| 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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