TOBA-299 - Getting issue details... STATUS
Below is an example ADaM dataset designed to support the summarization of concomitant medications. Included are a subset of variables that are commonly included to support a basic summary table - for a full list of commonly used and available variables please see Section 2.3.1.1 in the OCCDS section that references Concomitant Medications.
ADCM Dataset Metadata
| Dataset | Description | Class | Structure | Purpose | Keys | Location | Documentation |
|---|---|---|---|---|---|---|---|
| ADCM | Concomitant Medications Analysis Dataset | OCCURRENCE DATA STRUCTURE | One record per subject per medication | Analysis | STUDYID, USUBJID, CMDECOD, CMTRT | ADCM.xpt | ADCM.SAS/SAP |
ADXX Variable Metadata
Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | CDISC Notes |
|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Req | CM.STUDYID | |
| USUBJID | Unique Subject Identifier | text | Req | CM.USUBJID | |
| CMTRT | Reported Name of Drug, Med, or Therapy | text | Req | CM.CMTRT | |
| CMDECOD | Standardized Medication Name | text | Perm | CM.CMDECOD | |
| CMCLAS | Medication Class | text | Perm | CM.CMCLAS | |
| ASTDT | Analysis Start Date | integer | Perm | numeric SAS date variable based on CMSTDTC with no imputation for partial dates | |
| ASTDTF | Analysis Start Date Imputation Flag | Perm | |||
| AENDT | Analysis End Date | integer | Perm | numeric SAS date variable based on CMENDTC with no imputation for partial dates | |
| AENDTF | Analysis End Date Imputation Flag | Perm | |||
| ASTDY | Analysis Start Relative Day | integer | Perm | ASTDT-TRTSDT - add one if ASTDT is on or after TRTSDT | |
| AENDY | Analysis End Relative Day | integer | Perm | AENDT-TRTSDT - add one if ASTDT is on or after TRTSDT | |
| AOCCFL | 1st Occurrence within Subject Flag | text | Y | Perm | sort by USUBJID, CMCLAS, CMDECOD, CMSTDTC and then set to Y for the first record |
| AOCCPFL | 1st Occurrence of Preferred Term Flag | text | Y | Perm | sort by USUBJID, CMCLAS, CMDECOD, CMSTDTC and then set to Y for the first record within CMCLAS and CMDECOD |
| AOCC01FL | 1st Occurrence of CMCLAS | text | Y | Perm | sort by USUBJID, CMCLAS, CMDECOD, CMSTDTC and then set to Y for the first record within CMCLAS |
| PREFL | Pre-product Flag | text | Y | Cond | |
| ONTRTFL | On Product Record Flag | text | Y | Cond | |
| FUPFL | Follow-up Flag | text | Y | Cond | |
| TRTP | Planned Product | text | Cond | ADSL.TRT01P | |
| SAFFL | Safety Population Flag | text | Y;N | Cond | ADSL.SAFFL |
| CMDOSE | Dose per Administration | integer | Perm | CM.CMDOSE | |
| CMDOSTXT | Dose Description | text | Perm | CM.CMDOSTXT | |
| CMDOSU | Dose Units | text | Perm | CM.CMDOSU | |
| CMINDC | Indication | text | Perm | CM.CMINDC | |
| CMDOSFRM | Dose Form | text | Perm | CM.CMDOSFRM | |
| CMDOSFRQ | Dosing Frequency per Interval | text | Perm | CM.CMDOSFRQ | |
| CMROUTE | Route of Administration | text | Perm | CM.CMROUTE | |
| CMSTDTC | Start Date/Time of Medication | text | Perm | CM.CMSTDTC | |
| CMENDTC | End Date/Time of Medication | text | Perm | CM.CMENDTC | |
| CMENRF | End Relative to Reference Period | text | Perm | CM.CMENRF | |
| CMSEQ | Sequence Number | integer | Cond | CM.CMSEQ |
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