Concomitant Medication (ADCM)

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 CM dataset amd associate metadata 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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ADCM Variable Metadata

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

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Concomitant Medication (ADCM)