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Variable Name

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Variable Label

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Type

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Codelist/ Controlled Terms

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Core

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CDISC Notes

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FASFL

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Full Analysis Set Population Flag

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Char

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Y, N

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Cond

These flags identify whether

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the subject is included in the specified population. A minimum of

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1 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 Section 2.9.3

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.4, 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

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Section 2.9.3.

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4, Flag Variable Conventions.

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Include Page

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ADSL Population

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Char

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Y, N

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Cond

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ITTFL

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Intent-To-Treat Population Flag

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Char

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Y, N

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Cond

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PPROTFL

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Per-Protocol Population Flag

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Char

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Y, N

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Cond

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COMPLFL

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Completers Population Flag

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Char

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Y, N

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Cond

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RANDFL

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Randomized Population Flag

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Char

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Y, N

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Cond

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ENRLFL

Indicator Variables
ADSL Population Indicator Variables

Pagenav

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Enrolled Population Flag

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Char

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Y, N

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