Processes | Clinical | AE Severity ANOVA

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:
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.