| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Notes |
|---|---|---|---|---|---|
STUDYID | Study Identifier | text | |||
| USUBJID | Unique Subject Identifier | text | |||
| SITEID | Study Site Identifier | text | |||
| TRTP | Planned Treatment | text | |||
| TRT01P | Planned Treatment for Period 01 | text | |||
| TRT01A | Actual Treatment for Period 01 | text | |||
| ADT | Analysis Date | integer | |||
| ADTM | Analysis Datetime | integer | |||
| ADY | Analysis Relative Day | integer | |||
| AVISIT | Analysis Visit | text | |||
| AVISITN | Analysis Visit (N) | integer | |||
| ATPT | Analysis Timepoint | text | |||
| ATPTN | Analysis Timepoint (N) | float | |||
| PARAM | Parameter | text | |||
| PARAMCD | Parameter Code | text | |||
| PARAMN | Parameter (N) | integer | |||
| AVAL | Analysis Value | integer | |||
| BASE | Baseline Value | integer | |||
| CHG | Change from Baseline | integer | |||
| 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 | |||
| 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 | |||
| VISIT | Visit Name | text | |||
| VISITNUM | Visit Number | integer | |||
| VSSEQ | Sequence Number | integer | |||
| VSTPT | Planned Time Point Name | text | |||
| VSTPTNUM | Planned Time Point Number | float |
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