Subject Demographics Variables for ADSL Datasets

Variable Name	Variable Label	Type	Codelist/ Controlled Terms	Core	CDISC Notes
AGE	Age	Num		Req	DM.AGE. If analysis needs require a derived age that does not match DM.AGE, then AAGE must be added
AGEU	Age Units	Char	(AGEU)	Req	DM.AGEU
AGEGRy	Pooled Age Group y	Char		Perm	Character description of a grouping or pooling of the subject's age for analysis purposes. For example, AGEGR1 might have values of "<18", "18-65", and ">65"; AGEGR2 might have values of "Less than 35 y old" and "At least 35 y old".
AGEGRyN	Pooled Age Group y (N)	Num		Perm	Numeric representation of AGEGRy. Orders the grouping or pooling of subject age for analysis and reporting. There must be a one-to-one relationship between AGEGRyN and AGEGRy within a study. AGEGRyN cannot be present unless AGEGRy is also present. When AGEGRy and AGEGRyN are present, then on a given record, either both must be populated or both must be null.
AAGE	Analysis Age	Num		Cond	Age used for analysis that may be derived differently than DM.AGE. AAGE is required if age is calculated differently than DM.AGE.
SEX	Sex	Char	(SEX)	Req	DM.SEX.
RACE	Race	Char	(RACE)	Req	DM.RACE.
RACEGRy	Pooled Race Group y	Char		Perm	Character description of a grouping or pooling of the subject's race for analysis purposes.
RACEGRyN	Pooled Race Group y (N)	Num		Perm	Numeric representation of RACEGRy. Orders the grouping or pooling of subject race for analysis and reporting. There must be a one-to-one relationship between RACEGRyN and RACEGRy within a study. RACEGRyN cannot be present unless RACEGRy is also present. When RACEGRy and RACEGRyN are present, then on a given record, either both must be populated or both must be null.

Variable Name	Variable Label	Type	Codelist/ Controlled Terms	Core	CDISC 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. SUBJID is required in ADSL, but permissible in other datasets.
SITEID	Study Site Identifier	Char		Req	DM.SITEID. SITEID is required in ADSL, but permissible in other datasets.
SITEGRy	Pooled Site Group y	Char		Perm	Character description of a grouping or pooling of clinical sites for analysis purposes. For example, SITEGR3 is the name of a variable containing site group (pooled site) names, where the grouping has been done according to the third site grouping algorithm, defined in variable metadata; SITEGR3 does not mean the third group of sites.
SITEGRyN	Pooled Site Group y (N)	Num		Perm	Numeric representation of SITEGRy. There must be a one-to-one relationship between SITEGRyN and SITEGRy within a study. SITEGRyN cannot be present unless SITEGRy is also present. When SITEGRy and SITEGRyN are present, then on a given record, either both must be populated or both must be null.
REGIONy	Geographic Region y	Char		Perm	Character description of geographical region. For example, REGION1 might have values of "Asia", "Europe", "North America", "Rest of World"; REGION2 might have values of "United States", "Rest of World".
REGIONyN	Geographic Region y (N)	Num		Perm	Numeric representation of REGIONy. Orders REGIONy for analysis and reporting.There must be a one-to- one relationship between REGIONyN and REGIONy within a study. REGIONyN cannot be present unless REGIONy is also present. When REGIONy and REGIONyN are present, then on a given record, either both must be populated or both must be null.

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Subject Demographics Variables for ADSL Datasets