The Overview tab header of the Drug/Adverse Event Analysis page has a button for accessing the Case Series Analysis tool, and a drop-down menu that allows users to quickly Compare FAERS data filtered by the given AE across all comparator drugs within the MoA, Indication, or Drug Class selected for the given drug. For users with Evidex Signal Management (ESM) subscription access, “Add to ESM” buttons at the top right of the Summary table allow users to add the event as a Signal, Inquiry, or Request within ESM.
US and EU Label Status can be seen in the first Summary data table, and these are updated on a monthly basis by Advera’s analyst team.
Summary data are found in the first data table of the Overview tab, based on the user’s level of subscription access within Evidex and can include data from the following data sets:
1. FAERS
2. EVDAS
3. Clinical Data from Clinicaltrials.gov (Serious and Other)
4. ICSR
5. Health Canada
Data in the summary table includes case counts from each data set, disproportionality analytics, estimated reporting rates and positive dechallenge and rechallenge counts. Users can view this table to get a sense of whether the drug/event pair is shown as a safety observation across multiple data sets.
For FAERS data, a signal can be Not Active, Active, Watchlist, or Expired. Click here to read more about RxSignal. Clinical Data can be listed as No Signal, Elevated, or Confirmed. An Elevated signal has an Odds Ratio above 1.0, while a Confirmed signal has an Odds Ratio above 1.0 and a p-value below 0.05.
Subscribers of the ESM ICSR dataset will see a link on the count displayed in the ‘PS Case Count’ column. This will redirect the user to ESM -> Surveillance -> ICSR tab, with the case data filtered to show the underlying cases for that particular Drug/Event combination.
ESM subscribers can view any of their Signals or Inquiries in the “Related ESM Signals/Inquiries” section. Clicking on a Signal/Inquiry ID will direct users to the Signal or Inquiry Detail Report within their ESM module.
Case Line Listings
Users can select a data source sub-tab at the top of the Drug/AE Analysis Overview tab such as “FAERS Cases” to view cases for that data source. Click on an Individual Safety Report (ISR) number to view the FAERS Case Report details for a given case. Users can review cases, add comments and annotations on specific case details, and set priority status for further review of cases that are a potential safety signal. Click here to read more about Case Profiles.
Click on any column header within the lower data table to sort the table by the given column. Click on the down arrow within the column header to sort by ascending/descending order, hide the column, or pin the column to the left or right side of the data table. Users can enter criteria or select from the drop-down icons for each column header to quickly sort the data table. Click the menu in the upper right corner of the data table to export data or make column display selections. To display every column available, click the blue “Show All Columns” button to the upper right of the FAERS Cases data table.
Users can further segment cases by a particular column by clicking on “Group” from the column header down-arrow menu for one or more columns, then assess aggregate values for the given cases by total count, sum, minimum, maximum, and average. In the example below, the cases were first grouped by Gender, then aggregated to see the Average Age of each patient group for the given drug/AE pair.
Click on “Clinical Sources” to view the Clinical trials related to the given drug/AE pair. The Clinical Sources data table shows the total count and details of each Clinical trial where the given AE was reported. Clicking on a Trial ID brings users to the given Trial Detail page within Evidex. Clicking on the “Clinical Meta-Analysis” button will bring users to the Clinical Meta-Analysis form, pre-filled with the drug and AE from the Drug/AE Analysis page.
Clicking on the down arrow next to any column name opens a drop-down menu, which allows users to sort by the given column in ascending or descending order, hide the column from view, or pin the column to the or the right-hand side of the data table. Clicking on the menu icon in the upper right corner of the data table opens a drop-down menu which allows users to select which columns are visible, and export data to Excel or as a PDF.
Refresh the browser to restore the data table to its default settings.
If an organization has connected their internal ICSR database to Evidex, clicking on the ICSR tab will show all ICSRs for an organization’s internal database. Clicking on an Individual Safety Report (ISR number) will open the case profile details for the given case.
Clicking on the Vigibase tab will show all Vigibase Cases. Click on an ISR number to view the Vigibase case report details for a given case.
Subscribers of the Health Canada dataset will have access to the Health Canada Adverse Events tab of the Drug/AE Analysis Report. CVAR data includes all historical post-market adverse reaction (ADR) data from the Canada Vigilance Adverse Reaction (CVAR) Online Database. ADR reports are submitted by health professionals and consumers, either directly to Health Canada or via market authorization holders (manufacturers and distributors). The data is updated on a monthly refresh cycle with a 3-4 month data lag. The data table lists all reported cases for the given product/adverse event pair, along with descriptive and quantitative information on each product / adverse event pair. Users can click on the Report ID to view its Health Canada Case Profile page, which displays all of the available fields in a single report view.