The Summary sub-tab lists the Drug Description, taken from the Indications section of a drug’s FDA-approved prescribing information/package insert. The “Compare” drop-down menu allows users to navigate to the drug’s Mechanism, Indication, or Drug Class Comparison pages within Evidex. Under Regulatory Information, there is a timeline of FDA regulatory events, showing the drug’s FDA approval date through the most recent FDA Alert. Links to the FDA Alert are provided.
Scrolling down the Summary sub-tab, users can click on links to associated Company pages in Evidex. The Report Demographics section displays Average Age, % of each Gender, and average Duration of Treatment from all Primary Suspect FAERS reports for the given drug. Clicking the blue “Show All” button under the FDA Listed Names section will expand the list to display all permutations of the drug name as were submitted to FAERS. Advera Health’s RxFilter algorithm has ensured all variations and misspellings of a given drug’s name are brought together under the correct drug page within Evidex. Clicking on yellow “View Report” buttons will link users to the respective MoA, Drug Class, and Indication Comparison pages within Evidex related to the given drug.
The FAERS Report Timeline graph displays the number of Primary Suspect adverse event reports submitted to FAERS per month. Clicking on “All Suspect Reports” adds another plot to the line graph, showing the number of All Suspect cases reported to FAERS per month. The graph can be printed or saved by clicking on the drop-down menu icon in the upper right corner of the chart.
