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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

RowSTUDYIDDOMAINUSUBJIDEXSEQSPTOBIDEXREFIDEXTRTEXDOSEEXDOSUEXDOSFRMEXROUTEEXPSTRGEXPSTRGUEXSTDTCEXENDTC
1A123EXA20011VAPE-Z27CRT8754e-nicotine liquid6mLCARTRIDGERESPIRATORY (INHALATION)0mg/mL2021-01-082021-01-14
2A123EXA20012VAPE-Z27CRT8768e-nicotine liquid6.4mLCARTRIDGERESPIRATORY (INHALATION)0mg/mL2021-01-152021-01-21
3A123EXA20013VAPE-Z27CRT9756e-nicotine liquid7mLCARTRIDGERESPIRATORY (INHALATION)0mg/mL2021-01-222021-01-28
4A123EXA20081VAPE-Z27CRT8000e-nicotine liquid5mLCARTRIDGERESPIRATORY (INHALATION)8mg/mL2021-02-082021-02-14
5A123EXA20082VAPE-Z27CRT9006e-nicotine liquid7mLCARTRIDGERESPIRATORY (INHALATION)8mg/mL2021-02-152021-02-21
6A123EXA20083VAPE-Z27CRT9008e-nicotine liquid8mLCARTRIDGERESPIRATORY (INHALATION)8mg/mL2021-02-222021-03-01
7A123EXA30091VAPE-Z27CRT9128e-nicotine liquid8mLCARTRIDGERESPIRATORY (INHALATION)4mg/mL2021-06-092021-06-15
8A123EXA30092VAPE-Z27CRT6868e-nicotine liquid6.7mLCARTRIDGERESPIRATORY (INHALATION)4mg/mL2021-06-162021-06-21
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adex.xpt

STUDYIDUSUBJIDASTDTAENDTASTDYAENDYEXSTDTCEXENDTCTRTPEXTRTEXDOSEEXDOSUSAFFLEXSEQ
A123A2001



2020-06-262020-07-01Placeboe-nicotine liquid6mLY1
A123A2001



2020-07-012020-07-06Placeboe-nicotine liquid6.4mLY2
A123A2001



2020-07-062020-07-10Placeboe-nicotine liquid7mLY3
A123A2008



2020-07-102020-07-14Product Ae-nicotine liquid8mLY4
A123A2008



2020-09-012020-09-07Product Ae-nicotine liquid5mLY1
A123A2008



2020-09-072020-09-14Product Ae-nicotine liquid7mLY2
A123A3009



2020-09-142020-09-21Product Be-nicotine liquid8mLY3
A123A3009



2020-09-212020-09-28Product Be-nicotine liquid6mLY4
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ADEX Variable Metadata

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