Adverse Events Report

This process generates SAS reports of adverse event counts and percentages by treatment arms , sex, and race.

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 , SITEID , AEDECOD , AESTDTC , AEBODSYS , AESER , AEOUT , and AESEV .

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

Running this process generates SAS reports, in the format(s) specified, of adverse event counts and percentages by treatment arms, sex, and race. Refer to the Profile Subjects output documentation for detailed descriptions and guides to interpreting your results.