Processes | Clinical | Treatment Emergent AE Summary

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:
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.