Processes | Clinical | Events Incidence Screen

Events Incidence Screen
This process 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 processes.
Note: This process should be considered as two different processes: DS Incidence Screen and MH Incidence Screen, depending on which domain is specified in the dialog.
What do I need?
This process requires several demographic-, disposition-, and medical history-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),
DSDECOD, DSSTDTC, DSENDTC, MHDECOD, MHSTDTC, and MHENDTC.
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, DS, and MH 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 Events Incidence Screen output documentation for detailed descriptions and guides to interpreting your results.