Adverse Event Report

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

What do I need?

This process requires AE and either DM or ADSL . Required variables include USUBJID , TRT01A , ARM , AEDECOD , AEBODSYS , AESER , AGE , SEX , and RACE .

Output/Results

Running this process generates a PDF , rtf , or text file summary of the adverse events contained within the SV domain. Refer to the Adverse Events Report output documentation for detailed descriptions and guides to interpreting your results.