Customize the 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 JADER 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 (Three dots aligned vertically).

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 into two categories:

  • Product Alerts
  • Supplemental Views

These views are automatically created and published to all available login groups as part of installing JADER Signal Management.

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

Name Description

DME alert 3-Months

All designated medical events reported for the selected product, for which there have been one or more new reports in this review period.

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 product, for which there have been one or more new fatal reports in this review period.

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 product-product-event interaction signal score (INTSS) > 2.

New alert 3-Months

All events for the selected product for which there have been one or more new reports in this review period.

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)].

SDR alert 3-Months

Statistic/Signal of Disproportionate Reporting - Events with new reports in the last review period which (1) have an EB05 score >=2 or AllRGPS_ER05 >= 1.5, (2) are not flagged as listed and (3) the comment, if present, is not one of the comments indicating signal closure/dismissal.

TME alert 3-Months

All intensively monitored (targeted medical events) product-event combinations for which there have been one or more new reports in this review period.

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

Name Description

All 3-Months

All events reported for the selected product, ordered by SOC, then by descending EB05.

All DME 3-Months

All designated medical events reported for the selected product, ordered by SOC, then by descending EB05.

All TME 3-Months

All targeted medical events reported for the selected product, ordered by SOC, then by descending EB05.

All signals 3-Months

All events reported for the selected product 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 product-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 product with new reports in this review period 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 product-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 product, in descending order by EB05.

All trend 3-Months

All events with EB05 >= 1.5 and either Trend1=YES (EBGM increasing and non-overlapping CI relative to previous review period) or Trend2=YES (50% increase in EBGM over previous review period). The list is ordered by SOC, then by descending EB05.

All with new cases 3-Months

All events for the selected product for which there have been one or more new reports in this review period. The list is ordered by SOC, then by descending EB05.

Closed signals 3-Months

All events reported for the selected product 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 product for which the associated comment indicates that the signal has been explicitly closed and for which there are new reports in this review period. The list is ordered by SOC, then by descending EB05.

Open signals 3-Months

All events reported for the selected product 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 product with new reports in this review period 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.

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

Name Description

Filtered

Rows limited to product-event combinations with Filter = Yes.