This is an example of an ADEX dataset and is based primarily on input from the SDTM EX dataset. Other administrative data about the subjects are based on the ADSL dataset provided in Section x.x,Analysis Data Subject Level (ADSL).
This is an example of the input SDTM EX dataset used to create the ADEX. Only variables needed for illustration are shown in the example.
ex.xpt
ex.xpt
Row
STUDYID
DOMAIN
USUBJID
EXSEQ
SPTOBID
EXREFID
EXTRT
EXDOSE
EXDOSU
EXDOSFRM
EXROUTE
EXPSTRG
EXPSTRGU
EXSTDTC
EXENDTC
1
A123
EX
A2001
1
VAPE-Z27
CRT8754
e-nicotine liquid
6
mL
CARTRIDGE
RESPIRATORY (INHALATION)
0
mg/mL
2021-01-08
2021-01-14
2
A123
EX
A2001
2
VAPE-Z27
CRT8768
e-nicotine liquid
6.4
mL
CARTRIDGE
RESPIRATORY (INHALATION)
0
mg/mL
2021-01-15
2021-01-21
3
A123
EX
A2001
3
VAPE-Z27
CRT9756
e-nicotine liquid
7
mL
CARTRIDGE
RESPIRATORY (INHALATION)
0
mg/mL
2021-01-22
2021-01-28
4
A123
EX
A2008
1
VAPE-Z27
CRT8000
e-nicotine liquid
5
mL
CARTRIDGE
RESPIRATORY (INHALATION)
8
mg/mL
2021-02-08
2021-02-14
5
A123
EX
A2008
2
VAPE-Z27
CRT9006
e-nicotine liquid
7
mL
CARTRIDGE
RESPIRATORY (INHALATION)
8
mg/mL
2021-02-15
2021-02-21
6
A123
EX
A2008
3
VAPE-Z27
CRT9008
e-nicotine liquid
8
mL
CARTRIDGE
RESPIRATORY (INHALATION)
8
mg/mL
2021-02-22
2021-03-01
7
A123
EX
A3009
1
VAPE-Z27
CRT9128
e-nicotine liquid
8
mL
CARTRIDGE
RESPIRATORY (INHALATION)
4
mg/mL
2021-06-09
2021-06-15
8
A123
EX
A3009
2
VAPE-Z27
CRT6868
e-nicotine liquid
6.7
mL
CARTRIDGE
RESPIRATORY (INHALATION)
4
mg/mL
2021-06-16
2021-06-21
$warningHtml
This is an example of the ADEX dataset and associated metadata.
$titleHtml
adex.xpt
STUDYID
USUBJID
ASTDT
AENDT
ASTDY
AENDY
EXSTDTC
EXENDTC
TRTP
EXTRT
EXDOSE
EXDOSU
SAFFL
EXSEQ
A123
A2001
2020-06-26
2020-07-01
Placebo
e-nicotine liquid
6
mL
Y
1
A123
A2001
2020-07-01
2020-07-06
Placebo
e-nicotine liquid
6.4
mL
Y
2
A123
A2001
2020-07-06
2020-07-10
Placebo
e-nicotine liquid
7
mL
Y
3
A123
A2008
2020-07-10
2020-07-14
Product A
e-nicotine liquid
8
mL
Y
4
A123
A2008
2020-09-01
2020-09-07
Product A
e-nicotine liquid
5
mL
Y
1
A123
A2008
2020-09-07
2020-09-14
Product A
e-nicotine liquid
7
mL
Y
2
A123
A3009
2020-09-14
2020-09-21
Product B
e-nicotine liquid
8
mL
Y
3
A123
A3009
2020-09-21
2020-09-28
Product B
e-nicotine liquid
6
mL
Y
4
$warningHtml
ADEX Dataset Metadata
Dataset
Description
Class
Structure
Purpose
Keys
Location
Documentation
ADEX
SET
One record per subject
Analysis
ADEX.xpt
ADEX.SAS/SAP
ADEX Variable Metadata
Variable Name
Variable Label
Type
Codelist/Controlled Terms
Core
CDISC Notes
STUDYID
Study Identifier
text
EX.STUDYID
USUBJID
Unique Subject Identifier
text
EX.USUBJID
ASTDT
Analysis Start Date
integer
numeric SAS date variable based on EXSTDTC with no imputation for partial dates
AENDT
Analysis End Date
integer
numeric SAS date variable based on EXENDTC with no imputation for partial dates
ASTDY
Analysis Start Relative Day
integer
ASTDT-TRTSDT - add one if ASTDT is on or after TRTSDT
AENDY
Analysis End Relative Day
integer
AENDT-TRTSDT - add one if ASTDT is on or after TRTSDT