Adding or deleting a listed event

For interactive signal configurations, you can maintain a list of listed events for each drug. A listed event is an adverse event that is listed on the drug label. For example, Dizziness is a listed event for Ibuprofen.

Before you begin, consider the following:

• The Data Configuration for 2D Runs specified for the signal configuration must be present and valid.

• The Event Variable for 2D Runs and Drug Variable for 2D Runs specified for the signal configuration must exist in the Data Configuration for 2D Runs.

• You define listed events at the hierarchy level specified in the Event Variable for 2D Runs field for the signal configuration.

For example, if the Event Variable for 2D Runs is (Event) PT, you define listed events using preferred terms.

• You cannot add or delete a listed event while a signal configuration refresh is in progress.

• You must refresh the signal configuration for your changes to take effect.

• You must have the Manage Signaling Terms permission to manage listed events.

1.         Click the Signals tab.

2.         Click Drug Overviews.

3.         In the table, locate the drug.

4.         Click the row menu () for the drug, and then click Manage Listed Events.

The Manage Listed Events page appears.

5.         To add listed events:

A.        Specify the listed events for the drug using one of the following methods:

• Select <hierarchy> terms.

• Select available values.

• Select a saved list of terms.

• Type the terms.

Note: To prevent spelling and capitalization errors, Oracle recommends that you select rather than type values.

B.        Optionally select the Validate list when saving check box.

If you select the check box, Empirica Signal checks whether the terms that you specified are in the source data. If the terms are not in the source data, an error message appears and the invalid terms are moved to the end of the list.

C.        Click Save.

The listed events are saved and are applied when you refresh the signal configuration.

In the Drug-Event Combinations page, the LST column identifies drug-event combinations that are associated with a listed.

6.         To delete a listed event:

A.        Remove the listed event from the listed event list.

B.        Click Save.

Your change is saved and is applied when you refresh the signal configuration.