Trends Sub-Tab
Clicking on the Charts Tab for a Drug/AE Analysis page brings users to the Trends Sub-tab, which displays the Quarterly Trend Analysis for the Drug/AE pair. Primary Suspect Cases are on the left side Y-axis, with EB05 values on the right-side Y-axis. Hover over the line graph to view the EB05 value for a given quarter or month. The X-axis shows Quarters/Years as a default, though users can choose to view Monthly trends by clicking the “Change Chart Type” drop-down menu. Charts can be printed or downloaded by clicking the three-line menu in the upper right-hand corner of the chart. Clicking on a bar graph data point will take users to an automatically run Custom Analytics search that shows the individual cases and summary analytics related to the column of data. Users can also create their own Custom Analytics search by clicking the blue “Case Series Analysis” button.
“Serious Outcomes” includes case reports listing any of the following outcome types, as reported in each FAERS case: hospitalization, death, disability, life-threatening, congenital anomaly, or required intervention. “Other serious outcomes” includes all case reports listing “Other serious” as the outcome, as reported in FAERS. More information on FAERS patient outcomes can be found here, as stated by FDA.
Stratification Sub-Tab
To view FAERS Stratified Analyses for the given Drug/AE pair, click on the Stratification sub-tab. Clicking on the “Compare” drop-down menu allows users to navigate to the FAERS Adverse Events sub-tab for the Mechanism, Indication, or Drug Class Comparison pages, sorted by the given drug/AE pair.
By clicking on the “Change Chart Type” drop-down menu in the upper-right corner of the chart, users can choose to display a FAERS analysis including primary suspect cases and RORs for the Drug/AE pair by Outcomes, Age, Condition, Country of Occurrence, Dechallenge, Dose + Units, Dose Amount Only, Dose Form, Gender, Other Suspects, Rechallenge, Report Type, or Route of administration. If the ROR is not displayed as a default for the chosen analysis, users can click the “Request ROR” button to show the calculated RORs.
Each graph has a menu icon in the upper right corner, enabling users to print or download charts.
Clicking on a bar graph data point will take users to an automatically run Custom Analytics search that shows the individual cases and summary analytics related to the column. Users can also create their own Custom Analytics search by clicking the blue “Case Series Analysis” button.
