Concomitant Medication (CM)

Data relating to concomitant and prior medications used by the subject, such as those given on an as-needed basis or condition-appropriate medications are collected. The same basic data collection variables should be collected for all medications, treatments, and therapies (prior, general concomitant medications, and medications of interest). Reacreational substances are not represented in this domain. However, medical proudcts recognized to reduce nicotine dependence would be represented in this domain (e.g., Nicotine replacemnet patches).

Example

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This is the SDTM dataset associated with the above example CRF. This SDTM dataset used CMENRF to represent ongoing interventions. More information can be found in Section 2.8.7.6, Representing References and Relative Timing.

The applicant included CMDECOD. The applicant is required to provide the dictionary name and version in the Define-XML document.

Rows 1-4:	The subject reported each instance of aspirin use. The frequency of each instance is represented in CMDOSFRQ and is ONCE.
Rows 6-8:	The subject reports the use of 3 medications. Diovan and Zoloft were still being taken by the subject, Astelin was a nasal spray where 2 sprays were taken twice a day in each nostril. Note that only partial start dates are provided for Diovan and Zoloft.
Row 9:	The subject took aspirin with a frequency of "PRN". This approach assumes that knowing exactly when aspirin was used is not important for evaluating the product in this study.

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Row	STUDYID	DOMAIN	USUBJID	CMSEQ	CMTRT	CMDECOD	CMINDC	CMCLAS	CMDOSE	CMDOSTXT	CMDOSU	CMDOSFRM	CMDOSFRQ	CMROUTE	CMSTDTC	CMENDTC	CMENRF
1	ABC123	CM	ABC123-0001	1	ASPIRIN	acetylsalicylic acid	MIGRAINE	ANALGESICS	100		mg	TABLET	ONCE	ORAL	2006-10-14	2006-10-14
2	ABC123	CM	ABC123-0001	2	ASPIRIN	acetylsalicylic acid	MIGRAINE	ANALGESICS	100		mg	TABLET	ONCE	ORAL	2006-10-15	2006-10-15
3	ABC123	CM	ABC123-0001	3	ASPIRIN	acetylsalicylic acid	MIGRAINE	ANALGESICS	100		mg	TABLET	ONCE	ORAL	2006-10-16	2006-10-16
4	ABC123	CM	ABC123-0001	4	ASPIRIN	acetylsalicylic acid	MIGRAINE	ANALGESICS	100		mg	TABLET	ONCE	ORAL	2006-10-17	2006-10-17
5	ABC123	CM	ABC123-0001	5	ASPIRIN	acetylsalicylic acid	MIGRAINE	ANALGESICS	100		mg	TABLET	ONCE	ORAL	2006-01-18	2006-01-18
6	ABC123	CM	ABC123-0002	1	DIOVAN	valsartan	HYPERTENSION	ANTIHYPERTENSIVES	20		mg	TABLET	BID	ORAL	2004		AFTER
7	ABC123	CM	ABC123-0002	2	ZOLOFT	sertraline	PANIC ATTACKS	PSYCHOANALEPTICS	50		mg	TABLET	OD	ORAL	2004-01		AFTER
8	ABC123	CM	ABC123-0002	3	ASTELIN	azelastine	INFLUENZA	NASAL PREPARATIONS		2 sprays in each nostril-137 mcg	mcg	SPRAY	BID	NASAL	2006-02-26		AFTER
9	ABC123	CM	ABC123-0002	4	ASPIRIN	acetylsalicylic acid	PAIN	ANALGESICS	100		mg	TABLET	PRN	ORAL	2004-01-01		AFTER

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Dataset Wrapper Debug Message

Please add a row column to your dataset.

Example

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.

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Row	STUDYID	USUBJID	CMTRT	CMDECOD	CMCLAS	ASTDT	ASTDTF	AENDT	ASTDY	AENDY	AOCCFL	AOCCPFL	AOCC01FL	ONTRTFL	FUPFL	TRTP	SAFFL	CMDOSE	CMDOSTXT	CMDOSU	CMINDC	CMDOSFRM	CMDOSFRQ	CMROUTE	CMSTDTC	CMENDTC	CMENRF	CMSEQ
1	ABC123	A2001	ASPIRIN	acetylsalicylic acid	ANALGESICS	21JAN2021		22JAN2021	1	2	Y	Y	Y	Y		Placebo	Y	100		mg	MIGRAINE	TABLET	ONCE	ORAL	2021-01-21	2021-01-22		1
2	ABC123	A2008	DIOVAN	valsartan	ANTIHYPERTENSIVES	01JAN2004	M		-6230					Y	Y	Product A	Y	20		mg	HYPERTENSION	TABLET	BID	ORAL	2004		AFTER	2
3	ABC123	A2008	ZOLOFT	sertraline	PSYCHOANALEPTICS	01JAN2010	D		-4038					Y	Y	Product A	Y	50		mg	PANIC ATTACKS	TABLET	QD	ORAL	2010-01		AFTER	3
4	ABC123	A2008	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
5	ABC123	A3009	ASPIRIN	acetylsalicylic acid	ANALGESICS	01JAN2004			-6230					Y	Y	Product B	Y	100		mg	PAIN	TABLET	PRN	ORAL	2004-01-01		AFTER	5

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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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Concomitant Medication (CM)