This report screens all events from a domain by performing a Cochran-Mantel-Haenszel exact test on all 2 x 2 tables constructed from event incidence and treatment arm. Output is a table of multiplicity-adjusted p-values, an accompanying volcano plot of relative risk, and a SAS data set of indicator variables that can be used as input for other reports.
Note: This report should be considered as two different reports: DS Incidence Screen and MH Incidence Screen, depending on which domain is specified in the dialog.
Running this report for Nicardipine using default settings for medical history (MH) generates the Report window shown below. Refer to Events Incidence Screen requirements description for more information.
Refer to the AE Incidence Screen output description, keeping in mind the following important report differences in contrast with the example:
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Output (including tab names) reflects other event (for example, disposition events or medical history terms), rather than adverse event, incidence
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There is no option to Perform Double FDR Adjustment
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You cannot explicitly specify a Group Level from the dialog. Instead, this report automatically searches for the presence of xxBODSYS (or alternatively xxCAT if xxBODSYS is not found) and uses this variable for output organization and filtering.
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