AE Time to Event

The AE Time to Event process screens all adverse events by performing log-rank and Wilcoxon tests between treatment groups. The time to first occurrence of the adverse event is used as the response.

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 Time to Event output documentation for detailed descriptions and guides to interpreting your results.

Note : If you run this analysis using data from a blinded study or from a study that has only one ARM, you will generate a different set of output. See AE Time to Event (One ARM) for a detailed description.