Standard Signal Views

A signal view is a predefined set of columns and sorting preferences. 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 Signal Management. You can also create your own views. 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 on the Product-Event Combinations Header Action menu ().

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, create a new view from the existing view and 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, select the DME tab, select Save as View from the Header Action menu ( ), add the new tab using the Add Tab menu, and 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 organized into two categories:

• Product Alerts
• Supplemental Views

The Product Alerts category includes the following for each review period (1Month shown here). These represent the user-accessible alert type views.

Comment Text	Abbreviated Comment Text
DME alert 1M	All designated medical events reported for the selected drug, for which there have been one or more new reports in the last review period.
Elderly alert 1M	All events reported for the selected drug, for which [EB05(elderly) >= 2 and EB05(elderly) > EB95(adult)].
Fatal alert 1M	All events reported for the selected drug, for which there have been one or more new fatal reports in the last review period.
Female alert 1M	All events reported for the selected drug, for which [EB05(female) >= 2 and EB05(female) > EB95(male)]
Interaction alert 1M	All events reported for the selected drug, for which there is a drug-drug-event interaction signal score INTSS > 2.
Male alert 1M	All events reported for the selected drug, for which [EB05(male) >= 2 and EB05(male) > EB95(female)]
New cases alert 1M	All events reported for the selected drug, with new reports in the last review period.
Pediatric alert 1M	All events reported for the selected drug, for which [EB05(peds) >= 2 and EB05(peds) > EB95(adult)]
SDR alert 1M	Statistic/Signal of Disproportionate Reporting - Events with new spontaneous reports in the last review period 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.
Serious alert 1M	All events reported for the selected drug, for which there have been one or more new serious reports in the last review period.
TME alert 1M	All targeted medical events reported for the selected drug, for which there have been one or more new reports in the last review period.