This is an example of an ADSL dataset and is based on input from the SDTM DM and DS datasets. This is just an example and does not mean to indicate that ADSL must be used as the dataset name nor are the parameters described necessarily the ones that would be used in a particular study.
These are example SDTM datasets used to create the ADSL dataset. Only variables needed for illustration are shown in the examples.
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This is an example of the ADSL dataset and associated metadata.
Character description of a grouping or pooling of the subject's age for analysis purposes.
SEX
Sex
Char
(SEX)
Req
DM.SEX
RACE
Race
Char
(RACE)
Req
DM.RACE
ETHNIC
Ethnicity
Char
Perm
DM.ETHNIC
SAFFL
Safety Population Flag
Char
Y; N
Cond
Y if ADSL.TRTSDT is not null, otherwise N
RANDFL
Randomized Population Flag
Char
Y; N
Cond
Y if the subject was randomized, otherwise N
ARM
Description of Planned Arm
Char
Req
DM.ARM
ACTARM
Description of Actual Arm
Char
Perm
DM.ACTARM
TRT01P
Planned Treatment for Period 01
Char
Req
DM.ARM
TRT01PN
Planned Treatment for Period 01 (N)
Num
Perm
Assigned based on the ARM value
TRT01A
Actual Treatment for Period 01
Char
Cond
DM.ACTARM
TRT01AN
Actual Treatment for Period 01 (N)
Num
Perm
Assigned based on the ACTARM value
TRTSDT
Date of First Exposure to Treatment
Num
Cond
Numeric version of RFXSTDTC
TRTEDT
Date of Last Exposure to Treatment
Num
Cond
Numeric version of RFXENDTC
EOSSTT
End of Study Status
Char
(SBJTSTAT)
Perm
The subject's status as of the end of study or data cutoff. Examples: COMPLETED, DISCONTINUED, ONGOING.
EOSDT
End of Study Date
Num
Perm
Date subject ended the study - either date of completion or date of discontinuation or data cutoff date for interim analyses.
DCSREAS
Reason for Discontinuation from Study
Char
Perm
Reason for subject's discontinuation from study. The source would most likely be the SDTM DS dataset. Null for subjects who completed the study.
EOTSTT
End of Treatment Status
Char
(SBJTSTAT)
Perm
The subject's status as of the end of treatment or data cutoff. Examples: COMPLETED, DISCONTINUED, ONGOING.
DCTREAS
Reason for Discontinuation of Treatment
Char
Perm
If a subject discontinued treatment in the study, then this variable indicates the reason for discontinuation. This is for discontinuation of treatment in the overall study and not to be used for discontinuation reason within individual treatment periods.