Population Indicator Variables for ADSL Datasets

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 Flag Variable Conventions.

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	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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Population Indicator Variables for ADSL Datasets