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About the Signal Detection Dashboard
The Signal Detection Dashboard allows for easy filtering to help you analyze data and identify Product-Event pairs of interest, based on the defined Signal Product Profile and statistics. A Product-Event pair is the detected association between a Product and an Adverse Event, in other words, a potential Signal.
The Signal Detection Dashboard displays the results of a Signal detection run based on the specific Signal Product Profile parameters. Use chart options and filters to further narrow down the results.
The Signal detection run returns a list of Product-Event pairs for a selected Data Source and Reporting period. The results are represented by charts, lists, and graphs. You can change the Data Source and Reporting Period using the Detection Summary panel.
The Tracked Signals donut graph displays the number of tracked Product-Events in a given view or selection. Changes you make to this graph will update the other components on the Signal Detection Dashboard.
You can view the list of Product-Event pairs by plotting the results using the PRR and X2 calculation values on the Proportional Reporting Ratio (PRR) and X2 Distribution Chart (the bubble chart).
The MedDRA Heat Map Chart displays the Product-Event pairs based on the MedDRA hierarchy and the event Seriousness. You can view the MedDRA Heat Map below the bubble chart.
For easy searching and filtering, the Product-Event Combinations grid below the MedDRA Heat Map displays the Product-Event pairs in a tabular format.
The components on the Signal Detection Dashboard interact with one another. For example, zooming into the bubble chart updates the MedDRA Heat Map, Product-Event Combinations, and the Tracked Signals donut graph in the Detection Summary panel.
Lastly, the Detection Dashboard also displays the EVDAS eRMR detection tab beside the Detection Summary panel. However, this is a separate data source and contains Adverse Events and scores from the EVDAS database. To learn more, see EVDAS Signal Detection.
Prerequisites
Before you can access and use the Signal Detection Dashboard, the following prerequisites must be met:
Access the Signal Detection Dashboard
There are a few ways to access the Signal Detection Dashboard:
Note Opening the Detection Dashboard using method a or b opens an unfiltered dashboard and uses the default reporting period dates. Whereas opening the Detection Dashboard using method c opens a filtered dashboard.
- Go to Signal > Signal Product Profiles. Next to the Signal Product Profile, select Open Detection from the All Actions (
) menu. - From Signal > Signal Product Profiles, select a Signal Product Profile. From the All Actions () menu, select Open Detection.
Opening the Detection Dashboard using method a or b opens an unfiltered dashboard and uses the default reporting period dates. - Select a Signal Product Profile and then go to the Signal Product Reporting Period section. Next to a reporting period, select Open Detection from the All Actions () menu.
Opening the Detection Dashboard from a specific reporting period opens a filtered dashboard and automatically sets the Reporting Period Start and End dates according to what is specified on the respective Signal Product Reporting Period.
After opening the Signal Detection Dashboard for a new Signal Product Profile, select Run to retrieve the Signal data and generate the visualizations on the Signal Detection Dashboard. Subsequently, a Refresh button will replace Run, which also refreshes the results on this page. When you Run or Refresh, the Last Run information displayed directly above the bubble chart is updated.
Filter Data with the Detection Summary Panel
The Detection Summary panel displays the chart options (data sources and reporting periods), which can be applied to narrow down the data displayed on the Detection Dashboard. The data source set for the Signal Product Profile is automatically selected by default and can be changed.
The options on the Detection Summary Panel affect all the sections on the Signal Detection Dashboard, such as the PRR vs X2 Distribution chart, the MedDRA Heat Map, and the Product-Event Combinations grid.
You can further narrow down the results of Signal Detection using this panel:
- Tracked Signals: Select different segments of the Tracked Signals donut to update the data on the Detection Dashboard.
- Data Source: Select FAERS data, your Vault Safety (PV) data, or both the FAERS and PV Database to analyze a larger data set. Selecting a data source updates data on the Signal Detection Dashboard. See Signal Data Sources to learn more.
Note At least one source must be checked at all times.
- Reporting Period: Update the date range to retrieve data for a different period. Select the Refresh button above the bubble chart to apply your changes to the Signal Detection Dashboard.
Note that the reporting period uses the New Info Date for the PV source and the Receipt Date for the FAERS source.Note If you selected Open Detection from a Signal Product Reporting Period, the Reporting Period Start and End Dates are automatically populated according to the dates specified on the respective reporting period.
Select Reset to return the Detection Summary panel to the default values.
The following table describes all the chart options in the Detection Summary panel in detail:
| Field | Description |
|---|---|
| FAERS | Select FAERS to display Product-Event pairs from the FAERS Database. |
| PV Database | Select PV Database to display Product-Event pairs from your Vault Safety Database. |
| Reporting Period | Enter a date range to select a reporting period to display on the PRR vs X2 Distribution chart.
If you opened the Detection Dashboard from a Signal Product Profile, by default, the start date is populated based on the FAERS data and the end date is today’s date. If you opened the dashboard from a Signal Product Reporting Period, by default, the start and end date are populated based on the dates specified in the reporting period. |
Use the Proportional Reporting Ratio (PRR) and X2 Bubble Chart
You can use the PRR vs X2 Distribution chart to easily identify Product-Event pairs reported on a medicinal product for the selected data source. The distribution chart is an interactive bubble chart that plots the PRR scores against X2 values for Product-Event pairs.
The X-axis of the bubble chart represents the PRR threshold and the Y-axis represents the X2 threshold. Each bubble denotes a Product-Event pair. Any PRR or X2 values that don’t meet the specified thresholds on the Signal Product Profile will fall below or to the left of the X and Y dotted lines, respectively.
Analyze a Detected Signal
The PRR vs X2 Distribution chart can be dragged and resized to analyze Product-Event pairs. Hovering over a detected Product-Event displays information such as the adverse event, number of Cases, and the data used to detect the Product-Event.
| Name | Description |
|---|---|
| Adverse Event | The coded MedDRA Preferred Term (PT) for the detected Signal. |
| Source | The source of the Adverse Event (either FAERS or Vault Safety). |
| No. of cases | The number of Product-Event pairs discovered that match this MedDRA PT. |
| PRR025 | The calculated PRR025 value of the Adverse Event. |
| PRR | The calculated PRR value of the Adverse Event. |
| ROR025 | The calculated ROR025 value of the Adverse Event. |
| ROR | The calculated ROR value of the Adverse Event. |
| X2 Minimum | The calculated X2 value of the Adverse Event. |
| EBGM | The calculated EBGM value of the Adverse Event. |
| EB05 | The calculated EB05 value of the Adverse Event. |
| EB95 | The calculated EB95 value of the Adverse Event. |
Additional PRR vs X2 Distribution chart Actions
You can access additional actions by selecting the hamburger menu at the top right of the bubble chart. From the menu, you can view the bubble chart in full screen, print, or download the chart in various formats.
Use the MedDRA Heat Map
The MedDRA Heat Map allows you to quickly identify the strength of Product-Events using the MedDRA System Organ Class (SOC) level. The MedDRA Heat Map displays the highest level SOC tiles that are distributed based on the Product-Event (Case Count) and Seriousness.
The MedDRA Heat Map only displays the terms returned by the data mining run. For example, Blood and Lymphatic System Disorders SOC won’t be displayed if there are no associated Product-Event pairs found.
When you select the FAERS data source, the heat map reflects the highest ranking Seriousness on a Case because Seriousness is captured at the Case level. For the PV Database, the heat map reflects all the Case Adverse Events for a Case.
Navigate the Heat Map MedDRA Hierarchy
Selecting a tile narrows down the results in the order of the MedDRA hierarchy.
The following animation displays a user navigating through the MedDRA hierarchy of the MedDRA Heat Map:
You can use the Back button or the breadcrumbs above the Heat Map to navigate to a previous position in the MedDRA hierarchy.
Hovering over a MedDRA Heat Map tile displays a pop-up with the details of the MedDRA term at the current level of the hierarchy, the data source, and the number of Product-Event pairs found for the term:
The following diagram displays an example of the MedDRA hierarchy from the MedDRA Heat Map:
The Legend below the MedDRA Heat Map identifies the seriousness level of the adverse event and the evaluated seriousness criteria at that level:
Additional MedDRA Heat Map Actions
You can access additional actions by selecting the hamburger menu at the top right of the MedDRA Heat Map. From the menu, you can print or download the MedDRA Heat Map in various formats.
Use the Product-Event Combinations Grid
You can use the Product-Events Combination grid to sort through and track detected Product-Events. The Product-Events that appear in this list are the same as those populated in the PRR vs X2 Distribution chart, the MedDRA Heat Map, and the Tracked Signals donut graph.
When a score value falls below the threshold set on the Signal Product Profile, cells are highlighted in gray. The threshold for the PRR and X2 scores are also demonstrated by the threshold lines on the PRR vs X2 Distribution chart.
The following table describes the columns in the Product-Event Combinations grid:
| Column | Description |
|---|---|
| SOC | The Product-Event pair denoted by the primary System Organ Class (SOC) term for the listed PT. |
| PT | The Product-Event pair denoted by the MedDRA Preferred Term (PT). |
| Tracking | Allows users to track a Product-Event pair as a Product-Event record. Tracking a Product-Event updates the Detection Summary panel and creates an entry in the Product-Events section of Vault. |
| State | The current lifecycle state of the Product-Event record. |
| Case Count (N) | The number of Product-Event pairs for the Adverse Event. |
| PRR025 | The calculated PRR025 value of the Adverse Event. |
| PRR | The calculated PRR value of the Adverse Event. |
| ROR025 | The calculated ROR025 value of the Adverse Event. |
| ROR | The calculated ROR value of the Adverse Event. |
| X2 | The calculated X2 value of the Adverse Event. |
| EB05 | The calculated EB05 value of the Adverse Event. |
| EBGM | The calculated EBGM value of the Adverse Event. |
| EB95 | The calculated EB95 value of the Adverse Event. |
| EVDAS Case Count | The sum of the New EVPM case counts for EVDAS eRMR records that fall within the Reporting Period Start and End Date filters. You can also select a value to navigate to the EVDAS eRMR detection screen. To learn more, see EVDAS Signal Detection. |
Filter and Search in the Product-Events Combination Grid
You can apply filters within the numeric columns of the Product-Event Combination grid to filter the Product-Events. To do this, select the filter 
beside the column header. A filter modal then appears:
Complete the information in the modal:
- Qualifier: Select an option from the dropdown menu. If you leave this field blank, the system uses the = qualifier by default by default.
- Number: Enter a value in this field.
Select Apply to apply your filter.
The grid displays Product-Event pairs that are applicable to all applied filters, for example, if you filter for Case Count (N) > 1000 and PRR025 < 20, the results will meet both these criteria.
Note Grid filtering is available only for numeric columns.
You can also search for Product-Events by entering an SOC or PT term in the search bar:
Product-Event Combination Grid Search
Search is applied across both SOC and PT columns in the grid. For example, searching on “disorder” will return results for both “Eye disorders” (SOC) as well as “Liver disorder” (PT).
Any searches or applied filters also update the rest of the Signal Detection Dashboard.
Track a Product-Event
To track a detected Product-Event, select Track beside the Product-Event under the Tracking column.
When you track a Product-Event, the Detection Summary panel is updated with the number of Tracked Signals:
Tracking a Product-Event creates a Product-Event record in the Product-Events tab.
You can also manually create and track Product-Events from the Product-Events tab. See Manage a Product-Event for more information.
