Clicking on the FAERS – Adverse Events sub-tab on Comparison reports will display the Adverse Event Report for the given Comparison page, sorted by descending Primary Suspect case count for the most recently approved drug. The default setting for this data table is to display the Adverse Events grouped by Standardised MedDRA Query (SMQ) terms. To show Preferred Terms, users can click on the yellow “Show PT events” button. SMQs are validated sets of MedDRA Preferred Terms grouped together to allow for more sensitive and broad safety analysis. PTs (Preferred Terms) are more specific terms for more narrow analysis.
Clicking on the blue “Enable min/max highlight” button will display a green box around the drug with the lowest value in the data table and a red box around the drug with the highest value for the given drug/AE pair.
Users can switch between metrics by clicking the blue “Selected Metric” drop-down menu to the top left above the data table. Users can select to display Reporting Rate, ROR, ROR05, EBGM, EB05, IC, or IC25. After clicking on a new metric from the drop-down, the data table will be reloaded with the given metrics for each drug/AE pair.
Users can export data or make column display selections by clicking the menu icon in the top right corner of the data table, as seen in previous sections.
Searching for Specific Risks & Comparing RxSignals
Next, clicking on “Enable RxSignal Status” will display a tag next to each value indicating whether the PT is listed on the drug’s FDA-approved packing insert: “LAB” indicates the event is labeled; “NL” indicates the event is not labeled; “RX” indicates the event is an Active RxSignal; “RX+DR” indicates the event is a potentially disease-related Active RxSignal; “WL” indicates the event is a Watchlist RxSignal; “WL+DR” indicates the event is a potentially disease-related Watchlist RxSignal; “EX” indicates the event is an Expired RxSignal. Users can disable RxSignal status by clicking on the same button, now relabeled as “Disable RxSignal status.” Click here for more information on RxSignal.
Users can toggle between generic and trade/brand drug names by clicking on the “Show Generic drug names” button. Users can toggle between hiding or showing drugs with no case reports by clicking on the “Hide drugs with no case reports” button.
Clicking on any column header will sort the data table by the given column, as seen in other pages within Evidex.
Clicking on the blue “Filter Results” button opens the Adverse Events Criteria filter. Users can type in a keyword, set minimum/maximum case cut-offs, select a MedDRA SOC to search by, select to search by RxSignal status, search by RxSignal-eligible events, IME Serious events, or DME events. Users can also select which drugs are displayed in this filter by clicking the box next to its name(s).
Clicking the blue “Search” button will apply all selected criteria to the FAERS Adverse Event table for the given Comparison page. Clicking the yellow “Cancel” button will bring users back to the data table without applying their search criteria.
An example of selecting multiple criteria to return all Cardiac-related RxSignal events for the three drugs selected is shown below:
By selecting the Cardiac System Organ Class, and selecting each RxSignal box, then clicking Search, users will see their data table reloaded show all RxSignals for the drugs selected.
