SDTM Prior Treatments and Vaccination History

Illustrates Domains

Illustrates Variables

SPDEVID
CMTRT
CMDECOD
CMRSDISC
CMSTRF
CMEVLINT

Content

The CM domain was used to represent prior psoriasis treatments and vaccinations received during the study, or in the 6 months prior to enrollment in the study. The WHO drug codes included are example decodes and sponsors should confirm accuracy if using them. The Device Identification domain (DI) is required to define the sponsor-defined identifier (SPDEVID) for the device used for the administration of the treatment, but is not shown in this example.

cm.xpt

Row 1:	Shows the subject was previously treated with an "ANTIPSORIATIC" medication. CMPRESP and CMOCCUR are used to indicate that this was an occurrence of a pre-specified treatment.
Rows 2-3:	Show the subject previously used biologic treatments. CMSCAT was used to categorize the medications used as "BIOLOGIC". Note that CMSTRF is blank, because the complete start date is available.
Row 4:	Shows the subject did not receive a vaccination in the 6 months prior to enrollment in the study.
Row 5:	Shows the subject had a flu vaccination during the study period. The sponsor used the CMSTDTC to determine that vaccination occurred during the study.

cm.xpt

Row	STUDYID	DOMAIN	USUBJID	SPDEVID	CMSEQ	CMTRT	CMDECOD	CMCAT	CMSCAT	CMPRESP	CMOCCUR	CMDOSE	CMDOSU	CMDOSFRQ	CMROUTE	CMRSDISC	CMDTC	CMSTDTC	CMENDTC	CMSTRF	CMEVLINT
1	PS005	CM	3001		1	ANTIPSORIATIC		ANTIPSORIATIC		Y	Y						2014-07-14			BEFORE
2	PS005	CM	3001	SYRINGE	2	EFALIZUMAB	efalizumab	ANTIPSORIATIC	BIOLOGIC			1	mg/kg	EVERY WEEK	SUBCUTANEOUS	OTHER-NOT RELATED TO EFFICACY/ ADVERSE EVENTS	2014-07-14	2012-03-15	2012-07-15
3	PS005	CM	3001	MULTIPLE-DOSE PEN	3	HUMIRA	adalimumab	ANTIPSORIATIC	BIOLOGIC			40	mg	EVERY 2 WEEKS	SUBCUTANEOUS	ADVERSE EVENT	2014-07-14	2013-06-30	2013-11-30
4	PS005	CM	3001		4	VACCINE		VACCINATION		Y	N						2014-07-14			BEFORE	-P6M
5	PS005	CM	3001		5	INFLUENZA VACCINES	influenza vaccines	VACCINATION										2014-10-14	2014-10-14