AE Severity ANOVA

The AE Severity ANOVA process screens all adverse events by performing a mixed-model analysis of variance , with average ranked severity score as the dependent variable and customizable fixed and random effects . A separate ANOVA is fit for each distinct adverse event. Volcano plots and other output enable efficient screening of adverse event severities that differ between treatment groups. If a patient has multiple instances of a particular adverse event, then those scores are averaged to form a single score for analysis.

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 , 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 Severity ANOVA output documentation for detailed descriptions and guides to interpreting your results.