Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Notes |
|---|
| STUDYID | Study Identifier | text | ABC-123 | Req | ADSL.STUDYID | | USUBJID | Unique Subject Identifier | text |
| Req | PP.STUDYID | | TRTA | Actual Product | text | Product A | Cond | ADSL.TRT01A | | AVISIT | Analysis Visit | text | Day 1 | Cond | Set to propcase of PP.VISIT | | PARQUAL | Parameter Qualifier | text | NICOTINE
COTININE
NNN | Perm | PP.PPCAT | | PARAM | Parameter | text | AUC All (h*ng/mL)
Max Conc (ng/mL)
Time of CMAX (h) | Req | Assigned | | PARAMCD | Parameter Code | text | AUCALL
CMAX
TMAX | Req | Assigned | | AVAL | Analysis Value | float |
| Req | PP.PPSTRESN | | PPSPEC | Specimen Material Type | text | PLASMA | Perm | PP.PPSPEC | | PPSEQ | Sequence Number | text |
| Perm | PP.PPSEQ | | PKFL | PK Population Flag | text | Y;N | Cond | ADSL.PKFL |
|