Distribution Results When Counting Multiple Occurrences of an Event or Intervention

The percent calculations are performed only when a unique event/intervention is counted for each subject in the analysis. If you check the Count multiple occurrences of an event per subject (or Count multiple occurrences of an intervention per subject when running the Interventions Distribution ), all records are counted in the results report.

With this option specified, percent values are not computed and the Percent Occurrence Threshold is ignored since the counts of events no longer represent counts of subjects.

Results for the Nicardipine example study when AE Distribution was run for multiple occurrences of events are shown below.

Note : It might be useful to customize the results report data filter to include the computed Total Count column if you want to filter to more commonly occurring adverse events. The grouping and stacking capabilities and drill downs are still available with this view of the report.

The counts now might represent multiple occurrences of the same event for the same subject. For example, when a unique occurrence only was counted (for all Event Type s) in Nicardipine, there was a total of 560 subjects experiencing Vasoconstriction.

However, when all events (including multiple occurrences) are counted, there were 693 records of occurrence of Vasoconstriction across the subjects on the study.

The distinction in the interpretation of the counts is reflected in the text field above the plots on the Counts Graph tab.

When the check box is NOT checked (default behavior), the following text (circled) is shown:

When the check box is checked, the following text (circled) is shown: