Standard Signal Views

A signal view is a predefined set of columns and sorting preferences that you can apply to the Product-Event Combinations table. In addition, a signal view may contain a SQL expression to limit the rows that display in the table to product-event combinations that meet certain criteria.

The following table lists the set of standard, predefined signal views that are available for AERS Signal Management. You can also create your own. To see a list of available views, click the Add Tab button.

Tip:

If you have set the user preference for allowing SQL Where Clause for viewing signals, you can review the SQL statement used to select the rows for an added tab by selecting Columns from the Product-Event Combinations Header Action menu ().

Note:

By default, the standard signal views do not take the Filter flag into consideration. If you want to exclude suppressed combinations from a particular view, put parentheses around the existing SQL Where Clause and add the following:

and (FILTER is NULL or FILTER='NO')

For example, if you want the DME Alert view to exclude suppressed combinations, change its SQL Where Clause from

DME_ALERT is not NULL

to

(DME_ALERT is not NULL) and (FILTER is NULL or FILTER='NO').

The standard signal views are grouped in two categories:

• Product Alerts
• Supplemental Views

The Product Alerts category includes the following views for each review period. The table shows 3-Months views as an example.

Name	Description
DME alert 3-Months	All designated medical events reported for the selected drug, for which there have been one or more new reports in the last 3-Months.
Elderly alert 3-Months	All events for which [EB05(elderly) >= 2 and EB05(elderly) > EB95(adult)].
Fatal alert 3-Months	All events reported for the selected drug, for which there have been one or more new fatal reports in the last 3-Months.
Female alert 3-Months	All events for which [EB05(female) >= 2 and EB05(female) > EB95(male)].
Interaction alert 3-Months	All events for which there is a drug-drug-event interaction signal score (INTSS) > 2.
Male alert 3-Months	All events for which [EB05(male) >= 2 and EB05(male) > EB95(female)].
Pediatric alert 3-Months	All events for which [EB05(peds) >= 2 and EB05(peds) > EB95(adult)].
Serious alert 3-Months	All events reported for the selected drug, for which there have been one or more new serious reports in the last 3-Months.
TME alert 3-Months	All "targeted medical event" combinations for which there have been one or more new reports in the last 3-Months.

The Supplemental Views include the following views for each review period. The table shows 3-Months views as an example.

Name	Description
All 3-Months	All events reported for the selected drug, ordered by SOC, then by descending EB05.
All DME 3-Months	All designated medical events reported for the selected drug, ordered by SOC, then by descending EB05.
All signals 3-Months	All events reported for the selected drug for which either EB05 >=2 or there is a non-null comment. (A non-null comment is taken to indicate that, even if the current EB05 is < 2, the drug-event combination was considered to be a signal sometime in the past or that a reviewer has marked it as a signal during the current review period.) The list is ordered by SOC, then by descending EB05.
All signals with new cases 3-Months	All events reported for the selected drug with new reports in the last 3-Months for which either EB05 >=2 or there is a non-null comment. (A non-null comment is taken to indicate that, even if the current EB05 is < 2, the drug-event combination was considered to be a signal sometime in the past or that a reviewer has marked it as a signal during the current review period.) The list is ordered by SOC, then by descending EB05.
All SMQ 3-Months	All SMQ (Standardized MedDRA Queries) terms for the selected drug, in descending order by EB05.
All TME 3-Months	All targeted medical events reported for the selected drug, ordered by SOC, then by descending EB05.
All trend 3-Months	All events with EB05 >= 1.5 and either Trend1=YES (EBGM increasing and non-overlapping CI relative to 3-Months ago) or Trend2=YES (50% increase in EBGM over 3-Months ago). The list is ordered by SOC, then by descending EB05.
All with new cases 3-Months	All events for the selected drug for which there have been one or more new reports in the last 3-Months. The list is ordered by SOC, then by descending EB05.
Closed signals 3-Months	All events reported for the selected drug for which the associated comment indicates that the signal has been explicitly closed. The list is ordered by SOC, then by descending EB05.
Closed signals with new cases 3-Months	All events reported for the selected drug for which the associated comment indicates that the signal has been explicitly closed and for which there are new reports in the last 3-Months. The list is ordered by SOC, then by descending EB05.
Open signals 3-Months	All events reported for the selected drug for which one of the following is true: 1) there is a comment which is not one of the comments indicating signal closure; or 2) EB05 >=2 and the comment, if present, is not one of the comments indicating signal closure. The list is ordered by SOC, then by descending EB05.
Open signals with new cases 3-Months	All events reported for the selected drug with new reports in the last 3-Months for which one of the following is true: 1) there is a comment which is not one of the comments indicating signal closure; or 2) EB05 >=2 and the comment, if present, is not one of the comments indicating signal closure. The list is ordered by SOC, then by descending EB05.
New alert 3-Months	All events for the selected drug for which there have been one or more new reports in the last 3-Months.
SDR alert 3-Months	Statistic/Signal of Disproportionate Reporting - Events with new reports in the last 3-Months which (1) have an EB05 score >=2, (2) are not flagged as listed and (3) the comment, if present, is not one of the comments indicating signal closure/dismissal.

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

Name	Description
Filtered	Rows limited to drug-event combinations with Filter = Yes.