Count multiple occurrences of an event per subject

Select the method by which to compute counts of adverse events.

Box state:

Result:

Unchecked

Compute counts based on the number of subjects that experienced an adverse event.

Each subject contributes only one time to the occurrence count of an event, regardless of how many times that specific event might have occurred to the subject.

Note: This option sorts the data so that the first event occurring to a subject is based on seriousness (AESER), severity (AESEV or AETOXGR), and Study day (AESTDY).

Checked

Compute counts based on the overall counts of events, including multiple occurrences per subject.

To Specify the Basis for Computing Adverse Event Counts:

8 Leave the box unchecked to count only one occurrence of an event per subject.

8 Check the box to count multiple occurrences of an event per subject.

The resulting dashboard then shows all event records (including records for the same AE that might have occurred multiple times for a given subject).