SDTM Example.Concomitant Medication

NEED TO GET THE CORRECT REFERNCES More information can be found in SDTMIG Section 4.4.7, Use of Relative Timing Variables.

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 SDTMIG Section 4.4.7, Use of Relative Timing Variables. The sponsor include CMDECOD. The sponsor is required to provide the dictionary name and version in the Define-XML document.

Rows 1-6:	The subject reported each instance of aspirin use. The frequency of each instance is represented in CMDOSFRQ and is ONCE.
Rows 7-9:	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 10:	The subject took aspirin with a frequency of "PRN". This approach assumes that knowing exactly when aspirin was used is not important for evaluating safety and efficacy in this study.

cm.xpt

Row	STUDYID	DOMAIN	USUBJID	CMSEQ	CMTRT	CMDECOD	CMCLAS	CMDOSE	CMDOSTXT	CMDOSU	CMDOSFRM	CMDOSFRQ	CMROUTE	CMSTDTC	CMENDTC	CMENRF
1	ABC	CM	ABC-0001	1	ASPIRIN	acetylsalicylic acid	ANALGESICS	100		mg	TABLET	ONCE	ORAL	2004-01-01	2004-01-01
2	ABC	CM	ABC-0001	2	ASPIRIN	acetylsalicylic acid	ANALGESICS	100		mg	TABLET	ONCE	ORAL	2004-01-02	2004-01-02
3	ABC	CM	ABC-0001	3	ASPIRIN	acetylsalicylic acid	ANALGESICS	100		mg	TABLET	ONCE	ORAL	2004-01-03	2004-01-03
4	ABC	CM	ABC-0001	4	ASPIRIN	acetylsalicylic acid	ANALGESICS	100		mg	TABLET	ONCE	ORAL	2004-01-07	2004-01-07
5	ABC	CM	ABC-0001	5	ASPIRIN	acetylsalicylic acid	ANALGESICS	100		mg	TABLET	ONCE	ORAL	2004-01-07	2004-01-07
6	ABC	CM	ABC-0001	6	ASPIRIN	acetylsalicylic acid	ANALGESICS	100		mg	TABLET	ONCE	ORAL	2004-01-09	2004-01-09
7	ABC	CM	ABC-0002	1	DIOVAN	valsartan	ANTIHYPERTENSIVES	20		mg	TABLET	BID	ORAL	2004		AFTER
8	ABC	CM	ABC-0002	2	ZOLOFT	sertraline	PSYCHOANALEPTICS	50		mg	TABLET	OD	ORAL	2004-01		AFTER
9	ABC	CM	ABC-0002	3	ASTELIN	azelastine	NASAL PREPARATIONS		2 sprays in each nostril-137 mcg	mcg	SPRAY	BID	NASAL	2004-01-09	2004-06-10
10	ABC	CM	ABC-0003	1	ASPIRIN	acetylsalicylic acid	ANALGESICS	100		mg	TABLET	PRN	ORAL	2004-01-01		AFTER

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SDTM Example.Concomitant Medication