The Adverse Events sub-tab shows all AEs reported to FAERS for the given drug, along with descriptive information, quantitative data, and signal detection and validation analytics. The bubble chart displays the first 10 events from the data table below, with the X-axis showing number of Primary Suspect cases reported and the Y-axis showing the ROR for the given drug/AE pair. Bubble diameter corresponds to the calculated Reporting Rate for each drug/AE pair, with larger bubbles relating to higher reporting rates and smaller bubbles relating to lower reporting rates.
Clicking on the blue “Case Series Analysis”” button directs users to Advera Health’s Case Series Analysis tool within Custom Analytics. Clicking on the white “Compare” drop-down menu enables users to quickly access the FAERS Adverse Event tab of any Mechanism of Action, Indication, or Drug Class Comparison page related to the current drug being reviewed.
The lower data table lists all reported AEs for the given drug, sorted by RxSignal eligible terms. Active and Watchlist RxSignals are serious events that are: not listed in the drugs' FDA-approved package insert; showing at least 2 case reports in FAERS; showing an elevated ROR (above 1.0); and are on Advera Health’s RxSignal-eligible term list. RxSignal alerts users to 72% of all FDA Safety Labeling Changes, on average 5 years prior to FDA announcement. Advera Health’s detailed RxSignal methodology has been peer reviewed and published in Drug Safety, linked here.
Users can click on AE terms to view its Drug/Adverse Event Analysis page, which displays all safety information on a drug/adverse event pair from FAERS and Clinical trial data in Evidex. DME tags indicate the AE is on FDA’s Designated Medical Event list. DMEs are inherently serious and likely drug-induced, as classified by FDA.
Column headers are equipped with quick-filter options. Users can click on filters below any column header to filter by the data selections within that column. Users can also click on the text of a column header to sort the data in ascending or descending order. Refresh the browser to restore the data table to its default settings. To export data or edit displayed columns, click the menu in the upper right corner of the data table. US and EU Label Status is updated on a monthly basis by Advera’s analyst team.
Users can click on the blue “Filter Results” button to search by keyword, minimum or maximum case count, MedDRA SOC, Active/Watchlist/Expired RxSignals, Disease-Relatedness, US FDA and EU Label Status, Event Seriousness, DME (Designated Medical Event), or Risk Evaluation Mitigation Strategy (REMS).
Clicking on the blue “Search” button at the bottom right of the filter screen will apply the filter(s) selected to the FAERS AE data table for the given drug. To reset the data table to its default RxSignal sorting, users can click the refresh button on their browser. Clicking on the yellow “Cancel” button will exit the Filter without applying the selected criteria.
Users can edit their own monitoring Status of and make their own comments on a drug/AE pair within Evidex by clicking on the blue “edit” text within the “Status” column of the Adverse Event data table.
Users may type in comments within the text box and set a Status by clicking on the drop-down menu near the bottom left of the box. Note that all Evidex users within their organization will also be able to see these comments and statuses. By clicking “edit” users can also see the edit history of the given drug/AE pair from other users within their organization. To save Status changes and comments, click the blue “Submit” button. To close the window without saving changes, click the yellow “Exit” button.
Users can add a drug/AE pair as a Signal, Inquiry, or Request to Evidex Signal Management (ESM) by clicking the red “Signal,” “Inquiry,” or “Request” buttons in the ESM column (Users must have access to Evidex Signal Management for this functionality to display).
