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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.    

dm.xpt

dm.xpt

RowSTUDYIDDOMAINUSUBJIDSUBJIDRFSTDTCRFENDTCRFXSTDTCRFXENDTCRFICDTCRFPENDTCDTHDTCDTHFLSITEIDINVNAMBRTHDTCAGEAGEUSEXRACEETHNICARMCDARMACTARMCDACTARMARMNRSACTARMUDCOUNTRY
1A123DMA200120012021-01-082021-01-282021-01-082021-01-282021-01-022021-02-04

01JOHNSON, M1948-12-1372YEARSMWHITENOT HISPANIC OR LATINOPlacPlaceboPlacPlacebo

USA
2A123DMA200820082021-02-082021-03-012021-02-082021-03-012021-02-022021-03-10

02JAMES,A1955-03-2265YEARSMWHITENOT HISPANIC OR LATINOAProduct AAProduct A

USA
3A123DMA300930092021-06-092006-03-192021-06-092021-06-212021-06-012021-06-30

03ADAMS,J1964-01-1957YEARSFBLACK OR AFRICAN AMERICANNOT HISPANIC OR LATINOBProduct BBProduct B

USA
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ds.xpt

RowSTUDYIDDOMAINUSUBJIDDSSEQDSTERMDSDECODDSCATDSSCATEPOCHDSDTCDSSTDTC
1A123DS

A2001

1INFORMED CONSENT OBTAINEDINFORMED CONSENT OBTAINEDPROTOCOL MILESTONE

2021-01-022021-01-02
2A123DSA20012RANDOMIZEDRANDOMIZEDPROTOCOL MILESTONE

2021-01-072021-01-07
3A123DSA20013COMPLETEDCOMPLETEDDISPOSITION EVENTSTUDY PARTICIPATIONSCREENING2021-01-0720021-01-07
4A123DSA20014COMPLETEDCOMPLETEDDISPOSITION EVENTSTUDY PARTICIPATIONPRODUCT EXPOSURE2021-01-282021-01-28
5A123DSA20015COMPLETEDCOMPLETEDDISPOSITION EVENTSTUDY PARTICIPATIONFOLLOW-UP2021-02-042021-02-04












6A123DS

A2008

1INFORMED CONSENT OBTAINEDINFORMED CONSENT OBTAINEDPROTOCOL MILESTONE

2021-02-022021-02-02
7A123DSA20082RANDOMIZEDRANDOMIZEDPROTOCOL MILESTONE

2021-02-082021-02-08
3A123DSA20083COMPLETEDCOMPLETEDDISPOSITION EVENTSTUDY PARTICIPATIONSCREENING2021-02-082021-02-08
4A123DSA20084COMPLETEDCOMPLETEDDISPOSITION EVENTSTUDY PARTICIPATIONPRODUCT EXPOSURE2021-03-012021-03-01
5A123DSA20085COMPLETEDCOMPLETEDDISPOSITION EVENTSTUDY PARTICIPATIONFOLLOW-UP2021-03-102021-03-10












8A123DSA30091INFORMED CONSENT OBTAINEDINFORMED CONSENT OBTAINEDPROTOCOL MILESTONE

2021-06-012021-06-01
9A123DSA30092RANDOMIZEDRANDOMIZEDPROTOCOL MILESTONE

2021-06-092021-06-09
10A123DSA30093COMPLETEDCOMPLETEDDISPOSITION EVENTSTUDY PARTICIPATIONSCREENING2021-06-092003-06-09
10A123DSA30094FLUADVERSE EVENTDISPOSITION EVENTSTUDY PARTICIPATIONPRODUCT EXPOSURE2021-06-212021-06-21
11A123DSA30095COMPLETEDLOST TO FOLLOW-UPDISPOSITION EVENTSTUDY PARTICIPATIONPRODUCT EXPOSURE2021-06-302021-06-30
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  This is an example of the ADSL dataset and associated metadata.   

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adsl.xpt

STUDYIDUSUBJIDSUBJIDSITEIDAGEAGEUAGEGR1SEXRACEETHNICSAFFLRANDFLARMACTARMTRT01PTRT01PNTRT01ATRT01ANTRTSDTTRTEDTEOSSTTEOSDTDCSREAS
A123A200100010172YEARS<65MWHITENOT HISPANIC OR LATINOYYPlacPlacebo Placebo1Placebo12021-01-082021-01-28COMPLETED

A123A200820080265YEARS
MWHITENOT HISPANIC OR LATINOYYProduct AProduct AProduct A2Product A22021-02-082021-03-01COMPLETED
ADVERSE EVENT
A123A300930090357YEARS
FBLACK OR AFRICAN AMERICANNOT HISPANIC OR LATINOYYProduct BProduct BProduct B3Product B32021-06-092021-06-21DISCONTINUED

Dataset Debug Message

There is a leading, trailing, or non-breaking space in the dataset.

ADSL Dataset Metadata

ADSL Variable Metadata




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