This is an example of the ADSL dataset and associated metadata.
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adsl.xpt
Row
STUDYID
USUBJID
SUBJID
SITEID
AGE
AGEU
AGEGR1
SEX
RACE
ETHNIC
SAFFL
RANDFL
ARM
ACTARM
TRT01P
TRT01PN
TRT01A
TRT01AN
TRTSDT
TRTEDT
EOSSTT
EOSDT
DCSREAS
EOTSTT
DCTREAS
RANDDT
1
A123
A2001
2001
01
72
YEARS
>=65 Years
M
WHITE
NOT HISPANIC OR LATINO
Y
Y
Placebo
Placebo
Placebo
1
Placebo
1
2021-01-08
2021-01-28
COMPLETED
2021-02-04
2021-01-08
2
A123
A2008
2008
02
65
YEARS
>=65 Years
M
WHITE
NOT HISPANIC OR LATINO
Y
Y
Product A
Product A
Product A
2
Product A
2
2021-02-08
2021-03-01
COMPLETED
2021-03-10
2021-02-08
3
A123
A3009
3009
03
57
YEARS
<65 Years
F
BLACK OR AFRICAN AMERICAN
NOT HISPANIC OR LATINO
Y
Y
Product B
Product B
Product B
3
Product B
3
2021-06-09
2021-06-21
COMPLETED
2021-06-30
DISCONTINUED
ADVERSE EVENT
2021-06-09
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ADSL Dataset Metadata
Dataset
Description
Class
Structure
Purpose
Keys
Location
Documentation
ADSL
Subject-Level Analysis Dataset
SUBJECT LEVEL ANALYSIS DATASET
One record per subject
Analysis
STUDYID, USUBJID
ADSL.xpt
ADSL.SAS/SAP
ADSL Variable Metadata
Variable Name
Variable Label
Type
Codelist/Controlled Terms
Core
Notes
STUDYID
Study Identifier
Char
Req
DM.STUDYID
USUBJID
Unique Subject Identifier
Char
Req
DM.USUBJID
SUBJID
Subject Identifier for the Study
Char
Req
DM.SUBJID
SITEID
Study Site Identifier
Char
Req
DM.SITEID
AGE
Age
Num
Req
DM.AGE
AGEU
Age Units
Char
(AGEU)
Req
DM.AGEU
AGEGR1
Pooled Age Group 1
Char
Perm
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.