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Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | CDISC Notes |
---|---|---|---|---|---|
STUDYID | Study Identifier |
Char | Req | DM.STUDYID, ADSL STUDYID, and/or STUDYID from another ADaM or SDTM dataset appropriate to the analysis. | |||
USUBJID | Unique Subject Identifier | Char | Req | DM.USUBJID, ADSL.USUBJID, and/or USUBJID from another ADaM or SDTM dataset appropriate to the analysis. | |
SUBJID | Subject Identifier |
for the Study | Char | Perm | DM.SUBJID, ADSL.SUBJID, and/or SUBJID from another ADaM dataset appropriate to the analysis. SUBJID is required in ADSL, but permissible in other datasets. | |
SITEID | Study Site Identifier |
Char | Perm | DM.SITEID, ADSL.SITEID, and/or SITEID from another ADaM dataset appropriate to the analysis. SITEID is required in ADSL, but permissible in other datasets. | |||
ASEQ | Analysis Sequence Number | Num | Perm | Sequence number given to ensure uniqueness of subject records within an ADaM dataset. As long as values are unique within a subject within the dataset, any valid number can be used for ASEQ. ASEQ uniquely indexes records within a subject within an ADaM dataset. | |
ADT | Analysis Date | integer | |||
ADTM | Analysis Datetime | integer | |||
ADY | Analysis Relative Day | integer | |||
AVISIT | Analysis Visit | text | |||
AVISITN | Analysis Visit (N) | integer | |||
PARAM | Parameter | text | |||
PARAMCD | Parameter Code | text | |||
PARAMN | Parameter (N) | integer | |||
PARCAT1 | Parameter Category 1 | text | |||
AVAL | Analysis Value | float | |||
BASE | Baseline Value | float | |||
CHG | Change from Baseline | float | |||
ABLFL | Baseline Record Flag | text | |||
ANL01FL | Analysis Flag 01 | text | |||
COUNTRY | Country | text | |||
AGE | Age | integer | |||
SEX | Sex | text | |||
RACE | Race | text | |||
ETHNIC | Ethnicity | text | |||
SAFFL | Safety Population Flag | text | |||
RANDFL | Randomized Population Flag | text | |||
TRT01P | Planned Treatment for Period 01 | text | |||
TRT01A | Actual Treatment for Period 01 | text | |||
TRTSDT | Date of First Exposure to Treatment | integer | |||
TRTSDTM | Datetime of First Exposure to Treatment | integer | |||
TRTEDT | Date of Last Exposure to Treatment | integer | |||
TRTEDTM | Datetime of Last Exposure to Treatment | integer | |||
LBSEQ | Sequence Number | integer | |||
VISIT | Visit Name | text | |||
VISITNUM | Visit Number | float |
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