Variable Name

Variable Label

Type

Codelist/ Controlled Terms

Core

CDISC Notes

FASFLFull Analysis Set Population FlagCharY, NCond

Must be included if FASFL is defined and required per the SAP

SAFFL

Safety Population Flag

Char

Y, N

Cond

Must be included if SAFFL is defined and required per the SAP

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

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