This is an example of an ADCM dataset and is based primarily on the SDTM CM dataset.
Below is an xxample of the SDTM CM dataset.
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 references Concomitant Medications.
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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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