ADaM.ADSL Example 1

Variable Name	Variable Label	Type	Codelist/Controlled Terms	Core	Notes
STUDYID	Study Identifier	Char		Req	DM.STUDYID
USUBJID	Unique Subject Identifier	Char		Req	DM.USUBJID
SUBJID	Subject Identifier for the Study	Char		Req	DM.SUBJID
SITEID	Study Site Identifier	Char		Req	DM.SITEID
SEX				Req
RACE				Req
AGE	Age	Num		Req
AGEU	Age Units	Char		Req
SAFFL	Safety Population Flag	Char	Y; N	Cond	Y if ADSL.TR01SDT is not null, otherwise N
PPROTFL	Per-Protocol Population Flag	Char	Y; N	Cond	Y if ADSL.SAFFL=Y and at least one post-baseline assessment was done, otherwise N
RANDFL	Randomized Population Flag			Cond
ARM	Description of Planned Arm			Req
TRT01P	Planned Treatment for Period 01	Char	TREAT A; TREAT B	Req	Set to DM.ARM
TRT01A	Actual Treatment for Period 01	text	TREAT A; TREAT B	Perm	Set to EX.EXTRT
TRTSEQP	Planned Sequence of Treatments			Cond
TRTSDT	Date of First Exposure to Treatment	integer		Cond	Set to date part of DM.RFXSTDTC captured as a numeric variable
TRTSDTM	Datetime of First Exposure to Treatment			Cond
TRTEDT	Date of Last Exposure to Treatment	integer		Cond	Set to date part of DM.RFXENDTC and capture as a numeric variable
TRTEDTM	Datetime of Last Exposure to Treatment			Cond
APHASEw	Description of Phase w			Perm
EOSSTT	End of Study Status			Perm
EOSDT	End of Study Date			Perm
DCSREAS	Reason for Discontinuation from Study			Perm
DCSREASP	DCSREASP Reason Spec for Discont from Study			Perm
RFICDT	Date of Informed Consent			Perm
ENRLDT	Date of Enrollment			Perm
RANDDT	Date of Randomization			Cond
LSTALVDT	Date Last Known Alive			Perm
TRTDURD	Total Treatment Duration (Days)			Perm
DTHDT	Date of Death			Perm
DTHCAUS	Cause of Death			Perm
STRATAR	Strata Used for Randomization			Perm

Page tree

ADaM.ADSL Example 1