Panels of the Product-Event Combinations page

The Product-Event Combinations page enables you to review comprehensive product-event information and statistics.

You can access the Product-Event Combinations page from the Products page:

• From a Row Action menu (), select View Product-Event Combinations, or:
• Click the product name.
• Click a total count in a cell in the Products table.

The Product-Event Combinations page appears.

If you wish to return to the Products page, click the back arrow () to the left of the product heading at the top of the page.

Figure 2-1 Product-Event Combination page

Product Summary information (across the top): Product statistics appear here with the product name and Products By group, product group, percentage reviewed gauge, count of reviewed/total tracked alerts, the number of pending (unreviewed) alerts, product-event combinations associated with open topics (available if the signal configuration is integrated with Topics), and count of product-event combinations with comments.

System Organ Class (SOC) cards: The cards represent the alerts grouped by MedDRA system organ class. The counts represent Reviewed/Total tracked alerts. Selection of a card filters the Product-Event combinations table.

Product-Event Combinations panel: The Product-Event Combinations panel is a set of tables. You access a table by clicking a Product-Event Combinations tab. Each Product-Event Combinations tab is associated with a view or alert type rule. The view or alert type rule determines the columns, rows, and sort order of the tab’s table. Each tab displays a summary line with the number of combinations, the sort order, the number of rows per page, and the page number. You can add tabs, change pages, and customize the columns.

• When you enable the default signal view feature for the signal configuration you control the view used for the Product-Event Combinations panel’s first tab.
• The default view tab and added tabs have associated views that determine the table's columns rows and sort order. For Alert tabs, the table is defined by the Alert Type rule.
• If the configuration is multisource, there can be columns for the Lead and Secondary configurations.
• The first tab in the Product-Event Combinations panel is the product's default view or the signal configuration's default view when no product view is specified. No default view tab displays if the feature was disabled or no default view is specified for both the product and the signal configuration.
• Select another tab to show the Product-Event Combinations table associated with a different tab such as the Fatal, Serious, or New product-event combinations.
• The Status column indicates if the product-event combination has been reviewed and if there is a topic for the product-event combination.
• The Alerts column indicates which tracked alerts relate to the product-event combination in the most recent refresh. The icon color and letter were set up when the alert type was created and match the icons in the tabs. In the example above, F stands for Fatal and D for Designated Medical Event.
• Each tab contains the table for that alert type or signal view and reflect the current product and SOC selection. Hover over an alert tab for details about that alert type. You can add more tabs with the icon on the right.
• Click the hyperlinked (bold) value in a cell to display a menu to drill down to case-specific information. Menu items include:
  • View Cases
  • Create Case Series
  • Transfer to Case Series
  • Download Cases
  • Download Case Details
  • Reports to view a list of reports about cases and generate a report.

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 donuts 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.

The Details panel header displays the Product-Event name and indicates if the event is a Listed, TME, DME, or IME event.

The sections include:

• Recent History: Displays the most recent product-event alert and comment information plus up to two other rows of alert and comment information. It also includes a link to the Signal History page.
• Signal Statistics: Displays two graphs: a line graph for the chosen statistic and a bar graph for the chosen count. You can update the graph by selecting a different statistic, count, or subgroup. If you are working with a multisource signal configuration, statistics from lead and secondary configurations are available. You can drill down to cases and generate reports from the bars in the bar chart.
• Subgroup Statistics: Displays a doughnut chart of case counts for a subgroup, such as a Gender. You can update the graph by selecting a different subgroup. If you are working with a multisource signal configuration, statistics from the lead and secondary configurations are available. You can drill down to cases and generate reports from the sections of the pie chart.
• Associated Topic: Displays information about a topic if associated with the product-event combination, including counts of open and overdue actions. Click to view the topic in the Topic Viewer.