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Table 3.2.2 ADSL Subject Demographics Variables

Metadataspec
keysCore;CDISC Notes
Variable NameVariable LabelTypeCodelist/ Controlled TermsCoreCDISC Notes
AGEAgeNum
ReqDM.AGE. If analysis needs require a derived age that does not match DM.AGE, then AAGE must be added
AGEUAge UnitsChar(AGEU)Req

DM.AGEU

AGEGRyPooled Age Group yChar
PermCharacter 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".
AGEGRyNPooled 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.

AAGEAnalysis AgeNum
Cond

Age used for analysis that may be derived differently than DM.AGE. AAGE is required if age is calculated differently than DM.AGE.

SEXSexChar(SEX)ReqDM.SEX.
RACERaceChar(RACE)Req

DM.RACE.

RACEGRyPooled Race Group yChar
PermCharacter description of a grouping or pooling of the subject's race for analysis purposes.
RACEGRyNPooled 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.