Maintain a list of listed events

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

Before you begin, consider the following:

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

1. In the left navigation pane, click the Signal Review icon ().
2. (Optional) From the Products By drop-down list, select a product grouping, then select a card to filter the Products table.
3. Click the product's Row Action menu () and select Manage Listed Events.
4. To add listed events, specify the listed events for the product 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, we recommend that you select rather than type values.
5. (Optional) Select the Validate list when saving checkbox.

   If you select the checkbox, Oracle 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.

6. Click Save.
   • The listed events are saved and are applied when you refresh the signal configuration.
   • In the Product-Event Combinations page, the LST column identifies product-event combinations that are associated with a listed event.