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 plese 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 | ||
| ASTDT | Analysis Start Date | integer | numeric SAS date variable based on CMSTDTC with no imputation for partial dates | ||
| AENDT | Analysis End Date | integer | numeric SAS date variable based on CMENDTC with no imputation for partial dates | ||
| 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 | |||
| CMTRT | text | CM.CMTRT | |||
| CMDECOD | text | CM.CMDECOD | |||
| CMDOSE | CM.CMDOSE | ||||
| CMDOSTXT | text | CM.CMDOSTXT | |||
| CMDOSU | text | CM.CMDOSU | |||
| CMCLAS | text | CM.CMCLAS | |||
| SAFFL | text | ADSL.SAFFL | |||
| CMSEQ | integer | CM.CMSEQ |
STUDYID | USUBJID | ASTDT | AENDT | ASTDY | AENDY | CMSTDTC | CMENDTC | AOCCFL | AOCCPFL | AOCC01FL | PREFL | ONTRTFL | FUPFL | TRTP | SAFFL | CMTRT | CMDECOD | CMDOSE | CMDOSTXT | CMDOSU | CMCLAS | CMSEQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ABC123 | ABC12301001 | 01JAN2004 | 01JAN2004 | 1 | 1 | 2004-01-01 | 2004-01-01 | Y | Y | Y | Y | Product A | Y | ASPIRIN | acetylsalicylic acid | 100 | mg | ANALGESICS | 1 | |||
| ABC123 | ABC12301001 | 02JAN2004 | 02JAN2004 | 2 | 2 | 2004-01-02 | 2004-01-02 | Y | Y | ASPIRIN | acetylsalicylic acid | 100 | mg | ANALGESICS | 2 | |||||||
| ABC123 | ABC12301001 | 03JAN2004 | 03JAN2004 | 3 | 3 | 2004-01-03 | 2004-01-03 | Y | Y | ASPIRIN | acetylsalicylic acid | 100 | mg | ANALGESICS | 3 | |||||||
| ABC123 | ABC12301001 | 07JAN2004 | 07JAN2004 | 7 | 7 | 2004-01-07 | 2004-01-07 | Y | Y | ASPIRIN | acetylsalicylic acid | 100 | mg | ANALGESICS | 4 | |||||||
| ABC123 | ABC12301001 | 07JAN2004 | 07JAN2004 | 7 | 7 | 2004-01-07 | 2004-01-07 | Y | Y | ASPIRIN | acetylsalicylic acid | 100 | mg | ANALGESICS | 5 | |||||||
| ABC123 | ABC12301001 | 09JAN2004 | 09JAN2004 | 9 | 9 | 2004-01-09 | 2004-01-09 | Y | Y | ASPIRIN | acetylsalicylic acid | 100 | mg | ANALGESICS | 6 | |||||||
| ABC123 | ABC12301002 | 2004 | Y | Y | Y | Y | Y | Y | Y | DIOVAN | valsartan | 20 | mg | ANTIHYPERTENSIVES | 1 | |||||||
| ABC123 | ABC12301002 | 2004-01 | Y | Y | Y | Y | Y | Y | ZOLOFT | sertraline | 50 | mg | PSYCHOANALEPTICS | 2 | ||||||||
| ABC123 | ABC12301002 | 09JAN2004 | 10JUN2004 | 9 | 10 | 2004-01-09 | 2004-06-10 | Y | Y | Y | Y | Y | ASTELIN | azelastine | 2 sprays in each nostril-137 mcg | mcg | NASAL PREPARATIONS | 3 | ||||
| ABC123 | ABC12301003 | 01JAN2004 | 1 | 2004-01-01 | Y | Y | Y | Y | Y | Y | Y | ASPIRIN | acetylsalicylic acid | 100 | mg | ANALGESICS | 1 |
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