| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | CDISC Notes |
|---|
| Study Identifier | Char |
| Req | LB.STUDYID |
| USUBJID | Unique Subject Identifier | Char |
| Req | LB.USUBJID |
| TRTP | Planned Treatment | Char |
| Cond | ADSL.TRT01P |
| TRT01P | Planned Treatment for Period 01 | Char |
| Cond | ADSL.TRT01P |
| TRTA | Actual Treatment | Char |
| Cond | ADSL.TRT01A |
| TRTx01ATRT01A | Actual Treatment for Period 01 | Char |
| Cond | ADSL.TRT01A |
| ADT | Analysis Date | Num |
| Perm | LB.LBDTC captured in numeric format |
| ADY | Analysis Relative Day | Num |
| Perm | LB.LBDY |
| AVISIT | Analysis Visit | Char |
| Cond | LB.VISIT |
| AVISITN | Analysis Visit (N) | Num |
| Perm | LB.VISITNUM |
| PARAM | Parameter | Char |
| Req | LB.LBTEST concatenated with LB.LBSTRESU - if PARCAT1=URINALYSIS then preface with Urine |
| PARAMCD | Parameter Code | text |
| Req | LB.LBTESTCD - if PARCAT1=URINALYSIS then preface with U |
| PARAMN | Parameter (N) | Num |
| Perm | Numeric representation of PARAM. Sort by PARCAT! and PARAMCD and increment by 1 for each new LBTESTCD |
| PARCAT1 | Parameter Category 1 | Char |
| Perm | LB.LBCAT |
| AVAL | Analysis Value | Num |
| Cond | LB.LBSTRESN |
| AVALC | Analysis Value (C) | Char |
| Cond | LB.LBSTRESC where LB.LBSTRESN is null |
| BASE | Baseline Value | Num |
| Cond | AVAL where ABLFL=Y |
| CHG | Change from Baseline | Num |
| Perm | AVAL-BASE - populated on ABLFL=Y records and post-baseline records |
| PCHG | Percent Change from Baseline | Num |
| Perm | derived as ((AVAL-BASE)/BASE)*100 |
| ABLFL | Baseline Record Flag | Char | Y | Cond | set to Y for last pre-treatment value within each PARAM |
| ANL01FL | Analysis Flag 01 | Char | Y | Cond | set to Y for last value within PARAM and AVISIT |
| RANDFL | Randomized Population Flag | Char | Y;N | Cond | ADSL.RANDFL |
| SAFFL | Safety Population Flag | Char | Y;N | Cond | ADSL.SAFFL |
| TRTSDT | Date of First Exposure to Treatment | Num |
| Perm | ADSL.TRTSDT |
| TRTEDT | Date of Last Exposure to Treatment | Num |
| Perm | ADSL.TRTEDT |
| LBSEQ | Sequence Number | Num |
| Perm | LB.LBSEQ |
| VISITNUM | Visit Number | Num |
| Perm | LB.VISITNUM |
| LBDTC | Date/Time of Specimen Collection | Char |
| Perm | LB.LBDTC |