Below is an example ADaM dataset designed to support the summarization of concomitant medications. Included are a subset of variables that are commonly inluded 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 referecnes Concomitant Medications.
Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | CDISC Notes |
| STUDYID | Study Identifier | text | CM.STUDYID | ||
| USUBJID | Unique Subject Identifier | text | CM.USUBJID | ||
| CMTRT | text | CM.CMTRT | |||
| CMDECOD | text | CM.CMDECOD | |||
| CMCLAS | text | CM.CMCLAS | |||
| ASTDT | Analysis Start Date | integer | numeric SAS date variable based on CMSTDTC with no imputation for partial dates | ||
| ASTDTF | |||||
| AENDT | Analysis End Date | integer | numeric SAS date variable based on CMENDTC with no imputation for partial dates | ||
| AENDTF | |||||
| ASTDY | Analysis Start Relative Day | integer | ASTDT-TRTSDT - add one if ASTDT is on or after TRTSDT | ||
| AENDY | Analysis End Relative Day | integer | AENDT-TRTSDT - add one if ASTDT is on or after TRTSDT | ||
| CMSTDTC | text | CM.CMSTDTC | |||
| CMENDTC | text | CM.CMENDTC | |||
| 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-treatment Flag | text | Y | Cond | |
| ONTRTFL | On Treatment Record Flag | text | Y | Cond | |
| FUPFL | Follow-up Flag | text | Y | Cond | |
| TRTP | text | ADSL.TRT01P | |||
| CMDOSE | CM.CMDOSE | ||||
| SAFFL | |||||
| CMDOSTXT | text | CM.CMDOSTXT | |||
| CMDOSU | text | CM.CMDOSU | |||
| text | ADSL.SAFFL | ||||
| CMSEQ | integer | CM.CMSEQ |
STUDYID | USUBJID | CMTRT | CMDECOD | CMCLAS | ASTDT | ASTDTF | AENDT | AENDTF | ASTDY | AENDY | AOCCFL | AOCCPFL | AOCC01FL | PREFL | ONTRTFL | FUPFL | TRTP | SAFFL | CMDOSE | CMDOSTXT | CMDOSU | CMINDC | CMDOSFRM | CMDOSFRQ | CMROUTE | CMSTDTC | CMENDTC | CMENRF | CMSEQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ABC123 | A123 | ASPIRIN | acetylsalicylic acid | ANALGESICS | 21JAN2021 | 22JAN2021 | 1 | 2 | Y | Y | Y | Y | Product A | Y | 100 | mg | MIGRAINE | TABLET | ONCE | ORAL | 2021-01-21 | 2021-01-22 | 1 | ||||||
| ABC123 | A123 | DIOVAN | valsartan | ANTIHYPERTENSIVES | 01JAN2004 | M | -6230 | Y | Y | Product A | Y | 20 | mg | HYPERTENSION | TABLET | BID | ORAL | 2004 | AFTER | 2 | |||||||||
| ABC123 | A123 | ZOLOFT | sertraline | PSYCHOANALEPTICS | 01JAN2010 | D | -4038 | Y | Y | Product A | Y | 50 | mg | PANIC ATTACKS | TABLET | QD | ORAL | 2010-01 | AFTER | 3 | |||||||||
| ABC123 | A123 | ASTELIN | azelastine | NASAL PREPARATIONS | 26FEB2006 | -5443 | Y | Y | Product A | Y | 2 sprays in each nostril-137 mcg | mcg | INFLUENZA | SPRAY | BID | NASAL | 2006-02-26 | AFTER | 4 | ||||||||||
| ABC123 | A123 | ASPIRIN | acetylsalicylic acid | ANALGESICS | 01JAN2004 | -6230 | Y | Y | Product A | Y | 100 | mg | PAIN | TABLET | PRN | ORAL | 2004-01-01 | AFTER | 5 |
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