Treatment Emergent AE Summary

This process creates tabular and graphical overviews of treatment emergent adverse events for the safety population by actual treatment arm .

What do I need?

This process requires several demographic- and adverse event-related variables . These include:

•

USUBJID ,

•	a treatment variable ( the actual treatment received by each subject ( TRT01A )),

•	the planned treatment (intent-to-treat) for each subject ( TRT01P ), or the description of the planned treatment arm ( ARM ),

•	AGE , SEX , RACE , AEDECOD , AEBODSYS , AESTDTC , AESER , AESEV , AEOUT , and AEENDTC .

Variables can be taken either from the subject level analysis data set ( ADSL ) included in the Analysis Data Model ( ADaM ) folder or from the DM and AE domains in SDTM . Refer to Localization-Specific Value Specification for more information about these data sets.

Output/Results

The output generated by this process is summarized by a tabbed report. Refer to the Treatment Emergent AE Summary output documentation for detailed descriptions and guides to interpreting your results.