For interactive signal configurations, you can maintain a list of targeted medical events (TMEs) for each drug. A TME is an adverse event that your organization wants to monitor closely for a particular drug. For example, you might add Hepatic failure as a TME for Drug A.
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 TMEs 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 TMEs using preferred terms.
You cannot add or delete a targeted medical 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 TMEs.
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 click Manage TMEs.
The Manage Targeted Medical Events page appears. TMEs previously associated with the drug appear in the text box.
5. To add a TME:
A. Specify the TMEs for the drug using one of the following methods:
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 TMEs are saved and are applied when you refresh the signal configuration.
In the Drug-Event Combinations page, the TME column identifies drug-event combinations that are associated with a TME.
6. To delete a TME:
A. Remove the TME from the TME list.
B. Click Save.
Your change is saved and is applied when you refresh the signal configuration.