": [ + { + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Occurrence Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_254", + "name": "PRLOC", + "label": "PRLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Anatomic Site" + } + ], + "codeList": "CL.3edf8d8c" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_255", + "name": "PRSTDTC", + "label": "PRSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C117529", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Start Date and Time of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_256", + "name": "PRENDTC", + "label": "PRENDTC", + "mandatory": false, + "coding": [ + { + "code": "C117530", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "End Date and Time of Procedure" + } + ] + } + ], + "coding": [ + { + "code": "C17204", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "CT SCAN" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_52", + "name": "Magnetic Resonance Imaging", + "label": "Magnetic Resonance Imaging", + "aliases": [ + "Magnetic Resonance", + "MRI", + "MRI Scan", + "NMR", + "NMR Imaging" + ], + "href": "/mdr/bc/biomedicalconcepts/C16809", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_257", + "name": "PRTRT", + "label": "PRTRT", + "mandatory": true, + "coding": [ + { + "code": "C117511", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Reported Name of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_258", + "name": "PRDECOD", + "label": "PRDECOD", + "mandatory": true, + "coding": [ + { + "code": "C117512", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Standardized Name of Procedure" + } + ], + "codeList": "CL.d03f062b" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_259", + "name": "PRPRESP", + "label": "PRPRESP", + "mandatory": false, + "coding": [ + { + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Prespecified Event or Intervention Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_260", + "name": "PROCCUR", + "label": "PROCCUR", + "mandatory": false, + "coding": [ + { + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Occurrence Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_261", + "name": "PRLOC", + "label": "PRLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Anatomic Site" + } + ], + "codeList": "CL.e2fce626" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_262", + "name": "PRSTDTC", + "label": "PRSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C117529", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Start Date and Time of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_263", + "name": "PRENDTC", + "label": "PRENDTC", + "mandatory": false, + "coding": [ + { + "code": "C117530", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "End Date and Time of Procedure" + } + ] + } + ], + "coding": [ + { + "code": "C16809", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "MRI" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_54", + "name": "Concomitant Medication Yes No Indicator", + "label": "Concomitant Medication Yes No Indicator", + "aliases": [ + "CMYN" + ], + "href": "/mdr/bc/biomedicalconcepts/C83056", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_264", + "name": "Concomitant Medication Yes No Indicator", + "label": "Concomitant Medication Yes No Indicator", + "mandatory": true, + "coding": [ + { + "code": "C83056", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Concomitant Medication Yes No Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_265", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C83056", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Concomitant Medication Yes No Indicator" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_55", + "name": "Concomitant Therapy", + "label": "Concomitant Therapy", + "aliases": [ + "Concomitant Medication" + ], + "href": "/mdr/bc/biomedicalconcepts/C53630", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_266", + "name": "CMTRT", + "label": "CMTRT", + "mandatory": true, + "coding": [ + { + "code": "C70902", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Agent" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_267", + "name": "CMDECOD", + "label": "CMDECOD", + "mandatory": false, + "coding": [ + { + "code": "C83345", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dictionary Derived Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_268", + "name": "CMCLAS", + "label": "CMCLAS", + "mandatory": false, + "coding": [ + { + "code": "C83219", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Class" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_269", + "name": "CMINDC", + "label": "CMINDC", + "mandatory": false, + "coding": [ + { + "code": "C83085", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Use Indication" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_270", + "name": "CMDOSE", + "label": "CMDOSE", + "mandatory": false, + "coding": [ + { + "code": "C83221", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_271", + "name": "CMDOSTXT", + "label": "CMDOSTXT", + "mandatory": false, + "coding": [ + { + "code": "C83221", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_272", + "name": "CMDOSU", + "label": "CMDOSU", + "mandatory": false, + "coding": [ + { + "code": "C83034", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_273", + "name": "CMDOSFRM", + "label": "CMDOSFRM", + "mandatory": false, + "coding": [ + { + "code": "C83110", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose Form" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_274", + "name": "CMDOSFRQ", + "label": "CMDOSFRQ", + "mandatory": false, + "coding": [ + { + "code": "C83042", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose Frequency" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_275", + "name": "CMROUTE", + "label": "CMROUTE", + "mandatory": false, + "coding": [ + { + "code": "C83120", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Route of Administration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_276", + "name": "CMSTDTC", + "label": "CMSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83235", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Use Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_277", + "name": "CMENDTC", + "label": "CMENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83225", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Use End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_278", + "name": "CMSTRF", + "label": "CMSTRF", + "mandatory": false, + "coding": [ + { + "code": "C82559", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_279", + "name": "CMSTRTPT", + "label": "CMSTRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82560", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_280", + "name": "CMSTTPT", + "label": "CMSTTPT", + "mandatory": false, + "coding": [ + { + "code": "C82575", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference Start Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_281", + "name": "CMENRF", + "label": "CMENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_282", + "name": "CMENRTPT", + "label": "CMENRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_283", + "name": "CMENTPT", + "label": "CMENTPT", + "mandatory": false, + "coding": [ + { + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End" + } + ] + } + ], + "coding": [ + { + "code": "C53630", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Therapy" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_56", + "name": "Hemoglobin Measurement", + "label": "Hemoglobin Measurement", + "aliases": [ + "Hemoglobin", + "HGB" + ], + "href": "/mdr/bc/biomedicalconcepts/C64848", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_284", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_285", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C64571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Mass Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_286", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_287", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_288", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64848", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Hemoglobin Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_57", + "name": "Hematocrit Measurement", + "label": "Hematocrit Measurement", + "aliases": [ + "Hematocrit", + "Packed Cell Volume", + "PCV", + "Erythrocyte Volume Fraction", + "EVF" + ], + "href": "/mdr/bc/biomedicalconcepts/C64796", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_289", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_290", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C69174", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Volume Fraction" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_291", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_292", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_293", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64796", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Hematocrit Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_58", + "name": "Erythrocyte Count", + "label": "Erythrocyte Count", + "aliases": [ + "RBC", + "Red Blood Cells" + ], + "href": "/mdr/bc/biomedicalconcepts/C51946", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_294", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_295", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_296", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_297", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_298", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C51946", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Erythrocyte Count" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_59", + "name": "Erythrocyte Mean Corpuscular Hemoglobin", + "label": "Erythrocyte Mean Corpuscular Hemoglobin", + "aliases": [ + "RBC Mean Corpuscular Hemoglobin", + "MCH" + ], + "href": "/mdr/bc/biomedicalconcepts/C64797", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_299", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_300", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C25709", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Measure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_301", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.8d13b90f" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_302", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_303", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64797", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Erythrocyte Mean Corpuscular Hemoglobin" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_60", + "name": "Erythrocyte Mean Corpuscular Volume", + "label": "Erythrocyte Mean Corpuscular Volume", + "aliases": [ + "RBC Mean Corpuscular Volume", + "MCV" + ], + "href": "/mdr/bc/biomedicalconcepts/C64799", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_304", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_305", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C44279", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Volume" + } + ], + "codeList": "CL.d00a60ac" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_306", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.8d13b90f" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_307", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_308", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64799", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Erythrocyte Mean Corpuscular Volume" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_61", + "name": "Leukocyte Count", + "label": "Leukocyte Count", + "aliases": [ + "WBC", + "White Blood Cells" + ], + "href": "/mdr/bc/biomedicalconcepts/C51948", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_309", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_310", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_311", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_312", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_313", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C51948", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Leukocyte Count" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_62", + "name": "Segmented Neutrophil Count", + "label": "Segmented Neutrophil Count", + "aliases": [ + "Segmented Neutrophils", + "NEUTSG" + ], + "href": "/mdr/bc/biomedicalconcepts/C81997", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_314", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_315", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration" + } + ], + "codeList": "CL.d121315c" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_316", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_317", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_318", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C81997", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Segmented Neutrophil Count" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_63", + "name": "Neutrophil Band Form Count", + "label": "Neutrophil Band Form Count", + "aliases": [ + "Neutrophil Bands", + "Bands", + "NEUTB" + ], + "href": "/mdr/bc/biomedicalconcepts/C64830", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_319", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_320", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration" + } + ], + "codeList": "CL.b454d520" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_321", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_322", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_323", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64830", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Neutrophil Band Form Count" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_64", + "name": "Absolute Neutrophil Count", + "label": "Absolute Neutrophil Count", + "aliases": [ + "Neutrophils", + "Total Neutrophil Count", + "NEUT" + ], + "href": "/mdr/bc/biomedicalconcepts/C63321", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_324", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_325", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration" + } + ], + "codeList": "CL.d121315c" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_326", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_327", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_328", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C63321", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Absolute Neutrophil Count" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_65", + "name": "Monocyte Count", + "label": "Monocyte Count", + "aliases": [ + "Monocytes" + ], + "href": "/mdr/bc/biomedicalconcepts/C64823", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_329", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_330", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_331", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_332", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_333", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64823", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Monocyte Count" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_66", + "name": "Eosinophil Count", + "label": "Eosinophil Count", + "aliases": [ + "Eosinophils" + ], + "href": "/mdr/bc/biomedicalconcepts/C64550", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_334", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_335", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_336", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_337", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_338", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64550", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Eosinophil Count" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_67", + "name": "Absolute Basophil Count", + "label": "Absolute Basophil Count", + "aliases": [ + "Basophils", + "Total Basophil Count" + ], + "href": "/mdr/bc/biomedicalconcepts/C64470", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_339", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_340", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_341", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_342", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_343", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64470", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Absolute Basophil Count" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_68", + "name": "Platelet Count", + "label": "Platelet Count", + "aliases": [ + "Thrombocytes", + "Platelets", + "Anucleated Thrombocytes" + ], + "href": "/mdr/bc/biomedicalconcepts/C51951", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_344", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_345", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_346", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_347", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_348", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C51951", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Platelet Count" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_69", + "name": "Microcyte Count", + "label": "Microcyte Count", + "aliases": [ + "Microcytes", + "MICROCY" + ], + "href": "/mdr/bc/biomedicalconcepts/C64822", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_349", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_350", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_351", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_352", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64822", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Microcyte Count" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_70", + "name": "Macrocyte Count", + "label": "Macrocyte Count", + "aliases": [ + "Macrocytes", + "MACROCY" + ], + "href": "/mdr/bc/biomedicalconcepts/C64821", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_353", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_354", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_355", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_356", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64821", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Macrocyte Count" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_71", + "name": "Anisocyte Measurement", + "label": "Anisocyte Measurement", + "aliases": [ + "Anisocytes", + "Anisocytosis", + "ANISO" + ], + "href": "/mdr/bc/biomedicalconcepts/C74797", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_357", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_358", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_359", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_360", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C74797", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Anisocyte Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_72", + "name": "Poikilocyte Measurement", + "label": "Poikilocyte Measurement", + "aliases": [ + "POIKILO", + "Poikilocytes" + ], + "href": "/mdr/bc/biomedicalconcepts/C79602", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_361", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_362", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_363", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_364", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C79602", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Poikilocyte Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_73", + "name": "Polychromasia", + "label": "Polychromasia", + "aliases": [ + "POLYCHR" + ], + "href": "/mdr/bc/biomedicalconcepts/C64803", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_365", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_366", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_367", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_368", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64803", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Polychromasia" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_74", + "name": "Alanine Aminotransferase Measurement", + "label": "Alanine Aminotransferase Measurement", + "aliases": [ + "ALT", + "SGPT" + ], + "href": "/mdr/bc/biomedicalconcepts/C64433", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_369", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_370", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67365", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_371", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_372", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_373", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64433", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Alanine Aminotransferase Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_75", + "name": "Albumin Measurement", + "label": "Albumin Measurement", + "aliases": [ + "Albumin" + ], + "href": "/mdr/bc/biomedicalconcepts/C64431", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_374", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_375", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_376", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_377", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_378", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64431", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Albumin Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_76", + "name": "Alkaline Phosphatase Measurement", + "label": "Alkaline Phosphatase Measurement", + "aliases": [ + "Alkaline Phosphatase" + ], + "href": "/mdr/bc/biomedicalconcepts/C64432", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_379", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_380", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67365", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_381", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_382", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_383", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64432", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Alkaline Phosphatase Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_77", + "name": "Aspartate Aminotransferase Measurement", + "label": "Aspartate Aminotransferase Measurement", + "aliases": [ + "AST", + "SGOT" + ], + "href": "/mdr/bc/biomedicalconcepts/C64467", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_384", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_385", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67365", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_386", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_387", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_388", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64467", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Aspartate Aminotransferase Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_78", + "name": "Creatinine Measurement", + "label": "Creatinine Measurement", + "aliases": [ + "Creatinine" + ], + "href": "/mdr/bc/biomedicalconcepts/C64547", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_908", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_909", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_910", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_911", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_912", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64547", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Creatinine Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_79", + "name": "Potassium Measurement", + "label": "Potassium Measurement", + "aliases": [ + "Potassium", + "K" + ], + "href": "/mdr/bc/biomedicalconcepts/C64853", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_394", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_395", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C64567", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Molarity Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_396", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_397", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_398", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64853", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Potassium Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_80", + "name": "Sodium Measurement", + "label": "Sodium Measurement", + "aliases": [ + "Sodium", + "NA" + ], + "href": "/mdr/bc/biomedicalconcepts/C64809", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_399", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_400", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C64567", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Molarity Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_401", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_402", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_403", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64809", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Sodium Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_81", + "name": "Urea Nitrogen Measurement", + "label": "Urea Nitrogen Measurement", + "aliases": [ + "Urea Nitrogen" + ], + "href": "/mdr/bc/biomedicalconcepts/C125949", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_404", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_405", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_406", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_407", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_408", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C125949", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Urea Nitrogen Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_82", + "name": "Bicarbonate Measurement", + "label": "Bicarbonate Measurement", + "aliases": [ + "Bicarbonate", + "HCO3" + ], + "href": "/mdr/bc/biomedicalconcepts/C74667", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_409", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_410", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C64567", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Molarity Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_411", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_412", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_413", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C74667", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Bicarbonate Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_83", + "name": "Chloride Measurement", + "label": "Chloride Measurement", + "aliases": [ + "Chloride", + "CL" + ], + "href": "/mdr/bc/biomedicalconcepts/C64495", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_414", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_415", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C64567", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Molarity Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_416", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_417", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_418", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64495", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Chloride Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_84", + "name": "Total Bilirubin Measurement", + "label": "Total Bilirubin Measurement", + "aliases": [ + "Bilirubin", + "Total Bilirubin Level" + ], + "href": "/mdr/bc/biomedicalconcepts/C38037", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_419", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_420", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_421", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_422", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_423", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C38037", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Total Bilirubin Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_85", + "name": "Gamma Glutamyl Transpeptidase Measurement", + "label": "Gamma Glutamyl Transpeptidase Measurement", + "aliases": [ + "Gamma Glutamyl Transferase", + "GGT", + "GGTP" + ], + "href": "/mdr/bc/biomedicalconcepts/C64847", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_913", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_914", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67365", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_915", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_916", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_917", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64847", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Gamma Glutamyl Transpeptidase Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_86", + "name": "Urate Measurement", + "label": "Urate Measurement", + "aliases": [ + "Urate", + "Uric Acid" + ], + "href": "/mdr/bc/biomedicalconcepts/C64814", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_429", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_430", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_431", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_432", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_433", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64814", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Urate Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_87", + "name": "Phosphate Measurement", + "label": "Phosphate Measurement", + "aliases": [ + "Phosphorus", + "Phosphate" + ], + "href": "/mdr/bc/biomedicalconcepts/C64857", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_918", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_919", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_920", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_921", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_922", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64857", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Phosphate Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_88", + "name": "Calcium Measurement", + "label": "Calcium Measurement", + "aliases": [ + "Calcium", + "CA" + ], + "href": "/mdr/bc/biomedicalconcepts/C64488", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_923", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_924", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_925", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_926", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_927", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64488", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Calcium Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_89", + "name": "Glucose Measurement", + "label": "Glucose Measurement", + "aliases": [ + "Glucose" + ], + "href": "/mdr/bc/biomedicalconcepts/C105585", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_444", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_445", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_446", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_447", + "name": "LBMETHOD", + "label": "LBMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_448", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_449", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C105585", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Glucose Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_90", + "name": "Total Protein Measurement", + "label": "Total Protein Measurement", + "aliases": [ + "Protein" + ], + "href": "/mdr/bc/biomedicalconcepts/C64858", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_450", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_451", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_452", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_453", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_454", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ], + "codeList": "CL.cbd6ad98" + } + ], + "coding": [ + { + "code": "C64858", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Total Protein Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_91", + "name": "Cholesterol Measurement", + "label": "Cholesterol Measurement", + "aliases": [ + "CHOL", + "Cholesterol", + "Total Cholesterol" + ], + "href": "/mdr/bc/biomedicalconcepts/C105586", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_455", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_456", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_457", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_458", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_459", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C105586", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Cholesterol Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_92", + "name": "Triiodothyronine Uptake Measurement", + "label": "Triiodothyronine Uptake Measurement", + "aliases": [ + "T3UP", + "T3U", + "Triiodothyronine Resin Uptake" + ], + "href": "/mdr/bc/biomedicalconcepts/C74748", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_460", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_461", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48570", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Percent Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_462", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_463", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_464", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C74748", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Triiodothyronine Uptake Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_93", + "name": "Triiodothyronine Measurement", + "label": "Triiodothyronine Measurement", + "aliases": [ + "T3", + "Total T3" + ], + "href": "/mdr/bc/biomedicalconcepts/C74747", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_928", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_929", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_930", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_931", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_932", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C74747", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Triiodothyronine Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_94", + "name": "Free Thyroxine Measurement", + "label": "Free Thyroxine Measurement", + "aliases": [ + "Free T4", + "T4FR" + ], + "href": "/mdr/bc/biomedicalconcepts/C74786", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_470", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_471", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_472", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_473", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_474", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C74786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Free Thyroxine Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_95", + "name": "Free Thyroxine Index", + "label": "Free Thyroxine Index", + "aliases": [ + "T4FRIDX" + ], + "href": "/mdr/bc/biomedicalconcepts/C170598", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_475", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_476", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_477", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_478", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C170598", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Free Thyroxine Index" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_96", + "name": "Thyrotropin Measurement", + "label": "Thyrotropin Measurement", + "aliases": [ + "TSH", + "Thyrotropin" + ], + "href": "/mdr/bc/biomedicalconcepts/C64813", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_479", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_480", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67365", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_481", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_482", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_483", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64813", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Thyrotropin Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_97", + "name": "Folic Acid Measurement", + "label": "Folic Acid Measurement", + "aliases": [ + "Folate", + "Folic Acid", + "Vitamin B9", + "VITB9" + ], + "href": "/mdr/bc/biomedicalconcepts/C74676", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_484", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_485", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_486", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_487", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_488", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C74676", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Folic Acid Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_98", + "name": "Vitamin B12 Measurement", + "label": "Vitamin B12 Measurement", + "aliases": [ + "Cobalamin", + "Vitamin B12", + "VITB12" + ], + "href": "/mdr/bc/biomedicalconcepts/C64817", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_489", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_490", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_491", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_492", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_493", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ], + "codeList": "CL.1f6d4af1" + } + ], + "coding": [ + { + "code": "C64817", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Vitamin B12 Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_99", + "name": "Treponema pallidum Antibody Measurement", + "label": "Treponema pallidum Antibody Measurement", + "aliases": [ + "TPLAB", + "Treponema pallidum Antibody", + "Syphilis Antibody" + ], + "href": "/mdr/bc/biomedicalconcepts/C132388", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_494", + "name": "MBTSTDTL", + "label": "MBTSTDTL", + "mandatory": false, + "coding": [ + { + "code": "C117062", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Measurement, Test or Examination Detail" + } + ], + "codeList": "CL.b0ec3282" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_495", + "name": "MBORRES", + "label": "MBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_496", + "name": "MBSPEC", + "label": "MBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.64500426" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_497", + "name": "MBMETHOD", + "label": "MBMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_498", + "name": "MBDTC", + "label": "MBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C132388", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Treponema pallidum Antibody Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_100", + "name": "Treponema pallidum DNA Measurement", + "label": "Treponema pallidum DNA Measurement", + "aliases": [ + "TPADNA", + "Syphilis DNA" + ], + "href": "/mdr/bc/biomedicalconcepts/C198341", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_499", + "name": "MBTSTDTL", + "label": "MBTSTDTL", + "mandatory": false, + "coding": [ + { + "code": "C117062", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Measurement, Test or Examination Detail" + } + ], + "codeList": "CL.b0ec3282" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_500", + "name": "MBORRES", + "label": "MBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_501", + "name": "MBSPEC", + "label": "MBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_502", + "name": "MBMETHOD", + "label": "MBMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ], + "codeList": "CL.928af9cb" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_503", + "name": "MBDTC", + "label": "MBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C198341", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Treponema pallidum DNA Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_101", + "name": "Color Assessment", + "label": "Color Assessment", + "aliases": [ + "COLOR", + "Color" + ], + "href": "/mdr/bc/biomedicalconcepts/C64546", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_504", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_505", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.64329559" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_506", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64546", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Color Assessment" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_102", + "name": "Specific Gravity", + "label": "Specific Gravity", + "aliases": [ + "SPGRAV" + ], + "href": "/mdr/bc/biomedicalconcepts/C64832", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_824", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_825", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.64329559" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_826", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_827", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64832", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Specific Gravity" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_103", + "name": "Total Protein Measurement", + "label": null, + "aliases": [ + "Protein" + ], + "href": "/mdr/bc/biomedicalconcepts/C64858", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_511", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_512", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_513", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_514", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_515", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64858", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Total Protein Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_104", + "name": "Glucose Measurement", + "label": null, + "aliases": [ + "Glucose" + ], + "href": "/mdr/bc/biomedicalconcepts/C105585", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_828", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_829", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_830", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.64329559" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_831", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_832", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C105585", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Glucose Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_105", + "name": "Ketone Measurement", + "label": "Ketone Measurement", + "aliases": [ + "Ketones" + ], + "href": "/mdr/bc/biomedicalconcepts/C64854", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_521", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_522", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_523", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.64329559" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_524", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_525", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64854", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Ketone Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_106", + "name": "Total Bilirubin Measurement", + "label": null, + "aliases": [ + "Bilirubin", + "Total Bilirubin Level" + ], + "href": "/mdr/bc/biomedicalconcepts/C38037", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_526", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_527", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_528", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_529", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_530", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C38037", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Total Bilirubin Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_107", + "name": "Urobilinogen Measurement", + "label": "Urobilinogen Measurement", + "aliases": [ + "Urobilinogen", + "UROBIL" + ], + "href": "/mdr/bc/biomedicalconcepts/C64816", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_531", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_532", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_533", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.64329559" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_534", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_535", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64816", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Urobilinogen Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_108", + "name": "Occult Blood Measurement", + "label": "Occult Blood Measurement", + "aliases": [ + "Occult Blood", + "OCCBLD" + ], + "href": "/mdr/bc/biomedicalconcepts/C74686", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_536", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_537", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.65d42172" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_538", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_539", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C74686", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Occult Blood Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_109", + "name": "Nitrite Measurement", + "label": "Nitrite Measurement", + "aliases": [ + "NITRITE" + ], + "href": "/mdr/bc/biomedicalconcepts/C64810", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_833", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_834", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_835", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.64329559" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_836", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_837", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64810", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Nitrite Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_110", + "name": "Hemoglobin A1C Measurement", + "label": "Hemoglobin A1C Measurement", + "aliases": [ + "Hemoglobin A1C", + "HBA1C", + "Glycosylated Hemoglobin A1C" + ], + "href": "/mdr/bc/biomedicalconcepts/C64849", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_545", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_546", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_547", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_548", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C64849", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Hemoglobin A1C Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_111", + "name": "Hemoglobin A1C to Hemoglobin Ratio Measurement", + "label": "Hemoglobin A1C to Hemoglobin Ratio Measurement", + "aliases": [ + "Hemoglobin A1C/Hemoglobin", + "HBA1CHGB" + ], + "href": "/mdr/bc/biomedicalconcepts/C111207", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_549", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_550", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_551", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_552", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C111207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Hemoglobin A1C to Hemoglobin Ratio Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_112", + "name": "Exposure as Collected Domain", + "label": "Exposure as Collected Domain", + "aliases": [ + "EC", + "Exposure as Collected" + ], + "href": "/mdr/bc/biomedicalconcepts/C117466", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_553", + "name": "ECTRT", + "label": "ECTRT", + "mandatory": true, + "coding": [ + { + "code": "C117473", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Name of Treatment" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_554", + "name": "ECREFID", + "label": "ECREFID", + "mandatory": false, + "coding": [ + { + "code": "C117469", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Reference Identifier" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_555", + "name": "ECDOSE", + "label": "ECDOSE", + "mandatory": false, + "coding": [ + { + "code": "C117479", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Dose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_556", + "name": "ECDOSTXT", + "label": "ECDOSTXT", + "mandatory": false, + "coding": [ + { + "code": "C117480", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Dose Description" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_557", + "name": "ECDOSU", + "label": "ECDOSU", + "mandatory": false, + "coding": [ + { + "code": "C117481", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Dose Units" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_558", + "name": "ECDOSFRM", + "label": "ECDOSFRM", + "mandatory": false, + "coding": [ + { + "code": "C117482", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Dose Form" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_559", + "name": "ECDOSFRQ", + "label": "ECDOSFRQ", + "mandatory": false, + "coding": [ + { + "code": "C117483", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Dosing Frequency per Interval" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_560", + "name": "ECDOSRGM", + "label": "ECDOSRGM", + "mandatory": false, + "coding": [ + { + "code": "C117485", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Intended Dose Regimen" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_561", + "name": "ECROUTE", + "label": "ECROUTE", + "mandatory": false, + "coding": [ + { + "code": "C117486", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Route of Administration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_562", + "name": "ECLOC", + "label": "ECLOC", + "mandatory": false, + "coding": [ + { + "code": "C117488", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Location" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_563", + "name": "ECLAT", + "label": "ECLAT", + "mandatory": false, + "coding": [ + { + "code": "C117489", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_564", + "name": "ECDIR", + "label": "ECDIR", + "mandatory": false, + "coding": [ + { + "code": "C117490", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Directionality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_565", + "name": "ECSTDTC", + "label": "ECSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C117496", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Start Date and Time of Treatment" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_566", + "name": "ECENDTC", + "label": "ECENDTC", + "mandatory": false, + "coding": [ + { + "code": "C117497", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected End Date and Time of Treatment" + } + ], + "codeList": "CL.1f6d4af1" + } + ], + "coding": [ + { + "code": "C117466", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Exposure as Collected Domain" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_113", + "name": "TTS Acceptability Survey", + "label": "TTS Acceptability Survey", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/NEW_LZZT", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_567", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_568", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_569", + "name": "Test Occurrence", + "label": "Test Occurrence", + "mandatory": true, + "coding": [ + { + "code": "C82525", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Test Occurrence" + } + ] + } + ], + "coding": [ + { + "code": "NEW_LZZT", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "TTS Acceptability Survey" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_114", + "name": "TTS Acceptability Survey - Patch Acceptability", + "label": "TTS Acceptability Survey - Patch Acceptability", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/NEW_LZZT4", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_570", + "name": "QSORRES", + "label": "QSORRES", + "mandatory": false, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Ordinal Position" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_571", + "name": "QSDTC", + "label": "QSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_572", + "name": "QSEVAL", + "label": "QSEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ], + "codeList": "CL.d7c5855c" + } + ], + "coding": [ + { + "code": "NEW_LZZT4", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "TTS Acceptability Survey - Patch Acceptability" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_115", + "name": "TTS Acceptability Survey - Patch Appearance", + "label": "TTS Acceptability Survey - Patch Appearance", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/NEW_LZZT1", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_573", + "name": "QSORRES", + "label": "QSORRES", + "mandatory": false, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_574", + "name": "QSDTC", + "label": "QSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_575", + "name": "QSEVAL", + "label": "QSEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ], + "codeList": "CL.d7c5855c" + } + ], + "coding": [ + { + "code": "NEW_LZZT1", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "TTS Acceptability Survey - Patch Appearance" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_116", + "name": "TTS Acceptability Survey - Patch Durability", + "label": "TTS Acceptability Survey - Patch Durability", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/NEW_LZZT3", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_576", + "name": "QSORRES", + "label": "QSORRES", + "mandatory": false, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_577", + "name": "QSDTC", + "label": "QSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_578", + "name": "QSEVAL", + "label": "QSEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ], + "codeList": "CL.d7c5855c" + } + ], + "coding": [ + { + "code": "NEW_LZZT3", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "TTS Acceptability Survey - Patch Durability" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_117", + "name": "TTS Acceptability Survey - Patch Size", + "label": "TTS Acceptability Survey - Patch Size", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/NEW_LZZT2", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_579", + "name": "QSORRES", + "label": "QSORRES", + "mandatory": false, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_580", + "name": "QSDTC", + "label": "QSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_581", + "name": "QSEVAL", + "label": "QSEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ], + "codeList": "CL.d7c5855c" + } + ], + "coding": [ + { + "code": "NEW_LZZT2", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "TTS Acceptability Survey - Patch Size" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_134", + "name": "Adverse Event Yes No Indicator", + "label": "Adverse Event Yes No Indicator", + "aliases": [ + "AEYN" + ], + "href": "/mdr/bc/biomedicalconcepts/C83347", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_582", + "name": "Adverse Event Yes No Indicator", + "label": "Adverse Event Yes No Indicator", + "mandatory": true, + "coding": [ + { + "code": "C83347", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Yes No Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_583", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C83347", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Yes No Indicator" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_135", + "name": "Solicited Adverse Event", + "label": "Solicited Adverse Event", + "aliases": [ + "Adverse Event" + ], + "href": "/mdr/bc/biomedicalconcepts/C179175", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_584", + "name": "AETERM", + "label": "AETERM", + "mandatory": true, + "coding": [ + { + "code": "C78541", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Verbatim Description" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_585", + "name": "AEDECOD", + "label": "AEDECOD", + "mandatory": false, + "coding": [ + { + "code": "C83344", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Dictionary Derived Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_586", + "name": "AELOC", + "label": "AELOC", + "mandatory": false, + "coding": [ + { + "code": "C83205", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Location" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_587", + "name": "AESEV", + "label": "AESEV", + "mandatory": false, + "coding": [ + { + "code": "C53253", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Severity of Adverse Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_588", + "name": "AESER", + "label": "AESER", + "mandatory": false, + "coding": [ + { + "code": "C53252", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Seriousness of Adverse Event" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_589", + "name": "AEACN", + "label": "AEACN", + "mandatory": false, + "coding": [ + { + "code": "C83013", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Action Taken with Study Treatment" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_590", + "name": "AEACNOTH", + "label": "AEACNOTH", + "mandatory": false, + "coding": [ + { + "code": "C83109", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Other Actions taken in Response to Adverse Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_591", + "name": "AEREL", + "label": "AEREL", + "mandatory": false, + "coding": [ + { + "code": "C41358", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Attribution to Product or Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_592", + "name": "AERELNST", + "label": "AERELNST", + "mandatory": false, + "coding": [ + { + "code": "C83210", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Relationship to Non Study Treatment" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_593", + "name": "AEPATT", + "label": "AEPATT", + "mandatory": false, + "coding": [ + { + "code": "C83208", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Pattern" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_594", + "name": "AEOUT", + "label": "AEOUT", + "mandatory": false, + "coding": [ + { + "code": "C49489", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Outcome" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_595", + "name": "AESCAN", + "label": "AESCAN", + "mandatory": false, + "coding": [ + { + "code": "C83211", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Involves Cancer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_596", + "name": "AESCONG", + "label": "AESCONG", + "mandatory": false, + "coding": [ + { + "code": "C83117", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Seriousness Due to Congenital Anomaly" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_597", + "name": "AESDISAB", + "label": "AESDISAB", + "mandatory": false, + "coding": [ + { + "code": "C113380", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Disabling Adverse Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_598", + "name": "AESDTH", + "label": "AESDTH", + "mandatory": false, + "coding": [ + { + "code": "C48275", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Death Related to Adverse Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_599", + "name": "AESHOSP", + "label": "AESHOSP", + "mandatory": false, + "coding": [ + { + "code": "C83052", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event associated with Hospitalization" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_600", + "name": "AESLIFE", + "label": "AESLIFE", + "mandatory": false, + "coding": [ + { + "code": "C84266", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Life Threatening Adverse Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_601", + "name": "AESOD", + "label": "AESOD", + "mandatory": false, + "coding": [ + { + "code": "C83214", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Occurred with Overdose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_602", + "name": "AESMIE", + "label": "AESMIE", + "mandatory": false, + "coding": [ + { + "code": "C83053", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Associated with Serious Medical Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_603", + "name": "AECONTRT", + "label": "AECONTRT", + "mandatory": false, + "coding": [ + { + "code": "C83199", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Concomitant Treatment" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_604", + "name": "AETOXGR", + "label": "AETOXGR", + "mandatory": false, + "coding": [ + { + "code": "C78605", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Toxicity Grade" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_605", + "name": "AESTDTC", + "label": "AESTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83215", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_606", + "name": "AEENDTC", + "label": "AEENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83201", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_607", + "name": "AEENRF", + "label": "AEENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_608", + "name": "AEENRTPT", + "label": "AEENRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_609", + "name": "AEENTPT", + "label": "AEENTPT", + "mandatory": false, + "coding": [ + { + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End" + } + ] + } + ], + "coding": [ + { + "code": "C179175", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Solicited Adverse Event" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_136", + "name": "Complete", + "label": "Complete", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C25250", + "properties": [], + "coding": [ + { + "code": "C25250", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Complete [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_137", + "name": "Failure To Meet Continuation Criteria", + "label": "Failure To Meet Continuation Criteria", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C139236", + "properties": [], + "coding": [ + { + "code": "C139236", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Failure To Meet Continuation Criteria [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_138", + "name": "Dead", + "label": "Dead", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C28554", + "properties": [], + "coding": [ + { + "code": "C28554", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Dead [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_139", + "name": "Lack of Efficacy", + "label": "Lack of Efficacy", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C48226", + "properties": [], + "coding": [ + { + "code": "C48226", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Lack of Efficacy [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_140", + "name": "Lost To Follow-Up", + "label": "Lost To Follow-Up", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C48227", + "properties": [], + "coding": [ + { + "code": "C48227", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Lost To Follow-Up [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_141", + "name": "Adverse Event [RETIRED]", + "label": "Adverse Event [RETIRED]", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C41331", + "properties": [], + "coding": [ + { + "code": "C41331", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Adverse Event [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_142", + "name": "Physician Decision", + "label": "Physician Decision", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C48250", + "properties": [], + "coding": [ + { + "code": "C48250", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Physician Decision [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_143", + "name": "Pregnant Subject", + "label": "Pregnant Subject", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C191656", + "properties": [], + "coding": [ + { + "code": "C191656", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Pregnant Subject [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_144", + "name": "Progressive Disease", + "label": "Progressive Disease", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C35571", + "properties": [], + "coding": [ + { + "code": "C35571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Progressive Disease [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_145", + "name": "Protocol Deviation", + "label": "Protocol Deviation", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C50996", + "properties": [], + "coding": [ + { + "code": "C50996", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Protocol Deviation" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_146", + "name": "Study Site Transfer", + "label": "Study Site Transfer", + "aliases": [ + "Site Transfer", + "Study Subject Site Transfer" + ], + "href": "/mdr/bc/biomedicalconcepts/C186208", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_610", + "name": "DSDECOD", + "label": "DSDECOD", + "mandatory": true, + "coding": [ + { + "code": "C82977", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term" + } + ], + "codeList": "CL.fc6fa4d8" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_611", + "name": "DSTERM", + "label": "DSTERM", + "mandatory": true, + "coding": [ + { + "code": "C82571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_612", + "name": "DSSTDTC", + "label": "DSSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C82517", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C186208", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Study Site Transfer" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_147", + "name": "Study Terminated By Sponsor", + "label": "Study Terminated By Sponsor", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C49632", + "properties": [], + "coding": [ + { + "code": "C49632", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Study Terminated By Sponsor" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_148", + "name": "Subject Removed at Sponsor Request", + "label": "Subject Removed at Sponsor Request", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C161410", + "properties": [], + "coding": [ + { + "code": "C161410", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Subject Removed at Sponsor Request [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_149", + "name": "Trial Screen Failure", + "label": "Trial Screen Failure", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C49628", + "properties": [], + "coding": [ + { + "code": "C49628", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Trial Screen Failure" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_150", + "name": "Trial Site Terminated by Sponsor", + "label": "Trial Site Terminated by Sponsor", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C106576", + "properties": [], + "coding": [ + { + "code": "C106576", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Trial Site Terminated by Sponsor" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_151", + "name": "Withdrawal by Subject", + "label": "Withdrawal by Subject", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C49634", + "properties": [], + "coding": [ + { + "code": "C49634", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Withdrawal by Subject" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_152", + "name": "Withdrawal of Consent From Protocol-Specified Activity", + "label": "Withdrawal of Consent From Protocol-Specified Activity", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C170610", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_613", + "name": "DSDECOD", + "label": "DSDECOD", + "mandatory": true, + "coding": [ + { + "code": "C82977", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term" + } + ], + "codeList": "CL.6e594ef0" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_614", + "name": "DSTERM", + "label": "DSTERM", + "mandatory": true, + "coding": [ + { + "code": "C82571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_615", + "name": "DSSTDTC", + "label": "DSSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C82517", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C170610", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_153", + "name": "Systolic Blood Pressure", + "label": "Systolic Blood Pressure", + "aliases": [ + "SYSBP" + ], + "href": "/mdr/bc/biomedicalconcepts/C25298", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_616", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_617", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C49669", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Pressure" + } + ], + "codeList": "CL.5991b40f" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_618", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_619", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_620", + "name": "VSLAT", + "label": "VSLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_621", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C25298", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Systolic Blood Pressure" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_154", + "name": "Diastolic Blood Pressure", + "label": "Diastolic Blood Pressure", + "aliases": [ + "DIABP" + ], + "href": "/mdr/bc/biomedicalconcepts/C25299", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_838", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_839", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C49669", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Pressure" + } + ], + "codeList": "CL.5991b40f" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_840", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_841", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_842", + "name": "VSLAT", + "label": "VSLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_843", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C25299", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Diastolic Blood Pressure" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_155", + "name": "Heart Rate", + "label": "Heart Rate", + "aliases": [ + "HR" + ], + "href": "/mdr/bc/biomedicalconcepts/C49677", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_628", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_629", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C73688", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Count per Minute" + } + ], + "codeList": "CL.cbd6ad98" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_630", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_631", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_632", + "name": "VSLAT", + "label": "VSLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_633", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ], + "codeList": "CL.d00a60ac" + } + ], + "coding": [ + { + "code": "C49677", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Heart Rate" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_156", + "name": "Systolic Blood Pressure", + "label": "Systolic Blood Pressure", + "aliases": [ + "SYSBP" + ], + "href": "/mdr/bc/biomedicalconcepts/C25298", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_634", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ], + "codeList": "CL.8d13b90f" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_635", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C49669", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Pressure" + } + ], + "codeList": "CL.5991b40f" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_636", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_637", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_638", + "name": "VSLAT", + "label": "VSLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_639", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C25298", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Systolic Blood Pressure" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_157", + "name": "Diastolic Blood Pressure", + "label": "Diastolic Blood Pressure", + "aliases": [ + "DIABP" + ], + "href": "/mdr/bc/biomedicalconcepts/C25299", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_640", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_641", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C49669", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Pressure" + } + ], + "codeList": "CL.5991b40f" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_642", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_643", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_644", + "name": "VSLAT", + "label": "VSLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_645", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C25299", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Diastolic Blood Pressure" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_158", + "name": "Heart Rate", + "label": "Heart Rate", + "aliases": [ + "HR" + ], + "href": "/mdr/bc/biomedicalconcepts/C49677", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_646", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_647", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C73688", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Count per Minute" + } + ], + "codeList": "CL.cbd6ad98" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_648", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_649", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_650", + "name": "VSLAT", + "label": "VSLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_651", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C49677", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Heart Rate" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_159", + "name": "Isometric Muscle Strength", + "label": "Isometric Muscle Strength", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C138967", + "properties": [], + "coding": [ + { + "code": "C138967", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Isometric Muscle Strength" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_160", + "name": "Skeletal Muscle Mass Measurement", + "label": "Skeletal Muscle Mass Measurement", + "aliases": [ + "SMMASS", + "Skeletal Muscle Mass" + ], + "href": "/mdr/bc/biomedicalconcepts/C178017", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_652", + "name": "MKORRES", + "label": "MKORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_653", + "name": "MKORRESU", + "label": "MKORRESU", + "mandatory": false, + "coding": [ + { + "code": "C42579", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Mass" + } + ], + "codeList": "CL.d121315c" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_654", + "name": "MKLOC", + "label": "MKLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_655", + "name": "MKLAT", + "label": "MKLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_656", + "name": "MKMETHOD", + "label": "MKMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_657", + "name": "MKDTC", + "label": "MKDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C178017", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Skeletal Muscle Mass Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_161", + "name": "Muscle Endurance Measurement", + "label": "Muscle Endurance Measurement", + "aliases": [ + "ENDURM", + "Muscle Endurance" + ], + "href": "/mdr/bc/biomedicalconcepts/C181501", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_844", + "name": "Observation Result", + "label": "Observation Result", + "mandatory": true, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_845", + "name": "Unit of Time", + "label": "Unit of Time", + "mandatory": true, + "coding": [ + { + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Unit of Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_846", + "name": "Anatomic Site", + "label": "Anatomic Site", + "mandatory": true, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_847", + "name": "Laterality", + "label": "Laterality", + "mandatory": true, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_848", + "name": "Test Method", + "label": "Test Method", + "mandatory": true, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_849", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C181501", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Muscle Endurance Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_162", + "name": "ECG Continuous Monitoring Indicator", + "label": "ECG Continuous Monitoring Indicator", + "aliases": [ + "ECG Continuous Monitoring", + "EGCTMON" + ], + "href": "/mdr/bc/biomedicalconcepts/C119561", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_850", + "name": "TSPARMCD", + "label": "TSPARMCD", + "mandatory": false, + "coding": [ + { + "code": "C83445", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Code" + } + ], + "codeList": "CL.b57d3f41" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_851", + "name": "TSPARM", + "label": "TSPARM", + "mandatory": false, + "coding": [ + { + "code": "C49691", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter" + } + ], + "codeList": "CL.b57d3f41" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_852", + "name": "TSVAL", + "label": "TSVAL", + "mandatory": false, + "coding": [ + { + "code": "C83447", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Value" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_853", + "name": "TSVALCD", + "label": "TSVALCD", + "mandatory": false, + "coding": [ + { + "code": "C117458", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Value Code" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_854", + "name": "TSVCDREF", + "label": "TSVCDREF", + "mandatory": false, + "coding": [ + { + "code": "C117460", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Name of the Reference Terminology" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_855", + "name": "TSVCDVER", + "label": "TSVCDVER", + "mandatory": false, + "coding": [ + { + "code": "C117461", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Version of the Reference Terminology" + } + ] + } + ], + "coding": [ + { + "code": "C119561", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "ECG Continuous Monitoring Indicator" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_164", + "name": "TTS Acceptability Survey", + "label": "TTS Acceptability Survey", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/NEW_LZZT", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_670", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Category" + } + ], + "codeList": "CL.b57d3f41" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_671", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Collection Date Time" + } + ], + "codeList": "CL.b57d3f41" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_672", + "name": "Test Occurrence", + "label": "Test Occurrence", + "mandatory": true, + "coding": [ + { + "code": "C82525", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Test Occurrence" + } + ] + } + ], + "coding": [ + { + "code": "NEW_LZZT", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "TTS Acceptability Survey" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_165", + "name": "Magnetic Resonance Imaging", + "label": "Magnetic Resonance Imaging", + "aliases": [ + "Magnetic Resonance", + "MRI", + "MRI Scan", + "NMR", + "NMR Imaging" + ], + "href": "/mdr/bc/biomedicalconcepts/C16809", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_862", + "name": "PRTRT", + "label": "PRTRT", + "mandatory": true, + "coding": [ + { + "code": "C117511", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Reported Name of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_863", + "name": "PRDECOD", + "label": "PRDECOD", + "mandatory": true, + "coding": [ + { + "code": "C117512", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Standardized Name of Procedure" + } + ], + "codeList": "CL.d03f062b" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_864", + "name": "PRPRESP", + "label": "PRPRESP", + "mandatory": false, + "coding": [ + { + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Prespecified Event or Intervention Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_865", + "name": "PROCCUR", + "label": "PROCCUR", + "mandatory": false, + "coding": [ + { + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Occurrence Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_866", + "name": "PRLOC", + "label": "PRLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Anatomic Site" + } + ], + "codeList": "CL.e2fce626" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_867", + "name": "PRSTDTC", + "label": "PRSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C117529", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Start Date and Time of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_868", + "name": "PRENDTC", + "label": "PRENDTC", + "mandatory": false, + "coding": [ + { + "code": "C117530", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "End Date and Time of Procedure" + } + ] + } + ], + "coding": [ + { + "code": "C16809", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "MRI" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_166", + "name": "Computed Tomography", + "label": "Computed Tomography", + "aliases": [ + "CAT Scan", + "Computed Axial Tomography", + "Computed Tomography", + "Computerized Tomography", + "CT" + ], + "href": "/mdr/bc/biomedicalconcepts/C17204", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_869", + "name": "PRTRT", + "label": "PRTRT", + "mandatory": true, + "coding": [ + { + "code": "C117511", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Name of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_870", + "name": "PRDECOD", + "label": "PRDECOD", + "mandatory": true, + "coding": [ + { + "code": "C117512", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Standardized Name of Procedure" + } + ], + "codeList": "CL.2e4119e7" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_871", + "name": "PRPRESP", + "label": "PRPRESP", + "mandatory": false, + "coding": [ + { + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Prespecified Event or Intervention Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_872", + "name": "PROCCUR", + "label": "PROCCUR", + "mandatory": false, + "coding": [ + { + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Occurrence Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_873", + "name": "PRLOC", + "label": "PRLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_874", + "name": "PRSTDTC", + "label": "PRSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C117529", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Start Date and Time of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_875", + "name": "PRENDTC", + "label": "PRENDTC", + "mandatory": false, + "coding": [ + { + "code": "C117530", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "End Date and Time of Procedure" + } + ] + } + ], + "coding": [ + { + "code": "C17204", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "CT SCAN" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_168", + "name": "Vital Signs Measurement", + "label": "Vital Signs Measurement", + "aliases": [ + "Vital Signs", + "VS" + ], + "href": "/mdr/bc/biomedicalconcepts/C49672", + "properties": [], + "coding": [ + { + "code": "C49672", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Vital Signs Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_169", + "name": "Vital Signs Measurement", + "label": "Vital Signs Measurement", + "aliases": [ + "Vital Signs", + "VS" + ], + "href": "/mdr/bc/biomedicalconcepts/C49672", + "properties": [], + "coding": [ + { + "code": "C49672", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Vital Signs Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_170", + "name": "Adverse Event [RETIRED]", + "label": "Adverse Event [RETIRED]", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C41331", + "properties": [], + "coding": [ + { + "code": "C41331", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Adverse Event [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_171", + "name": "Adverse Event Yes No Indicator", + "label": "Adverse Event Yes No Indicator", + "aliases": [ + "AEYN" + ], + "href": "/mdr/bc/biomedicalconcepts/C83347", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_687", + "name": "Adverse Event Yes No Indicator", + "label": "Adverse Event Yes No Indicator", + "mandatory": true, + "coding": [ + { + "code": "C83347", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Yes No Indicator" + } + ], + "codeList": "CL.2e4119e7" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_688", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C83347", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Yes No Indicator" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_172", + "name": "CDISC ADAS-Cog - Word Recall Average Score", + "label": "CDISC ADAS-Cog - Word Recall Average Score", + "aliases": [ + "ADCRL", + "Word Recall", + "CDISC ADAS-Cog - Word Recall Average Score" + ], + "href": "/mdr/bc/biomedicalconcepts/C100177", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_689", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_690", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_691", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_692", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_693", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_694", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_695", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_696", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C100177", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Word Recall Average Score" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_173", + "name": "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score", + "label": "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score", + "aliases": [ + "ADCOF", + "Naming Objects and Fingers", + "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score" + ], + "href": "/mdr/bc/biomedicalconcepts/C100191", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_697", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_698", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_699", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_700", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_701", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_702", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_703", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_704", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C100191", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_174", + "name": "CDISC ADAS-Cog - Commands Summary Score", + "label": "CDISC ADAS-Cog - Commands Summary Score", + "aliases": [ + "ADCCMD", + "Commands", + "CDISC ADAS-Cog - Commands Summary Score" + ], + "href": "/mdr/bc/biomedicalconcepts/C100209", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_705", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_706", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_707", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_708", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_709", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_710", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_711", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_712", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C100209", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Commands Summary Score" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_175", + "name": "CDISC ADAS-Cog - Delayed Word Recall Summary Score", + "label": "CDISC ADAS-Cog - Delayed Word Recall Summary Score", + "aliases": [ + "ADCDRL", + "Delayed Word Recall", + "CDISC ADAS-Cog - Delayed Word Recall Summary Score" + ], + "href": "/mdr/bc/biomedicalconcepts/C100215", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_876", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_877", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_878", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_879", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_880", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_881", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_882", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_883", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C100215", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Delayed Word Recall Summary Score" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_176", + "name": "CDISC ADAS-Cog - Constructional Praxis Summary Score", + "label": "CDISC ADAS-Cog - Constructional Praxis Summary Score", + "aliases": [ + "ADCCP", + "Constructional Praxis", + "CDISC ADAS-Cog - Constructional Praxis Summary Score" + ], + "href": "/mdr/bc/biomedicalconcepts/C100226", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_721", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_722", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_723", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_724", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_725", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_726", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_727", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_728", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ] + } + ], + "coding": [ + { + "code": "C100226", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Constructional Praxis Summary Score" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_177", + "name": "CDISC ADAS-Cog - Ideational Praxis Summary Score", + "label": "CDISC ADAS-Cog - Ideational Praxis Summary Score", + "aliases": [ + "ADCIP", + "Ideational Praxis", + "CDISC ADAS-Cog - Ideational Praxis Summary Score" + ], + "href": "/mdr/bc/biomedicalconcepts/C100232", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_729", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_730", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_731", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_732", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_733", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_734", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_735", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_736", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ] + } + ], + "coding": [ + { + "code": "C100232", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Ideational Praxis Summary Score" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_178", + "name": "CDISC ADAS-Cog - Orientation Summary Score", + "label": "CDISC ADAS-Cog - Orientation Summary Score", + "aliases": [ + "ADCOR", + "Orientation", + "CDISC ADAS-Cog - Orientation Summary Score" + ], + "href": "/mdr/bc/biomedicalconcepts/C100238", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_737", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_738", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_739", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_740", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_741", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ], + "codeList": "CL.b0ec3282" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_742", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_743", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_744", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ] + } + ], + "coding": [ + { + "code": "C100238", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Orientation Summary Score" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_179", + "name": "CDISC ADAS-Cog - Word Recognition Summary Score", + "label": "CDISC ADAS-Cog - Word Recognition Summary Score", + "aliases": [ + "ADCRG", + "Word Recognition", + "CDISC ADAS-Cog - Word Recognition Summary Score" + ], + "href": "/mdr/bc/biomedicalconcepts/C100247", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_884", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_885", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_886", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_887", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_888", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_889", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_890", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_891", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + } + ], + "coding": [ + { + "code": "C100247", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Word Recognition Summary Score" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_180", + "name": "CDISC ADAS-Cog - Remembering Test Instructions", + "label": "CDISC ADAS-Cog - Remembering Test Instructions", + "aliases": [ + "ADCRI", + "Remembering Test Instructions", + "CDISC ADAS-Cog - Remembering Test Instructions" + ], + "href": "/mdr/bc/biomedicalconcepts/C100275", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_753", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_754", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_755", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_756", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_757", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_758", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_759", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_760", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ] + } + ], + "coding": [ + { + "code": "C100275", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Remembering Test Instructions" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_181", + "name": "CDISC ADAS-Cog - Spoken Language Ability", + "label": "CDISC ADAS-Cog - Spoken Language Ability", + "aliases": [ + "ADCSL", + "Spoken Language Ability", + "CDISC ADAS-Cog - Spoken Language Ability" + ], + "href": "/mdr/bc/biomedicalconcepts/C100276", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_761", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_762", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_763", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_764", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_765", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_766", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_767", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_768", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C100276", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Spoken Language Ability" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_182", + "name": "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech", + "label": "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech", + "aliases": [ + "ADCDIF", + "Word Finding Difficulty in Spont Speech", + "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech" + ], + "href": "/mdr/bc/biomedicalconcepts/C100277", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_769", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_770", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ], + "codeList": "CL.cbd6ad98" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_771", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_772", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_773", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_774", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_775", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_776", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + } + ], + "coding": [ + { + "code": "C100277", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_183", + "name": "CDISC ADAS-Cog - Comprehension", + "label": "CDISC ADAS-Cog - Comprehension", + "aliases": [ + "ADCCMP", + "Comprehension", + "CDISC ADAS-Cog - Comprehension" + ], + "href": "/mdr/bc/biomedicalconcepts/C100278", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_777", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_778", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_779", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_780", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_781", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_782", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_783", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_784", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C100278", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Comprehension" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_184", + "name": "CDISC ADAS-Cog - Concentration/Distractibility", + "label": "CDISC ADAS-Cog - Concentration/Distractibility", + "aliases": [ + "ADCCON", + "Concentration/Distractibility", + "CDISC ADAS-Cog - Concentration/Distractibility" + ], + "href": "/mdr/bc/biomedicalconcepts/C100279", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_892", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_893", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_894", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_895", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_896", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_897", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_898", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_899", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ] + } + ], + "coding": [ + { + "code": "C100279", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Concentration/Distractibility" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_185", + "name": "CDISC ADAS-Cog - Number Cancellation Summary Score", + "label": "CDISC ADAS-Cog - Number Cancellation Summary Score", + "aliases": [ + "ADCNC", + "Number Cancellation", + "CDISC ADAS-Cog - Number Cancellation Summary Score" + ], + "href": "/mdr/bc/biomedicalconcepts/C100280", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_900", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_901", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_902", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_903", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_904", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_905", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_906", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_907", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C100280", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Number Cancellation Summary Score" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_186", + "name": "CDISC ADAS-Cog - Executive Function Maze: Errors", + "label": "CDISC ADAS-Cog - Executive Function Maze: Errors", + "aliases": [ + "ADCMZ01", + "Executive Function Maze: Errors", + "CDISC ADAS-Cog - Executive Function Maze: Errors" + ], + "href": "/mdr/bc/biomedicalconcepts/C100285", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_801", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_802", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_803", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_804", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_805", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_806", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_807", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_808", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ], + "codeList": "CL.64329559" + } + ], + "coding": [ + { + "code": "C100285", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Executive Function Maze: Errors" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_187", + "name": "CDISC ADAS-Cog - Executive Function Maze: Time", + "label": "CDISC ADAS-Cog - Executive Function Maze: Time", + "aliases": [ + "ADCMZ02", + "Executive Function Maze: Time", + "CDISC ADAS-Cog - Executive Function Maze: Time" + ], + "href": "/mdr/bc/biomedicalconcepts/C100286", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_809", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_810", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_811", + "name": "Unit of Time", + "label": "Unit of Time", + "mandatory": true, + "coding": [ + { + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Unit of Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_812", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_813", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_814", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_815", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_816", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_817", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C100286", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Executive Function Maze: Time" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_163", + "name": "ECG Continuous Monitoring Indicator", + "label": "ECG Continuous Monitoring Indicator", + "aliases": [ + "ECG Continuous Monitoring", + "EGCTMON" + ], + "href": "/mdr/bc/biomedicalconcepts/C119561", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_856", + "name": "TSPARMCD", + "label": "TSPARMCD", + "mandatory": false, + "coding": [ + { + "code": "C83445", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Code" + } + ], + "codeList": "CL.b57d3f41" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_857", + "name": "TSPARM", + "label": "TSPARM", + "mandatory": false, + "coding": [ + { + "code": "C49691", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter" + } + ], + "codeList": "CL.b57d3f41" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_858", + "name": "TSVAL", + "label": "TSVAL", + "mandatory": false, + "coding": [ + { + "code": "C83447", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Value" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_859", + "name": "TSVALCD", + "label": "TSVALCD", + "mandatory": false, + "coding": [ + { + "code": "C117458", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Value Code" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_860", + "name": "TSVCDREF", + "label": "TSVCDREF", + "mandatory": false, + "coding": [ + { + "code": "C117460", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Name of the Reference Terminology" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_861", + "name": "TSVCDVER", + "label": "TSVCDVER", + "mandatory": false, + "coding": [ + { + "code": "C117461", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Version of the Reference Terminology" + } + ] + } + ], + "coding": [ + { + "code": "C119561", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "ECG Continuous Monitoring Indicator" + } + ] + } + ], + "conceptProperties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_1", + "name": "DSDECOD", + "label": "DSDECOD", + "mandatory": true, + "coding": [ + { + "code": "C82977", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term" + } + ], + "codeList": "CL.a30c10b2" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_2", + "name": "DSTERM", + "label": "DSTERM", + "mandatory": true, + "coding": [ + { + "code": "C82571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_3", + "name": "DSSTDTC", + "label": "DSSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C82517", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_4", + "name": "TIVERS", + "label": "TIVERS", + "mandatory": false, + "coding": [ + { + "code": "C83444", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Trial Inclusion Exclusion Criteria Version" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_5", + "name": "IEORRES", + "label": "IEORRES", + "mandatory": false, + "coding": [ + { + "code": "C181043", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Clinical Findings Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_6", + "name": "IEDTC", + "label": "IEDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_7", + "name": "Inclusion Exclusion Criteria Yes No Indicator", + "label": "Inclusion Exclusion Criteria Yes No Indicator", + "mandatory": true, + "coding": [ + { + "code": "C83063", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Inclusion Exclusion Criteria Yes No Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_8", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_9", + "name": "TIVERS", + "label": "TIVERS", + "mandatory": false, + "coding": [ + { + "code": "C83444", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Trial Inclusion Exclusion Criteria Version" + } + ], + "codeList": "CL.a30c10b2" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_10", + "name": "IEORRES", + "label": "IEORRES", + "mandatory": false, + "coding": [ + { + "code": "C181043", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Clinical Findings Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_11", + "name": "IEDTC", + "label": "IEDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_12", + "name": "DSDECOD", + "label": "DSDECOD", + "mandatory": true, + "coding": [ + { + "code": "C82977", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term" + } + ], + "codeList": "CL.e1a1b71c" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_13", + "name": "DSTERM", + "label": "DSTERM", + "mandatory": true, + "coding": [ + { + "code": "C82571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_14", + "name": "DSSTDTC", + "label": "DSSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C82517", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_15", + "name": "RACE", + "label": "RACE", + "mandatory": false, + "coding": [ + { + "code": "C17049", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Race" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_16", + "name": "DMDTC", + "label": "DMDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_17", + "name": "ETHNIC", + "label": "ETHNIC", + "mandatory": false, + "coding": [ + { + "code": "C16564", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Ethnic Group" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_18", + "name": "DMDTC", + "label": "DMDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_19", + "name": "AGE", + "label": "AGE", + "mandatory": false, + "coding": [ + { + "code": "C170981", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Numeric Age for Data Tabulation" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_20", + "name": "AGEU", + "label": "AGEU", + "mandatory": false, + "coding": [ + { + "code": "C50400", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Age Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_21", + "name": "DMDTC", + "label": "DMDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_22", + "name": "BRTHDTC", + "label": "BRTHDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_23", + "name": "DMDTC", + "label": "DMDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_24", + "name": "SEX", + "label": "SEX", + "mandatory": false, + "coding": [ + { + "code": "C28421", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-04-01", + "decode": "Sex" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_25", + "name": "DMDTC", + "label": "DMDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-04-01", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_26", + "name": "SCORRES", + "label": "SCORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_27", + "name": "SCDTC", + "label": "SCDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_28", + "name": "SCORRES", + "label": "SCORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ], + "codeList": "CL.e1a1b71c" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_29", + "name": "SCORRESU", + "label": "SCORRESU", + "mandatory": false, + "coding": [ + { + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time" + } + ], + "codeList": "CL.bf247815" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_30", + "name": "SCDTC", + "label": "SCDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ], + "codeList": "CL.e1a1b71c" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_31", + "name": "MHTERM", + "label": "MHTERM", + "mandatory": true, + "coding": [ + { + "code": "C83118", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Reported Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_32", + "name": "MHDECOD", + "label": "MHDECOD", + "mandatory": false, + "coding": [ + { + "code": "C83346", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Dictionary Derived Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_33", + "name": "MHSTDTC", + "label": "MHSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83338", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Event Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_34", + "name": "MHENDTC", + "label": "MHENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Event End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_35", + "name": "MHENRF", + "label": "MHENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_36", + "name": "MHENRTPT", + "label": "MHENRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "End Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_37", + "name": "MHENTPT", + "label": "MHENTPT", + "mandatory": false, + "coding": [ + { + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Reference End Time Point End" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_38", + "name": "SUTRT", + "label": "SUTRT", + "mandatory": true, + "coding": [ + { + "code": "C83092", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Reported Name" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_39", + "name": "SUPRESP", + "label": "SUPRESP", + "mandatory": false, + "coding": [ + { + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Prespecified Event or Intervention Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_40", + "name": "SUOCCUR", + "label": "SUOCCUR", + "mandatory": false, + "coding": [ + { + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Occurrence Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_41", + "name": "SUDOSE", + "label": "SUDOSE", + "mandatory": false, + "coding": [ + { + "code": "C83416", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_42", + "name": "SUDOSTXT", + "label": "SUDOSTXT", + "mandatory": false, + "coding": [ + { + "code": "C83041", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Description" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_43", + "name": "SUDOSU", + "label": "SUDOSU", + "mandatory": false, + "coding": [ + { + "code": "C83038", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_44", + "name": "SUDOSFRQ", + "label": "SUDOSFRQ", + "mandatory": false, + "coding": [ + { + "code": "C83044", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Frequency" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_45", + "name": "SUSTDTC", + "label": "SUSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83431", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_46", + "name": "SUENDTC", + "label": "SUENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83419", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_47", + "name": "SUSTRF", + "label": "SUSTRF", + "mandatory": false, + "coding": [ + { + "code": "C82559", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_48", + "name": "SUSTRTPT", + "label": "SUSTRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82560", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_49", + "name": "SUSTTPT", + "label": "SUSTTPT", + "mandatory": false, + "coding": [ + { + "code": "C82575", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference Start Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_50", + "name": "SUENRF", + "label": "SUENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_51", + "name": "SUENRTPT", + "label": "SUENRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_52", + "name": "SUENTPT", + "label": "SUENTPT", + "mandatory": false, + "coding": [ + { + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_53", + "name": "SUTRT", + "label": "SUTRT", + "mandatory": true, + "coding": [ + { + "code": "C83092", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Reported Name" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_54", + "name": "SUPRESP", + "label": "SUPRESP", + "mandatory": false, + "coding": [ + { + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Prespecified Event or Intervention Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_55", + "name": "SUOCCUR", + "label": "SUOCCUR", + "mandatory": false, + "coding": [ + { + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Occurrence Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_56", + "name": "SUDOSE", + "label": "SUDOSE", + "mandatory": false, + "coding": [ + { + "code": "C83416", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_57", + "name": "SUDOSTXT", + "label": "SUDOSTXT", + "mandatory": false, + "coding": [ + { + "code": "C83041", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Description" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_58", + "name": "SUDOSU", + "label": "SUDOSU", + "mandatory": false, + "coding": [ + { + "code": "C83038", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_59", + "name": "SUDOSFRQ", + "label": "SUDOSFRQ", + "mandatory": false, + "coding": [ + { + "code": "C83044", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Frequency" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_60", + "name": "SUSTDTC", + "label": "SUSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83431", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_61", + "name": "SUENDTC", + "label": "SUENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83419", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_62", + "name": "SUSTRF", + "label": "SUSTRF", + "mandatory": false, + "coding": [ + { + "code": "C82559", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_63", + "name": "SUSTRTPT", + "label": "SUSTRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82560", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_64", + "name": "SUSTTPT", + "label": "SUSTTPT", + "mandatory": false, + "coding": [ + { + "code": "C82575", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference Start Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_65", + "name": "SUENRF", + "label": "SUENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_66", + "name": "SUENRTPT", + "label": "SUENRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point" + } + ], + "codeList": "CL.bf247815" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_67", + "name": "SUENTPT", + "label": "SUENTPT", + "mandatory": false, + "coding": [ + { + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_68", + "name": "SUTRT", + "label": "SUTRT", + "mandatory": true, + "coding": [ + { + "code": "C83092", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Reported Name" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_69", + "name": "SUPRESP", + "label": "SUPRESP", + "mandatory": false, + "coding": [ + { + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Prespecified Event or Intervention Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_70", + "name": "SUOCCUR", + "label": "SUOCCUR", + "mandatory": false, + "coding": [ + { + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Occurrence Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_71", + "name": "SUDOSE", + "label": "SUDOSE", + "mandatory": false, + "coding": [ + { + "code": "C83416", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_72", + "name": "SUDOSTXT", + "label": "SUDOSTXT", + "mandatory": false, + "coding": [ + { + "code": "C83041", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Description" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_73", + "name": "SUDOSU", + "label": "SUDOSU", + "mandatory": false, + "coding": [ + { + "code": "C83038", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_74", + "name": "SUDOSFRQ", + "label": "SUDOSFRQ", + "mandatory": false, + "coding": [ + { + "code": "C83044", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Frequency" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_75", + "name": "SUSTDTC", + "label": "SUSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83431", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_76", + "name": "SUENDTC", + "label": "SUENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83419", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_77", + "name": "SUDUR", + "label": "SUDUR", + "mandatory": false, + "coding": [ + { + "code": "C83419", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_78", + "name": "SUSTRF", + "label": "SUSTRF", + "mandatory": false, + "coding": [ + { + "code": "C82559", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_79", + "name": "SUSTRTPT", + "label": "SUSTRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82560", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_80", + "name": "SUSTTPT", + "label": "SUSTTPT", + "mandatory": false, + "coding": [ + { + "code": "C82575", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference Start Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_81", + "name": "SUENRF", + "label": "SUENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_82", + "name": "SUENRTPT", + "label": "SUENRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_83", + "name": "SUENTPT", + "label": "SUENTPT", + "mandatory": false, + "coding": [ + { + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_84", + "name": "PRTRT", + "label": "PRTRT", + "mandatory": true, + "coding": [ + { + "code": "C117511", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Name of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_85", + "name": "PRDECOD", + "label": "PRDECOD", + "mandatory": true, + "coding": [ + { + "code": "C117512", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Standardized Name of Procedure" + } + ], + "codeList": "CL.82acb719" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_86", + "name": "PRPRESP", + "label": "PRPRESP", + "mandatory": false, + "coding": [ + { + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Prespecified Event or Intervention Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_87", + "name": "PROCCUR", + "label": "PROCCUR", + "mandatory": false, + "coding": [ + { + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Occurrence Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_88", + "name": "PRLOC", + "label": "PRLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_89", + "name": "PRSTDTC", + "label": "PRSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C117529", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Start Date and Time of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_90", + "name": "PRENDTC", + "label": "PRENDTC", + "mandatory": false, + "coding": [ + { + "code": "C117530", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "End Date and Time of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_91", + "name": "DSDECOD", + "label": "DSDECOD", + "mandatory": true, + "coding": [ + { + "code": "C82977", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term" + } + ], + "codeList": "CL.e1a1b71c" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_92", + "name": "DSTERM", + "label": "DSTERM", + "mandatory": true, + "coding": [ + { + "code": "C82571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_93", + "name": "DSSTDTC", + "label": "DSSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C82517", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_94", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_95", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C44276", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Temperature" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_96", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_97", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_98", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_99", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48208", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Weight" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_100", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_101", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_102", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C168688", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Height" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_103", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_104", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_105", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C73688", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Count per Minute" + } + ], + "codeList": "CL.cbd6ad98" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_106", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_107", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_108", + "name": "VSLAT", + "label": "VSLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_109", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_110", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_111", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C73688", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Count per Minute" + } + ], + "codeList": "CL.b63f6642" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_112", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_113", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_114", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C42575", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Mass Density" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_115", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_116", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C125009", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Clinical Interpretation" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_117", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_118", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_119", + "name": "EGCLSIG", + "label": "EGCLSIG", + "mandatory": false, + "coding": [ + { + "code": "C93532", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Clinically Significant Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_120", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_121", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_122", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_123", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_124", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_125", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_126", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_127", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_128", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_129", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_130", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_131", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_132", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_133", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_134", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_135", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_136", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C114120", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "ECG Recording Quality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_137", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_138", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_139", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_140", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_141", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_142", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_143", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_144", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_145", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_146", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_147", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_148", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_149", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_150", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_151", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_152", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_153", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_154", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_155", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_156", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_157", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_158", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_159", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_160", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_161", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_162", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_163", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_164", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_165", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_166", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_167", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ], + "codeList": "CL.cbd6ad98" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_168", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_169", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_170", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_171", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_172", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_173", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ], + "codeList": "CL.b63f6642" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_174", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_175", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_176", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_177", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_178", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_179", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C25330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Duration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_180", + "name": "EGORRESU", + "label": "EGORRESU", + "mandatory": false, + "coding": [ + { + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_181", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_182", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ], + "codeList": "CL.82acb719" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_183", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_184", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_185", + "name": "EGENDTC", + "label": "EGENDTC", + "mandatory": false, + "coding": [ + { + "code": "C82516", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_186", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C25330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Duration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_187", + "name": "EGORRESU", + "label": "EGORRESU", + "mandatory": false, + "coding": [ + { + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_188", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ], + "codeList": "CL.e1a1b71c" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_189", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_190", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_191", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_192", + "name": "EGENDTC", + "label": "EGENDTC", + "mandatory": false, + "coding": [ + { + "code": "C82516", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_193", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C25330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Duration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_194", + "name": "EGORRESU", + "label": "EGORRESU", + "mandatory": false, + "coding": [ + { + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_195", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_196", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_197", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_198", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_199", + "name": "EGENDTC", + "label": "EGENDTC", + "mandatory": false, + "coding": [ + { + "code": "C82516", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_200", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C25330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Duration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_201", + "name": "EGORRESU", + "label": "EGORRESU", + "mandatory": false, + "coding": [ + { + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_202", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_203", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_204", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_205", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_206", + "name": "EGENDTC", + "label": "EGENDTC", + "mandatory": false, + "coding": [ + { + "code": "C82516", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_207", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C25330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Duration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_208", + "name": "EGORRESU", + "label": "EGORRESU", + "mandatory": false, + "coding": [ + { + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_209", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_210", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_211", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_212", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_213", + "name": "EGENDTC", + "label": "EGENDTC", + "mandatory": false, + "coding": [ + { + "code": "C82516", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_214", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C25330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Duration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_215", + "name": "EGORRESU", + "label": "EGORRESU", + "mandatory": false, + "coding": [ + { + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_216", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_217", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ], + "codeList": "CL.cbd6ad98" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_218", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_219", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_220", + "name": "EGENDTC", + "label": "EGENDTC", + "mandatory": false, + "coding": [ + { + "code": "C82516", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation End Date Time" + } + ], + "codeList": "CL.b63f6642" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_221", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_222", + "name": "EGORRESU", + "label": "EGORRESU", + "mandatory": false, + "coding": [ + { + "code": "C73688", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Count per Minute" + } + ], + "codeList": "CL.cbd6ad98" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_223", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_224", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_225", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_226", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ], + "codeList": "CL.b63f6642" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_227", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_228", + "name": "EGORRESU", + "label": "EGORRESU", + "mandatory": false, + "coding": [ + { + "code": "C68667", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Degree Unit of Plane Angle" + } + ], + "codeList": "CL.04edb9f9" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_229", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_230", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_231", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_232", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_233", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C25330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Duration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_234", + "name": "EGORRESU", + "label": "EGORRESU", + "mandatory": false, + "coding": [ + { + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_235", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_236", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_237", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_238", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_239", + "name": "EGENDTC", + "label": "EGENDTC", + "mandatory": false, + "coding": [ + { + "code": "C82516", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_240", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_241", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_242", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_243", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_244", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_245", + "name": "EGORRES", + "label": "EGORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_246", + "name": "EGPOS", + "label": "EGPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_247", + "name": "EGMETHOD", + "label": "EGMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_248", + "name": "EGEVAL", + "label": "EGEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_249", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_250", + "name": "PRTRT", + "label": "PRTRT", + "mandatory": true, + "coding": [ + { + "code": "C117511", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Reported Name of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_251", + "name": "PRDECOD", + "label": "PRDECOD", + "mandatory": true, + "coding": [ + { + "code": "C117512", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Standardized Name of Procedure" + } + ], + "codeList": "CL.2e4119e7" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_252", + "name": "PRPRESP", + "label": "PRPRESP", + "mandatory": false, + "coding": [ + { + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Prespecified Event or Intervention Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_253", + "name": "PROCCUR", + "label": "PROCCUR", + "mandatory": false, + "coding": [ + { + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Occurrence Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_254", + "name": "PRLOC", + "label": "PRLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Anatomic Site" + } + ], + "codeList": "CL.3edf8d8c" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_255", + "name": "PRSTDTC", + "label": "PRSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C117529", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Start Date and Time of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_256", + "name": "PRENDTC", + "label": "PRENDTC", + "mandatory": false, + "coding": [ + { + "code": "C117530", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "End Date and Time of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_257", + "name": "PRTRT", + "label": "PRTRT", + "mandatory": true, + "coding": [ + { + "code": "C117511", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Reported Name of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_258", + "name": "PRDECOD", + "label": "PRDECOD", + "mandatory": true, + "coding": [ + { + "code": "C117512", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Standardized Name of Procedure" + } + ], + "codeList": "CL.d03f062b" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_259", + "name": "PRPRESP", + "label": "PRPRESP", + "mandatory": false, + "coding": [ + { + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Prespecified Event or Intervention Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_260", + "name": "PROCCUR", + "label": "PROCCUR", + "mandatory": false, + "coding": [ + { + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Occurrence Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_261", + "name": "PRLOC", + "label": "PRLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Anatomic Site" + } + ], + "codeList": "CL.e2fce626" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_262", + "name": "PRSTDTC", + "label": "PRSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C117529", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Start Date and Time of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_263", + "name": "PRENDTC", + "label": "PRENDTC", + "mandatory": false, + "coding": [ + { + "code": "C117530", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "End Date and Time of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_264", + "name": "Concomitant Medication Yes No Indicator", + "label": "Concomitant Medication Yes No Indicator", + "mandatory": true, + "coding": [ + { + "code": "C83056", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Concomitant Medication Yes No Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_265", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_266", + "name": "CMTRT", + "label": "CMTRT", + "mandatory": true, + "coding": [ + { + "code": "C70902", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Agent" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_267", + "name": "CMDECOD", + "label": "CMDECOD", + "mandatory": false, + "coding": [ + { + "code": "C83345", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dictionary Derived Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_268", + "name": "CMCLAS", + "label": "CMCLAS", + "mandatory": false, + "coding": [ + { + "code": "C83219", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Class" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_269", + "name": "CMINDC", + "label": "CMINDC", + "mandatory": false, + "coding": [ + { + "code": "C83085", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Use Indication" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_270", + "name": "CMDOSE", + "label": "CMDOSE", + "mandatory": false, + "coding": [ + { + "code": "C83221", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_271", + "name": "CMDOSTXT", + "label": "CMDOSTXT", + "mandatory": false, + "coding": [ + { + "code": "C83221", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_272", + "name": "CMDOSU", + "label": "CMDOSU", + "mandatory": false, + "coding": [ + { + "code": "C83034", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_273", + "name": "CMDOSFRM", + "label": "CMDOSFRM", + "mandatory": false, + "coding": [ + { + "code": "C83110", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose Form" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_274", + "name": "CMDOSFRQ", + "label": "CMDOSFRQ", + "mandatory": false, + "coding": [ + { + "code": "C83042", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose Frequency" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_275", + "name": "CMROUTE", + "label": "CMROUTE", + "mandatory": false, + "coding": [ + { + "code": "C83120", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Route of Administration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_276", + "name": "CMSTDTC", + "label": "CMSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83235", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Use Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_277", + "name": "CMENDTC", + "label": "CMENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83225", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Use End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_278", + "name": "CMSTRF", + "label": "CMSTRF", + "mandatory": false, + "coding": [ + { + "code": "C82559", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_279", + "name": "CMSTRTPT", + "label": "CMSTRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82560", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_280", + "name": "CMSTTPT", + "label": "CMSTTPT", + "mandatory": false, + "coding": [ + { + "code": "C82575", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference Start Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_281", + "name": "CMENRF", + "label": "CMENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_282", + "name": "CMENRTPT", + "label": "CMENRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_283", + "name": "CMENTPT", + "label": "CMENTPT", + "mandatory": false, + "coding": [ + { + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_284", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_285", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C64571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Mass Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_286", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_287", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_288", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_289", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_290", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C69174", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Volume Fraction" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_291", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_292", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_293", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_294", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_295", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_296", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_297", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_298", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_299", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_300", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C25709", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Measure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_301", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.8d13b90f" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_302", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_303", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_304", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_305", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C44279", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Volume" + } + ], + "codeList": "CL.d00a60ac" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_306", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.8d13b90f" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_307", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_308", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_309", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_310", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_311", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_312", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_313", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_314", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_315", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration" + } + ], + "codeList": "CL.d121315c" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_316", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_317", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_318", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_319", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_320", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration" + } + ], + "codeList": "CL.b454d520" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_321", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_322", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_323", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_324", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_325", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration" + } + ], + "codeList": "CL.d121315c" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_326", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_327", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_328", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_329", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_330", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_331", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_332", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_333", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_334", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_335", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_336", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_337", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_338", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_339", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_340", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_341", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_342", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_343", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_344", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_345", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_346", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_347", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_348", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_349", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_350", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_351", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_352", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_353", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_354", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_355", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_356", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_357", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_358", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_359", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_360", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_361", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_362", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_363", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_364", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_365", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_366", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_367", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_368", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_369", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_370", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67365", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_371", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_372", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_373", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_374", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_375", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_376", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_377", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_378", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_379", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_380", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67365", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_381", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_382", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_383", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_384", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_385", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67365", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_386", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_387", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_388", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_908", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_909", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_910", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_911", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_912", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_394", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_395", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C64567", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Molarity Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_396", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_397", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_398", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_399", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_400", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C64567", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Molarity Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_401", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_402", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_403", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_404", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_405", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_406", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_407", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_408", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_409", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_410", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C64567", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Molarity Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_411", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_412", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_413", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_414", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_415", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C64567", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Molarity Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_416", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_417", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_418", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_419", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_420", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_421", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_422", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_423", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_913", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_914", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67365", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_915", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_916", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_917", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_429", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_430", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_431", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_432", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_433", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_918", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_919", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_920", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_921", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_922", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_923", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_924", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_925", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_926", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_927", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_444", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_445", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_446", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_447", + "name": "LBMETHOD", + "label": "LBMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_448", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_449", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_450", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_451", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_452", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_453", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_454", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ], + "codeList": "CL.cbd6ad98" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_455", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_456", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_457", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_458", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_459", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_460", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_461", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48570", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Percent Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_462", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_463", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_464", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_928", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_929", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_930", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_931", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_932", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_470", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_471", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_472", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_473", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_474", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_475", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_476", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_477", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_478", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_479", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_480", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67365", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_481", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_482", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_483", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_484", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_485", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_486", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_487", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_488", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_489", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_490", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_491", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_492", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_493", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_494", + "name": "MBTSTDTL", + "label": "MBTSTDTL", + "mandatory": false, + "coding": [ + { + "code": "C117062", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Measurement, Test or Examination Detail" + } + ], + "codeList": "CL.b0ec3282" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_495", + "name": "MBORRES", + "label": "MBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_496", + "name": "MBSPEC", + "label": "MBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.64500426" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_497", + "name": "MBMETHOD", + "label": "MBMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_498", + "name": "MBDTC", + "label": "MBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_499", + "name": "MBTSTDTL", + "label": "MBTSTDTL", + "mandatory": false, + "coding": [ + { + "code": "C117062", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Measurement, Test or Examination Detail" + } + ], + "codeList": "CL.b0ec3282" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_500", + "name": "MBORRES", + "label": "MBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_501", + "name": "MBSPEC", + "label": "MBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_502", + "name": "MBMETHOD", + "label": "MBMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ], + "codeList": "CL.928af9cb" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_503", + "name": "MBDTC", + "label": "MBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_504", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_505", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.64329559" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_506", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_824", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_825", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.64329559" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_826", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_827", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_511", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_512", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_513", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_514", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_515", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_828", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_829", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_830", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.64329559" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_831", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_832", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_521", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_522", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_523", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.64329559" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_524", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_525", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_526", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_527", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_528", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_529", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_530", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_531", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_532", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_533", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.64329559" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_534", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_535", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_536", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_537", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.65d42172" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_538", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_539", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_833", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_834", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_835", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.64329559" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_836", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_837", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_545", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_546", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_547", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_548", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_549", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_550", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_551", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_552", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_553", + "name": "ECTRT", + "label": "ECTRT", + "mandatory": true, + "coding": [ + { + "code": "C117473", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Name of Treatment" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_554", + "name": "ECREFID", + "label": "ECREFID", + "mandatory": false, + "coding": [ + { + "code": "C117469", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Reference Identifier" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_555", + "name": "ECDOSE", + "label": "ECDOSE", + "mandatory": false, + "coding": [ + { + "code": "C117479", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Dose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_556", + "name": "ECDOSTXT", + "label": "ECDOSTXT", + "mandatory": false, + "coding": [ + { + "code": "C117480", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Dose Description" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_557", + "name": "ECDOSU", + "label": "ECDOSU", + "mandatory": false, + "coding": [ + { + "code": "C117481", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Dose Units" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_558", + "name": "ECDOSFRM", + "label": "ECDOSFRM", + "mandatory": false, + "coding": [ + { + "code": "C117482", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Dose Form" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_559", + "name": "ECDOSFRQ", + "label": "ECDOSFRQ", + "mandatory": false, + "coding": [ + { + "code": "C117483", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Dosing Frequency per Interval" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_560", + "name": "ECDOSRGM", + "label": "ECDOSRGM", + "mandatory": false, + "coding": [ + { + "code": "C117485", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Intended Dose Regimen" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_561", + "name": "ECROUTE", + "label": "ECROUTE", + "mandatory": false, + "coding": [ + { + "code": "C117486", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Route of Administration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_562", + "name": "ECLOC", + "label": "ECLOC", + "mandatory": false, + "coding": [ + { + "code": "C117488", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Location" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_563", + "name": "ECLAT", + "label": "ECLAT", + "mandatory": false, + "coding": [ + { + "code": "C117489", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_564", + "name": "ECDIR", + "label": "ECDIR", + "mandatory": false, + "coding": [ + { + "code": "C117490", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Directionality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_565", + "name": "ECSTDTC", + "label": "ECSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C117496", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Start Date and Time of Treatment" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_566", + "name": "ECENDTC", + "label": "ECENDTC", + "mandatory": false, + "coding": [ + { + "code": "C117497", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected End Date and Time of Treatment" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_567", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_568", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_569", + "name": "Test Occurrence", + "label": "Test Occurrence", + "mandatory": true, + "coding": [ + { + "code": "C82525", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Test Occurrence" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_570", + "name": "QSORRES", + "label": "QSORRES", + "mandatory": false, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Ordinal Position" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_571", + "name": "QSDTC", + "label": "QSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_572", + "name": "QSEVAL", + "label": "QSEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ], + "codeList": "CL.d7c5855c" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_573", + "name": "QSORRES", + "label": "QSORRES", + "mandatory": false, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_574", + "name": "QSDTC", + "label": "QSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_575", + "name": "QSEVAL", + "label": "QSEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ], + "codeList": "CL.d7c5855c" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_576", + "name": "QSORRES", + "label": "QSORRES", + "mandatory": false, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_577", + "name": "QSDTC", + "label": "QSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_578", + "name": "QSEVAL", + "label": "QSEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ], + "codeList": "CL.d7c5855c" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_579", + "name": "QSORRES", + "label": "QSORRES", + "mandatory": false, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_580", + "name": "QSDTC", + "label": "QSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_581", + "name": "QSEVAL", + "label": "QSEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ], + "codeList": "CL.d7c5855c" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_582", + "name": "Adverse Event Yes No Indicator", + "label": "Adverse Event Yes No Indicator", + "mandatory": true, + "coding": [ + { + "code": "C83347", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Yes No Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_583", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_584", + "name": "AETERM", + "label": "AETERM", + "mandatory": true, + "coding": [ + { + "code": "C78541", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Verbatim Description" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_585", + "name": "AEDECOD", + "label": "AEDECOD", + "mandatory": false, + "coding": [ + { + "code": "C83344", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Dictionary Derived Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_586", + "name": "AELOC", + "label": "AELOC", + "mandatory": false, + "coding": [ + { + "code": "C83205", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Location" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_587", + "name": "AESEV", + "label": "AESEV", + "mandatory": false, + "coding": [ + { + "code": "C53253", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Severity of Adverse Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_588", + "name": "AESER", + "label": "AESER", + "mandatory": false, + "coding": [ + { + "code": "C53252", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Seriousness of Adverse Event" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_589", + "name": "AEACN", + "label": "AEACN", + "mandatory": false, + "coding": [ + { + "code": "C83013", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Action Taken with Study Treatment" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_590", + "name": "AEACNOTH", + "label": "AEACNOTH", + "mandatory": false, + "coding": [ + { + "code": "C83109", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Other Actions taken in Response to Adverse Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_591", + "name": "AEREL", + "label": "AEREL", + "mandatory": false, + "coding": [ + { + "code": "C41358", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Attribution to Product or Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_592", + "name": "AERELNST", + "label": "AERELNST", + "mandatory": false, + "coding": [ + { + "code": "C83210", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Relationship to Non Study Treatment" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_593", + "name": "AEPATT", + "label": "AEPATT", + "mandatory": false, + "coding": [ + { + "code": "C83208", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Pattern" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_594", + "name": "AEOUT", + "label": "AEOUT", + "mandatory": false, + "coding": [ + { + "code": "C49489", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Outcome" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_595", + "name": "AESCAN", + "label": "AESCAN", + "mandatory": false, + "coding": [ + { + "code": "C83211", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Involves Cancer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_596", + "name": "AESCONG", + "label": "AESCONG", + "mandatory": false, + "coding": [ + { + "code": "C83117", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Seriousness Due to Congenital Anomaly" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_597", + "name": "AESDISAB", + "label": "AESDISAB", + "mandatory": false, + "coding": [ + { + "code": "C113380", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Disabling Adverse Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_598", + "name": "AESDTH", + "label": "AESDTH", + "mandatory": false, + "coding": [ + { + "code": "C48275", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Death Related to Adverse Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_599", + "name": "AESHOSP", + "label": "AESHOSP", + "mandatory": false, + "coding": [ + { + "code": "C83052", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event associated with Hospitalization" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_600", + "name": "AESLIFE", + "label": "AESLIFE", + "mandatory": false, + "coding": [ + { + "code": "C84266", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Life Threatening Adverse Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_601", + "name": "AESOD", + "label": "AESOD", + "mandatory": false, + "coding": [ + { + "code": "C83214", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Occurred with Overdose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_602", + "name": "AESMIE", + "label": "AESMIE", + "mandatory": false, + "coding": [ + { + "code": "C83053", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Associated with Serious Medical Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_603", + "name": "AECONTRT", + "label": "AECONTRT", + "mandatory": false, + "coding": [ + { + "code": "C83199", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Concomitant Treatment" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_604", + "name": "AETOXGR", + "label": "AETOXGR", + "mandatory": false, + "coding": [ + { + "code": "C78605", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Toxicity Grade" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_605", + "name": "AESTDTC", + "label": "AESTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83215", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_606", + "name": "AEENDTC", + "label": "AEENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83201", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_607", + "name": "AEENRF", + "label": "AEENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_608", + "name": "AEENRTPT", + "label": "AEENRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_609", + "name": "AEENTPT", + "label": "AEENTPT", + "mandatory": false, + "coding": [ + { + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_610", + "name": "DSDECOD", + "label": "DSDECOD", + "mandatory": true, + "coding": [ + { + "code": "C82977", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term" + } + ], + "codeList": "CL.fc6fa4d8" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_611", + "name": "DSTERM", + "label": "DSTERM", + "mandatory": true, + "coding": [ + { + "code": "C82571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_612", + "name": "DSSTDTC", + "label": "DSSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C82517", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_613", + "name": "DSDECOD", + "label": "DSDECOD", + "mandatory": true, + "coding": [ + { + "code": "C82977", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term" + } + ], + "codeList": "CL.6e594ef0" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_614", + "name": "DSTERM", + "label": "DSTERM", + "mandatory": true, + "coding": [ + { + "code": "C82571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_615", + "name": "DSSTDTC", + "label": "DSSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C82517", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_616", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_617", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C49669", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Pressure" + } + ], + "codeList": "CL.5991b40f" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_618", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_619", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_620", + "name": "VSLAT", + "label": "VSLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_621", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_838", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_839", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C49669", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Pressure" + } + ], + "codeList": "CL.5991b40f" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_840", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_841", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_842", + "name": "VSLAT", + "label": "VSLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_843", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_628", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_629", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C73688", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Count per Minute" + } + ], + "codeList": "CL.cbd6ad98" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_630", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_631", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_632", + "name": "VSLAT", + "label": "VSLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_633", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ], + "codeList": "CL.d00a60ac" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_634", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ], + "codeList": "CL.8d13b90f" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_635", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C49669", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Pressure" + } + ], + "codeList": "CL.5991b40f" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_636", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_637", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_638", + "name": "VSLAT", + "label": "VSLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_639", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_640", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_641", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C49669", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Pressure" + } + ], + "codeList": "CL.5991b40f" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_642", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_643", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_644", + "name": "VSLAT", + "label": "VSLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_645", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_646", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_647", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C73688", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Count per Minute" + } + ], + "codeList": "CL.cbd6ad98" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_648", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_649", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_650", + "name": "VSLAT", + "label": "VSLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_651", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_652", + "name": "MKORRES", + "label": "MKORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_653", + "name": "MKORRESU", + "label": "MKORRESU", + "mandatory": false, + "coding": [ + { + "code": "C42579", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Mass" + } + ], + "codeList": "CL.d121315c" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_654", + "name": "MKLOC", + "label": "MKLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_655", + "name": "MKLAT", + "label": "MKLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_656", + "name": "MKMETHOD", + "label": "MKMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_657", + "name": "MKDTC", + "label": "MKDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_844", + "name": "Observation Result", + "label": "Observation Result", + "mandatory": true, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_845", + "name": "Unit of Time", + "label": "Unit of Time", + "mandatory": true, + "coding": [ + { + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Unit of Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_846", + "name": "Anatomic Site", + "label": "Anatomic Site", + "mandatory": true, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_847", + "name": "Laterality", + "label": "Laterality", + "mandatory": true, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_848", + "name": "Test Method", + "label": "Test Method", + "mandatory": true, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_849", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_850", + "name": "TSPARMCD", + "label": "TSPARMCD", + "mandatory": false, + "coding": [ + { + "code": "C83445", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Code" + } + ], + "codeList": "CL.b57d3f41" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_851", + "name": "TSPARM", + "label": "TSPARM", + "mandatory": false, + "coding": [ + { + "code": "C49691", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter" + } + ], + "codeList": "CL.b57d3f41" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_852", + "name": "TSVAL", + "label": "TSVAL", + "mandatory": false, + "coding": [ + { + "code": "C83447", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Value" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_853", + "name": "TSVALCD", + "label": "TSVALCD", + "mandatory": false, + "coding": [ + { + "code": "C117458", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Value Code" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_854", + "name": "TSVCDREF", + "label": "TSVCDREF", + "mandatory": false, + "coding": [ + { + "code": "C117460", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Name of the Reference Terminology" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_855", + "name": "TSVCDVER", + "label": "TSVCDVER", + "mandatory": false, + "coding": [ + { + "code": "C117461", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Version of the Reference Terminology" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_670", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Category" + } + ], + "codeList": "CL.b57d3f41" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_671", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Collection Date Time" + } + ], + "codeList": "CL.b57d3f41" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_672", + "name": "Test Occurrence", + "label": "Test Occurrence", + "mandatory": true, + "coding": [ + { + "code": "C82525", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Test Occurrence" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_862", + "name": "PRTRT", + "label": "PRTRT", + "mandatory": true, + "coding": [ + { + "code": "C117511", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Reported Name of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_863", + "name": "PRDECOD", + "label": "PRDECOD", + "mandatory": true, + "coding": [ + { + "code": "C117512", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Standardized Name of Procedure" + } + ], + "codeList": "CL.d03f062b" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_864", + "name": "PRPRESP", + "label": "PRPRESP", + "mandatory": false, + "coding": [ + { + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Prespecified Event or Intervention Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_865", + "name": "PROCCUR", + "label": "PROCCUR", + "mandatory": false, + "coding": [ + { + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Occurrence Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_866", + "name": "PRLOC", + "label": "PRLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Anatomic Site" + } + ], + "codeList": "CL.e2fce626" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_867", + "name": "PRSTDTC", + "label": "PRSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C117529", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Start Date and Time of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_868", + "name": "PRENDTC", + "label": "PRENDTC", + "mandatory": false, + "coding": [ + { + "code": "C117530", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "End Date and Time of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_869", + "name": "PRTRT", + "label": "PRTRT", + "mandatory": true, + "coding": [ + { + "code": "C117511", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Name of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_870", + "name": "PRDECOD", + "label": "PRDECOD", + "mandatory": true, + "coding": [ + { + "code": "C117512", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Standardized Name of Procedure" + } + ], + "codeList": "CL.2e4119e7" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_871", + "name": "PRPRESP", + "label": "PRPRESP", + "mandatory": false, + "coding": [ + { + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Prespecified Event or Intervention Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_872", + "name": "PROCCUR", + "label": "PROCCUR", + "mandatory": false, + "coding": [ + { + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Occurrence Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_873", + "name": "PRLOC", + "label": "PRLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_874", + "name": "PRSTDTC", + "label": "PRSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C117529", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Start Date and Time of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_875", + "name": "PRENDTC", + "label": "PRENDTC", + "mandatory": false, + "coding": [ + { + "code": "C117530", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "End Date and Time of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_687", + "name": "Adverse Event Yes No Indicator", + "label": "Adverse Event Yes No Indicator", + "mandatory": true, + "coding": [ + { + "code": "C83347", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Yes No Indicator" + } + ], + "codeList": "CL.2e4119e7" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_688", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_689", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_690", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_691", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_692", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_693", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_694", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_695", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_696", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_697", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_698", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_699", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_700", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_701", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_702", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_703", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_704", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_705", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_706", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_707", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_708", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_709", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_710", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_711", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_712", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_876", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_877", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_878", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_879", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_880", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_881", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_882", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_883", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_721", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_722", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_723", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_724", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_725", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_726", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_727", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_728", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_729", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_730", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_731", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_732", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_733", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_734", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_735", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_736", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_737", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_738", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_739", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_740", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_741", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ], + "codeList": "CL.b0ec3282" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_742", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_743", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_744", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_884", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_885", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_886", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_887", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_888", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_889", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_890", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_891", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_753", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_754", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_755", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_756", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_757", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_758", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_759", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_760", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_761", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_762", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_763", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_764", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_765", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_766", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_767", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_768", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_769", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_770", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ], + "codeList": "CL.cbd6ad98" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_771", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_772", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_773", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_774", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_775", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_776", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_777", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_778", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_779", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ], + "codeList": "CL.2148028d" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_780", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_781", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_782", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_783", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_784", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_892", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_893", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_894", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_895", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_896", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_897", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_898", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_899", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_900", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_901", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_902", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_903", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_904", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_905", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_906", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_907", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_801", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_802", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_803", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_804", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_805", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_806", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_807", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_808", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ], + "codeList": "CL.64329559" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_809", + "name": "Ordinal Position", + "label": "Ordinal Position", + "mandatory": true, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position" + } + ], + "codeList": "CL.1f6d4af1" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_810", + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "mandatory": true, + "coding": [ + { + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_811", + "name": "Unit of Time", + "label": "Unit of Time", + "mandatory": true, + "coding": [ + { + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Unit of Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_812", + "name": "Category", + "label": "Category", + "mandatory": true, + "coding": [ + { + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_813", + "name": "Subcategory", + "label": "Subcategory", + "mandatory": true, + "coding": [ + { + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_814", + "name": "Completion Status", + "label": "Completion Status", + "mandatory": true, + "coding": [ + { + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_815", + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "mandatory": true, + "coding": [ + { + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_816", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_817", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_856", + "name": "TSPARMCD", + "label": "TSPARMCD", + "mandatory": false, + "coding": [ + { + "code": "C83445", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Code" + } + ], + "codeList": "CL.b57d3f41" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_857", + "name": "TSPARM", + "label": "TSPARM", + "mandatory": false, + "coding": [ + { + "code": "C49691", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter" + } + ], + "codeList": "CL.b57d3f41" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_858", + "name": "TSVAL", + "label": "TSVAL", + "mandatory": false, + "coding": [ + { + "code": "C83447", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Value" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_859", + "name": "TSVALCD", + "label": "TSVALCD", + "mandatory": false, + "coding": [ + { + "code": "C117458", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Value Code" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_860", + "name": "TSVCDREF", + "label": "TSVCDREF", + "mandatory": false, + "coding": [ + { + "code": "C117460", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Name of the Reference Terminology" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_861", + "name": "TSVCDVER", + "label": "TSVCDVER", + "mandatory": false, + "coding": [ + { + "code": "C117461", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Version of the Reference Terminology" + } + ] + } + ] +} diff --git a/data/soa_workbench/protocols/LZZT/H2Q-MC-LZZT-latest.json b/data/soa_workbench/protocols/LZZT/H2Q-MC-LZZT-latest.json new file mode 100644 index 0000000..ceb7e90 --- /dev/null +++ b/data/soa_workbench/protocols/LZZT/H2Q-MC-LZZT-latest.json @@ -0,0 +1,33893 @@ +{ + "study": { + "id": null, + "extensionAttributes": [], + "name": "H2Q-MC-LZZT", + "description": "Patients with probable mild to moderate AD will be studied in a randomized, double-blind, parallel (3 arm), placebo-controlled trial of 26 weeks duration. The study will be conducted on an outpatient basis. Approximately 300 patients will be enrolled", + "label": "Alzheimer Study", + "versions": [ + { + "id": "StudyVersion_1", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_153", + "url": "http://www.cdisc.org/usdm/extensions/studyDesignSolution", + "valueExtensionClass": { + "id": "ExtensionClass_1", + "url": "http://www.cdisc.org/usdm/extensions/StudyDesignSolution", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_154", + "url": "tool-name", + "valueString": "SoA Workbench", + "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_155", + "url": "tool-version", + "valueString": "1.4.0", + "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_156", + "url": "usdm-creation-date", + "valueString": "20260618T15:09", + "instanceType": "ExtensionAttribute" + } + ], + "instanceType": "ExtensionClass" + }, + "instanceType": "ExtensionAttribute" + } + ], + "versionIdentifier": "1", + "rationale": "", + "studyIdentifiers": [ + { + "id": "StudyIdentifier_1", + "extensionAttributes": [], + "text": "H2Q-MC-LZZT", + "scopeId": "Organization_1", + "instanceType": "StudyIdentifier" + } + ], + "referenceIdentifiers": [], + "studyDesigns": [ + { + "id": "InterventionalStudyDesign_1", + "extensionAttributes": [], + "name": "Darren", + "label": "Alzheimer Study", + "description": "Patients with probable mild to moderate AD will be studied in a randomized, double-blind, parallel (3 arm), placebo-controlled trial of 26 weeks duration. The study will be conducted on an outpatient basis. Approximately 300 patients will be enrolled", + "studyType": null, + "studyPhase": null, + "therapeuticAreas": [], + "characteristics": [], + "encounters": [ + { + "id": "Encounter_1", + "extensionAttributes": [], + "name": "SCREEN1", + "label": "Screening 1", + "description": "Screening encounter", + "type": { + "id": "Code_55", + "extensionAttributes": [], + "code": "C25716", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Visit", + "instanceType": "Code" + }, + "previousId": null, + "nextId": "Encounter_2", + "scheduledAtId": "Timing_1", + "environmentalSettings": [ + { + "id": "Code_84", + "extensionAttributes": [], + "code": "C211570", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "CLINIC", + "instanceType": "Code" + } + ], + "contactModes": [ + { + "id": "Code_164", + "extensionAttributes": [], + "code": "C175574", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "IN PERSON", + "instanceType": "Code" + } + ], + "transitionStartRule": { + "id": "TransitionRule_17", + "extensionAttributes": [], + "name": "ENCOUNTER_START_RULE_1", + "label": null, + "description": null, + "text": "Subject identifier", + "instanceType": "TransitionRule" + }, + "transitionEndRule": { + "id": "TransitionRule_18", + "extensionAttributes": [], + "name": "ENCOUNTER_END_RULE_2", + "label": null, + "description": null, + "text": "completion of screening activities", + "instanceType": "TransitionRule" + }, + "notes": [], + "instanceType": "Encounter" + }, + { + "id": "Encounter_2", + "extensionAttributes": [], + "name": "SCREEN2", + "label": "Screening 2", + "description": "Screening encounter - Ambulatory ECG Placement", + "type": { + "id": "Code_56", + "extensionAttributes": [], + "code": "C25716", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Visit", + "instanceType": "Code" + }, + "previousId": "Encounter_1", + "nextId": "Encounter_3", + "scheduledAtId": "Timing_2", + "environmentalSettings": [ + { + "id": "Code_85", + "extensionAttributes": [], + "code": "C211570", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "CLINIC", + "instanceType": "Code" + } + ], + "contactModes": [ + { + "id": "Code_165", + "extensionAttributes": [], + "code": "C175574", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "IN PERSON", + "instanceType": "Code" + } + ], + "transitionStartRule": null, + "transitionEndRule": { + "id": "TransitionRule_19", + "extensionAttributes": [], + "name": "ENCOUNTER_START_RULE_2", + "label": null, + "description": null, + "text": "subject leaves clinic after connection of ambulatory ECG machine", + "instanceType": "TransitionRule" + }, + "notes": [], + "instanceType": "Encounter" + }, + { + "id": "Encounter_3", + "extensionAttributes": [], + "name": "DOSE", + "label": "Baseline", + "description": "Baseline encounter - Ambulatory ECG Removal", + "type": { + "id": "Code_57", + "extensionAttributes": [], + "code": "C25716", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Visit", + "instanceType": "Code" + }, + "previousId": "Encounter_2", + "nextId": "Encounter_4", + "scheduledAtId": "Timing_3", + "environmentalSettings": [ + { + "id": "Code_86", + "extensionAttributes": [], + "code": "C211570", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "CLINIC", + "instanceType": "Code" + } + ], + "contactModes": [ + { + "id": "Code_166", + "extensionAttributes": [], + "code": "C175574", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "IN PERSON", + "instanceType": "Code" + } + ], + "transitionStartRule": { + "id": "TransitionRule_20", + "extensionAttributes": [], + "name": "ENCOUNTER_START_RULE_3", + "label": null, + "description": null, + "text": "subject has connection of ambulatory ECG machine removed", + "instanceType": "TransitionRule" + }, + "transitionEndRule": { + "id": "TransitionRule_21", + "extensionAttributes": [], + "name": "ENCOUNTER_END_RULE_5", + "label": null, + "description": null, + "text": "Radomized", + "instanceType": "TransitionRule" + }, + "notes": [], + "instanceType": "Encounter" + }, + { + "id": "Encounter_4", + "extensionAttributes": [], + "name": "WEEK2", + "label": "Week 2", + "description": "Day 14", + "type": { + "id": "Code_58", + "extensionAttributes": [], + "code": "C25716", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Visit", + "instanceType": "Code" + }, + "previousId": "Encounter_3", + "nextId": "Encounter_5", + "scheduledAtId": "Timing_4", + "environmentalSettings": [ + { + "id": "Code_87", + "extensionAttributes": [], + "code": "C211570", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "CLINIC", + "instanceType": "Code" + } + ], + "contactModes": [ + { + "id": "Code_167", + "extensionAttributes": [], + "code": "C175574", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "IN PERSON", + "instanceType": "Code" + } + ], + "transitionStartRule": null, + "transitionEndRule": null, + "notes": [], + "instanceType": "Encounter" + }, + { + "id": "Encounter_5", + "extensionAttributes": [], + "name": "WEEK4", + "label": "Week 4", + "description": "Day 28", + "type": { + "id": "Code_59", + "extensionAttributes": [], + "code": "C25716", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Visit", + "instanceType": "Code" + }, + "previousId": "Encounter_4", + "nextId": "Encounter_6", + "scheduledAtId": "Timing_5", + "environmentalSettings": [ + { + "id": "Code_88", + "extensionAttributes": [], + "code": "C211570", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "CLINIC", + "instanceType": "Code" + } + ], + "contactModes": [ + { + "id": "Code_168", + "extensionAttributes": [], + "code": "C175574", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "IN PERSON", + "instanceType": "Code" + } + ], + "transitionStartRule": null, + "transitionEndRule": null, + "notes": [], + "instanceType": "Encounter" + }, + { + "id": "Encounter_6", + "extensionAttributes": [], + "name": "WEEK6", + "label": "Week 6", + "description": "Day 42", + "type": { + "id": "Code_60", + "extensionAttributes": [], + "code": "C25716", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Visit", + "instanceType": "Code" + }, + "previousId": "Encounter_5", + "nextId": "Encounter_7", + "scheduledAtId": "Timing_6", + "environmentalSettings": [ + { + "id": "Code_89", + "extensionAttributes": [], + "code": "C211570", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "CLINIC", + "instanceType": "Code" + } + ], + "contactModes": [ + { + "id": "Code_169", + "extensionAttributes": [], + "code": "C175574", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "IN PERSON", + "instanceType": "Code" + } + ], + "transitionStartRule": null, + "transitionEndRule": null, + "notes": [], + "instanceType": "Encounter" + }, + { + "id": "Encounter_7", + "extensionAttributes": [], + "name": "WEEK8", + "label": "Week 8", + "description": "Day 56", + "type": { + "id": "Code_61", + "extensionAttributes": [], + "code": "C25716", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Visit", + "instanceType": "Code" + }, + "previousId": "Encounter_6", + "nextId": "Encounter_9", + "scheduledAtId": "Timing_7", + "environmentalSettings": [ + { + "id": "Code_90", + "extensionAttributes": [], + "code": "C211570", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "CLINIC", + "instanceType": "Code" + } + ], + "contactModes": [ + { + "id": "Code_170", + "extensionAttributes": [], + "code": "C175574", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "IN PERSON", + "instanceType": "Code" + } + ], + "transitionStartRule": null, + "transitionEndRule": null, + "notes": [], + "instanceType": "Encounter" + }, + { + "id": "Encounter_9", + "extensionAttributes": [], + "name": "WEEK12", + "label": "Week 12", + "description": "Day 84", + "type": { + "id": "Code_63", + "extensionAttributes": [], + "code": "C25716", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Visit", + "instanceType": "Code" + }, + "previousId": "Encounter_7", + "nextId": "Encounter_11", + "scheduledAtId": "Timing_8", + "environmentalSettings": [ + { + "id": "Code_92", + "extensionAttributes": [], + "code": "C211570", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "CLINIC", + "instanceType": "Code" + } + ], + "contactModes": [ + { + "id": "Code_171", + "extensionAttributes": [], + "code": "C175574", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "IN PERSON", + "instanceType": "Code" + } + ], + "transitionStartRule": null, + "transitionEndRule": null, + "notes": [], + "instanceType": "Encounter" + }, + { + "id": "Encounter_11", + "extensionAttributes": [], + "name": "WEEK16", + "label": "Week 16", + "description": "Day 112", + "type": { + "id": "Code_65", + "extensionAttributes": [], + "code": "C25716", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Visit", + "instanceType": "Code" + }, + "previousId": "Encounter_9", + "nextId": "Encounter_13", + "scheduledAtId": "Timing_9", + "environmentalSettings": [ + { + "id": "Code_94", + "extensionAttributes": [], + "code": "C211570", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "CLINIC", + "instanceType": "Code" + } + ], + "contactModes": [ + { + "id": "Code_172", + "extensionAttributes": [], + "code": "C175574", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "IN PERSON", + "instanceType": "Code" + } + ], + "transitionStartRule": null, + "transitionEndRule": null, + "notes": [], + "instanceType": "Encounter" + }, + { + "id": "Encounter_13", + "extensionAttributes": [], + "name": "WEEK20", + "label": "Week 20", + "description": "Day 140", + "type": { + "id": "Code_67", + "extensionAttributes": [], + "code": "C25716", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Visit", + "instanceType": "Code" + }, + "previousId": "Encounter_11", + "nextId": "Encounter_15", + "scheduledAtId": "Timing_10", + "environmentalSettings": [ + { + "id": "Code_96", + "extensionAttributes": [], + "code": "C211570", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "CLINIC", + "instanceType": "Code" + } + ], + "contactModes": [ + { + "id": "Code_173", + "extensionAttributes": [], + "code": "C175574", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "IN PERSON", + "instanceType": "Code" + } + ], + "transitionStartRule": null, + "transitionEndRule": null, + "notes": [], + "instanceType": "Encounter" + }, + { + "id": "Encounter_15", + "extensionAttributes": [], + "name": "WEEK24", + "label": "Week 24", + "description": "Day 168", + "type": { + "id": "Code_69", + "extensionAttributes": [], + "code": "C25716", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Visit", + "instanceType": "Code" + }, + "previousId": "Encounter_13", + "nextId": "Encounter_16", + "scheduledAtId": "Timing_11", + "environmentalSettings": [ + { + "id": "Code_98", + "extensionAttributes": [], + "code": "C211570", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "CLINIC", + "instanceType": "Code" + } + ], + "contactModes": [ + { + "id": "Code_174", + "extensionAttributes": [], + "code": "C175574", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "IN PERSON", + "instanceType": "Code" + } + ], + "transitionStartRule": null, + "transitionEndRule": null, + "notes": [], + "instanceType": "Encounter" + }, + { + "id": "Encounter_16", + "extensionAttributes": [], + "name": "WEEK26", + "label": "Week 26", + "description": "Day 182", + "type": { + "id": "Code_70", + "extensionAttributes": [], + "code": "C25716", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Visit", + "instanceType": "Code" + }, + "previousId": "Encounter_15", + "nextId": null, + "scheduledAtId": "Timing_12", + "environmentalSettings": [ + { + "id": "Code_99", + "extensionAttributes": [], + "code": "C211570", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "CLINIC", + "instanceType": "Code" + } + ], + "contactModes": [ + { + "id": "Code_175", + "extensionAttributes": [], + "code": "C175574", + "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", + "codeSystemVersion": "2025-09-26", + "decode": "IN PERSON", + "instanceType": "Code" + } + ], + "transitionStartRule": null, + "transitionEndRule": { + "id": "TransitionRule_22", + "extensionAttributes": [], + "name": "ENCOUNTER_START_RULE_12", + "label": null, + "description": null, + "text": "End of treatment", + "instanceType": "TransitionRule" + }, + "notes": [], + "instanceType": "Encounter" + } + ], + "activities": [ + { + "id": "Activity_1", + "extensionAttributes": [], + "name": "Informed Consent", + "label": "Informed Consent", + "description": "Informed consent activity", + "previousId": null, + "nextId": "Activity_2", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_1" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_2", + "extensionAttributes": [], + "name": "Inclusion/Exclusion Criteria", + "label": "Inclusion/Exclusion Criteria", + "description": "Inclusion/Exclusion Criteria activity", + "previousId": "Activity_1", + "nextId": "Activity_3", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_2", + "BiomedicalConcept_3", + "BiomedicalConcept_4" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_3", + "extensionAttributes": [], + "name": "Patient number assigned", + "label": "Patient Number assigned", + "description": "Patient Number assigned activity", + "previousId": "Activity_2", + "nextId": "Activity_4", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_5" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_4", + "extensionAttributes": [], + "name": "Demographics", + "label": "Demographics", + "description": "Demographics activity", + "previousId": "Activity_3", + "nextId": "Activity_5", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_6", + "BiomedicalConcept_7", + "BiomedicalConcept_8", + "BiomedicalConcept_9", + "BiomedicalConcept_10" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_5", + "extensionAttributes": [], + "name": "Education", + "label": "Education", + "description": "Education activity", + "previousId": "Activity_4", + "nextId": "Activity_6", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_11", + "BiomedicalConcept_12" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_6", + "extensionAttributes": [], + "name": "Hachinski", + "label": "Hachinski", + "description": "Hachinski test", + "previousId": "Activity_5", + "nextId": "Activity_7", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [], + "bcCategoryIds": [], + "bcSurrogateIds": [ + "BiomedicalConceptSurrogate_10", + "BiomedicalConceptSurrogate_11", + "BiomedicalConceptSurrogate_12", + "BiomedicalConceptSurrogate_13", + "BiomedicalConceptSurrogate_14", + "BiomedicalConceptSurrogate_15", + "BiomedicalConceptSurrogate_16", + "BiomedicalConceptSurrogate_17", + "BiomedicalConceptSurrogate_18", + "BiomedicalConceptSurrogate_9" + ], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_7", + "extensionAttributes": [], + "name": "MMSE", + "label": "MMSE", + "description": "MMSE test", + "previousId": "Activity_6", + "nextId": "Activity_8", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [], + "bcCategoryIds": [], + "bcSurrogateIds": [ + "BiomedicalConceptSurrogate_20", + "BiomedicalConceptSurrogate_21", + "BiomedicalConceptSurrogate_22", + "BiomedicalConceptSurrogate_23", + "BiomedicalConceptSurrogate_24", + "BiomedicalConceptSurrogate_25", + "BiomedicalConceptSurrogate_26" + ], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_8", + "extensionAttributes": [], + "name": "Physical examination", + "label": "Physical examination", + "description": "Physical examination results", + "previousId": "Activity_7", + "nextId": "Activity_9", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_159", + "BiomedicalConcept_160", + "BiomedicalConcept_161" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_9", + "extensionAttributes": [], + "name": "Medical History", + "label": "Medical History", + "description": "Medical History response", + "previousId": "Activity_8", + "nextId": "Activity_10", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_14" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_10", + "extensionAttributes": [], + "name": "Habits", + "label": "Habits", + "description": "List of habits", + "previousId": "Activity_9", + "nextId": "Activity_11", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_15", + "BiomedicalConcept_16", + "BiomedicalConcept_17" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_11", + "extensionAttributes": [], + "name": "Chest X-ray", + "label": "Chest X-ray", + "description": "Chest X-ray result", + "previousId": "Activity_10", + "nextId": "Activity_12", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_18" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_12", + "extensionAttributes": [], + "name": "Apo E genotyping", + "label": "Apo E genotyping", + "description": "Apo E genotyping test", + "previousId": "Activity_11", + "nextId": "Activity_13", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [], + "bcCategoryIds": [], + "bcSurrogateIds": [ + "BiomedicalConceptSurrogate_19" + ], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_13", + "extensionAttributes": [], + "name": "Patient randomised", + "label": "Patient randomized", + "description": "Patient randomized activity", + "previousId": "Activity_12", + "nextId": "Activity_14", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_19" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_14", + "extensionAttributes": [], + "name": "Vital Signs", + "label": "Vital Signs", + "description": "Vital Signs result", + "previousId": "Activity_13", + "nextId": "Activity_15", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_20", + "BiomedicalConcept_21", + "BiomedicalConcept_22", + "BiomedicalConcept_23", + "BiomedicalConcept_24", + "BiomedicalConcept_25", + "BiomedicalConcept_26" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_15", + "extensionAttributes": [], + "name": "Ambulatory ECG placed", + "label": "Ambulatory ECG placed", + "description": "Ambulatory ECG placed activity", + "previousId": "Activity_14", + "nextId": "Activity_16", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_162" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_16", + "extensionAttributes": [], + "name": "Ambulatory ECG removed", + "label": "Ambulatory ECG removed", + "description": "Ambulatory ECG removed activity", + "previousId": "Activity_15", + "nextId": "Activity_17", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_163" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_17", + "extensionAttributes": [], + "name": "ECG", + "label": "ECG", + "description": "ECG results", + "previousId": "Activity_16", + "nextId": "Activity_18", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_27", + "BiomedicalConcept_28", + "BiomedicalConcept_29", + "BiomedicalConcept_30", + "BiomedicalConcept_31", + "BiomedicalConcept_32", + "BiomedicalConcept_33", + "BiomedicalConcept_34", + "BiomedicalConcept_35", + "BiomedicalConcept_36", + "BiomedicalConcept_37", + "BiomedicalConcept_38", + "BiomedicalConcept_39", + "BiomedicalConcept_40", + "BiomedicalConcept_41", + "BiomedicalConcept_42", + "BiomedicalConcept_43", + "BiomedicalConcept_44", + "BiomedicalConcept_45", + "BiomedicalConcept_46", + "BiomedicalConcept_47", + "BiomedicalConcept_48", + "BiomedicalConcept_49", + "BiomedicalConcept_50" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_18", + "extensionAttributes": [], + "name": "Placebo TTS Test", + "label": "Placebo TTS Test", + "description": "Placebo TTS Test results", + "previousId": "Activity_17", + "nextId": "Activity_19", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_164" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_19", + "extensionAttributes": [], + "name": "CT Scan", + "label": "CT Scan", + "description": "CT Scan results", + "previousId": "Activity_18", + "nextId": "Activity_20", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_51" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_20", + "extensionAttributes": [], + "name": "MRI", + "label": "MRI", + "description": "MRI results", + "previousId": "Activity_19", + "nextId": "Activity_21", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_52" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_21", + "extensionAttributes": [], + "name": "MRI, CT Scan", + "label": "MRI, CT Scan", + "description": "MRI, CT Scan results", + "previousId": "Activity_20", + "nextId": "Activity_22", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_165", + "BiomedicalConcept_166" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_22", + "extensionAttributes": [], + "name": "Concomitant medications", + "label": "Concomitant medications", + "description": "Concomitant medications information", + "previousId": "Activity_21", + "nextId": "Activity_23", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_54", + "BiomedicalConcept_55" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_23", + "extensionAttributes": [], + "name": "Hematology", + "label": "Hematology", + "description": "Hematology results", + "previousId": "Activity_22", + "nextId": "Activity_24", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_56", + "BiomedicalConcept_57", + "BiomedicalConcept_58", + "BiomedicalConcept_59", + "BiomedicalConcept_60", + "BiomedicalConcept_61", + "BiomedicalConcept_62", + "BiomedicalConcept_63", + "BiomedicalConcept_64", + "BiomedicalConcept_65", + "BiomedicalConcept_66", + "BiomedicalConcept_67", + "BiomedicalConcept_68", + "BiomedicalConcept_69", + "BiomedicalConcept_70", + "BiomedicalConcept_71", + "BiomedicalConcept_72", + "BiomedicalConcept_73" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_24", + "extensionAttributes": [], + "name": "Chemistry", + "label": "Chemistry", + "description": "Chemistry test results", + "previousId": "Activity_23", + "nextId": "Activity_25", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_74", + "BiomedicalConcept_75", + "BiomedicalConcept_76", + "BiomedicalConcept_77", + "BiomedicalConcept_78", + "BiomedicalConcept_79", + "BiomedicalConcept_80", + "BiomedicalConcept_81", + "BiomedicalConcept_82", + "BiomedicalConcept_83", + "BiomedicalConcept_84", + "BiomedicalConcept_85", + "BiomedicalConcept_86", + "BiomedicalConcept_87", + "BiomedicalConcept_88", + "BiomedicalConcept_89", + "BiomedicalConcept_90", + "BiomedicalConcept_91", + "BiomedicalConcept_92", + "BiomedicalConcept_93", + "BiomedicalConcept_94", + "BiomedicalConcept_95", + "BiomedicalConcept_96", + "BiomedicalConcept_97", + "BiomedicalConcept_98", + "BiomedicalConcept_99", + "BiomedicalConcept_100" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_25", + "extensionAttributes": [], + "name": "Urinalysis", + "label": "Urinalysis", + "description": "Urinalysis results", + "previousId": "Activity_24", + "nextId": "Activity_26", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_101", + "BiomedicalConcept_102", + "BiomedicalConcept_103", + "BiomedicalConcept_104", + "BiomedicalConcept_105", + "BiomedicalConcept_106", + "BiomedicalConcept_107", + "BiomedicalConcept_108", + "BiomedicalConcept_109" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_26", + "extensionAttributes": [], + "name": "Plasma Specimen (Xanomeline)", + "label": "Plasma Specimen (Xanomeline)", + "description": "Plasma Specimen (Xanomeline) results", + "previousId": "Activity_25", + "nextId": "Activity_27", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_27", + "extensionAttributes": [], + "name": "Hemoglobin A1C", + "label": "Hemoglobin A1C", + "description": "Hemoglobin A1C results", + "previousId": "Activity_26", + "nextId": "Activity_28", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_110", + "BiomedicalConcept_111" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_28", + "extensionAttributes": [], + "name": "Study Drug", + "label": "Study Drug", + "description": "Study Drug activity", + "previousId": "Activity_27", + "nextId": "Activity_29", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_112" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_29", + "extensionAttributes": [], + "name": "TTS Acceptability Survey", + "label": "TTS Acceptability Survey", + "description": "TTS Acceptability Survey results", + "previousId": "Activity_28", + "nextId": "Activity_30", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_113", + "BiomedicalConcept_114", + "BiomedicalConcept_115", + "BiomedicalConcept_116", + "BiomedicalConcept_117" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_30", + "extensionAttributes": [], + "name": "ADAS-Cog", + "label": "ADAS-Cog", + "description": "ADAS-Cog results", + "previousId": "Activity_29", + "nextId": "Activity_31", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_172", + "BiomedicalConcept_173", + "BiomedicalConcept_174", + "BiomedicalConcept_175", + "BiomedicalConcept_176", + "BiomedicalConcept_177", + "BiomedicalConcept_178", + "BiomedicalConcept_179", + "BiomedicalConcept_180", + "BiomedicalConcept_181", + "BiomedicalConcept_182", + "BiomedicalConcept_183", + "BiomedicalConcept_184", + "BiomedicalConcept_185", + "BiomedicalConcept_186", + "BiomedicalConcept_187" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_31", + "extensionAttributes": [], + "name": "CIBIC+", + "label": "CIBIC+", + "description": "CIBIC+ results", + "previousId": "Activity_30", + "nextId": "Activity_32", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [], + "bcCategoryIds": [], + "bcSurrogateIds": [ + "BiomedicalConceptSurrogate_27" + ], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_32", + "extensionAttributes": [], + "name": "DAD", + "label": "DAD", + "description": "DAD results", + "previousId": "Activity_31", + "nextId": "Activity_33", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [], + "bcCategoryIds": [], + "bcSurrogateIds": [ + "BiomedicalConceptSurrogate_28" + ], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_33", + "extensionAttributes": [], + "name": "NPI-X", + "label": "NPI-X", + "description": "NPI-X results", + "previousId": "Activity_32", + "nextId": "Activity_34", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [], + "bcCategoryIds": [], + "bcSurrogateIds": [ + "BiomedicalConceptSurrogate_29", + "BiomedicalConceptSurrogate_30", + "BiomedicalConceptSurrogate_31", + "BiomedicalConceptSurrogate_32", + "BiomedicalConceptSurrogate_33", + "BiomedicalConceptSurrogate_34" + ], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_34", + "extensionAttributes": [], + "name": "Adverse Events", + "label": "Adverse Events", + "description": "Activities to conduct if occurence of Adverse Event", + "previousId": "Activity_33", + "nextId": "Activity_35", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_134", + "BiomedicalConcept_135" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_35", + "extensionAttributes": [], + "name": "Check Adverse Events", + "label": "Check Adverse Events", + "description": "TL: Adverse Event Timeline", + "previousId": "Activity_34", + "nextId": "Activity_36", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_170", + "BiomedicalConcept_171" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_36", + "extensionAttributes": [], + "name": "Patient Summary", + "label": "Patient Summary", + "description": "Patient Summary (Study Conclusion)", + "previousId": "Activity_35", + "nextId": "Activity_37", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_136", + "BiomedicalConcept_137", + "BiomedicalConcept_138", + "BiomedicalConcept_139", + "BiomedicalConcept_140", + "BiomedicalConcept_141", + "BiomedicalConcept_142", + "BiomedicalConcept_143", + "BiomedicalConcept_144", + "BiomedicalConcept_145", + "BiomedicalConcept_146", + "BiomedicalConcept_147", + "BiomedicalConcept_148", + "BiomedicalConcept_149", + "BiomedicalConcept_150", + "BiomedicalConcept_151", + "BiomedicalConcept_152" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_37", + "extensionAttributes": [], + "name": "Supine", + "label": "Supine", + "description": "Supine", + "previousId": "Activity_36", + "nextId": "Activity_38", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_168" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_38", + "extensionAttributes": [], + "name": "Vital Signs Supine", + "label": "Vital Signs Supine", + "description": "Vital Signs Supine", + "previousId": "Activity_37", + "nextId": "Activity_39", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_153", + "BiomedicalConcept_154", + "BiomedicalConcept_155" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_39", + "extensionAttributes": [], + "name": "Stand", + "label": "Stand", + "description": "Stand", + "previousId": "Activity_38", + "nextId": "Activity_40", + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_169" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + }, + { + "id": "Activity_40", + "extensionAttributes": [], + "name": "Vital Signs Standing", + "label": "Vital Signs Standing", + "description": "Vital Signs Standing", + "previousId": "Activity_39", + "nextId": null, + "childIds": [], + "definedProcedures": [], + "biomedicalConceptIds": [ + "BiomedicalConcept_156", + "BiomedicalConcept_157", + "BiomedicalConcept_158" + ], + "bcCategoryIds": [], + "bcSurrogateIds": [], + "timelineId": null, + "notes": [], + "instanceType": "Activity" + } + ], + "arms": [ + { + "id": "StudyArm_1", + "extensionAttributes": [], + "name": "Placebo", + "label": "Placebo", + "description": "Placebo ARM", + "type": { + "id": "Code_1", + "extensionAttributes": [], + "code": "C174268", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-26", + "decode": "Placebo Comparator Arm", + "instanceType": "Code" + }, + "dataOriginDescription": "Data collected from subjects", + "dataOriginType": { + "id": "Code_2", + "extensionAttributes": [], + "code": "C188866", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Data Generated Within Study", + "instanceType": "Code" + }, + "populationIds": [], + "notes": [], + "instanceType": "StudyArm" + }, + { + "id": "StudyArm_2", + "extensionAttributes": [], + "name": "Xanomeline Low Dose", + "label": "Xanomeline Low Dose", + "description": "Active substance low dose", + "type": { + "id": "Code_3", + "extensionAttributes": [], + "code": "C174267", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-26", + "decode": "Active Comparator Arm", + "instanceType": "Code" + }, + "dataOriginDescription": "Data collected from subjects", + "dataOriginType": { + "id": "Code_4", + "extensionAttributes": [], + "code": "C188866", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Data Generated Within Study", + "instanceType": "Code" + }, + "populationIds": [], + "notes": [], + "instanceType": "StudyArm" + }, + { + "id": "StudyArm_3", + "extensionAttributes": [], + "name": "Xanomeline High Dose", + "label": "Xanomeline High Dose", + "description": "Active Substance high dose", + "type": { + "id": "Code_5", + "extensionAttributes": [], + "code": "C174267", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-26", + "decode": "Active Comparator Arm", + "instanceType": "Code" + }, + "dataOriginDescription": "Data collected from subjects", + "dataOriginType": { + "id": "Code_6", + "extensionAttributes": [], + "code": "C188866", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Data Generated Within Study", + "instanceType": "Code" + }, + "populationIds": [], + "notes": [], + "instanceType": "StudyArm" + } + ], + "studyCells": [ + { + "id": "StudyCell_1", + "extensionAttributes": [], + "armId": "StudyArm_1", + "epochId": "StudyEpoch_1", + "elementIds": [ + "StudyElement_1" + ], + "instanceType": "StudyCell" + }, + { + "id": "StudyCell_2", + "extensionAttributes": [], + "armId": "StudyArm_1", + "epochId": "StudyEpoch_3", + "elementIds": [ + "StudyElement_2" + ], + "instanceType": "StudyCell" + }, + { + "id": "StudyCell_3", + "extensionAttributes": [], + "armId": "StudyArm_1", + "epochId": "StudyEpoch_4", + "elementIds": [ + "StudyElement_2" + ], + "instanceType": "StudyCell" + }, + { + "id": "StudyCell_4", + "extensionAttributes": [], + "armId": "StudyArm_1", + "epochId": "StudyEpoch_5", + "elementIds": [ + "StudyElement_2" + ], + "instanceType": "StudyCell" + }, + { + "id": "StudyCell_5", + "extensionAttributes": [], + "armId": "StudyArm_1", + "epochId": "StudyEpoch_2", + "elementIds": [ + "StudyElement_7" + ], + "instanceType": "StudyCell" + }, + { + "id": "StudyCell_11", + "extensionAttributes": [], + "armId": "StudyArm_3", + "epochId": "StudyEpoch_1", + "elementIds": [ + "StudyElement_1" + ], + "instanceType": "StudyCell" + }, + { + "id": "StudyCell_12", + "extensionAttributes": [], + "armId": "StudyArm_3", + "epochId": "StudyEpoch_3", + "elementIds": [ + "StudyElement_4" + ], + "instanceType": "StudyCell" + }, + { + "id": "StudyCell_13", + "extensionAttributes": [], + "armId": "StudyArm_3", + "epochId": "StudyEpoch_4", + "elementIds": [ + "StudyElement_5" + ], + "instanceType": "StudyCell" + }, + { + "id": "StudyCell_14", + "extensionAttributes": [], + "armId": "StudyArm_3", + "epochId": "StudyEpoch_5", + "elementIds": [ + "StudyElement_6" + ], + "instanceType": "StudyCell" + }, + { + "id": "StudyCell_15", + "extensionAttributes": [], + "armId": "StudyArm_3", + "epochId": "StudyEpoch_2", + "elementIds": [ + "StudyElement_7" + ], + "instanceType": "StudyCell" + }, + { + "id": "StudyCell_16", + "extensionAttributes": [], + "armId": "StudyArm_2", + "epochId": "StudyEpoch_1", + "elementIds": [ + "StudyElement_1" + ], + "instanceType": "StudyCell" + }, + { + "id": "StudyCell_17", + "extensionAttributes": [], + "armId": "StudyArm_2", + "epochId": "StudyEpoch_3", + "elementIds": [ + "StudyElement_3" + ], + "instanceType": "StudyCell" + }, + { + "id": "StudyCell_18", + "extensionAttributes": [], + "armId": "StudyArm_2", + "epochId": "StudyEpoch_4", + "elementIds": [ + "StudyElement_3" + ], + "instanceType": "StudyCell" + }, + { + "id": "StudyCell_19", + "extensionAttributes": [], + "armId": "StudyArm_2", + "epochId": "StudyEpoch_5", + "elementIds": [ + "StudyElement_3" + ], + "instanceType": "StudyCell" + }, + { + "id": "StudyCell_20", + "extensionAttributes": [], + "armId": "StudyArm_2", + "epochId": "StudyEpoch_2", + "elementIds": [ + "StudyElement_7" + ], + "instanceType": "StudyCell" + } + ], + "rationale": "", + "epochs": [ + { + "id": "StudyEpoch_1", + "extensionAttributes": [], + "name": "Screening", + "label": "Screening", + "description": "Screening Epoch", + "type": { + "id": "Code_10", + "extensionAttributes": [], + "code": "C202487", + "codeSystem": "https://library.cdisc.org", + "codeSystemVersion": "sdtmct-2025-09-26", + "decode": "SCREENING", + "instanceType": "Code" + }, + "previousId": null, + "nextId": "StudyEpoch_3", + "notes": [], + "instanceType": "StudyEpoch" + }, + { + "id": "StudyEpoch_3", + "extensionAttributes": [], + "name": "Treatment 1", + "label": "Treatment 1", + "description": "Treatment 1 Epoch", + "type": { + "id": "Code_11", + "extensionAttributes": [], + "code": "C101526", + "codeSystem": "https://library.cdisc.org", + "codeSystemVersion": "sdtmct-2025-09-26", + "decode": "TREATMENT", + "instanceType": "Code" + }, + "previousId": "StudyEpoch_1", + "nextId": "StudyEpoch_4", + "notes": [], + "instanceType": "StudyEpoch" + }, + { + "id": "StudyEpoch_4", + "extensionAttributes": [], + "name": "Treatment 2", + "label": "Treatment 2", + "description": "Treatment 2 Epoch", + "type": { + "id": "Code_13", + "extensionAttributes": [], + "code": "C101526", + "codeSystem": "https://library.cdisc.org", + "codeSystemVersion": "sdtmct-2025-09-26", + "decode": "TREATMENT", + "instanceType": "Code" + }, + "previousId": "StudyEpoch_3", + "nextId": "StudyEpoch_5", + "notes": [], + "instanceType": "StudyEpoch" + }, + { + "id": "StudyEpoch_5", + "extensionAttributes": [], + "name": "Treatment 3", + "label": "Treatment 3", + "description": "Treatment 3 Epoch", + "type": { + "id": "Code_14", + "extensionAttributes": [], + "code": "C101526", + "codeSystem": "https://library.cdisc.org", + "codeSystemVersion": "sdtmct-2025-09-26", + "decode": "TREATMENT", + "instanceType": "Code" + }, + "previousId": "StudyEpoch_4", + "nextId": "StudyEpoch_2", + "notes": [], + "instanceType": "StudyEpoch" + }, + { + "id": "StudyEpoch_2", + "extensionAttributes": [], + "name": "Follow-up", + "label": "Follow-up", + "description": "Follow-up Epoch", + "type": { + "id": "Code_12", + "extensionAttributes": [], + "code": "C202578", + "codeSystem": "https://library.cdisc.org", + "codeSystemVersion": "sdtmct-2025-09-26", + "decode": "FOLLOW-UP", + "instanceType": "Code" + }, + "previousId": "StudyEpoch_5", + "nextId": null, + "notes": [], + "instanceType": "StudyEpoch" + } + ], + "elements": [ + { + "id": "StudyElement_1", + "extensionAttributes": [], + "name": "EL1", + "label": "Screening", + "description": "Screening Element", + "transitionStartRule": { + "id": "TransitionRule_23", + "extensionAttributes": [], + "name": "ELEMENT_START_RULE_1", + "label": null, + "description": null, + "text": "Informed consent", + "instanceType": "TransitionRule" + }, + "transitionEndRule": { + "id": "TransitionRule_24", + "extensionAttributes": [], + "name": "ELEMENT_END_RULE_1", + "label": null, + "description": null, + "text": "Completion of all screening activities and no more than 2 weeks from informed consent", + "instanceType": "TransitionRule" + }, + "studyInterventionIds": [], + "notes": [], + "instanceType": "StudyElement" + }, + { + "id": "StudyElement_2", + "extensionAttributes": [], + "name": "EL2", + "label": "Placebo", + "description": "Placebo TTS (adhesive patches)", + "transitionStartRule": { + "id": "TransitionRule_27", + "extensionAttributes": [], + "name": "ELEMENT_START_RULE_2", + "label": null, + "description": null, + "text": "Administration\\u00a0of\\u00a0first\\u00a0dose", + "instanceType": "TransitionRule" + }, + "transitionEndRule": null, + "studyInterventionIds": [], + "notes": [], + "instanceType": "StudyElement" + }, + { + "id": "StudyElement_3", + "extensionAttributes": [], + "name": "EL3", + "label": "Low", + "description": "Xanomeline TTS (adhesive patches) 50 cm2, 54 mg", + "transitionStartRule": { + "id": "TransitionRule_28", + "extensionAttributes": [], + "name": "ELEMENT_START_RULE_3", + "label": null, + "description": null, + "text": "Administration\\u00a0of\\u00a0first\\u00a0dose", + "instanceType": "TransitionRule" + }, + "transitionEndRule": null, + "studyInterventionIds": [], + "notes": [], + "instanceType": "StudyElement" + }, + { + "id": "StudyElement_4", + "extensionAttributes": [], + "name": "EL4", + "label": "High - Start", + "description": "Xanomeline TTS (adhesive patches) 50 cm2, 54 mg", + "transitionStartRule": { + "id": "TransitionRule_29", + "extensionAttributes": [], + "name": "ELEMENT_START_RULE_4", + "label": null, + "description": null, + "text": "Randomized", + "instanceType": "TransitionRule" + }, + "transitionEndRule": null, + "studyInterventionIds": [], + "notes": [], + "instanceType": "StudyElement" + }, + { + "id": "StudyElement_5", + "extensionAttributes": [], + "name": "EL5", + "label": "High - Middle", + "description": "Xanomeline TTS (adhesive patches) 50 cm2, 54 mg + 25 cm2, 27 mg", + "transitionStartRule": { + "id": "TransitionRule_30", + "extensionAttributes": [], + "name": "ELEMENT_START_RULE_5", + "label": null, + "description": null, + "text": "Administration\\u00a0of\\u00a0first\\u00a0dose\\u00a0(from\\u00a0patches\\u00a0supplied\\u00a0at\\u00a0Visit\\u00a04)", + "instanceType": "TransitionRule" + }, + "transitionEndRule": null, + "studyInterventionIds": [], + "notes": [], + "instanceType": "StudyElement" + }, + { + "id": "StudyElement_6", + "extensionAttributes": [], + "name": "EL6", + "label": "High - End", + "description": "Xanomeline TTS (adhesive patches) 50 cm2, 54 mg", + "transitionStartRule": { + "id": "TransitionRule_31", + "extensionAttributes": [], + "name": "ELEMENT_START_RULE_6", + "label": null, + "description": null, + "text": "Administration\\u00a0of\\u00a0first\\u00a0dose\\u00a0(from\\u00a0patches\\u00a0supplied\\u00a0at\\u00a0Visit\\u00a012)", + "instanceType": "TransitionRule" + }, + "transitionEndRule": null, + "studyInterventionIds": [], + "notes": [], + "instanceType": "StudyElement" + }, + { + "id": "StudyElement_7", + "extensionAttributes": [], + "name": "EL7", + "label": "Follow up", + "description": "Follow up Element", + "transitionStartRule": { + "id": "TransitionRule_25", + "extensionAttributes": [], + "name": "ELEMENT_START_RULE_7", + "label": null, + "description": null, + "text": "End\\u00a0of\\u00a0last\\u00a0scheduled\\u00a0visit\\u00a0on\\u00a0study\\u00a0(including\\u00a0early\\u00a0termination)", + "instanceType": "TransitionRule" + }, + "transitionEndRule": { + "id": "TransitionRule_26", + "extensionAttributes": [], + "name": "ELEMENT_END_RULE_7", + "label": null, + "description": null, + "text": "Completion\\u00a0of\\u00a0all\\u00a0specified\\u00a0followup\\u00a0activities\\u00a0(which\\u00a0vary\\u00a0on\\u00a0a\\u00a0patient-by-patient\\u00a0basis)", + "instanceType": "TransitionRule" + }, + "studyInterventionIds": [], + "notes": [], + "instanceType": "StudyElement" + } + ], + "estimands": [ + { + "id": "Estimand_1", + "extensionAttributes": [], + "name": "Estimand 1", + "label": "Estimand 1", + "description": "Estimand 1", + "populationSummary": "Group mean changes from baseline in the primary efficacy parameters", + "analysisPopulationId": "", + "variableOfInterestId": "Endpoint_1", + "interventionIds": [ + "StudyIntervention_1" + ], + "intercurrentEvents": [ + { + "id": "IntercurrentEvent_1", + "extensionAttributes": [], + "name": "Disruption", + "label": "Disruption", + "description": "The disruption of treatment to the subject", + "text": "Temporary Treatment Interruption", + "strategy": "Treatment Policy. Continue to measure effect of treatment assignment regardless of interruption.", + "notes": [], + "instanceType": "IntercurrentEvent" + } + ], + "notes": [], + "instanceType": "Estimand" + } + ], + "indications": [ + { + "id": "Indication_1", + "extensionAttributes": [], + "name": "Indication 1", + "label": "Alzheimer's disease", + "description": "Alzheimer's disease", + "isRareDisease": false, + "codes": [ + { + "id": "Code_36968", + "extensionAttributes": [], + "code": "G30.9", + "codeSystem": "ICD-10-CM", + "codeSystemVersion": "1", + "decode": "Alzheimer's disease; unspecified", + "instanceType": "Code" + } + ], + "notes": [], + "instanceType": "Indication" + }, + { + "id": "Indication_2", + "extensionAttributes": [], + "name": "Indication 2", + "label": "Alzheimer's disease", + "description": "Alzheimer's disease", + "isRareDisease": false, + "codes": [ + { + "id": "Code_36969", + "extensionAttributes": [], + "code": "26929004", + "codeSystem": "SNOMED", + "codeSystemVersion": "2018-01-31", + "decode": "Alzheimer's disease", + "instanceType": "Code" + } + ], + "notes": [], + "instanceType": "Indication" + } + ], + "studyInterventionIds": [ + "StudyIntervention_1" + ], + "objectives": [ + { + "id": "Objective_1", + "extensionAttributes": [], + "name": "OBJ1", + "label": "Objective 1", + "description": "Main Objective", + "text": "To determine if there is a statistically significant relationship (overall Type 1 erroralpha=0.05) between the change in both the ADAS-Cog (11) and CIBIC+ scores, and drug dose (0, 50 cm2 [54 mg], and 75 cm2 [81 mg]).", + "dictionaryId": null, + "notes": [], + "level": { + "id": "Code_2508", + "extensionAttributes": [], + "code": "C85826", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "C85826", + "instanceType": "Code" + }, + "endpoints": [ + { + "id": "Endpoint_1", + "extensionAttributes": [], + "name": "ENDPT1", + "label": "Endpoint 1", + "description": "ADAS-Cog Week 24 Endpoint", + "text": "Alzheimer's Disease Assessment Scale - Cognitive Subscale, total of 11 items [ADAS-Cog (11)] at Week 24", + "dictionaryId": null, + "notes": [], + "purpose": "", + "level": { + "id": "Code_2514", + "extensionAttributes": [], + "code": "C94496", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "C94496", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + }, + { + "id": "Endpoint_2", + "extensionAttributes": [], + "name": "ENDPT2", + "label": "Endpoint 2", + "description": "Clinician Week 24 impression of change", + "text": "Video-referenced Clinician\\u2019s Interview-based Impression of Change (CIBIC+) at Week 24", + "dictionaryId": null, + "notes": [], + "purpose": "", + "level": { + "id": "Code_2515", + "extensionAttributes": [], + "code": "C94496", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "C94496", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + } + ], + "instanceType": "Objective" + }, + { + "id": "Objective_2", + "extensionAttributes": [], + "name": "OBJ2", + "label": "Objective 2", + "description": "Safety", + "text": "To document the safety profile of the xanomeline TTS.", + "dictionaryId": null, + "notes": [], + "level": { + "id": "Code_2509", + "extensionAttributes": [], + "code": "C85826", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "C85826", + "instanceType": "Code" + }, + "endpoints": [ + { + "id": "Endpoint_3", + "extensionAttributes": [], + "name": "ENDPT3", + "label": "Endpoint 3", + "description": "Adverse events", + "text": "Adverse events", + "dictionaryId": null, + "notes": [], + "purpose": "", + "level": { + "id": "Code_2516", + "extensionAttributes": [], + "code": "C94496", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "C94496", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + }, + { + "id": "Endpoint_4", + "extensionAttributes": [], + "name": "ENDPT4", + "label": "Endpoint 4", + "description": "Vital Signs", + "text": "Vital signs (weight, standing and supine blood pressure, heart rate)", + "dictionaryId": null, + "notes": [], + "purpose": "", + "level": { + "id": "Code_2517", + "extensionAttributes": [], + "code": "C94496", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "C94496", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + }, + { + "id": "Endpoint_5", + "extensionAttributes": [], + "name": "ENDPT5", + "label": "Endpoint 5", + "description": "Baseline", + "text": "The change from baseline laboratory value will be calculated as the difference between the baseline lab value and the endpoint value (i.e., the value at the specified visit) or the end of treatment observation\", \"text\": \"Laboratory evaluations (Change from Baseline)", + "dictionaryId": null, + "notes": [], + "purpose": "", + "level": { + "id": "Code_2518", + "extensionAttributes": [], + "code": "C94496", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "C94496", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + } + ], + "instanceType": "Objective" + }, + { + "id": "Objective_3", + "extensionAttributes": [], + "name": "OBJ3", + "label": "Objective 3", + "description": "Behaviour", + "text": "To assess the dose-dependent improvement in behavior. Improved scores on the Revised Neuropsychiatric Inventory (NPI-X) will indicate improvement in these areas.", + "dictionaryId": null, + "notes": [], + "level": { + "id": "Code_2510", + "extensionAttributes": [], + "code": "C85827", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "C85827", + "instanceType": "Code" + }, + "endpoints": [ + { + "id": "Endpoint_6", + "extensionAttributes": [], + "name": "ENDPT6", + "label": "Endpoint 6", + "description": "Cognitive Scale", + "text": "Alzheimer's Disease Assessment Scale - Cognitive Subscale, total of 11 items [ADAS-Cog (11)] at Weeks 8 and 16", + "dictionaryId": null, + "notes": [], + "purpose": "", + "level": { + "id": "Code_2519", + "extensionAttributes": [], + "code": "C139173", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "C139173", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + }, + { + "id": "Endpoint_7", + "extensionAttributes": [], + "name": "ENDPT7", + "label": "Endpoint 7", + "description": "Clinician impression at Week8 and Week16", + "text": "Video-referenced Clinician\\u2019s Interview-based Impression of Change (CIBIC+) at Weeks 8 and 16", + "dictionaryId": null, + "notes": [], + "purpose": "", + "level": { + "id": "Code_2520", + "extensionAttributes": [], + "code": "C139173", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "C139173", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + }, + { + "id": "Endpoint_8", + "extensionAttributes": [], + "name": "ENDPT8", + "label": "Endpoint 8", + "description": "NPI-X", + "text": "Mean Revised Neuropsychiatric Inventory (NPI-X) from Week 4 to Week 24", + "dictionaryId": null, + "notes": [], + "purpose": "", + "level": { + "id": "Code_2521", + "extensionAttributes": [], + "code": "C139173", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "C139173", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + } + ], + "instanceType": "Objective" + }, + { + "id": "Objective_4", + "extensionAttributes": [], + "name": "OBJ4", + "label": "Objective 4", + "description": "Improvements", + "text": "To assess the dose-dependent improvements in activities of daily living. Improved scores on the Disability Assessment for Dementia (DAD) will indicate improvement in these areas (see Attachment LZZT.5).", + "dictionaryId": null, + "notes": [], + "level": { + "id": "Code_2511", + "extensionAttributes": [], + "code": "C85827", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "C85827", + "instanceType": "Code" + }, + "endpoints": [ + { + "id": "Endpoint_9", + "extensionAttributes": [], + "name": "ENDPT9", + "label": "Endpoint 9", + "description": "UNK", + "text": "*** To be determined from protocol ***", + "dictionaryId": null, + "notes": [], + "purpose": "", + "level": { + "id": "Code_2522", + "extensionAttributes": [], + "code": "C139173", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "C139173", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + } + ], + "instanceType": "Objective" + }, + { + "id": "Objective_5", + "extensionAttributes": [], + "name": "OBJ5", + "label": "Objective 5", + "description": "Improvements", + "text": "To assess the dose-dependent improvements in an extended assessment of cognition that integrates attention/concentration tasks. The Alzheimer's Disease Assessment Scale-14 item Cognitive Subscale, hereafter referred to as ADAS-Cog (14), will be used for this assessment (see Attachment LZZT.2).", + "dictionaryId": null, + "notes": [], + "level": { + "id": "Code_2512", + "extensionAttributes": [], + "code": "C85827", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "C85827", + "instanceType": "Code" + }, + "endpoints": [ + { + "id": "Endpoint_10", + "extensionAttributes": [], + "name": "ENDPT10", + "label": "Endpoint 10", + "description": "UNK", + "text": "*** To be determined from protocol ***", + "dictionaryId": null, + "notes": [], + "purpose": "", + "level": { + "id": "Code_2523", + "extensionAttributes": [], + "code": "C139173", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "C139173", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + } + ], + "instanceType": "Objective" + }, + { + "id": "Objective_6", + "extensionAttributes": [], + "name": "OBJ6", + "label": "Objective 6", + "description": "Response", + "text": "To assess the treatment response as a function of Apo E genotype.", + "dictionaryId": null, + "notes": [], + "level": { + "id": "Code_2513", + "extensionAttributes": [], + "code": "C85827", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "C85827", + "instanceType": "Code" + }, + "endpoints": [ + { + "id": "Endpoint_11", + "extensionAttributes": [], + "name": "ENDPT11", + "label": "Endpoint 11", + "description": "UNK", + "text": "*** To be determined from protocol ***", + "dictionaryId": null, + "notes": [], + "purpose": "", + "level": { + "id": "Code_2524", + "extensionAttributes": [], + "code": "C139173", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "C139173", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + } + ], + "instanceType": "Objective" + } + ], + "population": { + "id": "StudyDesignPopulation_1", + "extensionAttributes": [], + "name": "Population_1", + "label": null, + "description": null, + "includesHealthySubjects": false, + "plannedEnrollmentNumber": null, + "plannedCompletionNumber": null, + "plannedSex": [], + "criterionIds": [], + "plannedAge": null, + "notes": [], + "cohorts": [], + "instanceType": "StudyDesignPopulation" + }, + "scheduleTimelines": [ + { + "id": "ScheduleTimeline_1", + "extensionAttributes": [], + "name": "Main Timeline", + "label": "Main Timeline", + "description": "This is the main timeline for the study design", + "mainTimeline": true, + "entryCondition": "Potential subject identified", + "entryId": "ScheduledActivityInstance_1", + "exits": [], + "timings": [ + { + "id": "Timing_1", + "extensionAttributes": [], + "name": "TIM1", + "label": "Screening", + "description": "Screening Timing", + "type": { + "id": "Code_20", + "extensionAttributes": [], + "code": "C201357", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Before", + "instanceType": "Code" + }, + "value": "-P2W", + "valueLabel": "2 Weeks Before Dose", + "relativeToFrom": { + "id": "Code_27", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_1", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", + "windowLower": null, + "windowUpper": null, + "windowLabel": null, + "instanceType": "Timing" + }, + { + "id": "Timing_2", + "extensionAttributes": [], + "name": "TIM2", + "label": "Pre-dose", + "description": "Pre-dose Timing", + "type": { + "id": "Code_22", + "extensionAttributes": [], + "code": "C201357", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Before", + "instanceType": "Code" + }, + "value": "-P2D", + "valueLabel": "2 Days Before Dose", + "relativeToFrom": { + "id": "Code_28", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_2", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", + "windowLower": "PT4H", + "windowUpper": "PT0H", + "windowLabel": "-4..0 hours", + "instanceType": "Timing" + }, + { + "id": "Timing_3", + "extensionAttributes": [], + "name": "TIM3", + "label": "Dosing", + "description": "Dosing Anchor", + "type": { + "id": "Code_18", + "extensionAttributes": [], + "code": "C201358", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Fixed Reference", + "instanceType": "Code" + }, + "value": "P1D", + "valueLabel": "1 Day", + "relativeToFrom": { + "id": "Code_19", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_3", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", + "windowLower": null, + "windowUpper": null, + "windowLabel": null, + "instanceType": "Timing" + }, + { + "id": "Timing_4", + "extensionAttributes": [], + "name": "TIM4", + "label": "Week 2", + "description": "Week 2 timing", + "type": { + "id": "Code_29", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "P2W", + "valueLabel": "2 Weeks", + "relativeToFrom": { + "id": "Code_25", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_4", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", + "windowLower": "P3D", + "windowUpper": "P3D", + "windowLabel": "-3..3 days", + "instanceType": "Timing" + }, + { + "id": "Timing_5", + "extensionAttributes": [], + "name": "TIM5", + "label": "Week 4", + "description": "Week 4 Timing", + "type": { + "id": "Code_30", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "P4W", + "valueLabel": "4 Weeks", + "relativeToFrom": { + "id": "Code_31", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_5", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", + "windowLower": "P3D", + "windowUpper": "P3D", + "windowLabel": "-3..3 days", + "instanceType": "Timing" + }, + { + "id": "Timing_6", + "extensionAttributes": [], + "name": "TIM6", + "label": "Week 6", + "description": "Week 6 Timing", + "type": { + "id": "Code_32", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "P6W", + "valueLabel": "6 Weeks", + "relativeToFrom": { + "id": "Code_33", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_6", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", + "windowLower": "P3D", + "windowUpper": "P3D", + "windowLabel": "-3..3 days", + "instanceType": "Timing" + }, + { + "id": "Timing_7", + "extensionAttributes": [], + "name": "TIM7", + "label": "Week 8", + "description": "Week 8 Timing", + "type": { + "id": "Code_34", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "P8W", + "valueLabel": "8 Weeks", + "relativeToFrom": { + "id": "Code_35", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_7", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", + "windowLower": "P3D", + "windowUpper": "P3D", + "windowLabel": "-3..3 days", + "instanceType": "Timing" + }, + { + "id": "Timing_8", + "extensionAttributes": [], + "name": "TIM9", + "label": "Week 12", + "description": "Week 12 Timing", + "type": { + "id": "Code_36", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "P12W", + "valueLabel": "12 Weeks", + "relativeToFrom": { + "id": "Code_37", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_19", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", + "windowLower": "P4D", + "windowUpper": "P4D", + "windowLabel": "-4..4 days", + "instanceType": "Timing" + }, + { + "id": "Timing_9", + "extensionAttributes": [], + "name": "TIM11", + "label": "Week 16", + "description": "Week 16 Timing", + "type": { + "id": "Code_38", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "P16W", + "valueLabel": "16 Weeks", + "relativeToFrom": { + "id": "Code_39", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_21", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", + "windowLower": "P4D", + "windowUpper": "P4D", + "windowLabel": "-4..4 days", + "instanceType": "Timing" + }, + { + "id": "Timing_10", + "extensionAttributes": [], + "name": "TIM13", + "label": "Week 20", + "description": "Week 20 Timing", + "type": { + "id": "Code_40", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "P20W", + "valueLabel": "20 Weeks", + "relativeToFrom": { + "id": "Code_41", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_23", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", + "windowLower": "P4D", + "windowUpper": "P4D", + "windowLabel": "-4..4 days", + "instanceType": "Timing" + }, + { + "id": "Timing_11", + "extensionAttributes": [], + "name": "TIM15", + "label": "Week 24", + "description": "Week 24 Timing", + "type": { + "id": "Code_42", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "P24W", + "valueLabel": "24 Weeks", + "relativeToFrom": { + "id": "Code_43", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_25", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", + "windowLower": "P4D", + "windowUpper": "P4D", + "windowLabel": "-4..4 days", + "instanceType": "Timing" + }, + { + "id": "Timing_12", + "extensionAttributes": [], + "name": "TIM16", + "label": "Week 26", + "description": "Week 26 Timing", + "type": { + "id": "Code_44", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "P26W", + "valueLabel": "26 Weeks", + "relativeToFrom": { + "id": "Code_45", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_26", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", + "windowLower": "P3D", + "windowUpper": "P3D", + "windowLabel": "-3..3 days", + "instanceType": "Timing" + }, + { + "id": "Timing_13", + "extensionAttributes": [], + "name": "TIM8", + "label": "Week 8 Home", + "description": "Week 8 Home Timing", + "type": { + "id": "Code_46", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "P2W", + "valueLabel": "2 Weeks", + "relativeToFrom": { + "id": "Code_47", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_8", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_7", + "windowLower": null, + "windowUpper": null, + "windowLabel": null, + "instanceType": "Timing" + }, + { + "id": "Timing_14", + "extensionAttributes": [], + "name": "TIM10", + "label": "Week 12 Home", + "description": "Week 12 Home Timing", + "type": { + "id": "Code_48", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "P2W", + "valueLabel": "2 Weeks", + "relativeToFrom": { + "id": "Code_49", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_20", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_19", + "windowLower": null, + "windowUpper": null, + "windowLabel": null, + "instanceType": "Timing" + }, + { + "id": "Timing_15", + "extensionAttributes": [], + "name": "TIM12", + "label": "Week 16 Home", + "description": "Week 16 Home Timing", + "type": { + "id": "Code_50", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "P2W", + "valueLabel": "2 Weeks", + "relativeToFrom": { + "id": "Code_51", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_22", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_21", + "windowLower": null, + "windowUpper": null, + "windowLabel": null, + "instanceType": "Timing" + }, + { + "id": "Timing_16", + "extensionAttributes": [], + "name": "TIM14", + "label": "Week 20 Home", + "description": "Week 20 Home Timing", + "type": { + "id": "Code_52", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "P2W", + "valueLabel": "2 Weeks", + "relativeToFrom": { + "id": "Code_53", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_24", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_23", + "windowLower": null, + "windowUpper": null, + "windowLabel": null, + "instanceType": "Timing" + } + ], + "instances": [ + { + "id": "ScheduledActivityInstance_1", + "extensionAttributes": [], + "name": "SCREEN1", + "label": "Screen 1", + "description": "Screen 1 Activity Instance", + "defaultConditionId": "ScheduledActivityInstance_2", + "epochId": "StudyEpoch_1", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_1", + "Activity_2", + "Activity_3", + "Activity_4", + "Activity_5", + "Activity_6", + "Activity_7", + "Activity_8", + "Activity_9", + "Activity_10", + "Activity_11", + "Activity_14", + "Activity_17", + "Activity_18", + "Activity_19", + "Activity_20", + "Activity_21", + "Activity_22", + "Activity_23", + "Activity_24", + "Activity_25", + "Activity_27", + "Activity_31", + "Activity_32", + "Activity_30", + "Activity_33" + ], + "encounterId": "Encounter_1" + }, + { + "id": "ScheduledActivityInstance_2", + "extensionAttributes": [], + "name": "SCREEN2", + "label": "Screen 2", + "description": "Screen 2 Activity Instance", + "defaultConditionId": "ScheduledActivityInstance_3", + "epochId": "StudyEpoch_1", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_14", + "Activity_15", + "Activity_33" + ], + "encounterId": "Encounter_2" + }, + { + "id": "ScheduledActivityInstance_3", + "extensionAttributes": [], + "name": "DOSE", + "label": "Dose", + "description": "Dose Activity Instance", + "defaultConditionId": "ScheduledActivityInstance_4", + "epochId": "StudyEpoch_3", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_13", + "Activity_14", + "Activity_16", + "Activity_22", + "Activity_28", + "Activity_26", + "Activity_30", + "Activity_31", + "Activity_32", + "Activity_33" + ], + "encounterId": "Encounter_3" + }, + { + "id": "ScheduledActivityInstance_4", + "extensionAttributes": [], + "name": "WEEK2", + "label": "Week 2", + "description": "Week 2 Activity Instance", + "defaultConditionId": "ScheduledActivityInstance_5", + "epochId": "StudyEpoch_3", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_12", + "Activity_14", + "Activity_22", + "Activity_23", + "Activity_25", + "Activity_26", + "Activity_28", + "Activity_17", + "Activity_24", + "Activity_33" + ], + "encounterId": "Encounter_4" + }, + { + "id": "ScheduledActivityInstance_5", + "extensionAttributes": [], + "name": "WEEK4", + "label": "Week 4", + "description": "Week 4 Activity Instance", + "defaultConditionId": "ScheduledActivityInstance_6", + "epochId": "StudyEpoch_4", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_14", + "Activity_17", + "Activity_22", + "Activity_23", + "Activity_24", + "Activity_26", + "Activity_28", + "Activity_33" + ], + "encounterId": "Encounter_5" + }, + { + "id": "ScheduledActivityInstance_6", + "extensionAttributes": [], + "name": "WEEK6", + "label": "Week 6", + "description": "Week 6 Activity Instance", + "defaultConditionId": "ScheduledActivityInstance_7", + "epochId": "StudyEpoch_4", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_14", + "Activity_17", + "Activity_22", + "Activity_23", + "Activity_24", + "Activity_26", + "Activity_28", + "Activity_33" + ], + "encounterId": "Encounter_6" + }, + { + "id": "ScheduledActivityInstance_7", + "extensionAttributes": [], + "name": "WEEK8", + "label": "Week 8", + "description": "Week 8 Activity Instance", + "defaultConditionId": "ScheduledActivityInstance_8", + "epochId": "StudyEpoch_4", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_14", + "Activity_14", + "Activity_17", + "Activity_17", + "Activity_22", + "Activity_22", + "Activity_23", + "Activity_23", + "Activity_24", + "Activity_24", + "Activity_28", + "Activity_28", + "Activity_30", + "Activity_30", + "Activity_31", + "Activity_31", + "Activity_32", + "Activity_32", + "Activity_33", + "Activity_33" + ], + "encounterId": "Encounter_7" + }, + { + "id": "ScheduledActivityInstance_8", + "extensionAttributes": [], + "name": "WEEK8N", + "label": "Week 8 NPI", + "description": "Week 8 NPI Activity Instance", + "defaultConditionId": "ScheduledActivityInstance_19", + "epochId": "StudyEpoch_4", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_14", + "Activity_14", + "Activity_17", + "Activity_17", + "Activity_22", + "Activity_22", + "Activity_23", + "Activity_23", + "Activity_24", + "Activity_24", + "Activity_28", + "Activity_28", + "Activity_30", + "Activity_30", + "Activity_31", + "Activity_31", + "Activity_32", + "Activity_32", + "Activity_33", + "Activity_33" + ], + "encounterId": "Encounter_7" + }, + { + "id": "ScheduledActivityInstance_19", + "extensionAttributes": [], + "name": "WEEK12", + "label": "Week 12", + "description": "Week 12", + "defaultConditionId": "ScheduledActivityInstance_20", + "epochId": "StudyEpoch_4", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_33", + "Activity_33", + "Activity_14", + "Activity_14", + "Activity_17", + "Activity_17", + "Activity_22", + "Activity_22", + "Activity_23", + "Activity_23", + "Activity_24", + "Activity_24", + "Activity_25", + "Activity_25", + "Activity_26", + "Activity_26", + "Activity_28", + "Activity_28" + ], + "encounterId": "Encounter_9" + }, + { + "id": "ScheduledActivityInstance_20", + "extensionAttributes": [], + "name": "WEEK12N", + "label": "Week 12 NPI", + "description": "Week 12 NPI", + "defaultConditionId": "ScheduledActivityInstance_21", + "epochId": "StudyEpoch_4", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_33", + "Activity_33", + "Activity_14", + "Activity_14", + "Activity_17", + "Activity_17", + "Activity_22", + "Activity_22", + "Activity_23", + "Activity_23", + "Activity_24", + "Activity_24", + "Activity_25", + "Activity_25", + "Activity_26", + "Activity_26", + "Activity_28", + "Activity_28" + ], + "encounterId": "Encounter_9" + }, + { + "id": "ScheduledActivityInstance_21", + "extensionAttributes": [], + "name": "WEEK16", + "label": "Week 16", + "description": "Week 16", + "defaultConditionId": "ScheduledActivityInstance_22", + "epochId": "StudyEpoch_4", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_14", + "Activity_14", + "Activity_17", + "Activity_17", + "Activity_22", + "Activity_22", + "Activity_23", + "Activity_23", + "Activity_24", + "Activity_24", + "Activity_28", + "Activity_28", + "Activity_30", + "Activity_30", + "Activity_32", + "Activity_32", + "Activity_31", + "Activity_31", + "Activity_33", + "Activity_33" + ], + "encounterId": "Encounter_11" + }, + { + "id": "ScheduledActivityInstance_22", + "extensionAttributes": [], + "name": "WEEK16N", + "label": "Week 16 NPI", + "description": "Week 16 NPI", + "defaultConditionId": "ScheduledActivityInstance_23", + "epochId": "StudyEpoch_4", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_14", + "Activity_14", + "Activity_17", + "Activity_17", + "Activity_22", + "Activity_22", + "Activity_23", + "Activity_23", + "Activity_24", + "Activity_24", + "Activity_28", + "Activity_28", + "Activity_30", + "Activity_30", + "Activity_32", + "Activity_32", + "Activity_31", + "Activity_31", + "Activity_33", + "Activity_33" + ], + "encounterId": "Encounter_11" + }, + { + "id": "ScheduledActivityInstance_23", + "extensionAttributes": [], + "name": "WEEK20", + "label": "Week 20", + "description": "Week 20", + "defaultConditionId": "ScheduledActivityInstance_24", + "epochId": "StudyEpoch_4", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_33", + "Activity_33", + "Activity_14", + "Activity_14", + "Activity_17", + "Activity_17", + "Activity_22", + "Activity_22", + "Activity_23", + "Activity_23", + "Activity_24", + "Activity_24", + "Activity_26", + "Activity_26", + "Activity_28", + "Activity_28" + ], + "encounterId": "Encounter_13" + }, + { + "id": "ScheduledActivityInstance_24", + "extensionAttributes": [], + "name": "WEEK20N", + "label": "Week 20 NPI", + "description": "Week 20 NPI", + "defaultConditionId": "ScheduledActivityInstance_25", + "epochId": "StudyEpoch_4", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_33", + "Activity_33", + "Activity_14", + "Activity_14", + "Activity_17", + "Activity_17", + "Activity_22", + "Activity_22", + "Activity_23", + "Activity_23", + "Activity_24", + "Activity_24", + "Activity_26", + "Activity_26", + "Activity_28", + "Activity_28" + ], + "encounterId": "Encounter_13" + }, + { + "id": "ScheduledActivityInstance_25", + "extensionAttributes": [], + "name": "WEEK24", + "label": "Week 24", + "description": "Week 24", + "defaultConditionId": "ScheduledActivityInstance_26", + "epochId": "StudyEpoch_5", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_33", + "Activity_14", + "Activity_17", + "Activity_22", + "Activity_23", + "Activity_24", + "Activity_25", + "Activity_28", + "Activity_30", + "Activity_32", + "Activity_31" + ], + "encounterId": "Encounter_15" + }, + { + "id": "ScheduledActivityInstance_26", + "extensionAttributes": [], + "name": "WEEK26", + "label": "Week 26", + "description": "Week 26", + "defaultConditionId": null, + "epochId": "StudyEpoch_2", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_33", + "Activity_14", + "Activity_17", + "Activity_22", + "Activity_23", + "Activity_24", + "Activity_28", + "Activity_29" + ], + "encounterId": "Encounter_16" + }, + { + "id": "ScheduledDecisionInstance_1", + "extensionAttributes": [], + "name": "testDecisionInstance", + "label": "testDecisionInstance", + "description": "testDecisionInstance", + "defaultConditionId": null, + "epochId": "StudyEpoch_3", + "instanceType": "ScheduledDecisionInstance", + "conditionAssignments": [ + { + "id": "Condition_1", + "extensionAttributes": [], + "condition": "is not null", + "conditionTargetId": "ScheduledActivityInstance_3", + "instanceType": "Condition" + } + ] + }, + { + "id": "ScheduledDecisionInstance_2", + "extensionAttributes": [], + "name": "test_2", + "label": "test_2", + "description": "test_2", + "defaultConditionId": "blahblahblah", + "epochId": "StudyEpoch_4", + "instanceType": "ScheduledDecisionInstance", + "conditionAssignments": [] + }, + { + "id": "ScheduledDecisionInstance_3", + "extensionAttributes": [], + "name": "test3", + "label": "test3", + "description": "test3", + "defaultConditionId": "ScheduledActivityInstance_11", + "epochId": "StudyEpoch_3", + "instanceType": "ScheduledDecisionInstance", + "conditionAssignments": [] + } + ], + "plannedDuration": null, + "instanceType": "ScheduleTimeline" + }, + { + "id": "ScheduleTimeline_6", + "extensionAttributes": [], + "name": "Adverse Event Timeline", + "label": "Adverse Event Timeline", + "description": "This is the adverse event timeline", + "mainTimeline": false, + "entryCondition": "Subject suffers an adverse event", + "entryId": "ScheduledActivityInstance_11", + "exits": [], + "timings": [ + { + "id": "Timing_17", + "extensionAttributes": [], + "name": "TIM17", + "label": "Adverse Event", + "description": "Adverse Event Timing", + "type": { + "id": "Code_105", + "extensionAttributes": [], + "code": "C201358", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Fixed Reference", + "instanceType": "Code" + }, + "value": "P1D", + "valueLabel": "1 Day", + "relativeToFrom": { + "id": "Code_106", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_11", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_11", + "windowLower": null, + "windowUpper": null, + "windowLabel": null, + "instanceType": "Timing" + } + ], + "instances": [ + { + "id": "ScheduledActivityInstance_11", + "extensionAttributes": [], + "name": "AE", + "label": "Adverse Event", + "description": "Occurrence of Adverse Event", + "defaultConditionId": null, + "epochId": null, + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [], + "encounterId": null + } + ], + "plannedDuration": null, + "instanceType": "ScheduleTimeline" + }, + { + "id": "ScheduleTimeline_7", + "extensionAttributes": [], + "name": "Early Termination Timeline", + "label": "Early Termination Timeline", + "description": "This is the early termination processing", + "mainTimeline": false, + "entryCondition": "Subject terminates the study early", + "entryId": "ScheduledActivityInstance_12", + "exits": [], + "timings": [ + { + "id": "Timing_18", + "extensionAttributes": [], + "name": "TIM18", + "label": "Early Termination", + "description": "Early Termination Timing", + "type": { + "id": "Code_107", + "extensionAttributes": [], + "code": "C201358", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Fixed Reference", + "instanceType": "Code" + }, + "value": "P1D", + "valueLabel": "1 Day", + "relativeToFrom": { + "id": "Code_108", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_12", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_12", + "windowLower": null, + "windowUpper": null, + "windowLabel": null, + "instanceType": "Timing" + } + ], + "instances": [ + { + "id": "ScheduledActivityInstance_12", + "extensionAttributes": [], + "name": "ET", + "label": "Early Termination", + "description": "Early Termination", + "defaultConditionId": null, + "epochId": null, + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [], + "encounterId": null + } + ], + "plannedDuration": null, + "instanceType": "ScheduleTimeline" + }, + { + "id": "ScheduleTimeline_8", + "extensionAttributes": [], + "name": "Vital Sign Blood Pressure Timeline", + "label": "Vital Sign Blood Pressure Timeline", + "description": "BP Profile", + "mainTimeline": false, + "entryCondition": "Automatic execution", + "entryId": "ScheduledActivityInstance_13", + "exits": [], + "timings": [ + { + "id": "Timing_19", + "extensionAttributes": [], + "name": "TIM19", + "label": "Supine", + "description": "VS Supine", + "type": { + "id": "Code_109", + "extensionAttributes": [], + "code": "C201358", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Fixed Reference", + "instanceType": "Code" + }, + "value": "PT0M", + "valueLabel": "0 mins", + "relativeToFrom": { + "id": "Code_110", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_13", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_13", + "windowLower": null, + "windowUpper": null, + "windowLabel": null, + "instanceType": "Timing" + }, + { + "id": "Timing_20", + "extensionAttributes": [], + "name": "TIM20", + "label": "VS while supine", + "description": "VS while supine", + "type": { + "id": "Code_111", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "PT5M", + "valueLabel": "5 mins", + "relativeToFrom": { + "id": "Code_112", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_14", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_13", + "windowLower": null, + "windowUpper": null, + "windowLabel": null, + "instanceType": "Timing" + }, + { + "id": "Timing_21", + "extensionAttributes": [], + "name": "TIM21", + "label": "Standing", + "description": "VS Standing", + "type": { + "id": "Code_113", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "PT0M", + "valueLabel": "0 mins", + "relativeToFrom": { + "id": "Code_114", + "extensionAttributes": [], + "code": "C201353", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "End to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_15", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_14", + "windowLower": null, + "windowUpper": null, + "windowLabel": null, + "instanceType": "Timing" + }, + { + "id": "Timing_22", + "extensionAttributes": [], + "name": "TIM22", + "label": "VS while standing", + "description": "VS while standing", + "type": { + "id": "Code_115", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "PT1M", + "valueLabel": "1 min", + "relativeToFrom": { + "id": "Code_116", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_16", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_15", + "windowLower": null, + "windowUpper": null, + "windowLabel": null, + "instanceType": "Timing" + }, + { + "id": "Timing_23", + "extensionAttributes": [], + "name": "TIM23", + "label": "Standing", + "description": "VS Standing", + "type": { + "id": "Code_117", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "PT0M", + "valueLabel": "0 min", + "relativeToFrom": { + "id": "Code_118", + "extensionAttributes": [], + "code": "C201353", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "End to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_17", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_16", + "windowLower": null, + "windowUpper": null, + "windowLabel": null, + "instanceType": "Timing" + }, + { + "id": "Timing_24", + "extensionAttributes": [], + "name": "TIM24", + "label": "VS while standing", + "description": "VS while standing", + "type": { + "id": "Code_119", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "PT2M", + "valueLabel": "2 min", + "relativeToFrom": { + "id": "Code_120", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_18", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_17", + "windowLower": null, + "windowUpper": null, + "windowLabel": null, + "instanceType": "Timing" + } + ], + "instances": [ + { + "id": "ScheduledActivityInstance_13", + "extensionAttributes": [], + "name": "VS_5MIN", + "label": "5 minute supine", + "description": "VS 5 minute supine", + "defaultConditionId": "ScheduledActivityInstance_14", + "epochId": null, + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [], + "encounterId": null + }, + { + "id": "ScheduledActivityInstance_14", + "extensionAttributes": [], + "name": "VS_SUPINE", + "label": "Vital signs supine", + "description": "VS Vital signs supine", + "defaultConditionId": "ScheduledActivityInstance_15", + "epochId": null, + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [], + "encounterId": null + }, + { + "id": "ScheduledActivityInstance_15", + "extensionAttributes": [], + "name": "VS_1MIN", + "label": "1 minute standing", + "description": "VS 1 minute standing", + "defaultConditionId": "ScheduledActivityInstance_16", + "epochId": null, + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [], + "encounterId": null + }, + { + "id": "ScheduledActivityInstance_16", + "extensionAttributes": [], + "name": "VS_STAND1", + "label": "Vital signs after 1 min standing", + "description": "VS Vital signs after 1 min standing", + "defaultConditionId": "ScheduledActivityInstance_17", + "epochId": null, + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [], + "encounterId": null + }, + { + "id": "ScheduledActivityInstance_17", + "extensionAttributes": [], + "name": "VS_2MIN", + "label": "2 minute standing", + "description": "VS 2 minute standing", + "defaultConditionId": "ScheduledActivityInstance_18", + "epochId": null, + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [], + "encounterId": null + }, + { + "id": "ScheduledActivityInstance_18", + "extensionAttributes": [], + "name": "VS_STAND3", + "label": "Vital signs after 3 min standing", + "description": "VS Vital signs after 3 min standing", + "defaultConditionId": null, + "epochId": null, + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [], + "encounterId": null + } + ], + "plannedDuration": null, + "instanceType": "ScheduleTimeline" + } + ], + "biospecimenRetentions": [], + "documentVersionIds": [], + "eligibilityCriteria": [], + "analysisPopulations": [], + "notes": [], + "subTypes": [], + "model": { + "id": "Code_StudyDesignModel", + "extensionAttributes": [], + "code": "", + "codeSystem": "", + "codeSystemVersion": "", + "decode": "", + "instanceType": "Code" + }, + "intentTypes": [], + "blindingSchema": null, + "instanceType": "InterventionalStudyDesign" + } + ], + "titles": [ + { + "id": "StudyTitle_1", + "extensionAttributes": [], + "text": "LZZT - Pilot", + "type": { + "id": "Code_27557", + "extensionAttributes": [], + "code": "C207646", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Study Acronym", + "instanceType": "Code" + }, + "instanceType": "StudyTitle" + }, + { + "id": "StudyTitle_2", + "extensionAttributes": [], + "text": "Xanomeline (LY246708)", + "type": { + "id": "Code_27601", + "extensionAttributes": [], + "code": "C207615", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Brief Study Title", + "instanceType": "Code" + }, + "instanceType": "StudyTitle" + }, + { + "id": "StudyTitle_3", + "extensionAttributes": [], + "text": "Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer's Disease", + "type": { + "id": "Code_27813", + "extensionAttributes": [], + "code": "C207616", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Official Study Title", + "instanceType": "Code" + }, + "instanceType": "StudyTitle" + } + ], + "documentVersionIds": [], + "dateValues": [], + "amendments": [ + { + "id": "StudyAmendment_1", + "extensionAttributes": [], + "notes": [], + "name": "AMEND_1", + "label": "Amendment 1", + "description": "First amendment", + "number": "1", + "summary": "Updated inclusion criteria", + "primaryReason": { + "id": "StudyAmendmentReason_1", + "extensionAttributes": [], + "code": { + "id": "Code_2525", + "extensionAttributes": [], + "code": "C207605", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "IRB/IEC Feedback", + "instanceType": "Code" + }, + "otherReason": null, + "instanceType": "StudyAmendmentReason" + }, + "secondaryReasons": [ + { + "id": "StudyAmendmentReason_2", + "extensionAttributes": [], + "code": { + "id": "Code_2526", + "extensionAttributes": [], + "code": "C17649", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "OTHER", + "instanceType": "Code" + }, + "otherReason": "Fix typographical errors", + "instanceType": "StudyAmendmentReason" + } + ], + "changes": [ + { + "id": "StudyChange_2", + "extensionAttributes": [], + "name": "AMEND_CHG_1", + "label": "Change 1", + "description": "Typographical errors lead to ambiguity when interpreting Inclusion Criteria", + "summary": "Fixed inclusion criteria text", + "rationale": "Subject safety", + "changedSections": [ + { + "id": "DocumentContentReference_2", + "extensionAttributes": [], + "sectionNumber": "1.5", + "sectionTitle": "Header 1.5", + "appliesToId": "StudyDefinitionDocument_1", + "instanceType": "DocumentContentReference" + } + ], + "instanceType": "StudyChange" + } + ], + "impacts": [ + { + "id": "StudyAmendmentImpact_1", + "extensionAttributes": [], + "notes": [], + "type": { + "id": "Code_2527", + "extensionAttributes": [], + "code": "C215665", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Study Subject Safety", + "instanceType": "Code" + }, + "text": "Enhance subject safety", + "isSubstantial": false, + "instanceType": "StudyAmendmentImpact" + } + ], + "geographicScopes": [ + { + "id": "GeographicScope_1", + "extensionAttributes": [], + "type": { + "id": "Code_12462", + "extensionAttributes": [], + "code": "C68846", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Global", + "instanceType": "Code" + }, + "code": null, + "instanceType": "GeographicScope" + }, + { + "id": "GeographicScope_5", + "extensionAttributes": [], + "type": { + "id": "Code_20010", + "extensionAttributes": [], + "code": "C41129", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Region", + "instanceType": "Code" + }, + "code": { + "id": "AliasCode_20011", + "extensionAttributes": [], + "standardCode": { + "id": "Code_20011", + "extensionAttributes": [], + "code": "150", + "codeSystem": "UN M49", + "codeSystemVersion": "2026", + "decode": "Europe", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "instanceType": "GeographicScope" + } + ], + "enrollments": [ + { + "id": "SubjectEnrollment_1", + "extensionAttributes": [], + "name": "Enrollment 1", + "label": null, + "description": null, + "quantity": { + "id": "SubjectEnrollment_1_Qty", + "extensionAttributes": [], + "value": 15.0, + "unit": null, + "instanceType": "Quantity" + }, + "forGeographicScope": { + "id": "GeographicScope_5", + "extensionAttributes": [], + "type": { + "id": "Code_20010", + "extensionAttributes": [], + "code": "C41129", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Region", + "instanceType": "Code" + }, + "code": { + "id": "AliasCode_20011", + "extensionAttributes": [], + "standardCode": { + "id": "Code_20011", + "extensionAttributes": [], + "code": "150", + "codeSystem": "UN M49", + "codeSystemVersion": "2026", + "decode": "Europe", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "instanceType": "GeographicScope" + }, + "forStudyCohortId": null, + "forStudySiteId": null, + "instanceType": "SubjectEnrollment" + } + ], + "dateValues": [ + { + "id": "GovernanceDate_1", + "extensionAttributes": [], + "name": "Protocol Approval", + "label": null, + "description": null, + "type": { + "id": "Code_13051", + "extensionAttributes": [], + "code": "C215663", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Effective Date", + "instanceType": "Code" + }, + "dateValue": "2006-06-01", + "geographicScopes": [ + { + "id": "GeographicScope_1", + "extensionAttributes": [], + "type": { + "id": "Code_12462", + "extensionAttributes": [], + "code": "C68846", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Global", + "instanceType": "Code" + }, + "code": null, + "instanceType": "GeographicScope" + } + ], + "instanceType": "GovernanceDate" + } + ], + "instanceType": "StudyAmendment" + } + ], + "organizations": [ + { + "id": "Organization_1", + "extensionAttributes": [], + "name": "LILLY", + "label": "Eli Lilly", + "identifier": "00-642-1325", + "identifierScheme": "DUNS", + "type": { + "id": "Code_28637", + "extensionAttributes": [], + "code": "C70793", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Clinical Study Sponsor", + "instanceType": "Code" + }, + "legalAddress": { + "id": "Address_1", + "extensionAttributes": [], + "text": "Lilly Corporate Ctr, Indianapolis, , IN, 4628, United States of America", + "lines": [ + "Lilly Corporate Ctr" + ], + "city": "Indianapolis", + "district": null, + "state": "IN", + "postalCode": "4628", + "country": { + "id": "Code_28638", + "extensionAttributes": [], + "code": "840", + "codeSystem": "ISO 3166 1 Numeric Code", + "codeSystemVersion": "2026", + "decode": "United States of America", + "instanceType": "Code" + }, + "instanceType": "Address" + }, + "managedSites": [], + "instanceType": "Organization" + }, + { + "id": "Organization_2", + "extensionAttributes": [], + "name": "CT-GOV", + "label": "ClinicalTrials.gov", + "identifier": "CT-GOV", + "identifierScheme": "USGOV", + "type": { + "id": "Code_28639", + "extensionAttributes": [], + "code": "C142578", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Independent Data Monitoring Committee", + "instanceType": "Code" + }, + "legalAddress": { + "id": "Address_2", + "extensionAttributes": [], + "text": "National Library of Medicine, Bethesda, 8600 Rockville Pike, MD, 20894, United States of America", + "lines": [ + "National Library of Medicine" + ], + "city": "Bethesda", + "district": "8600 Rockville Pike", + "state": "MD", + "postalCode": "20894", + "country": { + "id": "Code_28640", + "extensionAttributes": [], + "code": "840", + "codeSystem": "ISO 3166 1 Numeric Code", + "codeSystemVersion": "2026", + "decode": "United States of America", + "instanceType": "Code" + }, + "instanceType": "Address" + }, + "managedSites": [], + "instanceType": "Organization" + }, + { + "id": "Organization_3", + "extensionAttributes": [], + "name": "MLM Medical Labs", + "label": "Central Labu", + "identifier": "", + "identifierScheme": "", + "type": { + "id": "Code_39641", + "extensionAttributes": [], + "code": "C37984", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Laboratory", + "instanceType": "Code" + }, + "legalAddress": { + "id": "Address_3", + "extensionAttributes": [], + "text": null, + "lines": [], + "city": null, + "district": null, + "state": null, + "postalCode": null, + "country": { + "id": "Code_39642", + "extensionAttributes": [], + "code": "840", + "codeSystem": "ISO 3166 1 Numeric Code", + "codeSystemVersion": "2026", + "decode": "United States of America", + "instanceType": "Code" + }, + "instanceType": "Address" + }, + "managedSites": [], + "instanceType": "Organization" + } + ], + "roles": [ + { + "id": "StudyRole_1", + "extensionAttributes": [], + "name": "Role 1", + "label": "Sponsor", + "description": "Study Sponsor", + "code": { + "id": "Code_35642", + "extensionAttributes": [], + "code": "C70793", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Clinical Study Sponsor", + "instanceType": "Code" + }, + "organizationIds": [ + "Organization_1" + ], + "appliesToIds": [], + "assignedPersons": [], + "masking": { + "id": "Masking_1", + "extensionAttributes": [], + "text": "Masked", + "isMasked": true, + "instanceType": "Masking" + }, + "notes": [], + "instanceType": "StudyRole" + }, + { + "id": "StudyRole_3", + "extensionAttributes": [], + "name": "Laboratory Contact", + "label": "Lab Primary Contact", + "description": "The primary person to contact at the Central Lab", + "code": { + "id": "Code_40467", + "extensionAttributes": [], + "code": "C37984", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Laboratory", + "instanceType": "Code" + }, + "organizationIds": [ + "Organization_3" + ], + "appliesToIds": [], + "assignedPersons": [ + { + "id": "Person_2", + "extensionAttributes": [], + "name": "John Smith", + "label": null, + "description": null, + "personName": { + "id": "PersonName_2", + "extensionAttributes": [], + "text": null, + "familyName": "Smith", + "givenNames": [ + "John" + ], + "prefixes": [ + "Dr." + ], + "suffixes": [ + "PhD" + ], + "instanceType": "PersonName" + }, + "jobTitle": "", + "instanceType": "AssignedPerson" + } + ], + "masking": null, + "notes": [], + "instanceType": "StudyRole" + } + ], + "studyInterventions": [ + { + "id": "StudyIntervention_1", + "extensionAttributes": [], + "name": "XINONILINE", + "label": "Xinomiline", + "description": "Xinomiline", + "role": { + "id": "Code_36026", + "extensionAttributes": [], + "code": "C41161", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Experimental Intervention", + "instanceType": "Code" + }, + "type": { + "id": "Code_36027", + "extensionAttributes": [], + "code": "C1909", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-26", + "decode": "Pharmacologic Substance", + "instanceType": "Code" + }, + "minimumResponseDuration": { + "id": "Quantity_1", + "extensionAttributes": [], + "value": 1.0, + "unit": { + "id": "AliasCode_30645", + "extensionAttributes": [], + "standardCode": { + "id": "Code_36028", + "extensionAttributes": [], + "code": "C25301", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Day", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "instanceType": "Quantity" + }, + "codes": [ + { + "id": "Code_36144", + "extensionAttributes": [], + "code": "XIN", + "codeSystem": "SPONSOR", + "codeSystemVersion": "12", + "decode": "XIN", + "instanceType": "Code" + } + ], + "administrations": [], + "notes": [], + "instanceType": "StudyIntervention" + } + ], + "businessTherapeuticAreas": [], + "biomedicalConcepts": [ + { + "id": "BiomedicalConcept_1", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_126", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/CONSENT", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Informed Consent", + "label": null, + "synonyms": [ + "Informed Consent Obtained" + ], + "reference": "/mdr/bc/biomedicalconcepts/C16735", + "properties": [ + { + "id": "BiomedicalConceptProperty_1", + "extensionAttributes": [], + "name": "DSDECOD", + "label": "DSDECOD", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3021", + "instanceType": "ResponseCode", + "name": "INFORMED CONSENT OBTAINED", + "label": "INFORMED CONSENT OBTAINED", + "isEnabled": true, + "code": { + "id": "Code_42410", + "extensionAttributes": [], + "code": "C16735", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "INFORMED CONSENT OBTAINED", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37048", + "standardCode": { + "id": "Code_44335", + "extensionAttributes": [], + "code": "C82977", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_2", + "extensionAttributes": [], + "name": "DSTERM", + "label": "DSTERM", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37049", + "standardCode": { + "id": "Code_44336", + "extensionAttributes": [], + "code": "C82571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_3", + "extensionAttributes": [], + "name": "DSSTDTC", + "label": "DSSTDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37050", + "standardCode": { + "id": "Code_44337", + "extensionAttributes": [], + "code": "C82517", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_3151", + "extensionAttributes": [], + "standardCode": { + "id": "Code_3361", + "extensionAttributes": [], + "code": "C16735", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Informed Consent", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_2", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_127", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/INCL01", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Inclusion Criteria", + "label": "Inclusion Criteria", + "synonyms": [ + "Inclusion" + ], + "reference": "/mdr/bc/biomedicalconcepts/C25532", + "properties": [ + { + "id": "BiomedicalConceptProperty_4", + "extensionAttributes": [], + "name": "TIVERS", + "label": "TIVERS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37051", + "standardCode": { + "id": "Code_44338", + "extensionAttributes": [], + "code": "C83444", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Trial Inclusion Exclusion Criteria Version", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_5", + "extensionAttributes": [], + "name": "IEORRES", + "label": "IEORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37052", + "standardCode": { + "id": "Code_44339", + "extensionAttributes": [], + "code": "C181043", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Clinical Findings Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_6", + "extensionAttributes": [], + "name": "IEDTC", + "label": "IEDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37053", + "standardCode": { + "id": "Code_44340", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24523", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28641", + "extensionAttributes": [], + "code": "C25532", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Inclusion Criteria", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_3", + "extensionAttributes": [], + "name": "Inclusion Exclusion Criteria Yes No Indicator", + "label": "Inclusion Exclusion Criteria Yes No Indicator", + "synonyms": [ + "Inclusion Exclusion Criteria Yes No Indicator", + "IEYN" + ], + "reference": "/mdr/bc/biomedicalconcepts/C83063", + "properties": [ + { + "id": "BiomedicalConceptProperty_7", + "extensionAttributes": [], + "name": "Inclusion Exclusion Criteria Yes No Indicator", + "label": "Inclusion Exclusion Criteria Yes No Indicator", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37054", + "standardCode": { + "id": "Code_44341", + "extensionAttributes": [], + "code": "C83063", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Inclusion Exclusion Criteria Yes No Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_8", + "extensionAttributes": [], + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37055", + "standardCode": { + "id": "Code_44342", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_31819", + "extensionAttributes": [], + "standardCode": { + "id": "Code_38143", + "extensionAttributes": [], + "code": "C83063", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Inclusion Exclusion Criteria Yes No Indicator", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_4", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_1", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/EXCL01", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Exclusion Criteria", + "label": "Exclusion Criteria", + "synonyms": [ + "Exclusion" + ], + "reference": "/mdr/bc/biomedicalconcepts/C25370", + "properties": [ + { + "id": "BiomedicalConceptProperty_9", + "extensionAttributes": [], + "name": "TIVERS", + "label": "TIVERS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2841", + "instanceType": "ResponseCode", + "name": "INFORMED CONSENT OBTAINED", + "label": "INFORMED CONSENT OBTAINED", + "isEnabled": true, + "code": { + "id": "Code_40605", + "extensionAttributes": [], + "code": "C16735", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "INFORMED CONSENT OBTAINED", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37056", + "standardCode": { + "id": "Code_44343", + "extensionAttributes": [], + "code": "C83444", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Trial Inclusion Exclusion Criteria Version", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_10", + "extensionAttributes": [], + "name": "IEORRES", + "label": "IEORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37057", + "standardCode": { + "id": "Code_44344", + "extensionAttributes": [], + "code": "C181043", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Clinical Findings Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_11", + "extensionAttributes": [], + "name": "IEDTC", + "label": "IEDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37058", + "standardCode": { + "id": "Code_44345", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_3153", + "extensionAttributes": [], + "standardCode": { + "id": "Code_3363", + "extensionAttributes": [], + "code": "C25370", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Exclusion Criteria", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_5", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_2", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/RAND", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Subject is Randomized", + "label": "Subject is Randomized", + "synonyms": [ + "Randomized" + ], + "reference": "/mdr/bc/biomedicalconcepts/C114209", + "properties": [ + { + "id": "BiomedicalConceptProperty_12", + "extensionAttributes": [], + "name": "DSDECOD", + "label": "DSDECOD", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3022", + "instanceType": "ResponseCode", + "name": "RANDOMIZED", + "label": "RANDOMIZED", + "isEnabled": true, + "code": { + "id": "Code_42422", + "extensionAttributes": [], + "code": "C114209", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "RANDOMIZED", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37059", + "standardCode": { + "id": "Code_44346", + "extensionAttributes": [], + "code": "C82977", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_13", + "extensionAttributes": [], + "name": "DSTERM", + "label": "DSTERM", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37060", + "standardCode": { + "id": "Code_44347", + "extensionAttributes": [], + "code": "C82571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_14", + "extensionAttributes": [], + "name": "DSSTDTC", + "label": "DSSTDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37061", + "standardCode": { + "id": "Code_44348", + "extensionAttributes": [], + "code": "C82517", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_3160", + "extensionAttributes": [], + "standardCode": { + "id": "Code_3370", + "extensionAttributes": [], + "code": "C114209", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Subject is Randomized", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_6", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_125", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/RACE", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Race", + "label": "Race", + "synonyms": [ + "Racial Group" + ], + "reference": "/mdr/bc/biomedicalconcepts/C17049", + "properties": [ + { + "id": "BiomedicalConceptProperty_15", + "extensionAttributes": [], + "name": "RACE", + "label": "RACE", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37062", + "standardCode": { + "id": "Code_44349", + "extensionAttributes": [], + "code": "C17049", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Race", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_16", + "extensionAttributes": [], + "name": "DMDTC", + "label": "DMDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37063", + "standardCode": { + "id": "Code_44350", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_31820", + "extensionAttributes": [], + "standardCode": { + "id": "Code_38144", + "extensionAttributes": [], + "code": "C17049", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-04-01", + "decode": "Race", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_7", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_3", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/ETHNIC", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Ethnic Group", + "label": "Ethnic Group", + "synonyms": [ + "Ethnicity", + "Ethnic Origin" + ], + "reference": "/mdr/bc/biomedicalconcepts/C16564", + "properties": [ + { + "id": "BiomedicalConceptProperty_17", + "extensionAttributes": [], + "name": "ETHNIC", + "label": "ETHNIC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37064", + "standardCode": { + "id": "Code_44351", + "extensionAttributes": [], + "code": "C16564", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Ethnic Group", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_18", + "extensionAttributes": [], + "name": "DMDTC", + "label": "DMDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37065", + "standardCode": { + "id": "Code_44352", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_31821", + "extensionAttributes": [], + "standardCode": { + "id": "Code_38145", + "extensionAttributes": [], + "code": "C16564", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-04-01", + "decode": "Ethnic Group", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_8", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_4", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/AGE", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Subject Age", + "label": "Subject Age", + "synonyms": [ + "Age" + ], + "reference": "/mdr/bc/biomedicalconcepts/C69260", + "properties": [ + { + "id": "BiomedicalConceptProperty_19", + "extensionAttributes": [], + "name": "AGE", + "label": "AGE", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37066", + "standardCode": { + "id": "Code_44353", + "extensionAttributes": [], + "code": "C170981", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Numeric Age for Data Tabulation", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_20", + "extensionAttributes": [], + "name": "AGEU", + "label": "AGEU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37067", + "standardCode": { + "id": "Code_44354", + "extensionAttributes": [], + "code": "C50400", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Age Unit", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_21", + "extensionAttributes": [], + "name": "DMDTC", + "label": "DMDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37068", + "standardCode": { + "id": "Code_44355", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24524", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28642", + "extensionAttributes": [], + "code": "C69260", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-04-01", + "decode": "Subject Age", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_9", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_5", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/BRTHDTC", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Birth Date and Time", + "label": "Birth Date and Time", + "synonyms": [ + "BRTHDTC", + "Date/Time of Birth" + ], + "reference": "/mdr/bc/biomedicalconcepts/C83217", + "properties": [ + { + "id": "BiomedicalConceptProperty_22", + "extensionAttributes": [], + "name": "BRTHDTC", + "label": "BRTHDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37069", + "standardCode": { + "id": "Code_44356", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_23", + "extensionAttributes": [], + "name": "DMDTC", + "label": "DMDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37070", + "standardCode": { + "id": "Code_44357", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_3155", + "extensionAttributes": [], + "standardCode": { + "id": "Code_3365", + "extensionAttributes": [], + "code": "C83217", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Birth Date and Time", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_10", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_6", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/SEX", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Sex", + "label": null, + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/C28421", + "properties": [ + { + "id": "BiomedicalConceptProperty_24", + "extensionAttributes": [], + "name": "SEX", + "label": "SEX", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37071", + "standardCode": { + "id": "Code_44358", + "extensionAttributes": [], + "code": "C28421", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-04-01", + "decode": "Sex", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_25", + "extensionAttributes": [], + "name": "DMDTC", + "label": "DMDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37072", + "standardCode": { + "id": "Code_44359", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-04-01", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24525", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28643", + "extensionAttributes": [], + "code": "C28421", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-04-01", + "decode": "Sex", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_11", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_7", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/EDULEVEL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Education Level", + "label": "Education Level", + "synonyms": [ + "EDULEVEL", + "Education Level Completed", + "Education" + ], + "reference": "/mdr/bc/biomedicalconcepts/C17953", + "properties": [ + { + "id": "BiomedicalConceptProperty_26", + "extensionAttributes": [], + "name": "SCORRES", + "label": "SCORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37073", + "standardCode": { + "id": "Code_44360", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_27", + "extensionAttributes": [], + "name": "SCDTC", + "label": "SCDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37074", + "standardCode": { + "id": "Code_44361", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24526", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28644", + "extensionAttributes": [], + "code": "C17953", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Education Level", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_12", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_8", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/EDUYRNUM", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Number of Years of Education", + "label": "Number of Years of Education", + "synonyms": [ + "EDUYRNUM", + "Education" + ], + "reference": "/mdr/bc/biomedicalconcepts/C122393", + "properties": [ + { + "id": "BiomedicalConceptProperty_28", + "extensionAttributes": [], + "name": "SCORRES", + "label": "SCORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [ + { + "id": "ResponseCode_2850", + "instanceType": "ResponseCode", + "name": "RANDOMIZED", + "label": "RANDOMIZED", + "isEnabled": true, + "code": { + "id": "Code_40810", + "extensionAttributes": [], + "code": "C114209", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "RANDOMIZED", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37075", + "standardCode": { + "id": "Code_44362", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_29", + "extensionAttributes": [], + "name": "SCORRESU", + "label": "SCORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3023", + "instanceType": "ResponseCode", + "name": "YEARS", + "label": "YEARS", + "isEnabled": true, + "code": { + "id": "Code_42452", + "extensionAttributes": [], + "code": "C29848", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "YEARS", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37076", + "standardCode": { + "id": "Code_44363", + "extensionAttributes": [], + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_30", + "extensionAttributes": [], + "name": "SCDTC", + "label": "SCDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [ + { + "id": "ResponseCode_2842", + "instanceType": "ResponseCode", + "name": "RANDOMIZED", + "label": "RANDOMIZED", + "isEnabled": true, + "code": { + "id": "Code_40628", + "extensionAttributes": [], + "code": "C114209", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "RANDOMIZED", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37077", + "standardCode": { + "id": "Code_44364", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24527", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28645", + "extensionAttributes": [], + "code": "C122393", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Number of Years of Education", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_14", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_123", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/MEDHISTFREE", + "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_124", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/MHALZHEIMERS", + "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_128", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/MHVISUALHALLUCINATIONS", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Solicited Medical History", + "label": "Solicited Medical History", + "synonyms": [ + "Medical History", + "Medical History Collection" + ], + "reference": "/mdr/bc/biomedicalconcepts/C200145", + "properties": [ + { + "id": "BiomedicalConceptProperty_31", + "extensionAttributes": [], + "name": "MHTERM", + "label": "MHTERM", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37078", + "standardCode": { + "id": "Code_44365", + "extensionAttributes": [], + "code": "C83118", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Reported Term", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_32", + "extensionAttributes": [], + "name": "MHDECOD", + "label": "MHDECOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37079", + "standardCode": { + "id": "Code_44366", + "extensionAttributes": [], + "code": "C83346", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Dictionary Derived Term", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_33", + "extensionAttributes": [], + "name": "MHSTDTC", + "label": "MHSTDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37080", + "standardCode": { + "id": "Code_44367", + "extensionAttributes": [], + "code": "C83338", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Event Start Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_34", + "extensionAttributes": [], + "name": "MHENDTC", + "label": "MHENDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37081", + "standardCode": { + "id": "Code_44368", + "extensionAttributes": [], + "code": "C83330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Event End Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_35", + "extensionAttributes": [], + "name": "MHENRF", + "label": "MHENRF", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37082", + "standardCode": { + "id": "Code_44369", + "extensionAttributes": [], + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "End Relative to Reference Period", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_36", + "extensionAttributes": [], + "name": "MHENRTPT", + "label": "MHENRTPT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37083", + "standardCode": { + "id": "Code_44370", + "extensionAttributes": [], + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "End Relative to Reference Time Point", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_37", + "extensionAttributes": [], + "name": "MHENTPT", + "label": "MHENTPT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37084", + "standardCode": { + "id": "Code_44371", + "extensionAttributes": [], + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Reference End Time Point End", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_3156", + "extensionAttributes": [], + "standardCode": { + "id": "Code_3366", + "extensionAttributes": [], + "code": "C200145", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Solicited Medical History", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_15", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_134", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/ALCOHOLHX", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Alcohol Use History", + "label": "Alcohol Use History", + "synonyms": [ + "Alcohol History", + "Alcohol Use" + ], + "reference": "/mdr/bc/biomedicalconcepts/C81229", + "properties": [ + { + "id": "BiomedicalConceptProperty_38", + "extensionAttributes": [], + "name": "SUTRT", + "label": "SUTRT", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37085", + "standardCode": { + "id": "Code_44372", + "extensionAttributes": [], + "code": "C83092", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Reported Name", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_39", + "extensionAttributes": [], + "name": "SUPRESP", + "label": "SUPRESP", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37086", + "standardCode": { + "id": "Code_44373", + "extensionAttributes": [], + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Prespecified Event or Intervention Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_40", + "extensionAttributes": [], + "name": "SUOCCUR", + "label": "SUOCCUR", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37087", + "standardCode": { + "id": "Code_44374", + "extensionAttributes": [], + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Occurrence Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_41", + "extensionAttributes": [], + "name": "SUDOSE", + "label": "SUDOSE", + "isRequired": false, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37088", + "standardCode": { + "id": "Code_44375", + "extensionAttributes": [], + "code": "C83416", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_42", + "extensionAttributes": [], + "name": "SUDOSTXT", + "label": "SUDOSTXT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37089", + "standardCode": { + "id": "Code_44376", + "extensionAttributes": [], + "code": "C83041", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Description", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_43", + "extensionAttributes": [], + "name": "SUDOSU", + "label": "SUDOSU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37090", + "standardCode": { + "id": "Code_44377", + "extensionAttributes": [], + "code": "C83038", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Unit", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_44", + "extensionAttributes": [], + "name": "SUDOSFRQ", + "label": "SUDOSFRQ", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37091", + "standardCode": { + "id": "Code_44378", + "extensionAttributes": [], + "code": "C83044", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Frequency", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_45", + "extensionAttributes": [], + "name": "SUSTDTC", + "label": "SUSTDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37092", + "standardCode": { + "id": "Code_44379", + "extensionAttributes": [], + "code": "C83431", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Start Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_46", + "extensionAttributes": [], + "name": "SUENDTC", + "label": "SUENDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37093", + "standardCode": { + "id": "Code_44380", + "extensionAttributes": [], + "code": "C83419", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use End Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_47", + "extensionAttributes": [], + "name": "SUSTRF", + "label": "SUSTRF", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37094", + "standardCode": { + "id": "Code_44381", + "extensionAttributes": [], + "code": "C82559", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Period", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_48", + "extensionAttributes": [], + "name": "SUSTRTPT", + "label": "SUSTRTPT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37095", + "standardCode": { + "id": "Code_44382", + "extensionAttributes": [], + "code": "C82560", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Time Point", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_49", + "extensionAttributes": [], + "name": "SUSTTPT", + "label": "SUSTTPT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37096", + "standardCode": { + "id": "Code_44383", + "extensionAttributes": [], + "code": "C82575", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference Start Time Point", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_50", + "extensionAttributes": [], + "name": "SUENRF", + "label": "SUENRF", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37097", + "standardCode": { + "id": "Code_44384", + "extensionAttributes": [], + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_51", + "extensionAttributes": [], + "name": "SUENRTPT", + "label": "SUENRTPT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37098", + "standardCode": { + "id": "Code_44385", + "extensionAttributes": [], + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_52", + "extensionAttributes": [], + "name": "SUENTPT", + "label": "SUENTPT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37099", + "standardCode": { + "id": "Code_44386", + "extensionAttributes": [], + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24528", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28646", + "extensionAttributes": [], + "code": "C81229", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Alcohol Use History", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_16", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_135", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/CAFFEINEHX", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Caffeine Use History", + "label": "Caffeine Use History", + "synonyms": [ + "Caffeine History", + "Caffeine Use" + ], + "reference": "/mdr/bc/biomedicalconcepts/C201990", + "properties": [ + { + "id": "BiomedicalConceptProperty_53", + "extensionAttributes": [], + "name": "SUTRT", + "label": "SUTRT", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37100", + "standardCode": { + "id": "Code_44387", + "extensionAttributes": [], + "code": "C83092", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Reported Name", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_54", + "extensionAttributes": [], + "name": "SUPRESP", + "label": "SUPRESP", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37101", + "standardCode": { + "id": "Code_44388", + "extensionAttributes": [], + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Prespecified Event or Intervention Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_55", + "extensionAttributes": [], + "name": "SUOCCUR", + "label": "SUOCCUR", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37102", + "standardCode": { + "id": "Code_44389", + "extensionAttributes": [], + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Occurrence Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_56", + "extensionAttributes": [], + "name": "SUDOSE", + "label": "SUDOSE", + "isRequired": false, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37103", + "standardCode": { + "id": "Code_44390", + "extensionAttributes": [], + "code": "C83416", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_57", + "extensionAttributes": [], + "name": "SUDOSTXT", + "label": "SUDOSTXT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37104", + "standardCode": { + "id": "Code_44391", + "extensionAttributes": [], + "code": "C83041", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Description", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_58", + "extensionAttributes": [], + "name": "SUDOSU", + "label": "SUDOSU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37105", + "standardCode": { + "id": "Code_44392", + "extensionAttributes": [], + "code": "C83038", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Unit", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_59", + "extensionAttributes": [], + "name": "SUDOSFRQ", + "label": "SUDOSFRQ", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37106", + "standardCode": { + "id": "Code_44393", + "extensionAttributes": [], + "code": "C83044", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Frequency", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_60", + "extensionAttributes": [], + "name": "SUSTDTC", + "label": "SUSTDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37107", + "standardCode": { + "id": "Code_44394", + "extensionAttributes": [], + "code": "C83431", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Start Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_61", + "extensionAttributes": [], + "name": "SUENDTC", + "label": "SUENDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37108", + "standardCode": { + "id": "Code_44395", + "extensionAttributes": [], + "code": "C83419", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use End Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_62", + "extensionAttributes": [], + "name": "SUSTRF", + "label": "SUSTRF", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37109", + "standardCode": { + "id": "Code_44396", + "extensionAttributes": [], + "code": "C82559", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Period", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_63", + "extensionAttributes": [], + "name": "SUSTRTPT", + "label": "SUSTRTPT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37110", + "standardCode": { + "id": "Code_44397", + "extensionAttributes": [], + "code": "C82560", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Time Point", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_64", + "extensionAttributes": [], + "name": "SUSTTPT", + "label": "SUSTTPT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37111", + "standardCode": { + "id": "Code_44398", + "extensionAttributes": [], + "code": "C82575", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference Start Time Point", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_65", + "extensionAttributes": [], + "name": "SUENRF", + "label": "SUENRF", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37112", + "standardCode": { + "id": "Code_44399", + "extensionAttributes": [], + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_66", + "extensionAttributes": [], + "name": "SUENRTPT", + "label": "SUENRTPT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2843", + "instanceType": "ResponseCode", + "name": "YEARS", + "label": "YEARS", + "isEnabled": true, + "code": { + "id": "Code_40666", + "extensionAttributes": [], + "code": "C29848", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "YEARS", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37113", + "standardCode": { + "id": "Code_44400", + "extensionAttributes": [], + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_67", + "extensionAttributes": [], + "name": "SUENTPT", + "label": "SUENTPT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37114", + "standardCode": { + "id": "Code_44401", + "extensionAttributes": [], + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_3157", + "extensionAttributes": [], + "standardCode": { + "id": "Code_3367", + "extensionAttributes": [], + "code": "C201990", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Caffeine Use History", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_17", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_130", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/CIGARHX", + "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_131", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/CIGARETTEHX", + "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_132", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/PIPEHX", + "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_133", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/TOBACCOHX", + "instanceType": "ExtensionAttribute" + } + ], + "name": "History of Tobacco Use", + "label": "History of Tobacco Use", + "synonyms": [ + "Tobacco Use", + "Tobacco Use History" + ], + "reference": "/mdr/bc/biomedicalconcepts/C181760", + "properties": [ + { + "id": "BiomedicalConceptProperty_68", + "extensionAttributes": [], + "name": "SUTRT", + "label": "SUTRT", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37115", + "standardCode": { + "id": "Code_44402", + "extensionAttributes": [], + "code": "C83092", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Reported Name", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_69", + "extensionAttributes": [], + "name": "SUPRESP", + "label": "SUPRESP", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37116", + "standardCode": { + "id": "Code_44403", + "extensionAttributes": [], + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Prespecified Event or Intervention Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_70", + "extensionAttributes": [], + "name": "SUOCCUR", + "label": "SUOCCUR", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37117", + "standardCode": { + "id": "Code_44404", + "extensionAttributes": [], + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Occurrence Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_71", + "extensionAttributes": [], + "name": "SUDOSE", + "label": "SUDOSE", + "isRequired": false, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37118", + "standardCode": { + "id": "Code_44405", + "extensionAttributes": [], + "code": "C83416", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_72", + "extensionAttributes": [], + "name": "SUDOSTXT", + "label": "SUDOSTXT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37119", + "standardCode": { + "id": "Code_44406", + "extensionAttributes": [], + "code": "C83041", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Description", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_73", + "extensionAttributes": [], + "name": "SUDOSU", + "label": "SUDOSU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37120", + "standardCode": { + "id": "Code_44407", + "extensionAttributes": [], + "code": "C83038", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Unit", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_74", + "extensionAttributes": [], + "name": "SUDOSFRQ", + "label": "SUDOSFRQ", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37121", + "standardCode": { + "id": "Code_44408", + "extensionAttributes": [], + "code": "C83044", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Frequency", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_75", + "extensionAttributes": [], + "name": "SUSTDTC", + "label": "SUSTDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37122", + "standardCode": { + "id": "Code_44409", + "extensionAttributes": [], + "code": "C83431", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Start Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_76", + "extensionAttributes": [], + "name": "SUENDTC", + "label": "SUENDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37123", + "standardCode": { + "id": "Code_44410", + "extensionAttributes": [], + "code": "C83419", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use End Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_77", + "extensionAttributes": [], + "name": "SUDUR", + "label": "SUDUR", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37124", + "standardCode": { + "id": "Code_44411", + "extensionAttributes": [], + "code": "C83419", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use End Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_78", + "extensionAttributes": [], + "name": "SUSTRF", + "label": "SUSTRF", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37125", + "standardCode": { + "id": "Code_44412", + "extensionAttributes": [], + "code": "C82559", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Period", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_79", + "extensionAttributes": [], + "name": "SUSTRTPT", + "label": "SUSTRTPT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37126", + "standardCode": { + "id": "Code_44413", + "extensionAttributes": [], + "code": "C82560", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Time Point", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_80", + "extensionAttributes": [], + "name": "SUSTTPT", + "label": "SUSTTPT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37127", + "standardCode": { + "id": "Code_44414", + "extensionAttributes": [], + "code": "C82575", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference Start Time Point", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_81", + "extensionAttributes": [], + "name": "SUENRF", + "label": "SUENRF", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37128", + "standardCode": { + "id": "Code_44415", + "extensionAttributes": [], + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_82", + "extensionAttributes": [], + "name": "SUENRTPT", + "label": "SUENRTPT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37129", + "standardCode": { + "id": "Code_44416", + "extensionAttributes": [], + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_83", + "extensionAttributes": [], + "name": "SUENTPT", + "label": "SUENTPT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37130", + "standardCode": { + "id": "Code_44417", + "extensionAttributes": [], + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_3158", + "extensionAttributes": [], + "standardCode": { + "id": "Code_3368", + "extensionAttributes": [], + "code": "C181760", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "History of Tobacco Use", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_18", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_136", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/XRAY", + "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_137", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/XRAYCHEST", + "instanceType": "ExtensionAttribute" + } + ], + "name": "X-Ray Imaging", + "label": "X-Ray Imaging", + "synonyms": [ + "Conventional X-Ray", + "Medical Imaging", + "X-Ray", + "Static X-Ray" + ], + "reference": "/mdr/bc/biomedicalconcepts/C38101", + "properties": [ + { + "id": "BiomedicalConceptProperty_84", + "extensionAttributes": [], + "name": "PRTRT", + "label": "PRTRT", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37131", + "standardCode": { + "id": "Code_44418", + "extensionAttributes": [], + "code": "C117511", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Name of Procedure", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_85", + "extensionAttributes": [], + "name": "PRDECOD", + "label": "PRDECOD", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3024", + "instanceType": "ResponseCode", + "name": "X-RAY", + "label": "X-RAY", + "isEnabled": true, + "code": { + "id": "Code_42509", + "extensionAttributes": [], + "code": "C38101", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "X-RAY", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37132", + "standardCode": { + "id": "Code_44419", + "extensionAttributes": [], + "code": "C117512", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Standardized Name of Procedure", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_86", + "extensionAttributes": [], + "name": "PRPRESP", + "label": "PRPRESP", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37133", + "standardCode": { + "id": "Code_44420", + "extensionAttributes": [], + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Prespecified Event or Intervention Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_87", + "extensionAttributes": [], + "name": "PROCCUR", + "label": "PROCCUR", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37134", + "standardCode": { + "id": "Code_44421", + "extensionAttributes": [], + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Occurrence Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_88", + "extensionAttributes": [], + "name": "PRLOC", + "label": "PRLOC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37135", + "standardCode": { + "id": "Code_44422", + "extensionAttributes": [], + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_89", + "extensionAttributes": [], + "name": "PRSTDTC", + "label": "PRSTDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37136", + "standardCode": { + "id": "Code_44423", + "extensionAttributes": [], + "code": "C117529", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Start Date and Time of Procedure", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_90", + "extensionAttributes": [], + "name": "PRENDTC", + "label": "PRENDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37137", + "standardCode": { + "id": "Code_44424", + "extensionAttributes": [], + "code": "C117530", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "End Date and Time of Procedure", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_33681", + "extensionAttributes": [], + "standardCode": { + "id": "Code_40968", + "extensionAttributes": [], + "code": "C38101", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "X-RAY", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_19", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_138", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/RAND", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Subject is Randomized", + "label": null, + "synonyms": [ + "Randomized" + ], + "reference": "/mdr/bc/biomedicalconcepts/C114209", + "properties": [ + { + "id": "BiomedicalConceptProperty_91", + "extensionAttributes": [], + "name": "DSDECOD", + "label": "DSDECOD", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3025", + "instanceType": "ResponseCode", + "name": "RANDOMIZED", + "label": "RANDOMIZED", + "isEnabled": true, + "code": { + "id": "Code_42516", + "extensionAttributes": [], + "code": "C114209", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "RANDOMIZED", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37138", + "standardCode": { + "id": "Code_44425", + "extensionAttributes": [], + "code": "C82977", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_92", + "extensionAttributes": [], + "name": "DSTERM", + "label": "DSTERM", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37139", + "standardCode": { + "id": "Code_44426", + "extensionAttributes": [], + "code": "C82571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_93", + "extensionAttributes": [], + "name": "DSSTDTC", + "label": "DSSTDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37140", + "standardCode": { + "id": "Code_44427", + "extensionAttributes": [], + "code": "C82517", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_3160", + "extensionAttributes": [], + "standardCode": { + "id": "Code_3370", + "extensionAttributes": [], + "code": "C114209", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Subject is Randomized", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_20", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_9", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/TEMP", + "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_145", + "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", + "valueString": "/mdr/specializations/crf/packages/2026-06-30/specializations/TEMP_DENORMALIZED", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Body Temperature", + "label": "Body Temperature", + "synonyms": [ + "Temperature" + ], + "reference": "/mdr/bc/biomedicalconcepts/C174446", + "properties": [ + { + "id": "BiomedicalConceptProperty_94", + "extensionAttributes": [], + "name": "VSORRES", + "label": "VSORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37141", + "standardCode": { + "id": "Code_44428", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_95", + "extensionAttributes": [], + "name": "VSORRESU", + "label": "VSORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37142", + "standardCode": { + "id": "Code_44429", + "extensionAttributes": [], + "code": "C44276", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Temperature", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_96", + "extensionAttributes": [], + "name": "VSLOC", + "label": "VSLOC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37143", + "standardCode": { + "id": "Code_44430", + "extensionAttributes": [], + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_97", + "extensionAttributes": [], + "name": "VSDTC", + "label": "VSDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37144", + "standardCode": { + "id": "Code_44431", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_2640", + "extensionAttributes": [], + "standardCode": { + "id": "Code_2850", + "extensionAttributes": [], + "code": "C174446", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "VSTESTCD", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_21", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_10", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/WEIGHT", + "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_146", + "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", + "valueString": "/mdr/specializations/crf/packages/2026-06-30/specializations/WEIGHT_DENORMALIZED", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Body Weight", + "label": "Body Weight", + "synonyms": [ + "WEIGHT" + ], + "reference": "/mdr/bc/biomedicalconcepts/C81328", + "properties": [ + { + "id": "BiomedicalConceptProperty_98", + "extensionAttributes": [], + "name": "VSORRES", + "label": "VSORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37145", + "standardCode": { + "id": "Code_44432", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_99", + "extensionAttributes": [], + "name": "VSORRESU", + "label": "VSORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37146", + "standardCode": { + "id": "Code_44433", + "extensionAttributes": [], + "code": "C48208", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Weight", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_100", + "extensionAttributes": [], + "name": "VSDTC", + "label": "VSDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37147", + "standardCode": { + "id": "Code_44434", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_3161", + "extensionAttributes": [], + "standardCode": { + "id": "Code_3371", + "extensionAttributes": [], + "code": "C81328", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Body Weight", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_22", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_11", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/HEIGHT", + "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_147", + "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", + "valueString": "/mdr/specializations/crf/packages/2026-06-30/specializations/HEIGHT_DENORMALIZED", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Body Height", + "label": "Body Height", + "synonyms": [ + "HEIGHT" + ], + "reference": "/mdr/bc/biomedicalconcepts/C164634", + "properties": [ + { + "id": "BiomedicalConceptProperty_101", + "extensionAttributes": [], + "name": "VSORRES", + "label": "VSORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37148", + "standardCode": { + "id": "Code_44435", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_102", + "extensionAttributes": [], + "name": "VSORRESU", + "label": "VSORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37149", + "standardCode": { + "id": "Code_44436", + "extensionAttributes": [], + "code": "C168688", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Height", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_103", + "extensionAttributes": [], + "name": "VSDTC", + "label": "VSDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37150", + "standardCode": { + "id": "Code_44437", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24529", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28647", + "extensionAttributes": [], + "code": "C164634", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Body Height", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_23", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_12", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/PULSE", + "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_148", + "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", + "valueString": "/mdr/specializations/crf/packages/2026-06-30/specializations/PULSE_DENORMALIZED", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Pulse Rate", + "label": "Pulse Rate", + "synonyms": [ + "Pulse" + ], + "reference": "/mdr/bc/biomedicalconcepts/C49676", + "properties": [ + { + "id": "BiomedicalConceptProperty_104", + "extensionAttributes": [], + "name": "VSORRES", + "label": "VSORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37151", + "standardCode": { + "id": "Code_44438", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_105", + "extensionAttributes": [], + "name": "VSORRESU", + "label": "VSORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3026", + "instanceType": "ResponseCode", + "name": "beats/min", + "label": "beats/min", + "isEnabled": true, + "code": { + "id": "Code_42622", + "extensionAttributes": [], + "code": "C49673", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "beats/min", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37152", + "standardCode": { + "id": "Code_44439", + "extensionAttributes": [], + "code": "C73688", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Count per Minute", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_106", + "extensionAttributes": [], + "name": "VSPOS", + "label": "VSPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37153", + "standardCode": { + "id": "Code_44440", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_107", + "extensionAttributes": [], + "name": "VSLOC", + "label": "VSLOC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37154", + "standardCode": { + "id": "Code_44441", + "extensionAttributes": [], + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_108", + "extensionAttributes": [], + "name": "VSLAT", + "label": "VSLAT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37155", + "standardCode": { + "id": "Code_44442", + "extensionAttributes": [], + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_109", + "extensionAttributes": [], + "name": "VSDTC", + "label": "VSDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37156", + "standardCode": { + "id": "Code_44443", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_2664", + "extensionAttributes": [], + "standardCode": { + "id": "Code_2874", + "extensionAttributes": [], + "code": "C49676", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "VSTESTCD", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_24", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_13", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/RESP", + "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_149", + "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", + "valueString": "/mdr/specializations/crf/packages/2026-06-30/specializations/RESP_DENORMALIZED", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Respiratory Rate", + "label": "Respiratory Rate", + "synonyms": [ + "RESP", + "RESPRATE" + ], + "reference": "/mdr/bc/biomedicalconcepts/C49678", + "properties": [ + { + "id": "BiomedicalConceptProperty_110", + "extensionAttributes": [], + "name": "VSORRES", + "label": "VSORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37157", + "standardCode": { + "id": "Code_44444", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_111", + "extensionAttributes": [], + "name": "VSORRESU", + "label": "VSORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3027", + "instanceType": "ResponseCode", + "name": "breaths/min", + "label": "breaths/min", + "isEnabled": true, + "code": { + "id": "Code_42629", + "extensionAttributes": [], + "code": "C49674", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "breaths/min", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37158", + "standardCode": { + "id": "Code_44445", + "extensionAttributes": [], + "code": "C73688", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Count per Minute", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_112", + "extensionAttributes": [], + "name": "VSDTC", + "label": "VSDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37159", + "standardCode": { + "id": "Code_44446", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_2680", + "extensionAttributes": [], + "standardCode": { + "id": "Code_2890", + "extensionAttributes": [], + "code": "C49678", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "VSTESTCD", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_25", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_14", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/BMI", + "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_150", + "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", + "valueString": "/mdr/specializations/crf/packages/2026-06-30/specializations/BMI_DENORMALIZED", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Body Mass Index", + "label": "Body Mass Index", + "synonyms": [ + "BMI", + "Quetelet Index" + ], + "reference": "/mdr/bc/biomedicalconcepts/C16358", + "properties": [ + { + "id": "BiomedicalConceptProperty_113", + "extensionAttributes": [], + "name": "VSORRES", + "label": "VSORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37160", + "standardCode": { + "id": "Code_44447", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_114", + "extensionAttributes": [], + "name": "VSORRESU", + "label": "VSORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37161", + "standardCode": { + "id": "Code_44448", + "extensionAttributes": [], + "code": "C42575", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Mass Density", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_115", + "extensionAttributes": [], + "name": "VSDTC", + "label": "VSDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37162", + "standardCode": { + "id": "Code_44449", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24530", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28648", + "extensionAttributes": [], + "code": "C16358", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Body Mass Index", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_26", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_151", + "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", + "valueString": "/mdr/specializations/crf/packages/2026-06-30/specializations/DIABP_DENORMALIZED", + "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_152", + "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", + "valueString": "/mdr/specializations/crf/packages/2026-06-30/specializations/SYSBP_DENORMALIZED", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Blood Pressure", + "label": "Blood Pressure", + "synonyms": [ + "BP" + ], + "reference": "/mdr/bc/biomedicalconcepts/C54706", + "properties": [], + "code": { + "id": "AliasCode_3162", + "extensionAttributes": [], + "standardCode": { + "id": "Code_3372", + "extensionAttributes": [], + "code": "C54706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Blood Pressure", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_27", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_15", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/EGINTP", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Electrocardiogram Analysis", + "label": "Electrocardiogram Analysis", + "synonyms": [ + "ECG Analysis", + "EKG Analysis", + "Electrocardiogram Interpretation", + "ECG Interpretation", + "EKG Interpretation" + ], + "reference": "/mdr/bc/biomedicalconcepts/C181655", + "properties": [ + { + "id": "BiomedicalConceptProperty_116", + "extensionAttributes": [], + "name": "EGORRES", + "label": "EGORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37163", + "standardCode": { + "id": "Code_44450", + "extensionAttributes": [], + "code": "C125009", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Clinical Interpretation", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_117", + "extensionAttributes": [], + "name": "EGMETHOD", + "label": "EGMETHOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37164", + "standardCode": { + "id": "Code_44451", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_118", + "extensionAttributes": [], + "name": "EGEVAL", + "label": "EGEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37165", + "standardCode": { + "id": "Code_44452", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_119", + "extensionAttributes": [], + "name": "EGCLSIG", + "label": "EGCLSIG", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37166", + "standardCode": { + "id": "Code_44453", + "extensionAttributes": [], + "code": "C93532", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Clinically Significant Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_120", + "extensionAttributes": [], + "name": "EGDTC", + "label": "EGDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37167", + "standardCode": { + "id": "Code_44454", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24531", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28649", + "extensionAttributes": [], + "code": "C181655", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Electrocardiogram Analysis", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_28", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_16", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/AVCOND", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Atrioventricular Conduction ECG Assessment", + "label": "Atrioventricular Conduction ECG Assessment", + "synonyms": [ + "AVCOND", + "Atrioventricular Conduction" + ], + "reference": "/mdr/bc/biomedicalconcepts/C111131", + "properties": [ + { + "id": "BiomedicalConceptProperty_121", + "extensionAttributes": [], + "name": "EGORRES", + "label": "EGORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37168", + "standardCode": { + "id": "Code_44455", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_122", + "extensionAttributes": [], + "name": "EGPOS", + "label": "EGPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37169", + "standardCode": { + "id": "Code_44456", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_123", + "extensionAttributes": [], + "name": "EGMETHOD", + "label": "EGMETHOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37170", + "standardCode": { + "id": "Code_44457", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_124", + "extensionAttributes": [], + "name": "EGEVAL", + "label": "EGEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37171", + "standardCode": { + "id": "Code_44458", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_125", + "extensionAttributes": [], + "name": "EGDTC", + "label": "EGDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37172", + "standardCode": { + "id": "Code_44459", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24532", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28650", + "extensionAttributes": [], + "code": "C111131", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-17", + "decode": "Atrioventricular Conduction ECG Assessment", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_29", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_17", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/AXISVOLT", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Axis and Voltage ECG Assessment", + "label": "Axis and Voltage ECG Assessment", + "synonyms": [ + "AXISVOLT", + "Axis and Voltage" + ], + "reference": "/mdr/bc/biomedicalconcepts/C111132", + "properties": [ + { + "id": "BiomedicalConceptProperty_126", + "extensionAttributes": [], + "name": "EGORRES", + "label": "EGORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37173", + "standardCode": { + "id": "Code_44460", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_127", + "extensionAttributes": [], + "name": "EGPOS", + "label": "EGPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37174", + "standardCode": { + "id": "Code_44461", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_128", + "extensionAttributes": [], + "name": "EGMETHOD", + "label": "EGMETHOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37175", + "standardCode": { + "id": "Code_44462", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_129", + "extensionAttributes": [], + "name": "EGEVAL", + "label": "EGEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37176", + "standardCode": { + "id": "Code_44463", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_130", + "extensionAttributes": [], + "name": "EGDTC", + "label": "EGDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37177", + "standardCode": { + "id": "Code_44464", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24533", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28651", + "extensionAttributes": [], + "code": "C111132", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-17", + "decode": "Axis and Voltage ECG Assessment", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_30", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_18", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/CHYPTENL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Chamber Hypertrophy or Enlargement ECG Assessment", + "label": "Chamber Hypertrophy or Enlargement ECG Assessment", + "synonyms": [ + "CHYPTENL", + "Chamber Hypertrophy or Enlargement" + ], + "reference": "/mdr/bc/biomedicalconcepts/C111155", + "properties": [ + { + "id": "BiomedicalConceptProperty_131", + "extensionAttributes": [], + "name": "EGORRES", + "label": "EGORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37178", + "standardCode": { + "id": "Code_44465", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_132", + "extensionAttributes": [], + "name": "EGPOS", + "label": "EGPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37179", + "standardCode": { + "id": "Code_44466", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_133", + "extensionAttributes": [], + "name": "EGMETHOD", + "label": "EGMETHOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37180", + "standardCode": { + "id": "Code_44467", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_134", + "extensionAttributes": [], + "name": "EGEVAL", + "label": "EGEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37181", + "standardCode": { + "id": "Code_44468", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_135", + "extensionAttributes": [], + "name": "EGDTC", + "label": "EGDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37182", + "standardCode": { + "id": "Code_44469", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24534", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28652", + "extensionAttributes": [], + "code": "C111155", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-17", + "decode": "Chamber Hypertrophy or Enlargement ECG Assessment", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_31", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_19", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/TECHQUAL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "ECG Technical Quality", + "label": "ECG Technical Quality", + "synonyms": [ + "TECHQUAL" + ], + "reference": "/mdr/bc/biomedicalconcepts/C117807", + "properties": [ + { + "id": "BiomedicalConceptProperty_136", + "extensionAttributes": [], + "name": "EGORRES", + "label": "EGORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37183", + "standardCode": { + "id": "Code_44470", + "extensionAttributes": [], + "code": "C114120", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "ECG Recording Quality", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_137", + "extensionAttributes": [], + "name": "EGMETHOD", + "label": "EGMETHOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37184", + "standardCode": { + "id": "Code_44471", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_138", + "extensionAttributes": [], + "name": "EGEVAL", + "label": "EGEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37185", + "standardCode": { + "id": "Code_44472", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_139", + "extensionAttributes": [], + "name": "EGDTC", + "label": "EGDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37186", + "standardCode": { + "id": "Code_44473", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24535", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28653", + "extensionAttributes": [], + "code": "C117807", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "ECG Technical Quality", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_32", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_20", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/IVTIACD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Intraventricular and Intraatrial Conduction ECG Assessment", + "label": "Intraventricular and Intraatrial Conduction ECG Assessment", + "synonyms": [ + "IVTIACD", + "Intraventricular-Intraatrial Conduction" + ], + "reference": "/mdr/bc/biomedicalconcepts/C111238", + "properties": [ + { + "id": "BiomedicalConceptProperty_140", + "extensionAttributes": [], + "name": "EGORRES", + "label": "EGORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37187", + "standardCode": { + "id": "Code_44474", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_141", + "extensionAttributes": [], + "name": "EGPOS", + "label": "EGPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37188", + "standardCode": { + "id": "Code_44475", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_142", + "extensionAttributes": [], + "name": "EGMETHOD", + "label": "EGMETHOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37189", + "standardCode": { + "id": "Code_44476", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_143", + "extensionAttributes": [], + "name": "EGEVAL", + "label": "EGEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37190", + "standardCode": { + "id": "Code_44477", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_144", + "extensionAttributes": [], + "name": "EGDTC", + "label": "EGDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37191", + "standardCode": { + "id": "Code_44478", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24536", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28654", + "extensionAttributes": [], + "code": "C111238", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-17", + "decode": "Intraventricular and Intraatrial Conduction ECG Assessment", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_33", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_21", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/MI", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Myocardial Infarction ECG Assessment", + "label": "Myocardial Infarction ECG Assessment", + "synonyms": [ + "MI", + "Myocardial Infarction" + ], + "reference": "/mdr/bc/biomedicalconcepts/C111280", + "properties": [ + { + "id": "BiomedicalConceptProperty_145", + "extensionAttributes": [], + "name": "EGORRES", + "label": "EGORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37192", + "standardCode": { + "id": "Code_44479", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_146", + "extensionAttributes": [], + "name": "EGPOS", + "label": "EGPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37193", + "standardCode": { + "id": "Code_44480", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_147", + "extensionAttributes": [], + "name": "EGMETHOD", + "label": "EGMETHOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37194", + "standardCode": { + "id": "Code_44481", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_148", + "extensionAttributes": [], + "name": "EGEVAL", + "label": "EGEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37195", + "standardCode": { + "id": "Code_44482", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24537", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28655", + "extensionAttributes": [], + "code": "C111280", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-17", + "decode": "Myocardial Infarction ECG Assessment", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_34", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_22", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/PACEMAKR", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Pacemaker ECG Assessment", + "label": "Pacemaker ECG Assessment", + "synonyms": [ + "PACEMAKR", + "Pacemaker" + ], + "reference": "/mdr/bc/biomedicalconcepts/C111285", + "properties": [ + { + "id": "BiomedicalConceptProperty_149", + "extensionAttributes": [], + "name": "EGORRES", + "label": "EGORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37196", + "standardCode": { + "id": "Code_44483", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_150", + "extensionAttributes": [], + "name": "EGPOS", + "label": "EGPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37197", + "standardCode": { + "id": "Code_44484", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_151", + "extensionAttributes": [], + "name": "EGMETHOD", + "label": "EGMETHOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37198", + "standardCode": { + "id": "Code_44485", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_152", + "extensionAttributes": [], + "name": "EGEVAL", + "label": "EGEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37199", + "standardCode": { + "id": "Code_44486", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_153", + "extensionAttributes": [], + "name": "EGDTC", + "label": "EGDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37200", + "standardCode": { + "id": "Code_44487", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24538", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28656", + "extensionAttributes": [], + "code": "C111285", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-17", + "decode": "Pacemaker ECG Assessment", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_35", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_23", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/RHYNOS", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Rhythm Not Otherwise Specified ECG Assessment", + "label": "Rhythm Not Otherwise Specified ECG Assessment", + "synonyms": [ + "RHYNOS", + "Rhythm Not Otherwise Specified" + ], + "reference": "/mdr/bc/biomedicalconcepts/C111307", + "properties": [ + { + "id": "BiomedicalConceptProperty_154", + "extensionAttributes": [], + "name": "EGORRES", + "label": "EGORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37201", + "standardCode": { + "id": "Code_44488", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_155", + "extensionAttributes": [], + "name": "EGPOS", + "label": "EGPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37202", + "standardCode": { + "id": "Code_44489", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_156", + "extensionAttributes": [], + "name": "EGMETHOD", + "label": "EGMETHOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37203", + "standardCode": { + "id": "Code_44490", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_157", + "extensionAttributes": [], + "name": "EGEVAL", + "label": "EGEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37204", + "standardCode": { + "id": "Code_44491", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_158", + "extensionAttributes": [], + "name": "EGDTC", + "label": "EGDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37205", + "standardCode": { + "id": "Code_44492", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24539", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28657", + "extensionAttributes": [], + "code": "C111307", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-17", + "decode": "Rhythm Not Otherwise Specified ECG Assessment", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_36", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_24", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/STSTWUW", + "instanceType": "ExtensionAttribute" + } + ], + "name": "ST Segment, T wave, and U wave ECG Assessment", + "label": "ST Segment, T wave, and U wave ECG Assessment", + "synonyms": [ + "STSTWUW", + "ST Segment, T wave, and U wave" + ], + "reference": "/mdr/bc/biomedicalconcepts/C111363", + "properties": [ + { + "id": "BiomedicalConceptProperty_159", + "extensionAttributes": [], + "name": "EGORRES", + "label": "EGORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37206", + "standardCode": { + "id": "Code_44493", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_160", + "extensionAttributes": [], + "name": "EGPOS", + "label": "EGPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37207", + "standardCode": { + "id": "Code_44494", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_161", + "extensionAttributes": [], + "name": "EGMETHOD", + "label": "EGMETHOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37208", + "standardCode": { + "id": "Code_44495", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_162", + "extensionAttributes": [], + "name": "EGEVAL", + "label": "EGEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37209", + "standardCode": { + "id": "Code_44496", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_163", + "extensionAttributes": [], + "name": "EGDTC", + "label": "EGDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37210", + "standardCode": { + "id": "Code_44497", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24540", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28658", + "extensionAttributes": [], + "code": "C111363", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-17", + "decode": "ST Segment, T wave, and U wave ECG Assessment", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_37", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_25", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/SNRARRY", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Sinus Node Rhythm and Arrhythmia ECG Assessment", + "label": "Sinus Node Rhythm and Arrhythmia ECG Assessment", + "synonyms": [ + "SNRARRY", + "Sinus Node Rhythms and Arrhythmias" + ], + "reference": "/mdr/bc/biomedicalconcepts/C111312", + "properties": [ + { + "id": "BiomedicalConceptProperty_164", + "extensionAttributes": [], + "name": "EGORRES", + "label": "EGORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37211", + "standardCode": { + "id": "Code_44498", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_165", + "extensionAttributes": [], + "name": "EGPOS", + "label": "EGPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37212", + "standardCode": { + "id": "Code_44499", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_166", + "extensionAttributes": [], + "name": "EGMETHOD", + "label": "EGMETHOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37213", + "standardCode": { + "id": "Code_44500", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_167", + "extensionAttributes": [], + "name": "EGEVAL", + "label": "EGEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2848", + "instanceType": "ResponseCode", + "name": "beats/min", + "label": "beats/min", + "isEnabled": true, + "code": { + "id": "Code_40772", + "extensionAttributes": [], + "code": "C49673", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "beats/min", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37214", + "standardCode": { + "id": "Code_44501", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_168", + "extensionAttributes": [], + "name": "EGDTC", + "label": "EGDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37215", + "standardCode": { + "id": "Code_44502", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24541", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28659", + "extensionAttributes": [], + "code": "C111312", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-17", + "decode": "Sinus Node Rhythm and Arrhythmia ECG Assessment", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_38", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_26", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/SPRARRY", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Supraventricular Arrhythmia ECG Assessment", + "label": "Supraventricular Arrhythmia ECG Assessment", + "synonyms": [ + "SPRARRY", + "Supraventricular Arrhythmias" + ], + "reference": "/mdr/bc/biomedicalconcepts/C111320", + "properties": [ + { + "id": "BiomedicalConceptProperty_169", + "extensionAttributes": [], + "name": "EGORRES", + "label": "EGORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37216", + "standardCode": { + "id": "Code_44503", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_170", + "extensionAttributes": [], + "name": "EGPOS", + "label": "EGPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37217", + "standardCode": { + "id": "Code_44504", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_171", + "extensionAttributes": [], + "name": "EGMETHOD", + "label": "EGMETHOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37218", + "standardCode": { + "id": "Code_44505", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_172", + "extensionAttributes": [], + "name": "EGEVAL", + "label": "EGEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37219", + "standardCode": { + "id": "Code_44506", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_173", + "extensionAttributes": [], + "name": "EGDTC", + "label": "EGDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [ + { + "id": "ResponseCode_2849", + "instanceType": "ResponseCode", + "name": "breaths/min", + "label": "breaths/min", + "isEnabled": true, + "code": { + "id": "Code_40779", + "extensionAttributes": [], + "code": "C49674", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "breaths/min", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37220", + "standardCode": { + "id": "Code_44507", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24542", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28660", + "extensionAttributes": [], + "code": "C111320", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-17", + "decode": "Supraventricular Arrhythmia ECG Assessment", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_39", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_27", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/SPRTARRY", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Supraventricular Tachyarrhythmia ECG Assessment", + "label": "Supraventricular Tachyarrhythmia ECG Assessment", + "synonyms": [ + "SPRTARRY", + "Supraventricular Tachyarrhythmias" + ], + "reference": "/mdr/bc/biomedicalconcepts/C111321", + "properties": [ + { + "id": "BiomedicalConceptProperty_174", + "extensionAttributes": [], + "name": "EGORRES", + "label": "EGORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37221", + "standardCode": { + "id": "Code_44508", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_175", + "extensionAttributes": [], + "name": "EGPOS", + "label": "EGPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37222", + "standardCode": { + "id": "Code_44509", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_176", + "extensionAttributes": [], + "name": "EGMETHOD", + "label": "EGMETHOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37223", + "standardCode": { + "id": "Code_44510", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_177", + "extensionAttributes": [], + "name": "EGEVAL", + "label": "EGEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37224", + "standardCode": { + "id": "Code_44511", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_178", + "extensionAttributes": [], + "name": "EGDTC", + "label": "EGDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37225", + "standardCode": { + "id": "Code_44512", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24543", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28661", + "extensionAttributes": [], + "code": "C111321", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-17", + "decode": "Supraventricular Tachyarrhythmia ECG Assessment", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_40", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_28", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/PRAG", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Aggregate PR Interval", + "label": "Aggregate PR Interval", + "synonyms": [ + "PR Interval Aggregate", + "PQ Interval Aggregate", + "PRAG", + "PQAG" + ], + "reference": "/mdr/bc/biomedicalconcepts/C117773", + "properties": [ + { + "id": "BiomedicalConceptProperty_179", + "extensionAttributes": [], + "name": "EGORRES", + "label": "EGORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37226", + "standardCode": { + "id": "Code_44513", + "extensionAttributes": [], + "code": "C25330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Duration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_180", + "extensionAttributes": [], + "name": "EGORRESU", + "label": "EGORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37227", + "standardCode": { + "id": "Code_44514", + "extensionAttributes": [], + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_181", + "extensionAttributes": [], + "name": "EGPOS", + "label": "EGPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37228", + "standardCode": { + "id": "Code_44515", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_182", + "extensionAttributes": [], + "name": "EGMETHOD", + "label": "EGMETHOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2853", + "instanceType": "ResponseCode", + "name": "X-RAY", + "label": "X-RAY", + "isEnabled": true, + "code": { + "id": "Code_40968", + "extensionAttributes": [], + "code": "C38101", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "X-RAY", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37229", + "standardCode": { + "id": "Code_44516", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_183", + "extensionAttributes": [], + "name": "EGEVAL", + "label": "EGEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37230", + "standardCode": { + "id": "Code_44517", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_184", + "extensionAttributes": [], + "name": "EGDTC", + "label": "EGDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37231", + "standardCode": { + "id": "Code_44518", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_185", + "extensionAttributes": [], + "name": "EGENDTC", + "label": "EGENDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37232", + "standardCode": { + "id": "Code_44519", + "extensionAttributes": [], + "code": "C82516", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation End Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24544", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28662", + "extensionAttributes": [], + "code": "C117773", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Aggregate PR Interval", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_41", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_29", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/QRSAG", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Aggregate QRS Duration", + "label": "Aggregate QRS Duration", + "synonyms": [ + "QRS Aggregate Duration", + "QRSAG" + ], + "reference": "/mdr/bc/biomedicalconcepts/C117779", + "properties": [ + { + "id": "BiomedicalConceptProperty_186", + "extensionAttributes": [], + "name": "EGORRES", + "label": "EGORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37233", + "standardCode": { + "id": "Code_44520", + "extensionAttributes": [], + "code": "C25330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Duration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_187", + "extensionAttributes": [], + "name": "EGORRESU", + "label": "EGORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37234", + "standardCode": { + "id": "Code_44521", + "extensionAttributes": [], + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_188", + "extensionAttributes": [], + "name": "EGPOS", + "label": "EGPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2854", + "instanceType": "ResponseCode", + "name": "RANDOMIZED", + "label": "RANDOMIZED", + "isEnabled": true, + "code": { + "id": "Code_40975", + "extensionAttributes": [], + "code": "C114209", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "RANDOMIZED", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37235", + "standardCode": { + "id": "Code_44522", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_189", + "extensionAttributes": [], + "name": "EGMETHOD", + "label": "EGMETHOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37236", + "standardCode": { + "id": "Code_44523", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_190", + "extensionAttributes": [], + "name": "EGEVAL", + "label": "EGEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37237", + "standardCode": { + "id": "Code_44524", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_191", + "extensionAttributes": [], + "name": "EGDTC", + "label": "EGDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37238", + "standardCode": { + "id": "Code_44525", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_192", + "extensionAttributes": [], + "name": "EGENDTC", + "label": "EGENDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37239", + "standardCode": { + "id": "Code_44526", + "extensionAttributes": [], + "code": "C82516", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation End Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24545", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28663", + "extensionAttributes": [], + "code": "C117779", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Aggregate QRS Duration", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_42", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_30", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/QTAG", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Aggregate QT Interval", + "label": "Aggregate QT Interval", + "synonyms": [ + "QT Interval Aggregate", + "QTAG" + ], + "reference": "/mdr/bc/biomedicalconcepts/C117783", + "properties": [ + { + "id": "BiomedicalConceptProperty_193", + "extensionAttributes": [], + "name": "EGORRES", + "label": "EGORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37240", + "standardCode": { + "id": "Code_44527", + "extensionAttributes": [], + "code": "C25330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Duration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_194", + "extensionAttributes": [], + "name": "EGORRESU", + "label": "EGORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37241", + "standardCode": { + "id": "Code_44528", + "extensionAttributes": [], + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_195", + "extensionAttributes": [], + "name": "EGPOS", + "label": "EGPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37242", + "standardCode": { + "id": "Code_44529", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_196", + "extensionAttributes": [], + "name": "EGMETHOD", + "label": "EGMETHOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37243", + "standardCode": { + "id": "Code_44530", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_197", + "extensionAttributes": [], + "name": "EGEVAL", + "label": "EGEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37244", + "standardCode": { + "id": "Code_44531", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_198", + "extensionAttributes": [], + "name": "EGDTC", + "label": "EGDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37245", + "standardCode": { + "id": "Code_44532", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_199", + "extensionAttributes": [], + "name": "EGENDTC", + "label": "EGENDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37246", + "standardCode": { + "id": "Code_44533", + "extensionAttributes": [], + "code": "C82516", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation End Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24546", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28664", + "extensionAttributes": [], + "code": "C117783", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Aggregate QT Interval", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_43", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_31", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/QTCBAG", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Aggregate QTCB Interval", + "label": "Aggregate QTCB Interval", + "synonyms": [ + "QTCB Interval Aggregate", + "QTCBAG" + ], + "reference": "/mdr/bc/biomedicalconcepts/C117784", + "properties": [ + { + "id": "BiomedicalConceptProperty_200", + "extensionAttributes": [], + "name": "EGORRES", + "label": "EGORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37247", + "standardCode": { + "id": "Code_44534", + "extensionAttributes": [], + "code": "C25330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Duration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_201", + "extensionAttributes": [], + "name": "EGORRESU", + "label": "EGORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37248", + "standardCode": { + "id": "Code_44535", + "extensionAttributes": [], + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_202", + "extensionAttributes": [], + "name": "EGPOS", + "label": "EGPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37249", + "standardCode": { + "id": "Code_44536", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_203", + "extensionAttributes": [], + "name": "EGMETHOD", + "label": "EGMETHOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37250", + "standardCode": { + "id": "Code_44537", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_204", + "extensionAttributes": [], + "name": "EGEVAL", + "label": "EGEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37251", + "standardCode": { + "id": "Code_44538", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_205", + "extensionAttributes": [], + "name": "EGDTC", + "label": "EGDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37252", + "standardCode": { + "id": "Code_44539", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_206", + "extensionAttributes": [], + "name": "EGENDTC", + "label": "EGENDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37253", + "standardCode": { + "id": "Code_44540", + "extensionAttributes": [], + "code": "C82516", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation End Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24547", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28665", + "extensionAttributes": [], + "code": "C117784", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Aggregate QTCB Interval", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_44", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_32", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/QTCFAG", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Aggregate QTCF Interval", + "label": "Aggregate QTCF Interval", + "synonyms": [ + "QTCF Interval Aggregate", + "QTCFAG" + ], + "reference": "/mdr/bc/biomedicalconcepts/C117786", + "properties": [ + { + "id": "BiomedicalConceptProperty_207", + "extensionAttributes": [], + "name": "EGORRES", + "label": "EGORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37254", + "standardCode": { + "id": "Code_44541", + "extensionAttributes": [], + "code": "C25330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Duration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_208", + "extensionAttributes": [], + "name": "EGORRESU", + "label": "EGORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37255", + "standardCode": { + "id": "Code_44542", + "extensionAttributes": [], + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_209", + "extensionAttributes": [], + "name": "EGPOS", + "label": "EGPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37256", + "standardCode": { + "id": "Code_44543", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_210", + "extensionAttributes": [], + "name": "EGMETHOD", + "label": "EGMETHOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37257", + "standardCode": { + "id": "Code_44544", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_211", + "extensionAttributes": [], + "name": "EGEVAL", + "label": "EGEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37258", + "standardCode": { + "id": "Code_44545", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_212", + "extensionAttributes": [], + "name": "EGDTC", + "label": "EGDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37259", + "standardCode": { + "id": "Code_44546", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_213", + "extensionAttributes": [], + "name": "EGENDTC", + "label": "EGENDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37260", + "standardCode": { + "id": "Code_44547", + "extensionAttributes": [], + "code": "C82516", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation End Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24548", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28666", + "extensionAttributes": [], + "code": "C117786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Aggregate QTCF Interval", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_45", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_33", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/RRAG", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Aggregate RR Interval", + "label": "Aggregate RR Interval", + "synonyms": [ + "RR Interval Aggregate", + "RRAG" + ], + "reference": "/mdr/bc/biomedicalconcepts/C117791", + "properties": [ + { + "id": "BiomedicalConceptProperty_214", + "extensionAttributes": [], + "name": "EGORRES", + "label": "EGORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37261", + "standardCode": { + "id": "Code_44548", + "extensionAttributes": [], + "code": "C25330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Duration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_215", + "extensionAttributes": [], + "name": "EGORRESU", + "label": "EGORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37262", + "standardCode": { + "id": "Code_44549", + "extensionAttributes": [], + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_216", + "extensionAttributes": [], + "name": "EGPOS", + "label": "EGPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37263", + "standardCode": { + "id": "Code_44550", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_217", + "extensionAttributes": [], + "name": "EGMETHOD", + "label": "EGMETHOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2457", + "instanceType": "ResponseCode", + "name": "beats/min", + "label": "beats/min", + "isEnabled": true, + "code": { + "id": "Code_32362", + "extensionAttributes": [], + "code": "C49673", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "beats/min", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37264", + "standardCode": { + "id": "Code_44551", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_218", + "extensionAttributes": [], + "name": "EGEVAL", + "label": "EGEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37265", + "standardCode": { + "id": "Code_44552", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_219", + "extensionAttributes": [], + "name": "EGDTC", + "label": "EGDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37266", + "standardCode": { + "id": "Code_44553", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_220", + "extensionAttributes": [], + "name": "EGENDTC", + "label": "EGENDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [ + { + "id": "ResponseCode_2657", + "instanceType": "ResponseCode", + "name": "breaths/min", + "label": "breaths/min", + "isEnabled": true, + "code": { + "id": "Code_37230", + "extensionAttributes": [], + "code": "C49674", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "breaths/min", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37267", + "standardCode": { + "id": "Code_44554", + "extensionAttributes": [], + "code": "C82516", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation End Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24549", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28667", + "extensionAttributes": [], + "code": "C117791", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Aggregate RR Interval", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_46", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_34", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/EGHRMN", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Mean Heart Rate by Electrocardiogram", + "label": "Mean Heart Rate by Electrocardiogram", + "synonyms": [ + "ECG Mean Heart Rate", + "EKG Mean Heart Rate", + "EGHRMN" + ], + "reference": "/mdr/bc/biomedicalconcepts/C119259", + "properties": [ + { + "id": "BiomedicalConceptProperty_221", + "extensionAttributes": [], + "name": "EGORRES", + "label": "EGORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37268", + "standardCode": { + "id": "Code_44555", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_222", + "extensionAttributes": [], + "name": "EGORRESU", + "label": "EGORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3028", + "instanceType": "ResponseCode", + "name": "beats/min", + "label": "beats/min", + "isEnabled": true, + "code": { + "id": "Code_42741", + "extensionAttributes": [], + "code": "C49673", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "beats/min", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37269", + "standardCode": { + "id": "Code_44556", + "extensionAttributes": [], + "code": "C73688", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Count per Minute", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_223", + "extensionAttributes": [], + "name": "EGPOS", + "label": "EGPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37270", + "standardCode": { + "id": "Code_44557", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_224", + "extensionAttributes": [], + "name": "EGMETHOD", + "label": "EGMETHOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37271", + "standardCode": { + "id": "Code_44558", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_225", + "extensionAttributes": [], + "name": "EGEVAL", + "label": "EGEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37272", + "standardCode": { + "id": "Code_44559", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_226", + "extensionAttributes": [], + "name": "EGDTC", + "label": "EGDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [ + { + "id": "ResponseCode_2855", + "instanceType": "ResponseCode", + "name": "breaths/min", + "label": "breaths/min", + "isEnabled": true, + "code": { + "id": "Code_41016", + "extensionAttributes": [], + "code": "C49674", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "breaths/min", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37273", + "standardCode": { + "id": "Code_44560", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24550", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28668", + "extensionAttributes": [], + "code": "C119259", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Mean Heart Rate by Electrocardiogram", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_47", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_35", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/QRS_AXIS", + "instanceType": "ExtensionAttribute" + } + ], + "name": "QRS Axis", + "label": "QRS Axis", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/C118165", + "properties": [ + { + "id": "BiomedicalConceptProperty_227", + "extensionAttributes": [], + "name": "EGORRES", + "label": "EGORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37274", + "standardCode": { + "id": "Code_44561", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_228", + "extensionAttributes": [], + "name": "EGORRESU", + "label": "EGORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2777", + "instanceType": "ResponseCode", + "name": "deg", + "label": "deg", + "isEnabled": true, + "code": { + "id": "Code_38408", + "extensionAttributes": [], + "code": "C68667", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "deg", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37275", + "standardCode": { + "id": "Code_44562", + "extensionAttributes": [], + "code": "C68667", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Degree Unit of Plane Angle", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_229", + "extensionAttributes": [], + "name": "EGPOS", + "label": "EGPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37276", + "standardCode": { + "id": "Code_44563", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_230", + "extensionAttributes": [], + "name": "EGMETHOD", + "label": "EGMETHOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37277", + "standardCode": { + "id": "Code_44564", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_231", + "extensionAttributes": [], + "name": "EGEVAL", + "label": "EGEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37278", + "standardCode": { + "id": "Code_44565", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_232", + "extensionAttributes": [], + "name": "EGDTC", + "label": "EGDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37279", + "standardCode": { + "id": "Code_44566", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24551", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28669", + "extensionAttributes": [], + "code": "C118165", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "QRS Axis", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_48", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_36", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/QTCUNSAG", + "instanceType": "ExtensionAttribute" + } + ], + "name": "QTc Correction Method Unspecified, Aggregate", + "label": "QTc Correction Method Unspecified, Aggregate", + "synonyms": [ + "QTCUNSAG" + ], + "reference": "/mdr/bc/biomedicalconcepts/C174285", + "properties": [ + { + "id": "BiomedicalConceptProperty_233", + "extensionAttributes": [], + "name": "EGORRES", + "label": "EGORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37280", + "standardCode": { + "id": "Code_44567", + "extensionAttributes": [], + "code": "C25330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Duration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_234", + "extensionAttributes": [], + "name": "EGORRESU", + "label": "EGORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37281", + "standardCode": { + "id": "Code_44568", + "extensionAttributes": [], + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_235", + "extensionAttributes": [], + "name": "EGPOS", + "label": "EGPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37282", + "standardCode": { + "id": "Code_44569", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_236", + "extensionAttributes": [], + "name": "EGMETHOD", + "label": "EGMETHOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37283", + "standardCode": { + "id": "Code_44570", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_237", + "extensionAttributes": [], + "name": "EGEVAL", + "label": "EGEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37284", + "standardCode": { + "id": "Code_44571", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_238", + "extensionAttributes": [], + "name": "EGDTC", + "label": "EGDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37285", + "standardCode": { + "id": "Code_44572", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_239", + "extensionAttributes": [], + "name": "EGENDTC", + "label": "EGENDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37286", + "standardCode": { + "id": "Code_44573", + "extensionAttributes": [], + "code": "C82516", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation End Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24552", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28670", + "extensionAttributes": [], + "code": "C174285", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "QTc Correction Method Unspecified, Aggregate", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_49", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_37", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/VTARRY", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Ventricular Arrhythmia ECG Assessment", + "label": "Ventricular Arrhythmia ECG Assessment", + "synonyms": [ + "VTARRY", + "Ventricular Arrhythmias" + ], + "reference": "/mdr/bc/biomedicalconcepts/C111330", + "properties": [ + { + "id": "BiomedicalConceptProperty_240", + "extensionAttributes": [], + "name": "EGORRES", + "label": "EGORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37287", + "standardCode": { + "id": "Code_44574", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_241", + "extensionAttributes": [], + "name": "EGPOS", + "label": "EGPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37288", + "standardCode": { + "id": "Code_44575", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_242", + "extensionAttributes": [], + "name": "EGMETHOD", + "label": "EGMETHOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37289", + "standardCode": { + "id": "Code_44576", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_243", + "extensionAttributes": [], + "name": "EGEVAL", + "label": "EGEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37290", + "standardCode": { + "id": "Code_44577", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_244", + "extensionAttributes": [], + "name": "EGDTC", + "label": "EGDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37291", + "standardCode": { + "id": "Code_44578", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24553", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28671", + "extensionAttributes": [], + "code": "C111330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-17", + "decode": "Ventricular Arrhythmia ECG Assessment", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_50", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_38", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/VTTARRY", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Ventricular Tachyarrhythmia ECG Assessment", + "label": "Ventricular Tachyarrhythmia ECG Assessment", + "synonyms": [ + "VTTARRY", + "Ventricular Tachyarrhythmias" + ], + "reference": "/mdr/bc/biomedicalconcepts/C111331", + "properties": [ + { + "id": "BiomedicalConceptProperty_245", + "extensionAttributes": [], + "name": "EGORRES", + "label": "EGORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37292", + "standardCode": { + "id": "Code_44579", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_246", + "extensionAttributes": [], + "name": "EGPOS", + "label": "EGPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37293", + "standardCode": { + "id": "Code_44580", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_247", + "extensionAttributes": [], + "name": "EGMETHOD", + "label": "EGMETHOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37294", + "standardCode": { + "id": "Code_44581", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_248", + "extensionAttributes": [], + "name": "EGEVAL", + "label": "EGEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37295", + "standardCode": { + "id": "Code_44582", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_249", + "extensionAttributes": [], + "name": "EGDTC", + "label": "EGDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37296", + "standardCode": { + "id": "Code_44583", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24554", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28672", + "extensionAttributes": [], + "code": "C111331", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-17", + "decode": "Ventricular Tachyarrhythmia ECG Assessment", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_51", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_39", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/CTSCANCHEST", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Computed Tomography", + "label": "Computed Tomography", + "synonyms": [ + "CAT Scan", + "Computed Axial Tomography", + "Computed Tomography", + "Computerized Tomography", + "CT" + ], + "reference": "/mdr/bc/biomedicalconcepts/C17204", + "properties": [ + { + "id": "BiomedicalConceptProperty_250", + "extensionAttributes": [], + "name": "PRTRT", + "label": "PRTRT", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37297", + "standardCode": { + "id": "Code_44584", + "extensionAttributes": [], + "code": "C117511", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Reported Name of Procedure", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_251", + "extensionAttributes": [], + "name": "PRDECOD", + "label": "PRDECOD", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3029", + "instanceType": "ResponseCode", + "name": "CT SCAN", + "label": "CT SCAN", + "isEnabled": true, + "code": { + "id": "Code_42771", + "extensionAttributes": [], + "code": "C17204", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "CT SCAN", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37298", + "standardCode": { + "id": "Code_44585", + "extensionAttributes": [], + "code": "C117512", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Standardized Name of Procedure", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_252", + "extensionAttributes": [], + "name": "PRPRESP", + "label": "PRPRESP", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37299", + "standardCode": { + "id": "Code_44586", + "extensionAttributes": [], + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Prespecified Event or Intervention Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_253", + "extensionAttributes": [], + "name": "PROCCUR", + "label": "PROCCUR", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37300", + "standardCode": { + "id": "Code_44587", + "extensionAttributes": [], + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Occurrence Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_254", + "extensionAttributes": [], + "name": "PRLOC", + "label": "PRLOC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3030", + "instanceType": "ResponseCode", + "name": "CHEST", + "label": "CHEST", + "isEnabled": true, + "code": { + "id": "Code_42775", + "extensionAttributes": [], + "code": "C25389", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "CHEST", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37301", + "standardCode": { + "id": "Code_44588", + "extensionAttributes": [], + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Anatomic Site", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_255", + "extensionAttributes": [], + "name": "PRSTDTC", + "label": "PRSTDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37302", + "standardCode": { + "id": "Code_44589", + "extensionAttributes": [], + "code": "C117529", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Start Date and Time of Procedure", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_256", + "extensionAttributes": [], + "name": "PRENDTC", + "label": "PRENDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37303", + "standardCode": { + "id": "Code_44590", + "extensionAttributes": [], + "code": "C117530", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "End Date and Time of Procedure", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_28017", + "extensionAttributes": [], + "standardCode": { + "id": "Code_32135", + "extensionAttributes": [], + "code": "C17204", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "CT SCAN", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_52", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_40", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/MRIBRAIN", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Magnetic Resonance Imaging", + "label": "Magnetic Resonance Imaging", + "synonyms": [ + "Magnetic Resonance", + "MRI", + "MRI Scan", + "NMR", + "NMR Imaging" + ], + "reference": "/mdr/bc/biomedicalconcepts/C16809", + "properties": [ + { + "id": "BiomedicalConceptProperty_257", + "extensionAttributes": [], + "name": "PRTRT", + "label": "PRTRT", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37304", + "standardCode": { + "id": "Code_44591", + "extensionAttributes": [], + "code": "C117511", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Reported Name of Procedure", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_258", + "extensionAttributes": [], + "name": "PRDECOD", + "label": "PRDECOD", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3031", + "instanceType": "ResponseCode", + "name": "MRI", + "label": "MRI", + "isEnabled": true, + "code": { + "id": "Code_43034", + "extensionAttributes": [], + "code": "C16809", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "MRI", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37305", + "standardCode": { + "id": "Code_44592", + "extensionAttributes": [], + "code": "C117512", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Standardized Name of Procedure", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_259", + "extensionAttributes": [], + "name": "PRPRESP", + "label": "PRPRESP", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37306", + "standardCode": { + "id": "Code_44593", + "extensionAttributes": [], + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Prespecified Event or Intervention Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_260", + "extensionAttributes": [], + "name": "PROCCUR", + "label": "PROCCUR", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37307", + "standardCode": { + "id": "Code_44594", + "extensionAttributes": [], + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Occurrence Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_261", + "extensionAttributes": [], + "name": "PRLOC", + "label": "PRLOC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3032", + "instanceType": "ResponseCode", + "name": "BRAIN", + "label": "BRAIN", + "isEnabled": true, + "code": { + "id": "Code_43038", + "extensionAttributes": [], + "code": "C12439", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "BRAIN", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37308", + "standardCode": { + "id": "Code_44595", + "extensionAttributes": [], + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Anatomic Site", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_262", + "extensionAttributes": [], + "name": "PRSTDTC", + "label": "PRSTDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37309", + "standardCode": { + "id": "Code_44596", + "extensionAttributes": [], + "code": "C117529", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Start Date and Time of Procedure", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_263", + "extensionAttributes": [], + "name": "PRENDTC", + "label": "PRENDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37310", + "standardCode": { + "id": "Code_44597", + "extensionAttributes": [], + "code": "C117530", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "End Date and Time of Procedure", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_15783", + "extensionAttributes": [], + "standardCode": { + "id": "Code_16598", + "extensionAttributes": [], + "code": "C16809", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "MRI", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_54", + "extensionAttributes": [], + "name": "Concomitant Medication Yes No Indicator", + "label": "Concomitant Medication Yes No Indicator", + "synonyms": [ + "CMYN" + ], + "reference": "/mdr/bc/biomedicalconcepts/C83056", + "properties": [ + { + "id": "BiomedicalConceptProperty_264", + "extensionAttributes": [], + "name": "Concomitant Medication Yes No Indicator", + "label": "Concomitant Medication Yes No Indicator", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37311", + "standardCode": { + "id": "Code_44598", + "extensionAttributes": [], + "code": "C83056", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Concomitant Medication Yes No Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_265", + "extensionAttributes": [], + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37312", + "standardCode": { + "id": "Code_44599", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24555", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28673", + "extensionAttributes": [], + "code": "C83056", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Concomitant Medication Yes No Indicator", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_55", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_41", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/CMFREE", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Concomitant Therapy", + "label": "Concomitant Therapy", + "synonyms": [ + "Concomitant Medication" + ], + "reference": "/mdr/bc/biomedicalconcepts/C53630", + "properties": [ + { + "id": "BiomedicalConceptProperty_266", + "extensionAttributes": [], + "name": "CMTRT", + "label": "CMTRT", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37313", + "standardCode": { + "id": "Code_44600", + "extensionAttributes": [], + "code": "C70902", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Agent", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_267", + "extensionAttributes": [], + "name": "CMDECOD", + "label": "CMDECOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37314", + "standardCode": { + "id": "Code_44601", + "extensionAttributes": [], + "code": "C83345", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dictionary Derived Term", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_268", + "extensionAttributes": [], + "name": "CMCLAS", + "label": "CMCLAS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37315", + "standardCode": { + "id": "Code_44602", + "extensionAttributes": [], + "code": "C83219", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Class", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_269", + "extensionAttributes": [], + "name": "CMINDC", + "label": "CMINDC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37316", + "standardCode": { + "id": "Code_44603", + "extensionAttributes": [], + "code": "C83085", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Use Indication", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_270", + "extensionAttributes": [], + "name": "CMDOSE", + "label": "CMDOSE", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37317", + "standardCode": { + "id": "Code_44604", + "extensionAttributes": [], + "code": "C83221", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_271", + "extensionAttributes": [], + "name": "CMDOSTXT", + "label": "CMDOSTXT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37318", + "standardCode": { + "id": "Code_44605", + "extensionAttributes": [], + "code": "C83221", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_272", + "extensionAttributes": [], + "name": "CMDOSU", + "label": "CMDOSU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37319", + "standardCode": { + "id": "Code_44606", + "extensionAttributes": [], + "code": "C83034", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose Unit", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_273", + "extensionAttributes": [], + "name": "CMDOSFRM", + "label": "CMDOSFRM", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37320", + "standardCode": { + "id": "Code_44607", + "extensionAttributes": [], + "code": "C83110", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose Form", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_274", + "extensionAttributes": [], + "name": "CMDOSFRQ", + "label": "CMDOSFRQ", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37321", + "standardCode": { + "id": "Code_44608", + "extensionAttributes": [], + "code": "C83042", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose Frequency", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_275", + "extensionAttributes": [], + "name": "CMROUTE", + "label": "CMROUTE", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37322", + "standardCode": { + "id": "Code_44609", + "extensionAttributes": [], + "code": "C83120", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Route of Administration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_276", + "extensionAttributes": [], + "name": "CMSTDTC", + "label": "CMSTDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37323", + "standardCode": { + "id": "Code_44610", + "extensionAttributes": [], + "code": "C83235", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Use Start Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_277", + "extensionAttributes": [], + "name": "CMENDTC", + "label": "CMENDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37324", + "standardCode": { + "id": "Code_44611", + "extensionAttributes": [], + "code": "C83225", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Use End Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_278", + "extensionAttributes": [], + "name": "CMSTRF", + "label": "CMSTRF", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37325", + "standardCode": { + "id": "Code_44612", + "extensionAttributes": [], + "code": "C82559", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Period", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_279", + "extensionAttributes": [], + "name": "CMSTRTPT", + "label": "CMSTRTPT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37326", + "standardCode": { + "id": "Code_44613", + "extensionAttributes": [], + "code": "C82560", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Time Point", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_280", + "extensionAttributes": [], + "name": "CMSTTPT", + "label": "CMSTTPT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37327", + "standardCode": { + "id": "Code_44614", + "extensionAttributes": [], + "code": "C82575", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference Start Time Point", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_281", + "extensionAttributes": [], + "name": "CMENRF", + "label": "CMENRF", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37328", + "standardCode": { + "id": "Code_44615", + "extensionAttributes": [], + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_282", + "extensionAttributes": [], + "name": "CMENRTPT", + "label": "CMENRTPT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37329", + "standardCode": { + "id": "Code_44616", + "extensionAttributes": [], + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_283", + "extensionAttributes": [], + "name": "CMENTPT", + "label": "CMENTPT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37330", + "standardCode": { + "id": "Code_44617", + "extensionAttributes": [], + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24556", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28674", + "extensionAttributes": [], + "code": "C53630", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Therapy", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_56", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_42", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/HGBBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Hemoglobin Measurement", + "label": "Hemoglobin Measurement", + "synonyms": [ + "Hemoglobin", + "HGB" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64848", + "properties": [ + { + "id": "BiomedicalConceptProperty_284", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37331", + "standardCode": { + "id": "Code_44618", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_285", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37332", + "standardCode": { + "id": "Code_44619", + "extensionAttributes": [], + "code": "C64571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Mass Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_286", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3033", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_43064", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37333", + "standardCode": { + "id": "Code_44620", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_287", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37334", + "standardCode": { + "id": "Code_44621", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_288", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37335", + "standardCode": { + "id": "Code_44622", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24557", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28675", + "extensionAttributes": [], + "code": "C64848", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Hemoglobin Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_57", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_43", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/HCTBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Hematocrit Measurement", + "label": "Hematocrit Measurement", + "synonyms": [ + "Hematocrit", + "Packed Cell Volume", + "PCV", + "Erythrocyte Volume Fraction", + "EVF" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64796", + "properties": [ + { + "id": "BiomedicalConceptProperty_289", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37336", + "standardCode": { + "id": "Code_44623", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_290", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37337", + "standardCode": { + "id": "Code_44624", + "extensionAttributes": [], + "code": "C69174", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Volume Fraction", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_291", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2783", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_38477", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37338", + "standardCode": { + "id": "Code_44625", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_292", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37339", + "standardCode": { + "id": "Code_44626", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_293", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37340", + "standardCode": { + "id": "Code_44627", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24558", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28676", + "extensionAttributes": [], + "code": "C64796", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Hematocrit Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_58", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_44", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/RBCBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Erythrocyte Count", + "label": "Erythrocyte Count", + "synonyms": [ + "RBC", + "Red Blood Cells" + ], + "reference": "/mdr/bc/biomedicalconcepts/C51946", + "properties": [ + { + "id": "BiomedicalConceptProperty_294", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37341", + "standardCode": { + "id": "Code_44628", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_295", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37342", + "standardCode": { + "id": "Code_44629", + "extensionAttributes": [], + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_296", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3034", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_43075", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37343", + "standardCode": { + "id": "Code_44630", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_297", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37344", + "standardCode": { + "id": "Code_44631", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_298", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37345", + "standardCode": { + "id": "Code_44632", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24559", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28677", + "extensionAttributes": [], + "code": "C51946", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Erythrocyte Count", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_59", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_45", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/MCH", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Erythrocyte Mean Corpuscular Hemoglobin", + "label": "Erythrocyte Mean Corpuscular Hemoglobin", + "synonyms": [ + "RBC Mean Corpuscular Hemoglobin", + "MCH" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64797", + "properties": [ + { + "id": "BiomedicalConceptProperty_299", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37346", + "standardCode": { + "id": "Code_44633", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_300", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37347", + "standardCode": { + "id": "Code_44634", + "extensionAttributes": [], + "code": "C25709", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Measure", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_301", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2785", + "instanceType": "ResponseCode", + "name": "ERYTHROCYTES", + "label": "ERYTHROCYTES", + "isEnabled": true, + "code": { + "id": "Code_38489", + "extensionAttributes": [], + "code": "C12521", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "ERYTHROCYTES", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37348", + "standardCode": { + "id": "Code_44635", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_302", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37349", + "standardCode": { + "id": "Code_44636", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_303", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37350", + "standardCode": { + "id": "Code_44637", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24560", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28678", + "extensionAttributes": [], + "code": "C64797", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Erythrocyte Mean Corpuscular Hemoglobin", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_60", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_46", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/MCV", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Erythrocyte Mean Corpuscular Volume", + "label": "Erythrocyte Mean Corpuscular Volume", + "synonyms": [ + "RBC Mean Corpuscular Volume", + "MCV" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64799", + "properties": [ + { + "id": "BiomedicalConceptProperty_304", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37351", + "standardCode": { + "id": "Code_44638", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_305", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3035", + "instanceType": "ResponseCode", + "name": "fL", + "label": "fL", + "isEnabled": true, + "code": { + "id": "Code_43085", + "extensionAttributes": [], + "code": "C64780", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "fL", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37352", + "standardCode": { + "id": "Code_44639", + "extensionAttributes": [], + "code": "C44279", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Volume", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_306", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3036", + "instanceType": "ResponseCode", + "name": "ERYTHROCYTES", + "label": "ERYTHROCYTES", + "isEnabled": true, + "code": { + "id": "Code_43087", + "extensionAttributes": [], + "code": "C12521", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "ERYTHROCYTES", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37353", + "standardCode": { + "id": "Code_44640", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_307", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37354", + "standardCode": { + "id": "Code_44641", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_308", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37355", + "standardCode": { + "id": "Code_44642", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24561", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28679", + "extensionAttributes": [], + "code": "C64799", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Erythrocyte Mean Corpuscular Volume", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_61", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_47", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/WBCBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Leukocyte Count", + "label": "Leukocyte Count", + "synonyms": [ + "WBC", + "White Blood Cells" + ], + "reference": "/mdr/bc/biomedicalconcepts/C51948", + "properties": [ + { + "id": "BiomedicalConceptProperty_309", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37356", + "standardCode": { + "id": "Code_44643", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_310", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37357", + "standardCode": { + "id": "Code_44644", + "extensionAttributes": [], + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_311", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2583", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_33937", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37358", + "standardCode": { + "id": "Code_44645", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_312", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37359", + "standardCode": { + "id": "Code_44646", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_313", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37360", + "standardCode": { + "id": "Code_44647", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24562", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28680", + "extensionAttributes": [], + "code": "C51948", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Leukocyte Count", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_62", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_48", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/NEUTSGBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Segmented Neutrophil Count", + "label": "Segmented Neutrophil Count", + "synonyms": [ + "Segmented Neutrophils", + "NEUTSG" + ], + "reference": "/mdr/bc/biomedicalconcepts/C81997", + "properties": [ + { + "id": "BiomedicalConceptProperty_314", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37361", + "standardCode": { + "id": "Code_44648", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_315", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3037", + "instanceType": "ResponseCode", + "name": "10^9/L", + "label": "10^9/L", + "isEnabled": true, + "code": { + "id": "Code_43097", + "extensionAttributes": [], + "code": "C67255", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "10^9/L", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37362", + "standardCode": { + "id": "Code_44649", + "extensionAttributes": [], + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_316", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3038", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_43099", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37363", + "standardCode": { + "id": "Code_44650", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_317", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37364", + "standardCode": { + "id": "Code_44651", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_318", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37365", + "standardCode": { + "id": "Code_44652", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24563", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28681", + "extensionAttributes": [], + "code": "C81997", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Segmented Neutrophil Count", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_63", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_49", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/NEUTBBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Neutrophil Band Form Count", + "label": "Neutrophil Band Form Count", + "synonyms": [ + "Neutrophil Bands", + "Bands", + "NEUTB" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64830", + "properties": [ + { + "id": "BiomedicalConceptProperty_319", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37366", + "standardCode": { + "id": "Code_44653", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_320", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2789", + "instanceType": "ResponseCode", + "name": "10^6/L", + "label": "10^6/L", + "isEnabled": true, + "code": { + "id": "Code_38512", + "extensionAttributes": [], + "code": "C67452", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "10^6/L", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37367", + "standardCode": { + "id": "Code_44654", + "extensionAttributes": [], + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_321", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2790", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_38514", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37368", + "standardCode": { + "id": "Code_44655", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_322", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37369", + "standardCode": { + "id": "Code_44656", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_323", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37370", + "standardCode": { + "id": "Code_44657", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24564", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28682", + "extensionAttributes": [], + "code": "C64830", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Neutrophil Band Form Count", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_64", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_50", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/NEUTBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Absolute Neutrophil Count", + "label": "Absolute Neutrophil Count", + "synonyms": [ + "Neutrophils", + "Total Neutrophil Count", + "NEUT" + ], + "reference": "/mdr/bc/biomedicalconcepts/C63321", + "properties": [ + { + "id": "BiomedicalConceptProperty_324", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37371", + "standardCode": { + "id": "Code_44658", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_325", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3039", + "instanceType": "ResponseCode", + "name": "10^9/L", + "label": "10^9/L", + "isEnabled": true, + "code": { + "id": "Code_43109", + "extensionAttributes": [], + "code": "C67255", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "10^9/L", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37372", + "standardCode": { + "id": "Code_44659", + "extensionAttributes": [], + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_326", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3040", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_43111", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37373", + "standardCode": { + "id": "Code_44660", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_327", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37374", + "standardCode": { + "id": "Code_44661", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_328", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37375", + "standardCode": { + "id": "Code_44662", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24565", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28683", + "extensionAttributes": [], + "code": "C63321", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Absolute Neutrophil Count", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_65", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_51", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/MONOBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Monocyte Count", + "label": "Monocyte Count", + "synonyms": [ + "Monocytes" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64823", + "properties": [ + { + "id": "BiomedicalConceptProperty_329", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37376", + "standardCode": { + "id": "Code_44663", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_330", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37377", + "standardCode": { + "id": "Code_44664", + "extensionAttributes": [], + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_331", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2791", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_38525", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37378", + "standardCode": { + "id": "Code_44665", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_332", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37379", + "standardCode": { + "id": "Code_44666", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_333", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37380", + "standardCode": { + "id": "Code_44667", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24566", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28684", + "extensionAttributes": [], + "code": "C64823", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Monocyte Count", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_66", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_52", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/EOSBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Eosinophil Count", + "label": "Eosinophil Count", + "synonyms": [ + "Eosinophils" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64550", + "properties": [ + { + "id": "BiomedicalConceptProperty_334", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37381", + "standardCode": { + "id": "Code_44668", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_335", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37382", + "standardCode": { + "id": "Code_44669", + "extensionAttributes": [], + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_336", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3041", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_43122", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37383", + "standardCode": { + "id": "Code_44670", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_337", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37384", + "standardCode": { + "id": "Code_44671", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_338", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37385", + "standardCode": { + "id": "Code_44672", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24567", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28685", + "extensionAttributes": [], + "code": "C64550", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Eosinophil Count", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_67", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_53", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/BASOBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Absolute Basophil Count", + "label": "Absolute Basophil Count", + "synonyms": [ + "Basophils", + "Total Basophil Count" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64470", + "properties": [ + { + "id": "BiomedicalConceptProperty_339", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37386", + "standardCode": { + "id": "Code_44673", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_340", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37387", + "standardCode": { + "id": "Code_44674", + "extensionAttributes": [], + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_341", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2592", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_33976", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37388", + "standardCode": { + "id": "Code_44675", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_342", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37389", + "standardCode": { + "id": "Code_44676", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_343", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37390", + "standardCode": { + "id": "Code_44677", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_3354", + "extensionAttributes": [], + "standardCode": { + "id": "Code_3564", + "extensionAttributes": [], + "code": "C64470", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Absolute Basophil Count", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_68", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_54", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/PLATBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Platelet Count", + "label": "Platelet Count", + "synonyms": [ + "Thrombocytes", + "Platelets", + "Anucleated Thrombocytes" + ], + "reference": "/mdr/bc/biomedicalconcepts/C51951", + "properties": [ + { + "id": "BiomedicalConceptProperty_344", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37391", + "standardCode": { + "id": "Code_44678", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_345", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37392", + "standardCode": { + "id": "Code_44679", + "extensionAttributes": [], + "code": "C67391", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_346", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2793", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_38542", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37393", + "standardCode": { + "id": "Code_44680", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_347", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37394", + "standardCode": { + "id": "Code_44681", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_348", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37395", + "standardCode": { + "id": "Code_44682", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24568", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28686", + "extensionAttributes": [], + "code": "C51951", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Platelet Count", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_69", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_55", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/MICROCYBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Microcyte Count", + "label": "Microcyte Count", + "synonyms": [ + "Microcytes", + "MICROCY" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64822", + "properties": [ + { + "id": "BiomedicalConceptProperty_349", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37396", + "standardCode": { + "id": "Code_44683", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_350", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3042", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_43137", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37397", + "standardCode": { + "id": "Code_44684", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_351", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37398", + "standardCode": { + "id": "Code_44685", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_352", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37399", + "standardCode": { + "id": "Code_44686", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24569", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28687", + "extensionAttributes": [], + "code": "C64822", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Microcyte Count", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_70", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_56", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/MACROCYBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Macrocyte Count", + "label": "Macrocyte Count", + "synonyms": [ + "Macrocytes", + "MACROCY" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64821", + "properties": [ + { + "id": "BiomedicalConceptProperty_353", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37400", + "standardCode": { + "id": "Code_44687", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_354", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3043", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_43142", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37401", + "standardCode": { + "id": "Code_44688", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_355", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37402", + "standardCode": { + "id": "Code_44689", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_356", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37403", + "standardCode": { + "id": "Code_44690", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24570", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28688", + "extensionAttributes": [], + "code": "C64821", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Macrocyte Count", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_71", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_57", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/ANISOBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Anisocyte Measurement", + "label": "Anisocyte Measurement", + "synonyms": [ + "Anisocytes", + "Anisocytosis", + "ANISO" + ], + "reference": "/mdr/bc/biomedicalconcepts/C74797", + "properties": [ + { + "id": "BiomedicalConceptProperty_357", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37404", + "standardCode": { + "id": "Code_44691", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_358", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3044", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_43147", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37405", + "standardCode": { + "id": "Code_44692", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_359", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37406", + "standardCode": { + "id": "Code_44693", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_360", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37407", + "standardCode": { + "id": "Code_44694", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24571", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28689", + "extensionAttributes": [], + "code": "C74797", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Anisocyte Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_72", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_58", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/POIKILOBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Poikilocyte Measurement", + "label": "Poikilocyte Measurement", + "synonyms": [ + "POIKILO", + "Poikilocytes" + ], + "reference": "/mdr/bc/biomedicalconcepts/C79602", + "properties": [ + { + "id": "BiomedicalConceptProperty_361", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37408", + "standardCode": { + "id": "Code_44695", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_362", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2796", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_38561", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37409", + "standardCode": { + "id": "Code_44696", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_363", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37410", + "standardCode": { + "id": "Code_44697", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_364", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37411", + "standardCode": { + "id": "Code_44698", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24572", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28690", + "extensionAttributes": [], + "code": "C79602", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Poikilocyte Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_73", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_59", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/POLYCHRBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Polychromasia", + "label": "Polychromasia", + "synonyms": [ + "POLYCHR" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64803", + "properties": [ + { + "id": "BiomedicalConceptProperty_365", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37412", + "standardCode": { + "id": "Code_44699", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_366", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3045", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_43156", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37413", + "standardCode": { + "id": "Code_44700", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_367", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37414", + "standardCode": { + "id": "Code_44701", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_368", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37415", + "standardCode": { + "id": "Code_44702", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24573", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28691", + "extensionAttributes": [], + "code": "C64803", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Polychromasia", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_74", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_60", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/ALTSERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Alanine Aminotransferase Measurement", + "label": "Alanine Aminotransferase Measurement", + "synonyms": [ + "ALT", + "SGPT" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64433", + "properties": [ + { + "id": "BiomedicalConceptProperty_369", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37416", + "standardCode": { + "id": "Code_44703", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_370", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37417", + "standardCode": { + "id": "Code_44704", + "extensionAttributes": [], + "code": "C67365", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_371", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2797", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_38571", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37418", + "standardCode": { + "id": "Code_44705", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_372", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37419", + "standardCode": { + "id": "Code_44706", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_373", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37420", + "standardCode": { + "id": "Code_44707", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24574", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28692", + "extensionAttributes": [], + "code": "C64433", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Alanine Aminotransferase Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_75", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_61", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/ALBSERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Albumin Measurement", + "label": "Albumin Measurement", + "synonyms": [ + "Albumin" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64431", + "properties": [ + { + "id": "BiomedicalConceptProperty_374", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37421", + "standardCode": { + "id": "Code_44708", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_375", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37422", + "standardCode": { + "id": "Code_44709", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_376", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2798", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_38577", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37423", + "standardCode": { + "id": "Code_44710", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_377", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37424", + "standardCode": { + "id": "Code_44711", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_378", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37425", + "standardCode": { + "id": "Code_44712", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24575", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28693", + "extensionAttributes": [], + "code": "C64431", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Albumin Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_76", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_62", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/ALPSERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Alkaline Phosphatase Measurement", + "label": "Alkaline Phosphatase Measurement", + "synonyms": [ + "Alkaline Phosphatase" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64432", + "properties": [ + { + "id": "BiomedicalConceptProperty_379", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37426", + "standardCode": { + "id": "Code_44713", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_380", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37427", + "standardCode": { + "id": "Code_44714", + "extensionAttributes": [], + "code": "C67365", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_381", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3046", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_43172", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37428", + "standardCode": { + "id": "Code_44715", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_382", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37429", + "standardCode": { + "id": "Code_44716", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_383", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37430", + "standardCode": { + "id": "Code_44717", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24576", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28694", + "extensionAttributes": [], + "code": "C64432", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Alkaline Phosphatase Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_77", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_63", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/ASTSERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Aspartate Aminotransferase Measurement", + "label": "Aspartate Aminotransferase Measurement", + "synonyms": [ + "AST", + "SGOT" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64467", + "properties": [ + { + "id": "BiomedicalConceptProperty_384", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37431", + "standardCode": { + "id": "Code_44718", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_385", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37432", + "standardCode": { + "id": "Code_44719", + "extensionAttributes": [], + "code": "C67365", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_386", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3047", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_43178", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37433", + "standardCode": { + "id": "Code_44720", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_387", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37434", + "standardCode": { + "id": "Code_44721", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_388", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37435", + "standardCode": { + "id": "Code_44722", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24577", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28695", + "extensionAttributes": [], + "code": "C64467", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Aspartate Aminotransferase Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_78", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_64", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/CREATSERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Creatinine Measurement", + "label": "Creatinine Measurement", + "synonyms": [ + "Creatinine" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64547", + "properties": [ + { + "id": "BiomedicalConceptProperty_908", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37966", + "standardCode": { + "id": "Code_45253", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_909", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37967", + "standardCode": { + "id": "Code_45254", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_910", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3095", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_45256", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37968", + "standardCode": { + "id": "Code_45255", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_911", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37970", + "standardCode": { + "id": "Code_45257", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_912", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37971", + "standardCode": { + "id": "Code_45258", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_3355", + "extensionAttributes": [], + "standardCode": { + "id": "Code_3565", + "extensionAttributes": [], + "code": "C64547", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Creatinine Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_79", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_65", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/KBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Potassium Measurement", + "label": "Potassium Measurement", + "synonyms": [ + "Potassium", + "K" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64853", + "properties": [ + { + "id": "BiomedicalConceptProperty_394", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37441", + "standardCode": { + "id": "Code_44728", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_395", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37442", + "standardCode": { + "id": "Code_44729", + "extensionAttributes": [], + "code": "C64567", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Molarity Unit", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_396", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2800", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_38599", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37443", + "standardCode": { + "id": "Code_44730", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_397", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37444", + "standardCode": { + "id": "Code_44731", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_398", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37445", + "standardCode": { + "id": "Code_44732", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24578", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28696", + "extensionAttributes": [], + "code": "C64853", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Potassium Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_80", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_66", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/SODIUMBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Sodium Measurement", + "label": "Sodium Measurement", + "synonyms": [ + "Sodium", + "NA" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64809", + "properties": [ + { + "id": "BiomedicalConceptProperty_399", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37446", + "standardCode": { + "id": "Code_44733", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_400", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37447", + "standardCode": { + "id": "Code_44734", + "extensionAttributes": [], + "code": "C64567", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Molarity Unit", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_401", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3049", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_43195", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37448", + "standardCode": { + "id": "Code_44735", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_402", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37449", + "standardCode": { + "id": "Code_44736", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_403", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37450", + "standardCode": { + "id": "Code_44737", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24579", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28697", + "extensionAttributes": [], + "code": "C64809", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Sodium Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_81", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_67", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/UREANSERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Urea Nitrogen Measurement", + "label": "Urea Nitrogen Measurement", + "synonyms": [ + "Urea Nitrogen" + ], + "reference": "/mdr/bc/biomedicalconcepts/C125949", + "properties": [ + { + "id": "BiomedicalConceptProperty_404", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37451", + "standardCode": { + "id": "Code_44738", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_405", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37452", + "standardCode": { + "id": "Code_44739", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_406", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2606", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_34055", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37453", + "standardCode": { + "id": "Code_44740", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_407", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37454", + "standardCode": { + "id": "Code_44741", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_408", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37455", + "standardCode": { + "id": "Code_44742", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24580", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28698", + "extensionAttributes": [], + "code": "C125949", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Urea Nitrogen Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_82", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_68", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/BICARBBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Bicarbonate Measurement", + "label": "Bicarbonate Measurement", + "synonyms": [ + "Bicarbonate", + "HCO3" + ], + "reference": "/mdr/bc/biomedicalconcepts/C74667", + "properties": [ + { + "id": "BiomedicalConceptProperty_409", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37456", + "standardCode": { + "id": "Code_44743", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_410", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37457", + "standardCode": { + "id": "Code_44744", + "extensionAttributes": [], + "code": "C64567", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Molarity Unit", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_411", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2607", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_34061", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37458", + "standardCode": { + "id": "Code_44745", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_412", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37459", + "standardCode": { + "id": "Code_44746", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_413", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37460", + "standardCode": { + "id": "Code_44747", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24581", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28699", + "extensionAttributes": [], + "code": "C74667", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Bicarbonate Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_83", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_69", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/CLBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Chloride Measurement", + "label": "Chloride Measurement", + "synonyms": [ + "Chloride", + "CL" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64495", + "properties": [ + { + "id": "BiomedicalConceptProperty_414", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37461", + "standardCode": { + "id": "Code_44748", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_415", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37462", + "standardCode": { + "id": "Code_44749", + "extensionAttributes": [], + "code": "C64567", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Molarity Unit", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_416", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3050", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_43211", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37463", + "standardCode": { + "id": "Code_44750", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_417", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37464", + "standardCode": { + "id": "Code_44751", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_418", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37465", + "standardCode": { + "id": "Code_44752", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24582", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28700", + "extensionAttributes": [], + "code": "C64495", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Chloride Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_84", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_70", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/BILISERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Total Bilirubin Measurement", + "label": "Total Bilirubin Measurement", + "synonyms": [ + "Bilirubin", + "Total Bilirubin Level" + ], + "reference": "/mdr/bc/biomedicalconcepts/C38037", + "properties": [ + { + "id": "BiomedicalConceptProperty_419", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37466", + "standardCode": { + "id": "Code_44753", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_420", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37467", + "standardCode": { + "id": "Code_44754", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_421", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2802", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_38626", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37468", + "standardCode": { + "id": "Code_44755", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_422", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37469", + "standardCode": { + "id": "Code_44756", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_423", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37470", + "standardCode": { + "id": "Code_44757", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24583", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28701", + "extensionAttributes": [], + "code": "C38037", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Total Bilirubin Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_85", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_71", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/GGTSERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Gamma Glutamyl Transpeptidase Measurement", + "label": "Gamma Glutamyl Transpeptidase Measurement", + "synonyms": [ + "Gamma Glutamyl Transferase", + "GGT", + "GGTP" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64847", + "properties": [ + { + "id": "BiomedicalConceptProperty_913", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37972", + "standardCode": { + "id": "Code_45259", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_914", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37973", + "standardCode": { + "id": "Code_45260", + "extensionAttributes": [], + "code": "C67365", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_915", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3096", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_45262", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37974", + "standardCode": { + "id": "Code_45261", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_916", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37976", + "standardCode": { + "id": "Code_45263", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_917", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37977", + "standardCode": { + "id": "Code_45264", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_37996", + "extensionAttributes": [], + "standardCode": { + "id": "Code_45283", + "extensionAttributes": [], + "code": "C64847", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Gamma Glutamyl Transpeptidase Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_86", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_72", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/URATESERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Urate Measurement", + "label": "Urate Measurement", + "synonyms": [ + "Urate", + "Uric Acid" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64814", + "properties": [ + { + "id": "BiomedicalConceptProperty_429", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37476", + "standardCode": { + "id": "Code_44763", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_430", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37477", + "standardCode": { + "id": "Code_44764", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_431", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3051", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_43227", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37478", + "standardCode": { + "id": "Code_44765", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_432", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37479", + "standardCode": { + "id": "Code_44766", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_433", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37480", + "standardCode": { + "id": "Code_44767", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24584", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28702", + "extensionAttributes": [], + "code": "C64814", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Urate Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_87", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_73", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/PHOSSERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Phosphate Measurement", + "label": "Phosphate Measurement", + "synonyms": [ + "Phosphorus", + "Phosphate" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64857", + "properties": [ + { + "id": "BiomedicalConceptProperty_918", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37978", + "standardCode": { + "id": "Code_45265", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_919", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37979", + "standardCode": { + "id": "Code_45266", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_920", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3097", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_45268", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37980", + "standardCode": { + "id": "Code_45267", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_921", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37982", + "standardCode": { + "id": "Code_45269", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_922", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37983", + "standardCode": { + "id": "Code_45270", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24585", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28703", + "extensionAttributes": [], + "code": "C64857", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Phosphate Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_88", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_74", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/CABLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Calcium Measurement", + "label": "Calcium Measurement", + "synonyms": [ + "Calcium", + "CA" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64488", + "properties": [ + { + "id": "BiomedicalConceptProperty_923", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37984", + "standardCode": { + "id": "Code_45271", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_924", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37985", + "standardCode": { + "id": "Code_45272", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_925", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3098", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_45274", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37986", + "standardCode": { + "id": "Code_45273", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_926", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37988", + "standardCode": { + "id": "Code_45275", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_927", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37989", + "standardCode": { + "id": "Code_45276", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24586", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28704", + "extensionAttributes": [], + "code": "C64488", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Calcium Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_89", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_75", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/GLUCBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Glucose Measurement", + "label": "Glucose Measurement", + "synonyms": [ + "Glucose" + ], + "reference": "/mdr/bc/biomedicalconcepts/C105585", + "properties": [ + { + "id": "BiomedicalConceptProperty_444", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37491", + "standardCode": { + "id": "Code_44778", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_445", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37492", + "standardCode": { + "id": "Code_44779", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_446", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2471", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_32605", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37493", + "standardCode": { + "id": "Code_44780", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_447", + "extensionAttributes": [], + "name": "LBMETHOD", + "label": "LBMETHOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37494", + "standardCode": { + "id": "Code_44781", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_448", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37495", + "standardCode": { + "id": "Code_44782", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_449", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37496", + "standardCode": { + "id": "Code_44783", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24587", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28705", + "extensionAttributes": [], + "code": "C105585", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Glucose Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_90", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_76", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/PROTSERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Total Protein Measurement", + "label": "Total Protein Measurement", + "synonyms": [ + "Protein" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64858", + "properties": [ + { + "id": "BiomedicalConceptProperty_450", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37497", + "standardCode": { + "id": "Code_44784", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_451", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37498", + "standardCode": { + "id": "Code_44785", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_452", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3052", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_43249", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37499", + "standardCode": { + "id": "Code_44786", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_453", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37500", + "standardCode": { + "id": "Code_44787", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_454", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [ + { + "id": "ResponseCode_2858", + "instanceType": "ResponseCode", + "name": "beats/min", + "label": "beats/min", + "isEnabled": true, + "code": { + "id": "Code_41247", + "extensionAttributes": [], + "code": "C49673", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "beats/min", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37501", + "standardCode": { + "id": "Code_44788", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24588", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28706", + "extensionAttributes": [], + "code": "C64858", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Total Protein Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_91", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_77", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/CHOLSERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Cholesterol Measurement", + "label": "Cholesterol Measurement", + "synonyms": [ + "CHOL", + "Cholesterol", + "Total Cholesterol" + ], + "reference": "/mdr/bc/biomedicalconcepts/C105586", + "properties": [ + { + "id": "BiomedicalConceptProperty_455", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37502", + "standardCode": { + "id": "Code_44789", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_456", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37503", + "standardCode": { + "id": "Code_44790", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_457", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2805", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_38665", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37504", + "standardCode": { + "id": "Code_44791", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_458", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37505", + "standardCode": { + "id": "Code_44792", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_459", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37506", + "standardCode": { + "id": "Code_44793", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24589", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28707", + "extensionAttributes": [], + "code": "C105586", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Cholesterol Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_92", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_78", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/T3UPSERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Triiodothyronine Uptake Measurement", + "label": "Triiodothyronine Uptake Measurement", + "synonyms": [ + "T3UP", + "T3U", + "Triiodothyronine Resin Uptake" + ], + "reference": "/mdr/bc/biomedicalconcepts/C74748", + "properties": [ + { + "id": "BiomedicalConceptProperty_460", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37507", + "standardCode": { + "id": "Code_44794", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_461", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37508", + "standardCode": { + "id": "Code_44795", + "extensionAttributes": [], + "code": "C48570", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Percent Unit", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_462", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3053", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_43260", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37509", + "standardCode": { + "id": "Code_44796", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_463", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37510", + "standardCode": { + "id": "Code_44797", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_464", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37511", + "standardCode": { + "id": "Code_44798", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24590", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28708", + "extensionAttributes": [], + "code": "C74748", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Triiodothyronine Uptake Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_93", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_79", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/T3SERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Triiodothyronine Measurement", + "label": "Triiodothyronine Measurement", + "synonyms": [ + "T3", + "Total T3" + ], + "reference": "/mdr/bc/biomedicalconcepts/C74747", + "properties": [ + { + "id": "BiomedicalConceptProperty_928", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37990", + "standardCode": { + "id": "Code_45277", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_929", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37991", + "standardCode": { + "id": "Code_45278", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_930", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3099", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_45280", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37992", + "standardCode": { + "id": "Code_45279", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_931", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37994", + "standardCode": { + "id": "Code_45281", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_932", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37995", + "standardCode": { + "id": "Code_45282", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24591", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28709", + "extensionAttributes": [], + "code": "C74747", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Triiodothyronine Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_94", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_80", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/T4FRSERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Free Thyroxine Measurement", + "label": "Free Thyroxine Measurement", + "synonyms": [ + "Free T4", + "T4FR" + ], + "reference": "/mdr/bc/biomedicalconcepts/C74786", + "properties": [ + { + "id": "BiomedicalConceptProperty_470", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37517", + "standardCode": { + "id": "Code_44804", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_471", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2479", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_32638", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37518", + "standardCode": { + "id": "Code_44805", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_472", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3054", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_43271", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37519", + "standardCode": { + "id": "Code_44806", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_473", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37520", + "standardCode": { + "id": "Code_44807", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_474", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37521", + "standardCode": { + "id": "Code_44808", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24592", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28710", + "extensionAttributes": [], + "code": "C74786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Free Thyroxine Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_95", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_81", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/T4FRIDXSERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Free Thyroxine Index", + "label": "Free Thyroxine Index", + "synonyms": [ + "T4FRIDX" + ], + "reference": "/mdr/bc/biomedicalconcepts/C170598", + "properties": [ + { + "id": "BiomedicalConceptProperty_475", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37522", + "standardCode": { + "id": "Code_44809", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_476", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3055", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_43276", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37523", + "standardCode": { + "id": "Code_44810", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_477", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37524", + "standardCode": { + "id": "Code_44811", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_478", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37525", + "standardCode": { + "id": "Code_44812", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24593", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28711", + "extensionAttributes": [], + "code": "C170598", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Free Thyroxine Index", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_96", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_82", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/TSHBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Thyrotropin Measurement", + "label": "Thyrotropin Measurement", + "synonyms": [ + "TSH", + "Thyrotropin" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64813", + "properties": [ + { + "id": "BiomedicalConceptProperty_479", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37526", + "standardCode": { + "id": "Code_44813", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_480", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37527", + "standardCode": { + "id": "Code_44814", + "extensionAttributes": [], + "code": "C67365", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_481", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2481", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_32650", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37528", + "standardCode": { + "id": "Code_44815", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_482", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37529", + "standardCode": { + "id": "Code_44816", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_483", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37530", + "standardCode": { + "id": "Code_44817", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24594", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28712", + "extensionAttributes": [], + "code": "C64813", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Thyrotropin Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_97", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_83", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/VITB9BLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Folic Acid Measurement", + "label": "Folic Acid Measurement", + "synonyms": [ + "Folate", + "Folic Acid", + "Vitamin B9", + "VITB9" + ], + "reference": "/mdr/bc/biomedicalconcepts/C74676", + "properties": [ + { + "id": "BiomedicalConceptProperty_484", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37531", + "standardCode": { + "id": "Code_44818", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_485", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37532", + "standardCode": { + "id": "Code_44819", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_486", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3056", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_43287", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37533", + "standardCode": { + "id": "Code_44820", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_487", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37534", + "standardCode": { + "id": "Code_44821", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_488", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37535", + "standardCode": { + "id": "Code_44822", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_3218", + "extensionAttributes": [], + "standardCode": { + "id": "Code_3428", + "extensionAttributes": [], + "code": "C74676", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Folic Acid Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_98", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_84", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/VITB12BLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Vitamin B12 Measurement", + "label": "Vitamin B12 Measurement", + "synonyms": [ + "Cobalamin", + "Vitamin B12", + "VITB12" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64817", + "properties": [ + { + "id": "BiomedicalConceptProperty_489", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2483", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_32660", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37536", + "standardCode": { + "id": "Code_44823", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_490", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37537", + "standardCode": { + "id": "Code_44824", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_491", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2621", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_34155", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37538", + "standardCode": { + "id": "Code_44825", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_492", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37539", + "standardCode": { + "id": "Code_44826", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_493", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [ + { + "id": "ResponseCode_2484", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_32665", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37540", + "standardCode": { + "id": "Code_44827", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24595", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28713", + "extensionAttributes": [], + "code": "C64817", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Vitamin B12 Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_99", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_85", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/TPLAB", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Treponema pallidum Antibody Measurement", + "label": "Treponema pallidum Antibody Measurement", + "synonyms": [ + "TPLAB", + "Treponema pallidum Antibody", + "Syphilis Antibody" + ], + "reference": "/mdr/bc/biomedicalconcepts/C132388", + "properties": [ + { + "id": "BiomedicalConceptProperty_494", + "extensionAttributes": [], + "name": "MBTSTDTL", + "label": "MBTSTDTL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3057", + "instanceType": "ResponseCode", + "name": "DETECTION", + "label": "DETECTION", + "isEnabled": true, + "code": { + "id": "Code_43296", + "extensionAttributes": [], + "code": "C174330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "DETECTION", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37541", + "standardCode": { + "id": "Code_44828", + "extensionAttributes": [], + "code": "C117062", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Measurement, Test or Examination Detail", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_495", + "extensionAttributes": [], + "name": "MBORRES", + "label": "MBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37542", + "standardCode": { + "id": "Code_44829", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_496", + "extensionAttributes": [], + "name": "MBSPEC", + "label": "MBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3058", + "instanceType": "ResponseCode", + "name": "SERUM", + "label": "SERUM", + "isEnabled": true, + "code": { + "id": "Code_43299", + "extensionAttributes": [], + "code": "C13325", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37543", + "standardCode": { + "id": "Code_44830", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_497", + "extensionAttributes": [], + "name": "MBMETHOD", + "label": "MBMETHOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37544", + "standardCode": { + "id": "Code_44831", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_498", + "extensionAttributes": [], + "name": "MBDTC", + "label": "MBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37545", + "standardCode": { + "id": "Code_44832", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24596", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28714", + "extensionAttributes": [], + "code": "C132388", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Treponema pallidum Antibody Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_100", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_86", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/TPADNA", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Treponema pallidum DNA Measurement", + "label": "Treponema pallidum DNA Measurement", + "synonyms": [ + "TPADNA", + "Syphilis DNA" + ], + "reference": "/mdr/bc/biomedicalconcepts/C198341", + "properties": [ + { + "id": "BiomedicalConceptProperty_499", + "extensionAttributes": [], + "name": "MBTSTDTL", + "label": "MBTSTDTL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3059", + "instanceType": "ResponseCode", + "name": "DETECTION", + "label": "DETECTION", + "isEnabled": true, + "code": { + "id": "Code_43303", + "extensionAttributes": [], + "code": "C174330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "DETECTION", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37546", + "standardCode": { + "id": "Code_44833", + "extensionAttributes": [], + "code": "C117062", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Measurement, Test or Examination Detail", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_500", + "extensionAttributes": [], + "name": "MBORRES", + "label": "MBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37547", + "standardCode": { + "id": "Code_44834", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_501", + "extensionAttributes": [], + "name": "MBSPEC", + "label": "MBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37548", + "standardCode": { + "id": "Code_44835", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_502", + "extensionAttributes": [], + "name": "MBMETHOD", + "label": "MBMETHOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3060", + "instanceType": "ResponseCode", + "name": "LINE PROBE ASSAY", + "label": "LINE PROBE ASSAY", + "isEnabled": true, + "code": { + "id": "Code_43307", + "extensionAttributes": [], + "code": "C102656", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "LINE PROBE ASSAY", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37549", + "standardCode": { + "id": "Code_44836", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_503", + "extensionAttributes": [], + "name": "MBDTC", + "label": "MBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37550", + "standardCode": { + "id": "Code_44837", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24597", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28715", + "extensionAttributes": [], + "code": "C198341", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Treponema pallidum DNA Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_101", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_87", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/COLORURIN", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Color Assessment", + "label": "Color Assessment", + "synonyms": [ + "COLOR", + "Color" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64546", + "properties": [ + { + "id": "BiomedicalConceptProperty_504", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37551", + "standardCode": { + "id": "Code_44838", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_505", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3061", + "instanceType": "ResponseCode", + "name": "URINE", + "label": "URINE", + "isEnabled": true, + "code": { + "id": "Code_43311", + "extensionAttributes": [], + "code": "C13283", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "URINE", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37552", + "standardCode": { + "id": "Code_44839", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_506", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37553", + "standardCode": { + "id": "Code_44840", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24598", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28716", + "extensionAttributes": [], + "code": "C64546", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Color Assessment", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_102", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_88", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/SPGRAVURIN", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Specific Gravity", + "label": "Specific Gravity", + "synonyms": [ + "SPGRAV" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64832", + "properties": [ + { + "id": "BiomedicalConceptProperty_824", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37871", + "standardCode": { + "id": "Code_45158", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_825", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3084", + "instanceType": "ResponseCode", + "name": "URINE", + "label": "URINE", + "isEnabled": true, + "code": { + "id": "Code_45160", + "extensionAttributes": [], + "code": "C13283", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "URINE", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37872", + "standardCode": { + "id": "Code_45159", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_826", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37874", + "standardCode": { + "id": "Code_45161", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_827", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37875", + "standardCode": { + "id": "Code_45162", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_3219", + "extensionAttributes": [], + "standardCode": { + "id": "Code_3429", + "extensionAttributes": [], + "code": "C64832", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Specific Gravity", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_103", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_89", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/PROTSERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Total Protein Measurement", + "label": null, + "synonyms": [ + "Protein" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64858", + "properties": [ + { + "id": "BiomedicalConceptProperty_511", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37558", + "standardCode": { + "id": "Code_44845", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_512", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37559", + "standardCode": { + "id": "Code_44846", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_513", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3062", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_43320", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37560", + "standardCode": { + "id": "Code_44847", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_514", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37561", + "standardCode": { + "id": "Code_44848", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_515", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37562", + "standardCode": { + "id": "Code_44849", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24588", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28706", + "extensionAttributes": [], + "code": "C64858", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Total Protein Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_104", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_144", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/GLUCURIN", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Glucose Measurement", + "label": null, + "synonyms": [ + "Glucose" + ], + "reference": "/mdr/bc/biomedicalconcepts/C105585", + "properties": [ + { + "id": "BiomedicalConceptProperty_828", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37876", + "standardCode": { + "id": "Code_45163", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_829", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37877", + "standardCode": { + "id": "Code_45164", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_830", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3085", + "instanceType": "ResponseCode", + "name": "URINE", + "label": "URINE", + "isEnabled": true, + "code": { + "id": "Code_45166", + "extensionAttributes": [], + "code": "C13283", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "URINE", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37878", + "standardCode": { + "id": "Code_45165", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_831", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37880", + "standardCode": { + "id": "Code_45167", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_832", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37881", + "standardCode": { + "id": "Code_45168", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24587", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28705", + "extensionAttributes": [], + "code": "C105585", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Glucose Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_105", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_91", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/KETONESURIN", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Ketone Measurement", + "label": "Ketone Measurement", + "synonyms": [ + "Ketones" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64854", + "properties": [ + { + "id": "BiomedicalConceptProperty_521", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37568", + "standardCode": { + "id": "Code_44855", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_522", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37569", + "standardCode": { + "id": "Code_44856", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_523", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3063", + "instanceType": "ResponseCode", + "name": "URINE", + "label": "URINE", + "isEnabled": true, + "code": { + "id": "Code_43331", + "extensionAttributes": [], + "code": "C13283", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "URINE", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37570", + "standardCode": { + "id": "Code_44857", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_524", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37571", + "standardCode": { + "id": "Code_44858", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_525", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37572", + "standardCode": { + "id": "Code_44859", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24599", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28717", + "extensionAttributes": [], + "code": "C64854", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Ketone Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_106", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_92", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/BILISERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Total Bilirubin Measurement", + "label": null, + "synonyms": [ + "Bilirubin", + "Total Bilirubin Level" + ], + "reference": "/mdr/bc/biomedicalconcepts/C38037", + "properties": [ + { + "id": "BiomedicalConceptProperty_526", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37573", + "standardCode": { + "id": "Code_44860", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_527", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37574", + "standardCode": { + "id": "Code_44861", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_528", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3064", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_43337", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37575", + "standardCode": { + "id": "Code_44862", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_529", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37576", + "standardCode": { + "id": "Code_44863", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_530", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37577", + "standardCode": { + "id": "Code_44864", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24583", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28701", + "extensionAttributes": [], + "code": "C38037", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Total Bilirubin Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_107", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_93", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/UROBILURIN", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Urobilinogen Measurement", + "label": "Urobilinogen Measurement", + "synonyms": [ + "Urobilinogen", + "UROBIL" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64816", + "properties": [ + { + "id": "BiomedicalConceptProperty_531", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37578", + "standardCode": { + "id": "Code_44865", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_532", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37579", + "standardCode": { + "id": "Code_44866", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_533", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3065", + "instanceType": "ResponseCode", + "name": "URINE", + "label": "URINE", + "isEnabled": true, + "code": { + "id": "Code_43343", + "extensionAttributes": [], + "code": "C13283", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "URINE", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37580", + "standardCode": { + "id": "Code_44867", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_534", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37581", + "standardCode": { + "id": "Code_44868", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_535", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37582", + "standardCode": { + "id": "Code_44869", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24600", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28718", + "extensionAttributes": [], + "code": "C64816", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Urobilinogen Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_108", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_94", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/OCCBLDSTOOL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Occult Blood Measurement", + "label": "Occult Blood Measurement", + "synonyms": [ + "Occult Blood", + "OCCBLD" + ], + "reference": "/mdr/bc/biomedicalconcepts/C74686", + "properties": [ + { + "id": "BiomedicalConceptProperty_536", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37583", + "standardCode": { + "id": "Code_44870", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_537", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3066", + "instanceType": "ResponseCode", + "name": "STOOL", + "label": "STOOL", + "isEnabled": true, + "code": { + "id": "Code_43348", + "extensionAttributes": [], + "code": "C13234", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "STOOL", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37584", + "standardCode": { + "id": "Code_44871", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_538", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37585", + "standardCode": { + "id": "Code_44872", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_539", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37586", + "standardCode": { + "id": "Code_44873", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_3356", + "extensionAttributes": [], + "standardCode": { + "id": "Code_3566", + "extensionAttributes": [], + "code": "C74686", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Occult Blood Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_109", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_95", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/NITRITEURIN", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Nitrite Measurement", + "label": "Nitrite Measurement", + "synonyms": [ + "NITRITE" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64810", + "properties": [ + { + "id": "BiomedicalConceptProperty_833", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37882", + "standardCode": { + "id": "Code_45169", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_834", + "extensionAttributes": [], + "name": "LBORRESU", + "label": "LBORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37883", + "standardCode": { + "id": "Code_45170", + "extensionAttributes": [], + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_835", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3086", + "instanceType": "ResponseCode", + "name": "URINE", + "label": "URINE", + "isEnabled": true, + "code": { + "id": "Code_45172", + "extensionAttributes": [], + "code": "C13283", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "URINE", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37884", + "standardCode": { + "id": "Code_45171", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_836", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37886", + "standardCode": { + "id": "Code_45173", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_837", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37887", + "standardCode": { + "id": "Code_45174", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_3357", + "extensionAttributes": [], + "standardCode": { + "id": "Code_3567", + "extensionAttributes": [], + "code": "C64810", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Nitrite Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_110", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_96", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/HBA1CBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Hemoglobin A1C Measurement", + "label": "Hemoglobin A1C Measurement", + "synonyms": [ + "Hemoglobin A1C", + "HBA1C", + "Glycosylated Hemoglobin A1C" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64849", + "properties": [ + { + "id": "BiomedicalConceptProperty_545", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37592", + "standardCode": { + "id": "Code_44879", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_546", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2819", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_38768", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37593", + "standardCode": { + "id": "Code_44880", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_547", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37594", + "standardCode": { + "id": "Code_44881", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_548", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37595", + "standardCode": { + "id": "Code_44882", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24601", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28719", + "extensionAttributes": [], + "code": "C64849", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Hemoglobin A1C Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_111", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_97", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/HBA1CHGBBLD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Hemoglobin A1C to Hemoglobin Ratio Measurement", + "label": "Hemoglobin A1C to Hemoglobin Ratio Measurement", + "synonyms": [ + "Hemoglobin A1C/Hemoglobin", + "HBA1CHGB" + ], + "reference": "/mdr/bc/biomedicalconcepts/C111207", + "properties": [ + { + "id": "BiomedicalConceptProperty_549", + "extensionAttributes": [], + "name": "LBORRES", + "label": "LBORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37596", + "standardCode": { + "id": "Code_44883", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_550", + "extensionAttributes": [], + "name": "LBSPEC", + "label": "LBSPEC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3067", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_43362", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37597", + "standardCode": { + "id": "Code_44884", + "extensionAttributes": [], + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_551", + "extensionAttributes": [], + "name": "LBFAST", + "label": "LBFAST", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37598", + "standardCode": { + "id": "Code_44885", + "extensionAttributes": [], + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_552", + "extensionAttributes": [], + "name": "LBDTC", + "label": "LBDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37599", + "standardCode": { + "id": "Code_44886", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24602", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28720", + "extensionAttributes": [], + "code": "C111207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Hemoglobin A1C to Hemoglobin Ratio Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_112", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_98", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/EXPOSCOLL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Exposure as Collected Domain", + "label": "Exposure as Collected Domain", + "synonyms": [ + "EC", + "Exposure as Collected" + ], + "reference": "/mdr/bc/biomedicalconcepts/C117466", + "properties": [ + { + "id": "BiomedicalConceptProperty_553", + "extensionAttributes": [], + "name": "ECTRT", + "label": "ECTRT", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2685", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_37592", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37600", + "standardCode": { + "id": "Code_44887", + "extensionAttributes": [], + "code": "C117473", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Name of Treatment", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_554", + "extensionAttributes": [], + "name": "ECREFID", + "label": "ECREFID", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37601", + "standardCode": { + "id": "Code_44888", + "extensionAttributes": [], + "code": "C117469", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Reference Identifier", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_555", + "extensionAttributes": [], + "name": "ECDOSE", + "label": "ECDOSE", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37602", + "standardCode": { + "id": "Code_44889", + "extensionAttributes": [], + "code": "C117479", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Dose", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_556", + "extensionAttributes": [], + "name": "ECDOSTXT", + "label": "ECDOSTXT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37603", + "standardCode": { + "id": "Code_44890", + "extensionAttributes": [], + "code": "C117480", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Dose Description", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_557", + "extensionAttributes": [], + "name": "ECDOSU", + "label": "ECDOSU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37604", + "standardCode": { + "id": "Code_44891", + "extensionAttributes": [], + "code": "C117481", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Dose Units", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_558", + "extensionAttributes": [], + "name": "ECDOSFRM", + "label": "ECDOSFRM", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37605", + "standardCode": { + "id": "Code_44892", + "extensionAttributes": [], + "code": "C117482", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Dose Form", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_559", + "extensionAttributes": [], + "name": "ECDOSFRQ", + "label": "ECDOSFRQ", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37606", + "standardCode": { + "id": "Code_44893", + "extensionAttributes": [], + "code": "C117483", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Dosing Frequency per Interval", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_560", + "extensionAttributes": [], + "name": "ECDOSRGM", + "label": "ECDOSRGM", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37607", + "standardCode": { + "id": "Code_44894", + "extensionAttributes": [], + "code": "C117485", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Intended Dose Regimen", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_561", + "extensionAttributes": [], + "name": "ECROUTE", + "label": "ECROUTE", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37608", + "standardCode": { + "id": "Code_44895", + "extensionAttributes": [], + "code": "C117486", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Route of Administration", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_562", + "extensionAttributes": [], + "name": "ECLOC", + "label": "ECLOC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2687", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_37603", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37609", + "standardCode": { + "id": "Code_44896", + "extensionAttributes": [], + "code": "C117488", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Location", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_563", + "extensionAttributes": [], + "name": "ECLAT", + "label": "ECLAT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37610", + "standardCode": { + "id": "Code_44897", + "extensionAttributes": [], + "code": "C117489", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Laterality", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_564", + "extensionAttributes": [], + "name": "ECDIR", + "label": "ECDIR", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37611", + "standardCode": { + "id": "Code_44898", + "extensionAttributes": [], + "code": "C117490", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Directionality", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_565", + "extensionAttributes": [], + "name": "ECSTDTC", + "label": "ECSTDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37612", + "standardCode": { + "id": "Code_44899", + "extensionAttributes": [], + "code": "C117496", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected Start Date and Time of Treatment", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_566", + "extensionAttributes": [], + "name": "ECENDTC", + "label": "ECENDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [ + { + "id": "ResponseCode_2688", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_37608", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37613", + "standardCode": { + "id": "Code_44900", + "extensionAttributes": [], + "code": "C117497", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Exposure as Collected End Date and Time of Treatment", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24603", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28721", + "extensionAttributes": [], + "code": "C117466", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Exposure as Collected Domain", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_113", + "extensionAttributes": [], + "name": "TTS Acceptability Survey", + "label": "TTS Acceptability Survey", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/NEW_LZZT", + "properties": [ + { + "id": "BiomedicalConceptProperty_567", + "extensionAttributes": [], + "name": "Category", + "label": "Category", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37614", + "standardCode": { + "id": "Code_44901", + "extensionAttributes": [], + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Category", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_568", + "extensionAttributes": [], + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37615", + "standardCode": { + "id": "Code_44902", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_569", + "extensionAttributes": [], + "name": "Test Occurrence", + "label": "Test Occurrence", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37616", + "standardCode": { + "id": "Code_44903", + "extensionAttributes": [], + "code": "C82525", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Test Occurrence", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24604", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28722", + "extensionAttributes": [], + "code": "NEW_LZZT", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "TTS Acceptability Survey", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_114", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_99", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/PATCHSURVEYACCEPTABILITY", + "instanceType": "ExtensionAttribute" + } + ], + "name": "TTS Acceptability Survey - Patch Acceptability", + "label": "TTS Acceptability Survey - Patch Acceptability", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/NEW_LZZT4", + "properties": [ + { + "id": "BiomedicalConceptProperty_570", + "extensionAttributes": [], + "name": "QSORRES", + "label": "QSORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [ + { + "id": "ResponseCode_2689", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_37613", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37617", + "standardCode": { + "id": "Code_44904", + "extensionAttributes": [], + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Ordinal Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_571", + "extensionAttributes": [], + "name": "QSDTC", + "label": "QSDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37618", + "standardCode": { + "id": "Code_44905", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_572", + "extensionAttributes": [], + "name": "QSEVAL", + "label": "QSEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2821", + "instanceType": "ResponseCode", + "name": "CAREGIVER", + "label": "CAREGIVER", + "isEnabled": true, + "code": { + "id": "Code_38796", + "extensionAttributes": [], + "code": "C17445", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "CAREGIVER", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37619", + "standardCode": { + "id": "Code_44906", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24605", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28723", + "extensionAttributes": [], + "code": "NEW_LZZT4", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "TTS Acceptability Survey - Patch Acceptability", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_115", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_100", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/PATCHSURVEYAPPEARANCE", + "instanceType": "ExtensionAttribute" + } + ], + "name": "TTS Acceptability Survey - Patch Appearance", + "label": "TTS Acceptability Survey - Patch Appearance", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/NEW_LZZT1", + "properties": [ + { + "id": "BiomedicalConceptProperty_573", + "extensionAttributes": [], + "name": "QSORRES", + "label": "QSORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37620", + "standardCode": { + "id": "Code_44907", + "extensionAttributes": [], + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Ordinal Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_574", + "extensionAttributes": [], + "name": "QSDTC", + "label": "QSDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [ + { + "id": "ResponseCode_2690", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_37618", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37621", + "standardCode": { + "id": "Code_44908", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_575", + "extensionAttributes": [], + "name": "QSEVAL", + "label": "QSEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2822", + "instanceType": "ResponseCode", + "name": "CAREGIVER", + "label": "CAREGIVER", + "isEnabled": true, + "code": { + "id": "Code_38800", + "extensionAttributes": [], + "code": "C17445", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "CAREGIVER", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37622", + "standardCode": { + "id": "Code_44909", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24606", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28724", + "extensionAttributes": [], + "code": "NEW_LZZT1", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "TTS Acceptability Survey - Patch Appearance", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_116", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_101", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/PATCHSURVEYDURABILITY", + "instanceType": "ExtensionAttribute" + } + ], + "name": "TTS Acceptability Survey - Patch Durability", + "label": "TTS Acceptability Survey - Patch Durability", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/NEW_LZZT3", + "properties": [ + { + "id": "BiomedicalConceptProperty_576", + "extensionAttributes": [], + "name": "QSORRES", + "label": "QSORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37623", + "standardCode": { + "id": "Code_44910", + "extensionAttributes": [], + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Ordinal Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_577", + "extensionAttributes": [], + "name": "QSDTC", + "label": "QSDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37624", + "standardCode": { + "id": "Code_44911", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_578", + "extensionAttributes": [], + "name": "QSEVAL", + "label": "QSEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3068", + "instanceType": "ResponseCode", + "name": "CAREGIVER", + "label": "CAREGIVER", + "isEnabled": true, + "code": { + "id": "Code_43391", + "extensionAttributes": [], + "code": "C17445", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "CAREGIVER", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37625", + "standardCode": { + "id": "Code_44912", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24607", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28725", + "extensionAttributes": [], + "code": "NEW_LZZT3", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "TTS Acceptability Survey - Patch Durability", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_117", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_102", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/PATCHSURVEYSIZE", + "instanceType": "ExtensionAttribute" + } + ], + "name": "TTS Acceptability Survey - Patch Size", + "label": "TTS Acceptability Survey - Patch Size", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/NEW_LZZT2", + "properties": [ + { + "id": "BiomedicalConceptProperty_579", + "extensionAttributes": [], + "name": "QSORRES", + "label": "QSORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37626", + "standardCode": { + "id": "Code_44913", + "extensionAttributes": [], + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Ordinal Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_580", + "extensionAttributes": [], + "name": "QSDTC", + "label": "QSDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37627", + "standardCode": { + "id": "Code_44914", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_581", + "extensionAttributes": [], + "name": "QSEVAL", + "label": "QSEVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3069", + "instanceType": "ResponseCode", + "name": "CAREGIVER", + "label": "CAREGIVER", + "isEnabled": true, + "code": { + "id": "Code_43395", + "extensionAttributes": [], + "code": "C17445", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "CAREGIVER", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37628", + "standardCode": { + "id": "Code_44915", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24608", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28726", + "extensionAttributes": [], + "code": "NEW_LZZT2", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "TTS Acceptability Survey - Patch Size", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_134", + "extensionAttributes": [], + "name": "Adverse Event Yes No Indicator", + "label": "Adverse Event Yes No Indicator", + "synonyms": [ + "AEYN" + ], + "reference": "/mdr/bc/biomedicalconcepts/C83347", + "properties": [ + { + "id": "BiomedicalConceptProperty_582", + "extensionAttributes": [], + "name": "Adverse Event Yes No Indicator", + "label": "Adverse Event Yes No Indicator", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37629", + "standardCode": { + "id": "Code_44916", + "extensionAttributes": [], + "code": "C83347", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Yes No Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_583", + "extensionAttributes": [], + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37630", + "standardCode": { + "id": "Code_44917", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24609", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28727", + "extensionAttributes": [], + "code": "C83347", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Yes No Indicator", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_135", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_103", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/AE", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Solicited Adverse Event", + "label": "Solicited Adverse Event", + "synonyms": [ + "Adverse Event" + ], + "reference": "/mdr/bc/biomedicalconcepts/C179175", + "properties": [ + { + "id": "BiomedicalConceptProperty_584", + "extensionAttributes": [], + "name": "AETERM", + "label": "AETERM", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37631", + "standardCode": { + "id": "Code_44918", + "extensionAttributes": [], + "code": "C78541", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Verbatim Description", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_585", + "extensionAttributes": [], + "name": "AEDECOD", + "label": "AEDECOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37632", + "standardCode": { + "id": "Code_44919", + "extensionAttributes": [], + "code": "C83344", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Dictionary Derived Term", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_586", + "extensionAttributes": [], + "name": "AELOC", + "label": "AELOC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37633", + "standardCode": { + "id": "Code_44920", + "extensionAttributes": [], + "code": "C83205", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Location", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_587", + "extensionAttributes": [], + "name": "AESEV", + "label": "AESEV", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37634", + "standardCode": { + "id": "Code_44921", + "extensionAttributes": [], + "code": "C53253", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Severity of Adverse Event", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_588", + "extensionAttributes": [], + "name": "AESER", + "label": "AESER", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [ + { + "id": "ResponseCode_2693", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_37635", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37635", + "standardCode": { + "id": "Code_44922", + "extensionAttributes": [], + "code": "C53252", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Seriousness of Adverse Event", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_589", + "extensionAttributes": [], + "name": "AEACN", + "label": "AEACN", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2872", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_41396", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37636", + "standardCode": { + "id": "Code_44923", + "extensionAttributes": [], + "code": "C83013", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Action Taken with Study Treatment", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_590", + "extensionAttributes": [], + "name": "AEACNOTH", + "label": "AEACNOTH", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37637", + "standardCode": { + "id": "Code_44924", + "extensionAttributes": [], + "code": "C83109", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Other Actions taken in Response to Adverse Event", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_591", + "extensionAttributes": [], + "name": "AEREL", + "label": "AEREL", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37638", + "standardCode": { + "id": "Code_44925", + "extensionAttributes": [], + "code": "C41358", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Attribution to Product or Procedure", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_592", + "extensionAttributes": [], + "name": "AERELNST", + "label": "AERELNST", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37639", + "standardCode": { + "id": "Code_44926", + "extensionAttributes": [], + "code": "C83210", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Relationship to Non Study Treatment", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_593", + "extensionAttributes": [], + "name": "AEPATT", + "label": "AEPATT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37640", + "standardCode": { + "id": "Code_44927", + "extensionAttributes": [], + "code": "C83208", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Pattern", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_594", + "extensionAttributes": [], + "name": "AEOUT", + "label": "AEOUT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37641", + "standardCode": { + "id": "Code_44928", + "extensionAttributes": [], + "code": "C49489", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Outcome", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_595", + "extensionAttributes": [], + "name": "AESCAN", + "label": "AESCAN", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37642", + "standardCode": { + "id": "Code_44929", + "extensionAttributes": [], + "code": "C83211", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Involves Cancer", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_596", + "extensionAttributes": [], + "name": "AESCONG", + "label": "AESCONG", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37643", + "standardCode": { + "id": "Code_44930", + "extensionAttributes": [], + "code": "C83117", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Seriousness Due to Congenital Anomaly", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_597", + "extensionAttributes": [], + "name": "AESDISAB", + "label": "AESDISAB", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37644", + "standardCode": { + "id": "Code_44931", + "extensionAttributes": [], + "code": "C113380", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Disabling Adverse Event", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_598", + "extensionAttributes": [], + "name": "AESDTH", + "label": "AESDTH", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37645", + "standardCode": { + "id": "Code_44932", + "extensionAttributes": [], + "code": "C48275", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Death Related to Adverse Event", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_599", + "extensionAttributes": [], + "name": "AESHOSP", + "label": "AESHOSP", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37646", + "standardCode": { + "id": "Code_44933", + "extensionAttributes": [], + "code": "C83052", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event associated with Hospitalization", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_600", + "extensionAttributes": [], + "name": "AESLIFE", + "label": "AESLIFE", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37647", + "standardCode": { + "id": "Code_44934", + "extensionAttributes": [], + "code": "C84266", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Life Threatening Adverse Event", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_601", + "extensionAttributes": [], + "name": "AESOD", + "label": "AESOD", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37648", + "standardCode": { + "id": "Code_44935", + "extensionAttributes": [], + "code": "C83214", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Occurred with Overdose", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_602", + "extensionAttributes": [], + "name": "AESMIE", + "label": "AESMIE", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37649", + "standardCode": { + "id": "Code_44936", + "extensionAttributes": [], + "code": "C83053", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Associated with Serious Medical Event", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_603", + "extensionAttributes": [], + "name": "AECONTRT", + "label": "AECONTRT", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37650", + "standardCode": { + "id": "Code_44937", + "extensionAttributes": [], + "code": "C83199", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Concomitant Treatment", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_604", + "extensionAttributes": [], + "name": "AETOXGR", + "label": "AETOXGR", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2876", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_41415", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37651", + "standardCode": { + "id": "Code_44938", + "extensionAttributes": [], + "code": "C78605", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Toxicity Grade", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_605", + "extensionAttributes": [], + "name": "AESTDTC", + "label": "AESTDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37652", + "standardCode": { + "id": "Code_44939", + "extensionAttributes": [], + "code": "C83215", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Start Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_606", + "extensionAttributes": [], + "name": "AEENDTC", + "label": "AEENDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37653", + "standardCode": { + "id": "Code_44940", + "extensionAttributes": [], + "code": "C83201", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event End Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_607", + "extensionAttributes": [], + "name": "AEENRF", + "label": "AEENRF", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37654", + "standardCode": { + "id": "Code_44941", + "extensionAttributes": [], + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_608", + "extensionAttributes": [], + "name": "AEENRTPT", + "label": "AEENRTPT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37655", + "standardCode": { + "id": "Code_44942", + "extensionAttributes": [], + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_609", + "extensionAttributes": [], + "name": "AEENTPT", + "label": "AEENTPT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37656", + "standardCode": { + "id": "Code_44943", + "extensionAttributes": [], + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24610", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28728", + "extensionAttributes": [], + "code": "C179175", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Solicited Adverse Event", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_136", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_104", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/PROTCOMP", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Complete", + "label": "Complete", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/C25250", + "properties": [], + "code": { + "id": "AliasCode_24611", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28729", + "extensionAttributes": [], + "code": "C25250", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Complete [RETIRED]", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_137", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_105", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/FAILCONT", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Failure To Meet Continuation Criteria", + "label": "Failure To Meet Continuation Criteria", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/C139236", + "properties": [], + "code": { + "id": "AliasCode_24612", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28730", + "extensionAttributes": [], + "code": "C139236", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Failure To Meet Continuation Criteria [RETIRED]", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_138", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_106", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/DEAD", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Dead", + "label": "Dead", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/C28554", + "properties": [], + "code": { + "id": "AliasCode_24613", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28731", + "extensionAttributes": [], + "code": "C28554", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Dead [RETIRED]", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_139", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_107", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/LACKEFFICACY", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Lack of Efficacy", + "label": "Lack of Efficacy", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/C48226", + "properties": [], + "code": { + "id": "AliasCode_24614", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28732", + "extensionAttributes": [], + "code": "C48226", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Lack of Efficacy [RETIRED]", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_140", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_108", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/LTFUP", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Lost To Follow-Up", + "label": "Lost To Follow-Up", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/C48227", + "properties": [], + "code": { + "id": "AliasCode_24615", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28733", + "extensionAttributes": [], + "code": "C48227", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Lost To Follow-Up [RETIRED]", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_141", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_109", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/ADVEVENT", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Adverse Event [RETIRED]", + "label": "Adverse Event [RETIRED]", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/C41331", + "properties": [], + "code": { + "id": "AliasCode_24616", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28734", + "extensionAttributes": [], + "code": "C41331", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Adverse Event [RETIRED]", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_142", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_110", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/PHYDECISION", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Physician Decision", + "label": "Physician Decision", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/C48250", + "properties": [], + "code": { + "id": "AliasCode_24617", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28735", + "extensionAttributes": [], + "code": "C48250", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Physician Decision [RETIRED]", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_143", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_111", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/SUBJPREG", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Pregnant Subject", + "label": "Pregnant Subject", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/C191656", + "properties": [], + "code": { + "id": "AliasCode_24618", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28736", + "extensionAttributes": [], + "code": "C191656", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Pregnant Subject [RETIRED]", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_144", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_112", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/PROGDISEASE", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Progressive Disease", + "label": "Progressive Disease", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/C35571", + "properties": [], + "code": { + "id": "AliasCode_24619", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28737", + "extensionAttributes": [], + "code": "C35571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Progressive Disease [RETIRED]", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_145", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_113", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/PROTDEV", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Protocol Deviation", + "label": "Protocol Deviation", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/C50996", + "properties": [], + "code": { + "id": "AliasCode_1747", + "extensionAttributes": [], + "standardCode": { + "id": "Code_1937", + "extensionAttributes": [], + "code": "C50996", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Protocol Deviation", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_146", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_114", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/SITETRANSFER", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Study Site Transfer", + "label": "Study Site Transfer", + "synonyms": [ + "Site Transfer", + "Study Subject Site Transfer" + ], + "reference": "/mdr/bc/biomedicalconcepts/C186208", + "properties": [ + { + "id": "BiomedicalConceptProperty_610", + "extensionAttributes": [], + "name": "DSDECOD", + "label": "DSDECOD", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3070", + "instanceType": "ResponseCode", + "name": "SITE TRANSFER", + "label": "SITE TRANSFER", + "isEnabled": true, + "code": { + "id": "Code_43425", + "extensionAttributes": [], + "code": "C186208", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SITE TRANSFER", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37657", + "standardCode": { + "id": "Code_44944", + "extensionAttributes": [], + "code": "C82977", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_611", + "extensionAttributes": [], + "name": "DSTERM", + "label": "DSTERM", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37658", + "standardCode": { + "id": "Code_44945", + "extensionAttributes": [], + "code": "C82571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_612", + "extensionAttributes": [], + "name": "DSSTDTC", + "label": "DSSTDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37659", + "standardCode": { + "id": "Code_44946", + "extensionAttributes": [], + "code": "C82517", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_1753", + "extensionAttributes": [], + "standardCode": { + "id": "Code_1943", + "extensionAttributes": [], + "code": "C186208", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Study Site Transfer", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_147", + "extensionAttributes": [], + "name": "Study Terminated By Sponsor", + "label": "Study Terminated By Sponsor", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/C49632", + "properties": [], + "code": { + "id": "AliasCode_1758", + "extensionAttributes": [], + "standardCode": { + "id": "Code_1948", + "extensionAttributes": [], + "code": "C49632", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Study Terminated By Sponsor", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_148", + "extensionAttributes": [], + "name": "Subject Removed at Sponsor Request", + "label": "Subject Removed at Sponsor Request", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/C161410", + "properties": [], + "code": { + "id": "AliasCode_29205", + "extensionAttributes": [], + "standardCode": { + "id": "Code_33323", + "extensionAttributes": [], + "code": "C161410", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Subject Removed at Sponsor Request [RETIRED]", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_149", + "extensionAttributes": [], + "name": "Trial Screen Failure", + "label": "Trial Screen Failure", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/C49628", + "properties": [], + "code": { + "id": "AliasCode_1760", + "extensionAttributes": [], + "standardCode": { + "id": "Code_1950", + "extensionAttributes": [], + "code": "C49628", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Trial Screen Failure", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_150", + "extensionAttributes": [], + "name": "Trial Site Terminated by Sponsor", + "label": "Trial Site Terminated by Sponsor", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/C106576", + "properties": [], + "code": { + "id": "AliasCode_1761", + "extensionAttributes": [], + "standardCode": { + "id": "Code_1951", + "extensionAttributes": [], + "code": "C106576", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Trial Site Terminated by Sponsor", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_151", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_115", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/SUBJWITHDRAW", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Withdrawal by Subject", + "label": "Withdrawal by Subject", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/C49634", + "properties": [], + "code": { + "id": "AliasCode_1762", + "extensionAttributes": [], + "standardCode": { + "id": "Code_1952", + "extensionAttributes": [], + "code": "C49634", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Withdrawal by Subject", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_152", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_116", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/CONSWDRL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Withdrawal of Consent From Protocol-Specified Activity", + "label": "Withdrawal of Consent From Protocol-Specified Activity", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/C170610", + "properties": [ + { + "id": "BiomedicalConceptProperty_613", + "extensionAttributes": [], + "name": "DSDECOD", + "label": "DSDECOD", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2825", + "instanceType": "ResponseCode", + "name": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY", + "label": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY", + "isEnabled": true, + "code": { + "id": "Code_39422", + "extensionAttributes": [], + "code": "C170610", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37660", + "standardCode": { + "id": "Code_44947", + "extensionAttributes": [], + "code": "C82977", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_614", + "extensionAttributes": [], + "name": "DSTERM", + "label": "DSTERM", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2879", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_41428", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37661", + "standardCode": { + "id": "Code_44948", + "extensionAttributes": [], + "code": "C82571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_615", + "extensionAttributes": [], + "name": "DSSTDTC", + "label": "DSSTDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37662", + "standardCode": { + "id": "Code_44949", + "extensionAttributes": [], + "code": "C82517", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_33098", + "extensionAttributes": [], + "standardCode": { + "id": "Code_39422", + "extensionAttributes": [], + "code": "C170610", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_153", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_117", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/SYSBP", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Systolic Blood Pressure", + "label": "Systolic Blood Pressure", + "synonyms": [ + "SYSBP" + ], + "reference": "/mdr/bc/biomedicalconcepts/C25298", + "properties": [ + { + "id": "BiomedicalConceptProperty_616", + "extensionAttributes": [], + "name": "VSORRES", + "label": "VSORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [ + { + "id": "ResponseCode_2509", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_32836", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37663", + "standardCode": { + "id": "Code_44950", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_617", + "extensionAttributes": [], + "name": "VSORRESU", + "label": "VSORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3071", + "instanceType": "ResponseCode", + "name": "mmHg", + "label": "mmHg", + "isEnabled": true, + "code": { + "id": "Code_43433", + "extensionAttributes": [], + "code": "C49670", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "mmHg", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37664", + "standardCode": { + "id": "Code_44951", + "extensionAttributes": [], + "code": "C49669", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Pressure", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_618", + "extensionAttributes": [], + "name": "VSPOS", + "label": "VSPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37665", + "standardCode": { + "id": "Code_44952", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_619", + "extensionAttributes": [], + "name": "VSLOC", + "label": "VSLOC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37666", + "standardCode": { + "id": "Code_44953", + "extensionAttributes": [], + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_620", + "extensionAttributes": [], + "name": "VSLAT", + "label": "VSLAT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37667", + "standardCode": { + "id": "Code_44954", + "extensionAttributes": [], + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_621", + "extensionAttributes": [], + "name": "VSDTC", + "label": "VSDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37668", + "standardCode": { + "id": "Code_44955", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_1834", + "extensionAttributes": [], + "standardCode": { + "id": "Code_2024", + "extensionAttributes": [], + "code": "C25298", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Systolic Blood Pressure", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_154", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_118", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/DIABP", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Diastolic Blood Pressure", + "label": "Diastolic Blood Pressure", + "synonyms": [ + "DIABP" + ], + "reference": "/mdr/bc/biomedicalconcepts/C25299", + "properties": [ + { + "id": "BiomedicalConceptProperty_838", + "extensionAttributes": [], + "name": "VSORRES", + "label": "VSORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37888", + "standardCode": { + "id": "Code_45175", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_839", + "extensionAttributes": [], + "name": "VSORRESU", + "label": "VSORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3087", + "instanceType": "ResponseCode", + "name": "mmHg", + "label": "mmHg", + "isEnabled": true, + "code": { + "id": "Code_45177", + "extensionAttributes": [], + "code": "C49670", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "mmHg", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37889", + "standardCode": { + "id": "Code_45176", + "extensionAttributes": [], + "code": "C49669", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Pressure", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_840", + "extensionAttributes": [], + "name": "VSPOS", + "label": "VSPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37891", + "standardCode": { + "id": "Code_45178", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_841", + "extensionAttributes": [], + "name": "VSLOC", + "label": "VSLOC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37892", + "standardCode": { + "id": "Code_45179", + "extensionAttributes": [], + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_842", + "extensionAttributes": [], + "name": "VSLAT", + "label": "VSLAT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37893", + "standardCode": { + "id": "Code_45180", + "extensionAttributes": [], + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_843", + "extensionAttributes": [], + "name": "VSDTC", + "label": "VSDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37894", + "standardCode": { + "id": "Code_45181", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_26219", + "extensionAttributes": [], + "standardCode": { + "id": "Code_30337", + "extensionAttributes": [], + "code": "C25299", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Diastolic Blood Pressure", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_155", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_119", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/HR", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Heart Rate", + "label": "Heart Rate", + "synonyms": [ + "HR" + ], + "reference": "/mdr/bc/biomedicalconcepts/C49677", + "properties": [ + { + "id": "BiomedicalConceptProperty_628", + "extensionAttributes": [], + "name": "VSORRES", + "label": "VSORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37675", + "standardCode": { + "id": "Code_44962", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_629", + "extensionAttributes": [], + "name": "VSORRESU", + "label": "VSORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3072", + "instanceType": "ResponseCode", + "name": "beats/min", + "label": "beats/min", + "isEnabled": true, + "code": { + "id": "Code_43446", + "extensionAttributes": [], + "code": "C49673", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "beats/min", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37676", + "standardCode": { + "id": "Code_44963", + "extensionAttributes": [], + "code": "C73688", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Count per Minute", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_630", + "extensionAttributes": [], + "name": "VSPOS", + "label": "VSPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37677", + "standardCode": { + "id": "Code_44964", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_631", + "extensionAttributes": [], + "name": "VSLOC", + "label": "VSLOC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37678", + "standardCode": { + "id": "Code_44965", + "extensionAttributes": [], + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_632", + "extensionAttributes": [], + "name": "VSLAT", + "label": "VSLAT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37679", + "standardCode": { + "id": "Code_44966", + "extensionAttributes": [], + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_633", + "extensionAttributes": [], + "name": "VSDTC", + "label": "VSDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [ + { + "id": "ResponseCode_2885", + "instanceType": "ResponseCode", + "name": "fL", + "label": "fL", + "isEnabled": true, + "code": { + "id": "Code_41453", + "extensionAttributes": [], + "code": "C64780", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "fL", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37680", + "standardCode": { + "id": "Code_44967", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_1833", + "extensionAttributes": [], + "standardCode": { + "id": "Code_2023", + "extensionAttributes": [], + "code": "C49677", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Heart Rate", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_156", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_120", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/SYSBP", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Systolic Blood Pressure", + "label": "Systolic Blood Pressure", + "synonyms": [ + "SYSBP" + ], + "reference": "/mdr/bc/biomedicalconcepts/C25298", + "properties": [ + { + "id": "BiomedicalConceptProperty_634", + "extensionAttributes": [], + "name": "VSORRES", + "label": "VSORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [ + { + "id": "ResponseCode_2886", + "instanceType": "ResponseCode", + "name": "ERYTHROCYTES", + "label": "ERYTHROCYTES", + "isEnabled": true, + "code": { + "id": "Code_41455", + "extensionAttributes": [], + "code": "C12521", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "ERYTHROCYTES", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37681", + "standardCode": { + "id": "Code_44968", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_635", + "extensionAttributes": [], + "name": "VSORRESU", + "label": "VSORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2827", + "instanceType": "ResponseCode", + "name": "mmHg", + "label": "mmHg", + "isEnabled": true, + "code": { + "id": "Code_39446", + "extensionAttributes": [], + "code": "C49670", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "mmHg", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37682", + "standardCode": { + "id": "Code_44969", + "extensionAttributes": [], + "code": "C49669", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Pressure", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_636", + "extensionAttributes": [], + "name": "VSPOS", + "label": "VSPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37683", + "standardCode": { + "id": "Code_44970", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_637", + "extensionAttributes": [], + "name": "VSLOC", + "label": "VSLOC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37684", + "standardCode": { + "id": "Code_44971", + "extensionAttributes": [], + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_638", + "extensionAttributes": [], + "name": "VSLAT", + "label": "VSLAT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37685", + "standardCode": { + "id": "Code_44972", + "extensionAttributes": [], + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_639", + "extensionAttributes": [], + "name": "VSDTC", + "label": "VSDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37686", + "standardCode": { + "id": "Code_44973", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_1834", + "extensionAttributes": [], + "standardCode": { + "id": "Code_2024", + "extensionAttributes": [], + "code": "C25298", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Systolic Blood Pressure", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_157", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_121", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/DIABP", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Diastolic Blood Pressure", + "label": "Diastolic Blood Pressure", + "synonyms": [ + "DIABP" + ], + "reference": "/mdr/bc/biomedicalconcepts/C25299", + "properties": [ + { + "id": "BiomedicalConceptProperty_640", + "extensionAttributes": [], + "name": "VSORRES", + "label": "VSORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37687", + "standardCode": { + "id": "Code_44974", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_641", + "extensionAttributes": [], + "name": "VSORRESU", + "label": "VSORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3073", + "instanceType": "ResponseCode", + "name": "mmHg", + "label": "mmHg", + "isEnabled": true, + "code": { + "id": "Code_43459", + "extensionAttributes": [], + "code": "C49670", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "mmHg", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37688", + "standardCode": { + "id": "Code_44975", + "extensionAttributes": [], + "code": "C49669", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Pressure", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_642", + "extensionAttributes": [], + "name": "VSPOS", + "label": "VSPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37689", + "standardCode": { + "id": "Code_44976", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_643", + "extensionAttributes": [], + "name": "VSLOC", + "label": "VSLOC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37690", + "standardCode": { + "id": "Code_44977", + "extensionAttributes": [], + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_644", + "extensionAttributes": [], + "name": "VSLAT", + "label": "VSLAT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2888", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_41467", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37691", + "standardCode": { + "id": "Code_44978", + "extensionAttributes": [], + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_645", + "extensionAttributes": [], + "name": "VSDTC", + "label": "VSDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37692", + "standardCode": { + "id": "Code_44979", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_26219", + "extensionAttributes": [], + "standardCode": { + "id": "Code_30337", + "extensionAttributes": [], + "code": "C25299", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Diastolic Blood Pressure", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_158", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_122", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/HR", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Heart Rate", + "label": "Heart Rate", + "synonyms": [ + "HR" + ], + "reference": "/mdr/bc/biomedicalconcepts/C49677", + "properties": [ + { + "id": "BiomedicalConceptProperty_646", + "extensionAttributes": [], + "name": "VSORRES", + "label": "VSORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37693", + "standardCode": { + "id": "Code_44980", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_647", + "extensionAttributes": [], + "name": "VSORRESU", + "label": "VSORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3074", + "instanceType": "ResponseCode", + "name": "beats/min", + "label": "beats/min", + "isEnabled": true, + "code": { + "id": "Code_43466", + "extensionAttributes": [], + "code": "C49673", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "beats/min", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37694", + "standardCode": { + "id": "Code_44981", + "extensionAttributes": [], + "code": "C73688", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Count per Minute", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_648", + "extensionAttributes": [], + "name": "VSPOS", + "label": "VSPOS", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37695", + "standardCode": { + "id": "Code_44982", + "extensionAttributes": [], + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_649", + "extensionAttributes": [], + "name": "VSLOC", + "label": "VSLOC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37696", + "standardCode": { + "id": "Code_44983", + "extensionAttributes": [], + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_650", + "extensionAttributes": [], + "name": "VSLAT", + "label": "VSLAT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37697", + "standardCode": { + "id": "Code_44984", + "extensionAttributes": [], + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_651", + "extensionAttributes": [], + "name": "VSDTC", + "label": "VSDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37698", + "standardCode": { + "id": "Code_44985", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_1833", + "extensionAttributes": [], + "standardCode": { + "id": "Code_2023", + "extensionAttributes": [], + "code": "C49677", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Heart Rate", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_159", + "extensionAttributes": [], + "name": "Isometric Muscle Strength", + "label": "Isometric Muscle Strength", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/C138967", + "properties": [], + "code": { + "id": "AliasCode_2312", + "extensionAttributes": [], + "standardCode": { + "id": "Code_2502", + "extensionAttributes": [], + "code": "C138967", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Isometric Muscle Strength", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_160", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_129", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/SMMASS", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Skeletal Muscle Mass Measurement", + "label": "Skeletal Muscle Mass Measurement", + "synonyms": [ + "SMMASS", + "Skeletal Muscle Mass" + ], + "reference": "/mdr/bc/biomedicalconcepts/C178017", + "properties": [ + { + "id": "BiomedicalConceptProperty_652", + "extensionAttributes": [], + "name": "MKORRES", + "label": "MKORRES", + "isRequired": false, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37699", + "standardCode": { + "id": "Code_44986", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_653", + "extensionAttributes": [], + "name": "MKORRESU", + "label": "MKORRESU", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2890", + "instanceType": "ResponseCode", + "name": "10^9/L", + "label": "10^9/L", + "isEnabled": true, + "code": { + "id": "Code_41478", + "extensionAttributes": [], + "code": "C67255", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "10^9/L", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37700", + "standardCode": { + "id": "Code_44987", + "extensionAttributes": [], + "code": "C42579", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Mass", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_654", + "extensionAttributes": [], + "name": "MKLOC", + "label": "MKLOC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2891", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_41480", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37701", + "standardCode": { + "id": "Code_44988", + "extensionAttributes": [], + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_655", + "extensionAttributes": [], + "name": "MKLAT", + "label": "MKLAT", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37702", + "standardCode": { + "id": "Code_44989", + "extensionAttributes": [], + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_656", + "extensionAttributes": [], + "name": "MKMETHOD", + "label": "MKMETHOD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37703", + "standardCode": { + "id": "Code_44990", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_657", + "extensionAttributes": [], + "name": "MKDTC", + "label": "MKDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37704", + "standardCode": { + "id": "Code_44991", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_2313", + "extensionAttributes": [], + "standardCode": { + "id": "Code_2503", + "extensionAttributes": [], + "code": "C178017", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Skeletal Muscle Mass Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_161", + "extensionAttributes": [], + "name": "Muscle Endurance Measurement", + "label": "Muscle Endurance Measurement", + "synonyms": [ + "ENDURM", + "Muscle Endurance" + ], + "reference": "/mdr/bc/biomedicalconcepts/C181501", + "properties": [ + { + "id": "BiomedicalConceptProperty_844", + "extensionAttributes": [], + "name": "Observation Result", + "label": "Observation Result", + "isRequired": true, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37895", + "standardCode": { + "id": "Code_45182", + "extensionAttributes": [], + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Observation Result", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_845", + "extensionAttributes": [], + "name": "Unit of Time", + "label": "Unit of Time", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37896", + "standardCode": { + "id": "Code_45183", + "extensionAttributes": [], + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Unit of Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_846", + "extensionAttributes": [], + "name": "Anatomic Site", + "label": "Anatomic Site", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37897", + "standardCode": { + "id": "Code_45184", + "extensionAttributes": [], + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Anatomic Site", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_847", + "extensionAttributes": [], + "name": "Laterality", + "label": "Laterality", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37898", + "standardCode": { + "id": "Code_45185", + "extensionAttributes": [], + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Laterality", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_848", + "extensionAttributes": [], + "name": "Test Method", + "label": "Test Method", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37899", + "standardCode": { + "id": "Code_45186", + "extensionAttributes": [], + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Test Method", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_849", + "extensionAttributes": [], + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37900", + "standardCode": { + "id": "Code_45187", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24620", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28738", + "extensionAttributes": [], + "code": "C181501", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Muscle Endurance Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_162", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_139", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/EGCTMON", + "instanceType": "ExtensionAttribute" + } + ], + "name": "ECG Continuous Monitoring Indicator", + "label": "ECG Continuous Monitoring Indicator", + "synonyms": [ + "ECG Continuous Monitoring", + "EGCTMON" + ], + "reference": "/mdr/bc/biomedicalconcepts/C119561", + "properties": [ + { + "id": "BiomedicalConceptProperty_850", + "extensionAttributes": [], + "name": "TSPARMCD", + "label": "TSPARMCD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3088", + "instanceType": "ResponseCode", + "name": "EGCTMON", + "label": "EGCTMON", + "isEnabled": true, + "code": { + "id": "Code_45189", + "extensionAttributes": [], + "code": "C119561", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "EGCTMON", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37901", + "standardCode": { + "id": "Code_45188", + "extensionAttributes": [], + "code": "C83445", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Code", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_851", + "extensionAttributes": [], + "name": "TSPARM", + "label": "TSPARM", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3089", + "instanceType": "ResponseCode", + "name": "ECG Continuous Monitoring", + "label": "ECG Continuous Monitoring", + "isEnabled": true, + "code": { + "id": "Code_45191", + "extensionAttributes": [], + "code": "C119561", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "ECG Continuous Monitoring", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37903", + "standardCode": { + "id": "Code_45190", + "extensionAttributes": [], + "code": "C49691", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_852", + "extensionAttributes": [], + "name": "TSVAL", + "label": "TSVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37905", + "standardCode": { + "id": "Code_45192", + "extensionAttributes": [], + "code": "C83447", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Value", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_853", + "extensionAttributes": [], + "name": "TSVALCD", + "label": "TSVALCD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37906", + "standardCode": { + "id": "Code_45193", + "extensionAttributes": [], + "code": "C117458", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Value Code", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_854", + "extensionAttributes": [], + "name": "TSVCDREF", + "label": "TSVCDREF", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37907", + "standardCode": { + "id": "Code_45194", + "extensionAttributes": [], + "code": "C117460", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Name of the Reference Terminology", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_855", + "extensionAttributes": [], + "name": "TSVCDVER", + "label": "TSVCDVER", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37908", + "standardCode": { + "id": "Code_45195", + "extensionAttributes": [], + "code": "C117461", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Version of the Reference Terminology", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_2311", + "extensionAttributes": [], + "standardCode": { + "id": "Code_2501", + "extensionAttributes": [], + "code": "C119561", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "ECG Continuous Monitoring Indicator", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_164", + "extensionAttributes": [], + "name": "TTS Acceptability Survey", + "label": "TTS Acceptability Survey", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/NEW_LZZT", + "properties": [ + { + "id": "BiomedicalConceptProperty_670", + "extensionAttributes": [], + "name": "Category", + "label": "Category", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3075", + "instanceType": "ResponseCode", + "name": "EGCTMON", + "label": "EGCTMON", + "isEnabled": true, + "code": { + "id": "Code_43490", + "extensionAttributes": [], + "code": "C119561", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "EGCTMON", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37717", + "standardCode": { + "id": "Code_45004", + "extensionAttributes": [], + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Category", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_671", + "extensionAttributes": [], + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [ + { + "id": "ResponseCode_3076", + "instanceType": "ResponseCode", + "name": "ECG Continuous Monitoring", + "label": "ECG Continuous Monitoring", + "isEnabled": true, + "code": { + "id": "Code_43492", + "extensionAttributes": [], + "code": "C119561", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "ECG Continuous Monitoring", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37718", + "standardCode": { + "id": "Code_45005", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_672", + "extensionAttributes": [], + "name": "Test Occurrence", + "label": "Test Occurrence", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37719", + "standardCode": { + "id": "Code_45006", + "extensionAttributes": [], + "code": "C82525", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Test Occurrence", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24604", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28722", + "extensionAttributes": [], + "code": "NEW_LZZT", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "TTS Acceptability Survey", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_165", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_141", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/MRIBRAIN", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Magnetic Resonance Imaging", + "label": "Magnetic Resonance Imaging", + "synonyms": [ + "Magnetic Resonance", + "MRI", + "MRI Scan", + "NMR", + "NMR Imaging" + ], + "reference": "/mdr/bc/biomedicalconcepts/C16809", + "properties": [ + { + "id": "BiomedicalConceptProperty_862", + "extensionAttributes": [], + "name": "PRTRT", + "label": "PRTRT", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37917", + "standardCode": { + "id": "Code_45204", + "extensionAttributes": [], + "code": "C117511", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Reported Name of Procedure", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_863", + "extensionAttributes": [], + "name": "PRDECOD", + "label": "PRDECOD", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3092", + "instanceType": "ResponseCode", + "name": "MRI", + "label": "MRI", + "isEnabled": true, + "code": { + "id": "Code_45206", + "extensionAttributes": [], + "code": "C16809", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "MRI", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37918", + "standardCode": { + "id": "Code_45205", + "extensionAttributes": [], + "code": "C117512", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Standardized Name of Procedure", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_864", + "extensionAttributes": [], + "name": "PRPRESP", + "label": "PRPRESP", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37920", + "standardCode": { + "id": "Code_45207", + "extensionAttributes": [], + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Prespecified Event or Intervention Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_865", + "extensionAttributes": [], + "name": "PROCCUR", + "label": "PROCCUR", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37921", + "standardCode": { + "id": "Code_45208", + "extensionAttributes": [], + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Occurrence Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_866", + "extensionAttributes": [], + "name": "PRLOC", + "label": "PRLOC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3093", + "instanceType": "ResponseCode", + "name": "BRAIN", + "label": "BRAIN", + "isEnabled": true, + "code": { + "id": "Code_45210", + "extensionAttributes": [], + "code": "C12439", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "BRAIN", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37922", + "standardCode": { + "id": "Code_45209", + "extensionAttributes": [], + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Anatomic Site", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_867", + "extensionAttributes": [], + "name": "PRSTDTC", + "label": "PRSTDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37924", + "standardCode": { + "id": "Code_45211", + "extensionAttributes": [], + "code": "C117529", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Start Date and Time of Procedure", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_868", + "extensionAttributes": [], + "name": "PRENDTC", + "label": "PRENDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37925", + "standardCode": { + "id": "Code_45212", + "extensionAttributes": [], + "code": "C117530", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "End Date and Time of Procedure", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_15783", + "extensionAttributes": [], + "standardCode": { + "id": "Code_16598", + "extensionAttributes": [], + "code": "C16809", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "MRI", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_166", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_142", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/CTSCAN", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Computed Tomography", + "label": "Computed Tomography", + "synonyms": [ + "CAT Scan", + "Computed Axial Tomography", + "Computed Tomography", + "Computerized Tomography", + "CT" + ], + "reference": "/mdr/bc/biomedicalconcepts/C17204", + "properties": [ + { + "id": "BiomedicalConceptProperty_869", + "extensionAttributes": [], + "name": "PRTRT", + "label": "PRTRT", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37926", + "standardCode": { + "id": "Code_45213", + "extensionAttributes": [], + "code": "C117511", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Name of Procedure", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_870", + "extensionAttributes": [], + "name": "PRDECOD", + "label": "PRDECOD", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3094", + "instanceType": "ResponseCode", + "name": "CT SCAN", + "label": "CT SCAN", + "isEnabled": true, + "code": { + "id": "Code_45215", + "extensionAttributes": [], + "code": "C17204", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "CT SCAN", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37927", + "standardCode": { + "id": "Code_45214", + "extensionAttributes": [], + "code": "C117512", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Standardized Name of Procedure", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_871", + "extensionAttributes": [], + "name": "PRPRESP", + "label": "PRPRESP", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37929", + "standardCode": { + "id": "Code_45216", + "extensionAttributes": [], + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Prespecified Event or Intervention Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_872", + "extensionAttributes": [], + "name": "PROCCUR", + "label": "PROCCUR", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37930", + "standardCode": { + "id": "Code_45217", + "extensionAttributes": [], + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Occurrence Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_873", + "extensionAttributes": [], + "name": "PRLOC", + "label": "PRLOC", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37931", + "standardCode": { + "id": "Code_45218", + "extensionAttributes": [], + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_874", + "extensionAttributes": [], + "name": "PRSTDTC", + "label": "PRSTDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37932", + "standardCode": { + "id": "Code_45219", + "extensionAttributes": [], + "code": "C117529", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Start Date and Time of Procedure", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_875", + "extensionAttributes": [], + "name": "PRENDTC", + "label": "PRENDTC", + "isRequired": false, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37933", + "standardCode": { + "id": "Code_45220", + "extensionAttributes": [], + "code": "C117530", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "End Date and Time of Procedure", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_28017", + "extensionAttributes": [], + "standardCode": { + "id": "Code_32135", + "extensionAttributes": [], + "code": "C17204", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "CT SCAN", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_168", + "extensionAttributes": [], + "name": "Vital Signs Measurement", + "label": "Vital Signs Measurement", + "synonyms": [ + "Vital Signs", + "VS" + ], + "reference": "/mdr/bc/biomedicalconcepts/C49672", + "properties": [], + "code": { + "id": "AliasCode_24621", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28739", + "extensionAttributes": [], + "code": "C49672", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Vital Signs Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_169", + "extensionAttributes": [], + "name": "Vital Signs Measurement", + "label": "Vital Signs Measurement", + "synonyms": [ + "Vital Signs", + "VS" + ], + "reference": "/mdr/bc/biomedicalconcepts/C49672", + "properties": [], + "code": { + "id": "AliasCode_24621", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28739", + "extensionAttributes": [], + "code": "C49672", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Vital Signs Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_170", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_143", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/ADVEVENT", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Adverse Event [RETIRED]", + "label": "Adverse Event [RETIRED]", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/C41331", + "properties": [], + "code": { + "id": "AliasCode_24616", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28734", + "extensionAttributes": [], + "code": "C41331", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Adverse Event [RETIRED]", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_171", + "extensionAttributes": [], + "name": "Adverse Event Yes No Indicator", + "label": "Adverse Event Yes No Indicator", + "synonyms": [ + "AEYN" + ], + "reference": "/mdr/bc/biomedicalconcepts/C83347", + "properties": [ + { + "id": "BiomedicalConceptProperty_687", + "extensionAttributes": [], + "name": "Adverse Event Yes No Indicator", + "label": "Adverse Event Yes No Indicator", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3078", + "instanceType": "ResponseCode", + "name": "CT SCAN", + "label": "CT SCAN", + "isEnabled": true, + "code": { + "id": "Code_43510", + "extensionAttributes": [], + "code": "C17204", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "CT SCAN", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37734", + "standardCode": { + "id": "Code_45021", + "extensionAttributes": [], + "code": "C83347", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Yes No Indicator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_688", + "extensionAttributes": [], + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37735", + "standardCode": { + "id": "Code_45022", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24609", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28727", + "extensionAttributes": [], + "code": "C83347", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Yes No Indicator", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_172", + "extensionAttributes": [], + "name": "CDISC ADAS-Cog - Word Recall Average Score", + "label": "CDISC ADAS-Cog - Word Recall Average Score", + "synonyms": [ + "ADCRL", + "Word Recall", + "CDISC ADAS-Cog - Word Recall Average Score" + ], + "reference": "/mdr/bc/biomedicalconcepts/C100177", + "properties": [ + { + "id": "BiomedicalConceptProperty_689", + "extensionAttributes": [], + "name": "Evaluator", + "label": "Evaluator", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37736", + "standardCode": { + "id": "Code_45023", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_690", + "extensionAttributes": [], + "name": "Ordinal Position", + "label": "Ordinal Position", + "isRequired": true, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37737", + "standardCode": { + "id": "Code_45024", + "extensionAttributes": [], + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_691", + "extensionAttributes": [], + "name": "Completion Status", + "label": "Completion Status", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37738", + "standardCode": { + "id": "Code_45025", + "extensionAttributes": [], + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_692", + "extensionAttributes": [], + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2901", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_41528", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37739", + "standardCode": { + "id": "Code_45026", + "extensionAttributes": [], + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_693", + "extensionAttributes": [], + "name": "Subcategory", + "label": "Subcategory", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2714", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_37767", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37740", + "standardCode": { + "id": "Code_45027", + "extensionAttributes": [], + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_694", + "extensionAttributes": [], + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "isRequired": true, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37741", + "standardCode": { + "id": "Code_45028", + "extensionAttributes": [], + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_695", + "extensionAttributes": [], + "name": "Category", + "label": "Category", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37742", + "standardCode": { + "id": "Code_45029", + "extensionAttributes": [], + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_696", + "extensionAttributes": [], + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37743", + "standardCode": { + "id": "Code_45030", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24622", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28740", + "extensionAttributes": [], + "code": "C100177", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Word Recall Average Score", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_173", + "extensionAttributes": [], + "name": "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score", + "label": "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score", + "synonyms": [ + "ADCOF", + "Naming Objects and Fingers", + "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score" + ], + "reference": "/mdr/bc/biomedicalconcepts/C100191", + "properties": [ + { + "id": "BiomedicalConceptProperty_697", + "extensionAttributes": [], + "name": "Ordinal Position", + "label": "Ordinal Position", + "isRequired": true, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37744", + "standardCode": { + "id": "Code_45031", + "extensionAttributes": [], + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_698", + "extensionAttributes": [], + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37745", + "standardCode": { + "id": "Code_45032", + "extensionAttributes": [], + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_699", + "extensionAttributes": [], + "name": "Evaluator", + "label": "Evaluator", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2715", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_37774", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37746", + "standardCode": { + "id": "Code_45033", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_700", + "extensionAttributes": [], + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37747", + "standardCode": { + "id": "Code_45034", + "extensionAttributes": [], + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_701", + "extensionAttributes": [], + "name": "Completion Status", + "label": "Completion Status", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2903", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_41539", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37748", + "standardCode": { + "id": "Code_45035", + "extensionAttributes": [], + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_702", + "extensionAttributes": [], + "name": "Subcategory", + "label": "Subcategory", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37749", + "standardCode": { + "id": "Code_45036", + "extensionAttributes": [], + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_703", + "extensionAttributes": [], + "name": "Category", + "label": "Category", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37750", + "standardCode": { + "id": "Code_45037", + "extensionAttributes": [], + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_704", + "extensionAttributes": [], + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37751", + "standardCode": { + "id": "Code_45038", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_27242", + "extensionAttributes": [], + "standardCode": { + "id": "Code_31360", + "extensionAttributes": [], + "code": "C100191", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_174", + "extensionAttributes": [], + "name": "CDISC ADAS-Cog - Commands Summary Score", + "label": "CDISC ADAS-Cog - Commands Summary Score", + "synonyms": [ + "ADCCMD", + "Commands", + "CDISC ADAS-Cog - Commands Summary Score" + ], + "reference": "/mdr/bc/biomedicalconcepts/C100209", + "properties": [ + { + "id": "BiomedicalConceptProperty_705", + "extensionAttributes": [], + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37752", + "standardCode": { + "id": "Code_45039", + "extensionAttributes": [], + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_706", + "extensionAttributes": [], + "name": "Category", + "label": "Category", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37753", + "standardCode": { + "id": "Code_45040", + "extensionAttributes": [], + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_707", + "extensionAttributes": [], + "name": "Subcategory", + "label": "Subcategory", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37754", + "standardCode": { + "id": "Code_45041", + "extensionAttributes": [], + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_708", + "extensionAttributes": [], + "name": "Completion Status", + "label": "Completion Status", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37755", + "standardCode": { + "id": "Code_45042", + "extensionAttributes": [], + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_709", + "extensionAttributes": [], + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2717", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_37786", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37756", + "standardCode": { + "id": "Code_45043", + "extensionAttributes": [], + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_710", + "extensionAttributes": [], + "name": "Evaluator", + "label": "Evaluator", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2905", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_41550", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37757", + "standardCode": { + "id": "Code_45044", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_711", + "extensionAttributes": [], + "name": "Ordinal Position", + "label": "Ordinal Position", + "isRequired": true, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37758", + "standardCode": { + "id": "Code_45045", + "extensionAttributes": [], + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_712", + "extensionAttributes": [], + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37759", + "standardCode": { + "id": "Code_45046", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24623", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28741", + "extensionAttributes": [], + "code": "C100209", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Commands Summary Score", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_175", + "extensionAttributes": [], + "name": "CDISC ADAS-Cog - Delayed Word Recall Summary Score", + "label": "CDISC ADAS-Cog - Delayed Word Recall Summary Score", + "synonyms": [ + "ADCDRL", + "Delayed Word Recall", + "CDISC ADAS-Cog - Delayed Word Recall Summary Score" + ], + "reference": "/mdr/bc/biomedicalconcepts/C100215", + "properties": [ + { + "id": "BiomedicalConceptProperty_876", + "extensionAttributes": [], + "name": "Ordinal Position", + "label": "Ordinal Position", + "isRequired": true, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37934", + "standardCode": { + "id": "Code_45221", + "extensionAttributes": [], + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_877", + "extensionAttributes": [], + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "isRequired": true, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37935", + "standardCode": { + "id": "Code_45222", + "extensionAttributes": [], + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_878", + "extensionAttributes": [], + "name": "Category", + "label": "Category", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37936", + "standardCode": { + "id": "Code_45223", + "extensionAttributes": [], + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_879", + "extensionAttributes": [], + "name": "Subcategory", + "label": "Subcategory", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37937", + "standardCode": { + "id": "Code_45224", + "extensionAttributes": [], + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_880", + "extensionAttributes": [], + "name": "Completion Status", + "label": "Completion Status", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37938", + "standardCode": { + "id": "Code_45225", + "extensionAttributes": [], + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_881", + "extensionAttributes": [], + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37939", + "standardCode": { + "id": "Code_45226", + "extensionAttributes": [], + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_882", + "extensionAttributes": [], + "name": "Evaluator", + "label": "Evaluator", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37940", + "standardCode": { + "id": "Code_45227", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_883", + "extensionAttributes": [], + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37941", + "standardCode": { + "id": "Code_45228", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_27243", + "extensionAttributes": [], + "standardCode": { + "id": "Code_31361", + "extensionAttributes": [], + "code": "C100215", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Delayed Word Recall Summary Score", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_176", + "extensionAttributes": [], + "name": "CDISC ADAS-Cog - Constructional Praxis Summary Score", + "label": "CDISC ADAS-Cog - Constructional Praxis Summary Score", + "synonyms": [ + "ADCCP", + "Constructional Praxis", + "CDISC ADAS-Cog - Constructional Praxis Summary Score" + ], + "reference": "/mdr/bc/biomedicalconcepts/C100226", + "properties": [ + { + "id": "BiomedicalConceptProperty_721", + "extensionAttributes": [], + "name": "Evaluator", + "label": "Evaluator", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37768", + "standardCode": { + "id": "Code_45055", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_722", + "extensionAttributes": [], + "name": "Completion Status", + "label": "Completion Status", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2908", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_41565", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37769", + "standardCode": { + "id": "Code_45056", + "extensionAttributes": [], + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_723", + "extensionAttributes": [], + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [ + { + "id": "ResponseCode_2720", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_37803", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37770", + "standardCode": { + "id": "Code_45057", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_724", + "extensionAttributes": [], + "name": "Category", + "label": "Category", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37771", + "standardCode": { + "id": "Code_45058", + "extensionAttributes": [], + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_725", + "extensionAttributes": [], + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37772", + "standardCode": { + "id": "Code_45059", + "extensionAttributes": [], + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_726", + "extensionAttributes": [], + "name": "Ordinal Position", + "label": "Ordinal Position", + "isRequired": true, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37773", + "standardCode": { + "id": "Code_45060", + "extensionAttributes": [], + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_727", + "extensionAttributes": [], + "name": "Subcategory", + "label": "Subcategory", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37774", + "standardCode": { + "id": "Code_45061", + "extensionAttributes": [], + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_728", + "extensionAttributes": [], + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37775", + "standardCode": { + "id": "Code_45062", + "extensionAttributes": [], + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_27244", + "extensionAttributes": [], + "standardCode": { + "id": "Code_31362", + "extensionAttributes": [], + "code": "C100226", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Constructional Praxis Summary Score", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_177", + "extensionAttributes": [], + "name": "CDISC ADAS-Cog - Ideational Praxis Summary Score", + "label": "CDISC ADAS-Cog - Ideational Praxis Summary Score", + "synonyms": [ + "ADCIP", + "Ideational Praxis", + "CDISC ADAS-Cog - Ideational Praxis Summary Score" + ], + "reference": "/mdr/bc/biomedicalconcepts/C100232", + "properties": [ + { + "id": "BiomedicalConceptProperty_729", + "extensionAttributes": [], + "name": "Subcategory", + "label": "Subcategory", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37776", + "standardCode": { + "id": "Code_45063", + "extensionAttributes": [], + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_730", + "extensionAttributes": [], + "name": "Category", + "label": "Category", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37777", + "standardCode": { + "id": "Code_45064", + "extensionAttributes": [], + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_731", + "extensionAttributes": [], + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2910", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_41576", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37778", + "standardCode": { + "id": "Code_45065", + "extensionAttributes": [], + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_732", + "extensionAttributes": [], + "name": "Evaluator", + "label": "Evaluator", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37779", + "standardCode": { + "id": "Code_45066", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_733", + "extensionAttributes": [], + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [ + { + "id": "ResponseCode_2722", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_37815", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37780", + "standardCode": { + "id": "Code_45067", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_734", + "extensionAttributes": [], + "name": "Completion Status", + "label": "Completion Status", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37781", + "standardCode": { + "id": "Code_45068", + "extensionAttributes": [], + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_735", + "extensionAttributes": [], + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37782", + "standardCode": { + "id": "Code_45069", + "extensionAttributes": [], + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_736", + "extensionAttributes": [], + "name": "Ordinal Position", + "label": "Ordinal Position", + "isRequired": true, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37783", + "standardCode": { + "id": "Code_45070", + "extensionAttributes": [], + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24624", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28742", + "extensionAttributes": [], + "code": "C100232", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Ideational Praxis Summary Score", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_178", + "extensionAttributes": [], + "name": "CDISC ADAS-Cog - Orientation Summary Score", + "label": "CDISC ADAS-Cog - Orientation Summary Score", + "synonyms": [ + "ADCOR", + "Orientation", + "CDISC ADAS-Cog - Orientation Summary Score" + ], + "reference": "/mdr/bc/biomedicalconcepts/C100238", + "properties": [ + { + "id": "BiomedicalConceptProperty_737", + "extensionAttributes": [], + "name": "Subcategory", + "label": "Subcategory", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37784", + "standardCode": { + "id": "Code_45071", + "extensionAttributes": [], + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_738", + "extensionAttributes": [], + "name": "Completion Status", + "label": "Completion Status", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37785", + "standardCode": { + "id": "Code_45072", + "extensionAttributes": [], + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_739", + "extensionAttributes": [], + "name": "Category", + "label": "Category", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37786", + "standardCode": { + "id": "Code_45073", + "extensionAttributes": [], + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_740", + "extensionAttributes": [], + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "isRequired": true, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [ + { + "id": "ResponseCode_2912", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_41587", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37787", + "standardCode": { + "id": "Code_45074", + "extensionAttributes": [], + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_741", + "extensionAttributes": [], + "name": "Ordinal Position", + "label": "Ordinal Position", + "isRequired": true, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [ + { + "id": "ResponseCode_2724", + "instanceType": "ResponseCode", + "name": "DETECTION", + "label": "DETECTION", + "isEnabled": true, + "code": { + "id": "Code_37825", + "extensionAttributes": [], + "code": "C174330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "DETECTION", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37788", + "standardCode": { + "id": "Code_45075", + "extensionAttributes": [], + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_742", + "extensionAttributes": [], + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37789", + "standardCode": { + "id": "Code_45076", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_743", + "extensionAttributes": [], + "name": "Evaluator", + "label": "Evaluator", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37790", + "standardCode": { + "id": "Code_45077", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_744", + "extensionAttributes": [], + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37791", + "standardCode": { + "id": "Code_45078", + "extensionAttributes": [], + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_27245", + "extensionAttributes": [], + "standardCode": { + "id": "Code_31363", + "extensionAttributes": [], + "code": "C100238", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Orientation Summary Score", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_179", + "extensionAttributes": [], + "name": "CDISC ADAS-Cog - Word Recognition Summary Score", + "label": "CDISC ADAS-Cog - Word Recognition Summary Score", + "synonyms": [ + "ADCRG", + "Word Recognition", + "CDISC ADAS-Cog - Word Recognition Summary Score" + ], + "reference": "/mdr/bc/biomedicalconcepts/C100247", + "properties": [ + { + "id": "BiomedicalConceptProperty_884", + "extensionAttributes": [], + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "isRequired": true, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37942", + "standardCode": { + "id": "Code_45229", + "extensionAttributes": [], + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_885", + "extensionAttributes": [], + "name": "Subcategory", + "label": "Subcategory", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37943", + "standardCode": { + "id": "Code_45230", + "extensionAttributes": [], + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_886", + "extensionAttributes": [], + "name": "Completion Status", + "label": "Completion Status", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37944", + "standardCode": { + "id": "Code_45231", + "extensionAttributes": [], + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_887", + "extensionAttributes": [], + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37945", + "standardCode": { + "id": "Code_45232", + "extensionAttributes": [], + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_888", + "extensionAttributes": [], + "name": "Evaluator", + "label": "Evaluator", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37946", + "standardCode": { + "id": "Code_45233", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_889", + "extensionAttributes": [], + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37947", + "standardCode": { + "id": "Code_45234", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_890", + "extensionAttributes": [], + "name": "Ordinal Position", + "label": "Ordinal Position", + "isRequired": true, + "isEnabled": true, + "datatype": "decimal", + "responseCodes": [], + "code": { + "id": "AliasCode_37948", + "standardCode": { + "id": "Code_45235", + "extensionAttributes": [], + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_891", + "extensionAttributes": [], + "name": "Category", + "label": "Category", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37949", + "standardCode": { + "id": "Code_45236", + "extensionAttributes": [], + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24625", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28743", + "extensionAttributes": [], + "code": "C100247", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Word Recognition Summary Score", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_180", + "extensionAttributes": [], + "name": "CDISC ADAS-Cog - Remembering Test Instructions", + "label": "CDISC ADAS-Cog - Remembering Test Instructions", + "synonyms": [ + "ADCRI", + "Remembering Test Instructions", + "CDISC ADAS-Cog - Remembering Test Instructions" + ], + "reference": "/mdr/bc/biomedicalconcepts/C100275", + "properties": [ + { + "id": "BiomedicalConceptProperty_753", + "extensionAttributes": [], + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37800", + "standardCode": { + "id": "Code_45087", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_754", + "extensionAttributes": [], + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37801", + "standardCode": { + "id": "Code_45088", + "extensionAttributes": [], + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_755", + "extensionAttributes": [], + "name": "Completion Status", + "label": "Completion Status", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37802", + "standardCode": { + "id": "Code_45089", + "extensionAttributes": [], + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_756", + "extensionAttributes": [], + "name": "Subcategory", + "label": "Subcategory", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37803", + "standardCode": { + "id": "Code_45090", + "extensionAttributes": [], + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_757", + "extensionAttributes": [], + "name": "Category", + "label": "Category", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37804", + "standardCode": { + "id": "Code_45091", + "extensionAttributes": [], + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_758", + "extensionAttributes": [], + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37805", + "standardCode": { + "id": "Code_45092", + "extensionAttributes": [], + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_759", + "extensionAttributes": [], + "name": "Ordinal Position", + "label": "Ordinal Position", + "isRequired": true, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [ + { + "id": "ResponseCode_2916", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_41610", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37806", + "standardCode": { + "id": "Code_45093", + "extensionAttributes": [], + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_760", + "extensionAttributes": [], + "name": "Evaluator", + "label": "Evaluator", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37807", + "standardCode": { + "id": "Code_45094", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24626", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28744", + "extensionAttributes": [], + "code": "C100275", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Remembering Test Instructions", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_181", + "extensionAttributes": [], + "name": "CDISC ADAS-Cog - Spoken Language Ability", + "label": "CDISC ADAS-Cog - Spoken Language Ability", + "synonyms": [ + "ADCSL", + "Spoken Language Ability", + "CDISC ADAS-Cog - Spoken Language Ability" + ], + "reference": "/mdr/bc/biomedicalconcepts/C100276", + "properties": [ + { + "id": "BiomedicalConceptProperty_761", + "extensionAttributes": [], + "name": "Completion Status", + "label": "Completion Status", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37808", + "standardCode": { + "id": "Code_45095", + "extensionAttributes": [], + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_762", + "extensionAttributes": [], + "name": "Subcategory", + "label": "Subcategory", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37809", + "standardCode": { + "id": "Code_45096", + "extensionAttributes": [], + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_763", + "extensionAttributes": [], + "name": "Evaluator", + "label": "Evaluator", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37810", + "standardCode": { + "id": "Code_45097", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_764", + "extensionAttributes": [], + "name": "Category", + "label": "Category", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37811", + "standardCode": { + "id": "Code_45098", + "extensionAttributes": [], + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_765", + "extensionAttributes": [], + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37812", + "standardCode": { + "id": "Code_45099", + "extensionAttributes": [], + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_766", + "extensionAttributes": [], + "name": "Ordinal Position", + "label": "Ordinal Position", + "isRequired": true, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37813", + "standardCode": { + "id": "Code_45100", + "extensionAttributes": [], + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_767", + "extensionAttributes": [], + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37814", + "standardCode": { + "id": "Code_45101", + "extensionAttributes": [], + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_768", + "extensionAttributes": [], + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37815", + "standardCode": { + "id": "Code_45102", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24627", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28745", + "extensionAttributes": [], + "code": "C100276", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Spoken Language Ability", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_182", + "extensionAttributes": [], + "name": "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech", + "label": "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech", + "synonyms": [ + "ADCDIF", + "Word Finding Difficulty in Spont Speech", + "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech" + ], + "reference": "/mdr/bc/biomedicalconcepts/C100277", + "properties": [ + { + "id": "BiomedicalConceptProperty_769", + "extensionAttributes": [], + "name": "Evaluator", + "label": "Evaluator", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2732", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_37861", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37816", + "standardCode": { + "id": "Code_45103", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_770", + "extensionAttributes": [], + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2347", + "instanceType": "ResponseCode", + "name": "beats/min", + "label": "beats/min", + "isEnabled": true, + "code": { + "id": "Code_31239", + "extensionAttributes": [], + "code": "C49673", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "beats/min", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37817", + "standardCode": { + "id": "Code_45104", + "extensionAttributes": [], + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_771", + "extensionAttributes": [], + "name": "Completion Status", + "label": "Completion Status", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37818", + "standardCode": { + "id": "Code_45105", + "extensionAttributes": [], + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_772", + "extensionAttributes": [], + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37819", + "standardCode": { + "id": "Code_45106", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_773", + "extensionAttributes": [], + "name": "Ordinal Position", + "label": "Ordinal Position", + "isRequired": true, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37820", + "standardCode": { + "id": "Code_45107", + "extensionAttributes": [], + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_774", + "extensionAttributes": [], + "name": "Subcategory", + "label": "Subcategory", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37821", + "standardCode": { + "id": "Code_45108", + "extensionAttributes": [], + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_775", + "extensionAttributes": [], + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37822", + "standardCode": { + "id": "Code_45109", + "extensionAttributes": [], + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_776", + "extensionAttributes": [], + "name": "Category", + "label": "Category", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37823", + "standardCode": { + "id": "Code_45110", + "extensionAttributes": [], + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24628", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28746", + "extensionAttributes": [], + "code": "C100277", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_183", + "extensionAttributes": [], + "name": "CDISC ADAS-Cog - Comprehension", + "label": "CDISC ADAS-Cog - Comprehension", + "synonyms": [ + "ADCCMP", + "Comprehension", + "CDISC ADAS-Cog - Comprehension" + ], + "reference": "/mdr/bc/biomedicalconcepts/C100278", + "properties": [ + { + "id": "BiomedicalConceptProperty_777", + "extensionAttributes": [], + "name": "Evaluator", + "label": "Evaluator", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37824", + "standardCode": { + "id": "Code_45111", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_778", + "extensionAttributes": [], + "name": "Ordinal Position", + "label": "Ordinal Position", + "isRequired": true, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37825", + "standardCode": { + "id": "Code_45112", + "extensionAttributes": [], + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_779", + "extensionAttributes": [], + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2919", + "instanceType": "ResponseCode", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "isEnabled": true, + "code": { + "id": "Code_41633", + "extensionAttributes": [], + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37826", + "standardCode": { + "id": "Code_45113", + "extensionAttributes": [], + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_780", + "extensionAttributes": [], + "name": "Category", + "label": "Category", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37827", + "standardCode": { + "id": "Code_45114", + "extensionAttributes": [], + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_781", + "extensionAttributes": [], + "name": "Subcategory", + "label": "Subcategory", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37828", + "standardCode": { + "id": "Code_45115", + "extensionAttributes": [], + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_782", + "extensionAttributes": [], + "name": "Completion Status", + "label": "Completion Status", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37829", + "standardCode": { + "id": "Code_45116", + "extensionAttributes": [], + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_783", + "extensionAttributes": [], + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37830", + "standardCode": { + "id": "Code_45117", + "extensionAttributes": [], + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_784", + "extensionAttributes": [], + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37831", + "standardCode": { + "id": "Code_45118", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24629", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28747", + "extensionAttributes": [], + "code": "C100278", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Comprehension", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_184", + "extensionAttributes": [], + "name": "CDISC ADAS-Cog - Concentration/Distractibility", + "label": "CDISC ADAS-Cog - Concentration/Distractibility", + "synonyms": [ + "ADCCON", + "Concentration/Distractibility", + "CDISC ADAS-Cog - Concentration/Distractibility" + ], + "reference": "/mdr/bc/biomedicalconcepts/C100279", + "properties": [ + { + "id": "BiomedicalConceptProperty_892", + "extensionAttributes": [], + "name": "Category", + "label": "Category", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37950", + "standardCode": { + "id": "Code_45237", + "extensionAttributes": [], + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_893", + "extensionAttributes": [], + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37951", + "standardCode": { + "id": "Code_45238", + "extensionAttributes": [], + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_894", + "extensionAttributes": [], + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37952", + "standardCode": { + "id": "Code_45239", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_895", + "extensionAttributes": [], + "name": "Evaluator", + "label": "Evaluator", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37953", + "standardCode": { + "id": "Code_45240", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_896", + "extensionAttributes": [], + "name": "Ordinal Position", + "label": "Ordinal Position", + "isRequired": true, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37954", + "standardCode": { + "id": "Code_45241", + "extensionAttributes": [], + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_897", + "extensionAttributes": [], + "name": "Completion Status", + "label": "Completion Status", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37955", + "standardCode": { + "id": "Code_45242", + "extensionAttributes": [], + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_898", + "extensionAttributes": [], + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37956", + "standardCode": { + "id": "Code_45243", + "extensionAttributes": [], + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_899", + "extensionAttributes": [], + "name": "Subcategory", + "label": "Subcategory", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37957", + "standardCode": { + "id": "Code_45244", + "extensionAttributes": [], + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24630", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28748", + "extensionAttributes": [], + "code": "C100279", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Concentration/Distractibility", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_185", + "extensionAttributes": [], + "name": "CDISC ADAS-Cog - Number Cancellation Summary Score", + "label": "CDISC ADAS-Cog - Number Cancellation Summary Score", + "synonyms": [ + "ADCNC", + "Number Cancellation", + "CDISC ADAS-Cog - Number Cancellation Summary Score" + ], + "reference": "/mdr/bc/biomedicalconcepts/C100280", + "properties": [ + { + "id": "BiomedicalConceptProperty_900", + "extensionAttributes": [], + "name": "Category", + "label": "Category", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37958", + "standardCode": { + "id": "Code_45245", + "extensionAttributes": [], + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_901", + "extensionAttributes": [], + "name": "Subcategory", + "label": "Subcategory", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37959", + "standardCode": { + "id": "Code_45246", + "extensionAttributes": [], + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_902", + "extensionAttributes": [], + "name": "Completion Status", + "label": "Completion Status", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37960", + "standardCode": { + "id": "Code_45247", + "extensionAttributes": [], + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_903", + "extensionAttributes": [], + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37961", + "standardCode": { + "id": "Code_45248", + "extensionAttributes": [], + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_904", + "extensionAttributes": [], + "name": "Evaluator", + "label": "Evaluator", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37962", + "standardCode": { + "id": "Code_45249", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_905", + "extensionAttributes": [], + "name": "Ordinal Position", + "label": "Ordinal Position", + "isRequired": true, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37963", + "standardCode": { + "id": "Code_45250", + "extensionAttributes": [], + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_906", + "extensionAttributes": [], + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "isRequired": true, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37964", + "standardCode": { + "id": "Code_45251", + "extensionAttributes": [], + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_907", + "extensionAttributes": [], + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37965", + "standardCode": { + "id": "Code_45252", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24631", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28749", + "extensionAttributes": [], + "code": "C100280", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Number Cancellation Summary Score", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_186", + "extensionAttributes": [], + "name": "CDISC ADAS-Cog - Executive Function Maze: Errors", + "label": "CDISC ADAS-Cog - Executive Function Maze: Errors", + "synonyms": [ + "ADCMZ01", + "Executive Function Maze: Errors", + "CDISC ADAS-Cog - Executive Function Maze: Errors" + ], + "reference": "/mdr/bc/biomedicalconcepts/C100285", + "properties": [ + { + "id": "BiomedicalConceptProperty_801", + "extensionAttributes": [], + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37848", + "standardCode": { + "id": "Code_45135", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_802", + "extensionAttributes": [], + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37849", + "standardCode": { + "id": "Code_45136", + "extensionAttributes": [], + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_803", + "extensionAttributes": [], + "name": "Evaluator", + "label": "Evaluator", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37850", + "standardCode": { + "id": "Code_45137", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_804", + "extensionAttributes": [], + "name": "Category", + "label": "Category", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37851", + "standardCode": { + "id": "Code_45138", + "extensionAttributes": [], + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_805", + "extensionAttributes": [], + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "isRequired": true, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37852", + "standardCode": { + "id": "Code_45139", + "extensionAttributes": [], + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_806", + "extensionAttributes": [], + "name": "Ordinal Position", + "label": "Ordinal Position", + "isRequired": true, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37853", + "standardCode": { + "id": "Code_45140", + "extensionAttributes": [], + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_807", + "extensionAttributes": [], + "name": "Subcategory", + "label": "Subcategory", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37854", + "standardCode": { + "id": "Code_45141", + "extensionAttributes": [], + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_808", + "extensionAttributes": [], + "name": "Completion Status", + "label": "Completion Status", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_2740", + "instanceType": "ResponseCode", + "name": "URINE", + "label": "URINE", + "isEnabled": true, + "code": { + "id": "Code_37908", + "extensionAttributes": [], + "code": "C13283", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "URINE", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37855", + "standardCode": { + "id": "Code_45142", + "extensionAttributes": [], + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24632", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28750", + "extensionAttributes": [], + "code": "C100285", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Executive Function Maze: Errors", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_187", + "extensionAttributes": [], + "name": "CDISC ADAS-Cog - Executive Function Maze: Time", + "label": "CDISC ADAS-Cog - Executive Function Maze: Time", + "synonyms": [ + "ADCMZ02", + "Executive Function Maze: Time", + "CDISC ADAS-Cog - Executive Function Maze: Time" + ], + "reference": "/mdr/bc/biomedicalconcepts/C100286", + "properties": [ + { + "id": "BiomedicalConceptProperty_809", + "extensionAttributes": [], + "name": "Ordinal Position", + "label": "Ordinal Position", + "isRequired": true, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [ + { + "id": "ResponseCode_2923", + "instanceType": "ResponseCode", + "name": "BLOOD", + "label": "BLOOD", + "isEnabled": true, + "code": { + "id": "Code_41667", + "extensionAttributes": [], + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37856", + "standardCode": { + "id": "Code_45143", + "extensionAttributes": [], + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Ordinal Position", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_810", + "extensionAttributes": [], + "name": "Clinical or Research Assessment Answer", + "label": "Clinical or Research Assessment Answer", + "isRequired": true, + "isEnabled": true, + "datatype": "integer", + "responseCodes": [], + "code": { + "id": "AliasCode_37857", + "standardCode": { + "id": "Code_45144", + "extensionAttributes": [], + "code": "C91106", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Clinical or Research Assessment Answer", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_811", + "extensionAttributes": [], + "name": "Unit of Time", + "label": "Unit of Time", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37858", + "standardCode": { + "id": "Code_45145", + "extensionAttributes": [], + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Unit of Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_812", + "extensionAttributes": [], + "name": "Category", + "label": "Category", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37859", + "standardCode": { + "id": "Code_45146", + "extensionAttributes": [], + "code": "C25372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Category", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_813", + "extensionAttributes": [], + "name": "Subcategory", + "label": "Subcategory", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37860", + "standardCode": { + "id": "Code_45147", + "extensionAttributes": [], + "code": "C25692", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Subcategory", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_814", + "extensionAttributes": [], + "name": "Completion Status", + "label": "Completion Status", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37861", + "standardCode": { + "id": "Code_45148", + "extensionAttributes": [], + "code": "C41202", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Completion Status", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_815", + "extensionAttributes": [], + "name": "Not-Done Reason", + "label": "Not-Done Reason", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37862", + "standardCode": { + "id": "Code_45149", + "extensionAttributes": [], + "code": "C82556", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Not-Done Reason", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_816", + "extensionAttributes": [], + "name": "Evaluator", + "label": "Evaluator", + "isRequired": true, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37863", + "standardCode": { + "id": "Code_45150", + "extensionAttributes": [], + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Evaluator", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_817", + "extensionAttributes": [], + "name": "Collection Date Time", + "label": "Collection Date Time", + "isRequired": true, + "isEnabled": true, + "datatype": "datetime", + "responseCodes": [], + "code": { + "id": "AliasCode_37864", + "standardCode": { + "id": "Code_45151", + "extensionAttributes": [], + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Collection Date Time", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_24633", + "extensionAttributes": [], + "standardCode": { + "id": "Code_28751", + "extensionAttributes": [], + "code": "C100286", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "CDISC ADAS-Cog - Executive Function Maze: Time", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_163", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_140", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/EGCTMON", + "instanceType": "ExtensionAttribute" + } + ], + "name": "ECG Continuous Monitoring Indicator", + "label": "ECG Continuous Monitoring Indicator", + "synonyms": [ + "ECG Continuous Monitoring", + "EGCTMON" + ], + "reference": "/mdr/bc/biomedicalconcepts/C119561", + "properties": [ + { + "id": "BiomedicalConceptProperty_856", + "extensionAttributes": [], + "name": "TSPARMCD", + "label": "TSPARMCD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3090", + "instanceType": "ResponseCode", + "name": "EGCTMON", + "label": "EGCTMON", + "isEnabled": true, + "code": { + "id": "Code_45197", + "extensionAttributes": [], + "code": "C119561", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "EGCTMON", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37909", + "standardCode": { + "id": "Code_45196", + "extensionAttributes": [], + "code": "C83445", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Code", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_857", + "extensionAttributes": [], + "name": "TSPARM", + "label": "TSPARM", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [ + { + "id": "ResponseCode_3091", + "instanceType": "ResponseCode", + "name": "ECG Continuous Monitoring", + "label": "ECG Continuous Monitoring", + "isEnabled": true, + "code": { + "id": "Code_45199", + "extensionAttributes": [], + "code": "C119561", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "ECG Continuous Monitoring", + "instanceType": "Code" + } + } + ], + "code": { + "id": "AliasCode_37911", + "standardCode": { + "id": "Code_45198", + "extensionAttributes": [], + "code": "C49691", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_858", + "extensionAttributes": [], + "name": "TSVAL", + "label": "TSVAL", + "isRequired": false, + "isEnabled": true, + "datatype": "boolean", + "responseCodes": [], + "code": { + "id": "AliasCode_37913", + "standardCode": { + "id": "Code_45200", + "extensionAttributes": [], + "code": "C83447", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Value", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_859", + "extensionAttributes": [], + "name": "TSVALCD", + "label": "TSVALCD", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37914", + "standardCode": { + "id": "Code_45201", + "extensionAttributes": [], + "code": "C117458", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Value Code", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_860", + "extensionAttributes": [], + "name": "TSVCDREF", + "label": "TSVCDREF", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37915", + "standardCode": { + "id": "Code_45202", + "extensionAttributes": [], + "code": "C117460", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Name of the Reference Terminology", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + }, + { + "id": "BiomedicalConceptProperty_861", + "extensionAttributes": [], + "name": "TSVCDVER", + "label": "TSVCDVER", + "isRequired": false, + "isEnabled": true, + "datatype": "string", + "responseCodes": [], + "code": { + "id": "AliasCode_37916", + "standardCode": { + "id": "Code_45203", + "extensionAttributes": [], + "code": "C117461", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Version of the Reference Terminology", + "instanceType": "Code" + }, + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_2311", + "extensionAttributes": [], + "standardCode": { + "id": "Code_2501", + "extensionAttributes": [], + "code": "C119561", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "ECG Continuous Monitoring Indicator", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + } + ], + "bcSurrogates": [ + { + "id": "BiomedicalConceptSurrogate_9", + "extensionAttributes": [], + "name": "MHIS-NACC / MHIS01", + "label": "Modified Hachinski Ischemic Scale (C112523)", + "description": "Modified Hachinski Ischemic Scale-NACC Version Questionnaire", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112523", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_10", + "extensionAttributes": [], + "name": "MHIS0101", + "label": "Abrupt Onset (C112618)", + "description": "Modified Hachinski Ischemic Scale-NACC Version - Abrupt onset (re: cognitive status).", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112618", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_11", + "extensionAttributes": [], + "name": "MHIS0102", + "label": "Stepwise Deterioration (C112619)", + "description": "Modified Hachinski Ischemic Scale-NACC Version - Stepwise deterioration (re: cognitive status).", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112619", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_12", + "extensionAttributes": [], + "name": "MHIS0103", + "label": "Emotional Incontinence (C112620)", + "description": "Modified Hachinski Ischemic Scale-NACC Version - Emotional incontinence.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112620", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_13", + "extensionAttributes": [], + "name": "MHIS0104", + "label": "History or Presence of Hypertension (C112621)", + "description": "Modified Hachinski Ischemic Scale-NACC Version - History or presence of hypertension.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112621", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_14", + "extensionAttributes": [], + "name": "MHIS0105", + "label": "History of Stroke (C112622)", + "description": "Modified Hachinski Ischemic Scale-NACC Version - History of stroke.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112622", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_15", + "extensionAttributes": [], + "name": "MHIS0106", + "label": "Focal Neurological Symptoms (C112623)", + "description": "MHIS-NACC - Focal Neurological Symptoms", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112623", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_16", + "extensionAttributes": [], + "name": "MHIS0107", + "label": "Focal Neurological Signs (C112624)", + "description": "Modified Hachinski Ischemic Scale-NACC Version - Focal neurological signs.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112624", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_17", + "extensionAttributes": [], + "name": "MHIS0108", + "label": "Somatic Complaints (C112813)", + "description": "Modified Hachinski Ischemic Scale-NACC Version - Somatic complaints.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112813", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_18", + "extensionAttributes": [], + "name": "MHIS0109", + "label": "Total Score (C112625)", + "description": "Modified Hachinski Ischemic Scale-NACC Version - Sum all circled answers for a total score.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112625", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_19", + "extensionAttributes": [], + "name": "APOE Gene", + "label": "APOE Gene (C84468)", + "description": "This gene is involved in lipid transport and metabolism.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C84468", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_20", + "extensionAttributes": [], + "name": "Mini-Mental Status Exam", + "label": "Mini-Mental Status Exam (C74982)", + "description": "Mini-Mental State Examination (MMSE) (MMSE Copyright 1975, 1998, 2001 by MiniMental, LLC All rights reserved. Published 2001 by Psychological Assessment Resources, Inc. May not be reproduced in whole or in part in any form or by any means without written permission of Psychological Assessment Resources, Inc.).", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C74982", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_21", + "extensionAttributes": [], + "name": "MMSE - Question 1", + "label": "MMSE - Question 1 (C100542)", + "description": "The Mini-Mental State Examination (MMSE) Question 1.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100542", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_22", + "extensionAttributes": [], + "name": "MMSE - Question 2", + "label": "MMSE - Question 2 (C100548)", + "description": "The Mini-Mental State Examination (MMSE) Question 2.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100548", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_23", + "extensionAttributes": [], + "name": "MMSE - Question 3", + "label": "MMSE - Question 3 (C100554)", + "description": "The Mini-Mental State Examination (MMSE) Question 3.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100554", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_24", + "extensionAttributes": [], + "name": "MMSE - Question 4", + "label": "MMSE - Question 4 (C100558)", + "description": "The Mini-Mental State Examination (MMSE) Question 4.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100558", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_25", + "extensionAttributes": [], + "name": "MMSE - Question 6", + "label": "MMSE - Question 6 (C100575)", + "description": "The Mini-Mental State Examination (MMSE) Question 6.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100575", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_26", + "extensionAttributes": [], + "name": "MMSE Functional Test Question", + "label": "MMSE Functional Test Question (C100118)", + "description": "A question associated with the MMSE functional test.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100118", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_27", + "extensionAttributes": [], + "name": "ADCS-CGIC", + "label": "ADCS-CGIC Questionnaire Question (C103490)", + "description": "A question associated with the ADCS-CGIC questionnaire.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103490", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_28", + "extensionAttributes": [], + "name": "DAD", + "label": "Disability Assessment for Dementia Questionnaire (C105165)", + "description": "Disability Assessment for Dementia (DAD) (copyright 1994 by L. Gauthier I. Gelinas. All rights reserved.).", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C105165", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_29", + "extensionAttributes": [], + "name": "NPI - NPI Total Distress Score", + "label": "NPI - NPI Total Distress Score (C112482)", + "description": "Neuropsychiatric Inventory - Sub-total of distress score.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112482", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_30", + "extensionAttributes": [], + "name": "NPI - Anxiety Severity", + "label": "NPI - Anxiety Severity (C103615)", + "description": "Neuropsychiatric Inventory - Severity of the anxiety.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103615", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_31", + "extensionAttributes": [], + "name": "NPI - Disinhibition Frequency", + "label": "NPI - Disinhibition Frequency (C103623)", + "description": "Neuropsychiatric Inventory - Frequency of the disinhibition.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103623", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_32", + "extensionAttributes": [], + "name": "NPI - Disinhibition Severity", + "label": "NPI - Disinhibition Severity (C103624)", + "description": "Neuropsychiatric Inventory - Severity of the disinhibition.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103624", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_33", + "extensionAttributes": [], + "name": "NPI - Disinhibition Distress", + "label": "NPI - Disinhibition Distress (C103625)", + "description": "Neuropsychiatric Inventory - How emotionally distressing do you find this behavior?", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103625", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_34", + "extensionAttributes": [], + "name": "NPI - Disinhibition FxS Score", + "label": "NPI - Disinhibition FxS Score (C112476)", + "description": "Neuropsychiatric Inventory - Disinhibition: (frequency score x severity score).", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112476", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + } + ], + "bcCategories": [], + "eligibilityCriterionItems": [], + "narrativeContentItems": [], + "abbreviations": [], + "administrableProducts": [], + "medicalDevices": [], + "productOrganizationRoles": [], + "dictionaries": [], + "conditions": [], + "notes": [], + "instanceType": "StudyVersion" + } + ], + "documentedBy": [], + "instanceType": "Study" + }, + "usdmVersion": "4.0", + "systemName": "SOA Workbench", + "systemVersion": "1.4.0" +}