Events Distribution

This process compares distributions of events from a domain and demographic variables across treatment arms .

Note : This process should be considered as two different processes: DS Distribution and MH Distribution , 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:

•

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 ),

•	AGE , SEX , RACE , SITEID , DSDECOD , DSSTDTC , 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 by a tabbed report. Refer to the Events Distribution output documentation for detailed descriptions and guides to interpreting your results.