SDTM Example.Concomitant Medication

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 sponsor include CMDECOD. The sponsor 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 safety and efficacy in this study.

cm.xpt

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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