AE Incidence Screen

The AE Incidence Screen process screens all adverse events by performing a Cochran-Mantel-Haenszel exact test on all 2 x 2 tables constructed from event incidence and treatment arm . Output one or more volcano plots of risk differences when using default settings. However, plots of relative risks or odds ratios can be generated depending on the selected option for the x-Axis for Volcano Plot . If Study ID varies among the subjects for analysis, the test is stratified by Study ID .

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 ),

•	AEDECOD , AESTDTC , AEBODSYS , AESER , 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 in a tabbed report. Refer to the AE Incidence Screen output documentation for detailed descriptions and guides to interpreting your results.