Summary Report

Use this option to include an output adverse event (AE) report that lists AE summary statistics for the patients in the study. This box is checked by default.

Note: This report requires the AE_SUMMARY_REPORT.sas program file located in the StandardReports safety reports folder.

Note: Standard Safety Reports uses AETERM instead of AEDECOD to build the tables for adverse events reports.

To Specify This Option:

8

Make sure that the Include adverse event reports box is checked.

8

Check the Summary Report box.