Unique Occurrence Subject Counts

This down is useful when the AE Distribution report dialog option to Count multiple occurrences of an event per subject is checked.

The resulting dashboard then shows all event records (including records for the same AE that might have occurred multiple times for a given subject). Once that report is generated, the user can select certain criteria for given Adverse Events either interactively, or through the Demographic Counts down shown on the report dashboard. This action button can then be run to consider the selected/filtered AE records only and take the FIRST OCCURRENCE for each subject per each adverse event.

This enables you to create a subject count representation of AE occurrence based on any general criteria.

For example: When the Count multiple occurrences of an event per subject dialog check box is UNCHECKED, the software automatically chooses representative subject event records based on the most SERIOUS (AESER = Y), SEVER (AESEV), and then first occurring. In this way, the descriptive quality of the AE occurrence selected to be representative of each subject is likely the most notable.

Instead, if you CHECK the box for count multiple occurrences, then you can make an arbitrary filter (for example, all MILD events) and use this action button to get a representative count of all subjects that experienced a given (for example, MILD) AE. These numbers would not have been reflected if one of those same subjects also experienced a SEVER event as well as a MILD given event.

Down Buttons

down buttons provide you with an easy way to down into your data. The following down buttons are generated by this report:

•	Create Static Report : Click to generate a standardized pdf - or rtf -formatted report containing the plots and charts of selected sections.

•	Profile Subjects : Select subjects and click to generate the patient profiles for subjects experiencing selected events. See Profile Subjects for additional information.

•	Show Subjects : Select subjects and click to open the ADSL (or DM if ADSL is unavailable) of selected subjects for subjects experiencing selected events.

•	Cluster Subjects : Select subjects and click to cluster subjects experiencing selected events based on available covariates . See Cluster Subjects for additional information.

•	Adverse Events Narrative Generation : Select subjects and click to open the AE Narrative dialog. From this dialog, you can customize options and generate a narrative.

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Demographic Counts : Select subjects and click to create a data set of USUBJID s for subjects experiencing selected events, which subsets all subsequently run reports to those selected subjects. The currently available filter data set can be applied by selecting Apply Subject Filter in any report dialog .