Processes | Clinical | AE Time to Event

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:
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.