AE Resolution Screen

This process screens all adverse events by performing a Cochran-Mantel-Haenszel exact test on all 2 x 2 tables constructed from event resolution and treatment arm . Resolution is computed directly from the end time of an adverse event and the end time of the trial, or from a resolution time window that you specify.

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 , AESEV , AEOUT , 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 Resolution Screen output documentation for detailed descriptions and guides to interpreting your results.