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Variable Name

Variable Label

Type

Codelist/ Controlled Terms

Core

CDISC Notes

FASFL

Full Analysis Set Population Flag

Char

Y, N

Cond

These flags identify whether or not the subject is included in the specified population. A minimum of one subject-level population flag variable is required in ADSL.

Not all of the indicators listed here need to be included in ADSL. As stated in Flag Variable Conventions, only those indicators corresponding to populations defined in the statistical analysis plan or populations used as a basis for analysis need be included in ADSL.

This list of flags is not meant to be all-inclusive. Additional population flags may be added.

The values of subject-level population flags cannot be blank. If a flag is used, the corresponding numeric version (*FN, where 0 = No and 1 = Yes) of the population flag can also be included. Please also refer to .

SAFFL

Safety Population Flag

Char

Y, N

Cond

ITTFL

Intent-To-Treat Population Flag

Char

Y, N

Cond

PPROTFL

Per-Protocol Population Flag

Char

Y, N

Cond

COMPLFL

Completers Population Flag

Char

Y, N

Cond

RANDFL

Randomized Population Flag

Char

Y, N

Cond

ENRLFL

Enrolled Population Flag

Char

Y, N

Cond