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 Section 3.1.4, Item 2,
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 Section 3.1.4."
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,
