Standard Signal Supplemental Views

The Supplemental Views include the following for each review period (1Month shown here).

Name Description

All events 1M

All events reported for the selected drug.

Closed/dismissed signals 1M

Events for the selected drug, for which the associated comment or topic state indicates that the signal has been explicitly closed.

DMEs and TMEs 1M

All designated medical events and targeted medical events reported for the selected drug.

New spontaneous cases 1M

Events reported for the selected drug, for which there have been one or more new spontaneous reports since the last review period.

New study cases 1M

Events reported for the selected drug, for which there have been one or more new study reports since the last review period.

Open/potential signals 1M

Events reported for the selected drug, for which one of the following is true:

  • There is a comment indicating an open signal.
  • There is an associated topic that is not closed.
  • EB05 >=2; the event is unlisted; if present, the comment is not one of the comments indicating signal closure; if present, the topic is not in a final state.

Open/potential signals with new cases 1M

Events reported for the selected drug, with new reports in the last review period for which one of the following is true:

  • There is a comment indicating an open signal.
  • There is an associated topic that is not closed.
  • EB05 >=2; the event is unlisted; if present, the comment is not one of the comments indicating signal closure; if present, the topic is not in a final state.

Recently reviewed 1M

Events reported for the selected drug, for which 'Submit Review' action has recently occurred.

Significant case score 1M

Events reported for the selected drug with new reports in the last review period for which Period Sum Case Score >= 144 or Cumulative Average Case Score >= 144

SMQs and custom terms 1M

SMQs and custom terms for the selected drug.

Additionally, Supplemental Views includes one view that is not review-period specific.

Name Description

Increased frequency

Listed drug-event combinations with increased frequency of spontaneous reports.