| 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 Product | Char |
| Cond | ADSL.TRT01P |
| ADT | Analysis Date | Num |
| Perm | LB.LBDTC captured as a date in numeric format |
| ADTM |
| Num |
| Perm | LB.LBDTC captured as a dateTIME in numeric format |
| AENDTM |
| Num |
| Perm | LB.LBENDTC captured as a datetime in numeric format. |
| 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 |
| PARAMCD | Parameter Code | text |
| Req | LB.LBTESTCD |
| PARCAT1 | Parameter Category 1 | Char |
| Perm | LB.LBCAT |
| AVAL | Analysis Value | Num |
| Cond | LB.LBSTRESN |
| ABLFL | Baseline Record Flag | Char | Y | Cond | set to Y for last pre-Product assessment fir each parameter |
| SAFFL | Safety Population Flag | Char | Y;N | Cond | ADSL.SAFFL |
| TRTSDT | Date of First Exposure to product | Num |
| Perm | ADSL.TRTSDT |
| TRTEDT | Date of Last Exposure to Product | Num |
| Perm | ADSL.TRTEDT |
| LBSTRESN | Numeric
Result/Finding
in Standard
Units |
|
| Perm | LB.LBSTRESN |
| LBSTRESU | Standard Units |
|
| Perm | LB.LBSTRESU |
| LBNAM | Vendor Name | Char |
| Perm | LB.LBNAM |
| LBLOINC | LOINC Code | Char |
| Perm | LB.LBLOINC |
| LBSPEC | Specimen Type | Char |
| Perm | LB.LBSPEC |
| LBMETHOD | Method of Test or Examination | Char |
| Perm | LB.LBMETHOD |
| LBLOBXFL | Last Observation Before Exposure Flag | Char |
| Perm | LB.LBLOBXFL |
| LBLLOQ | Lower Limit of Quantitation | Num |
| Perm | LB.LBLLOQ |
| VISIT | Visit Name | Char |
| Perm | LB.LB.VISIT |
| VISITNUM | Visit Number | Num |
| Perm | LB.VISITNUM |
| LBDTC | Date/Time of Specimen Collection | Char |
| Perm | LB.LBDTC |
| LBENDTC | End Date/Time of Specimen Collection | Char |
| Perm | LB.LBENDTC |
| LBSEQ | Sequence Number | Num |
| Perm | LB.LBSEQ |