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This is an example of an ADAE dataset and is based primarily on input from the SDTM AE dataset. Other adminstrative data about the subjects are based on the ADSL datset provided ...  > add the link.  Only variables needed for illustration are shown in the examples.  

This is an example of the input SDTM AE datasets used to create the ADAE.  

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Below is the example ADAE dataset and associated metadata. This is just an example and does not mean to indicate that ADAE must be used as the dataset name nor are the parameters described necessarily the ones that would be used in a particular study. 

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adae.xpt

STUDYID

USUBJIDASTDTASTDTMAENDTAENDTMASTDYAENDYPREFLTRTEMFLFUPFLAETRTEMAOCCFLAOCCPFLAOCCSFLAESERAERELRELGR1AESEVAEACNTRTASAFFLTRTSDT
ABC12312310112OCT2005
12OCT2005
-1-1Y





NDEFINITELY NOT RELATEDNOT RELATEDSEVERENOT APPLICABLEProduct AY13OCT2005
ABC12312310113OCT200513OCT2005:13:0513OCT200513OCT2005:19:0011
Y
YYYYNProduct ARELATEDMODERATEDOSE REDUCEDProduct AY13OCT2005
ABC12312310121OCT2005


9

YYY
YYYPROBABLY NOT RELATEDNOT RELATEDMODERATEDOSE REDUCEDProduct AY13OCT2005
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ADAE Dataset Metadata

ADAE Variable Metadata





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