Variable Name | Variable Label | Type | Codelist/ Controlled Terms | Core | CDISC Notes |
|---|
| FASFL | Full Analysis Set Population Flag | Char | Y, N | Cond | Must be included if FASFL is defined and required per the SAP |
SAFFL | Safety Population Flag | Char | Y, N | Cond | ITTFL | Intent-To-Treat Population Flag | Must be included if SAFFL is defined and required per the SAP |
Char | Y, N | Cond | PPROTFL | Per-Protocol Population Flag | Char | Y, N | Cond | Must be included if PPROTFL is defined and required per the SAP |
COMPLFL | Completers Population Flag | Char | Y, N | Cond | Must be included if COMPLFL is defined and required per the SAP |
RANDFL | Randomized Population Flag | Char | Y, N | Cond | Must be included if RANDFL is defined and required per the SAP |
ENRLFL | Enrolled Population Flag | Char | Y, N | Cond | Must be iif ENRLFL is defined and required per the SAP |