Product-Event Combinations page

Use the Product-Event Combinations page to access to comprehensive product-event information and statistics.

1. In the Oracle Empirica Signal application, in the navigation pane on the left, click the

   Signal Review

   icon ( ).

   The Products page appears.

2. Click a product name or an alert count.

   The Product-Event Combinations page appears. This page contains:

   • Product Summary information (across the top and always on display): Product statistics appear here and include the product name, product group, percentage reviewed gauge, reviewed tracked alerts/total tracked alerts, and the number of pending alerts, open topics (only available if the selected signal configuration is integrated with Topics), and comments. Under the product name is the selected Products By card.
   • System Organ Class (SOC) cards: The cards represent the alerts grouped by MedDRA system organ class. The counts represent tracked alerts Reviewed/Total. Selection of a card filters the Product-Event Combinations table.
   • Product-Event Combinations table: Lists the product-event details for the selected product. The number of product-event combinations appear in a row above the table and includes the total number of product-event combinations, the sort order, and the number of rows per page and the page number.

     By default, each tab represents an alert. The rows and columns displayed in the tab’s table are defined by the alert’s view and further filtered by the card selection. You can add tabs and customize the columns.

   • Detail panel: The Detail panel on the right graphically depicts Recent History, Signal Statistics, Subgroup Statistics, and Associated topics for the selected product-event combination. Topics appear only if your configuration is integrated with Oracle Empirica Topics. You can select different variables to graph, such as All EB05, Age Group, or Gender, using the drop-down lists in the Signal Statistics or Subgroup Statistics sections. To perform further actions on the data associated with a bar or donut slice, click the bar or slice to display the Action menu. You can select View Cases or other actions related to case series and reports. You can show () or hide () the sections in the Detail panel. If you add a comment or change the associated topic information, the panel updates.
3. To select the columns to display, click the Header Action menu (), and then click Columns.

   For information on each column that you can select, rest the cursor on a column heading to display a description.