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 3.3.6.1, Subject-level Analysis Dataset (ADSL).

Example

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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This is an example of the ADEX dataset and associated metadata.

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adex.xpt

RowSTUDYIDUSUBJIDASTDTASTDYAENDTAENDYEXTRTDOSCUMAEXSTDTCEXENDTCTRTAEXDOSEEXDOSUSAFFL
1A123A200108JAN2021

1

14JAN2021

7

e-nicotine liquid

6

021-01-082021-01-14Placebo6mLY
2A123A2001

15JAN2021

8

21JAN2021

14e-nicotine liquid12.42021-01-152021-01-21Placebo6.4mLY
3A123A2001

22JAN2021

15

28JAN2021

21e-nicotine liquid19.42021-01-222021-01-28Placebo7mLY
4A123A2008

08FEB2021

1

14FEB2021

7

e-nicotine liquid52021-02-082021-02-14Product A5mLY
5A123A200815FEB2021821FEB202114e-nicotine liquid122021-02-152021-02-21Product A7mLY
6A123A200822FEB20211501MAR202122e-nicotine liquid202021-02-222021-03-01Product A8mLY
7A123A300909JUN2021

1

15JUN2021

7

e-nicotine liquid82021-06-092021-06-15Product B8mLY
8A123A300916JUN2021821JUN202113e-nicotine liquid14.72021-06-162021-06-21Product B6.7mLY
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ADEX Dataset Metadata

ADEX Variable Metadata

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adexsum.xpt

RowSTUDYIDUSUBJID

TRTA

PARAM

PARAMCD

PARAMN

AVAL

SAFFL

1A123A2001

Placebo

Number of Days Exposed

NDAYS

1

21

Y

2A123A2001

Placebo

Average Daily Dose

ADD

2

0.92381Y
3A123A2001

Placebo

Total Dose

TOTDOSE

3

19.4Y
4A123A2008

Product A

Number of Days Exposed

NDAYS

1

22Y
5A123A2008

Product A

Average Daily Dose

ADD

2

0.90909Y
6A123A2008

Product A

Total Dose

TOTDOSE

3

20Y
7A123A3009

Product B

Number of Days Exposed

NDAYS

1

13Y
8A123A3009

Product B

Average Daily Dose

ADD

2

1.13077Y
9A123A3009

Product B

Total Dose

TOTDOSE

3

14.7Y
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ADEXSUM Dataset Metadata

ADEXSUM Variable Metadata

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