This is an example of an ADCM dataset and is based primarily on input from the SDTM CM dataset. Other administrative data about the subjects are based on the ADSL dataset provided in Section x.x, Analysis Data Subject Level (ADSL).
Example
This is an example of the input SDTM CM datasets used to create the ADCM. Only variables needed for illustration are shown in the examples.
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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.
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 |
ADCM 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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