Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | CDISC Notes |
---|---|---|---|---|---|
STUDYID | 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 | |
TRTx01A | 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 |
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