By clicking on the Safety Summary sub-tab, users can access Comparative Adverse Event Rates for Serious AEs, Discontinuation AEs, Other (non-serious) AEs, and Death for the Treatment and Control Groups. The statistical calculations are constrained to work only for randomized/controlled trials within a user’s search criteria. By default, this aggregates across all curated trials for the drug.
In the Comparative AE Rates table, users can view the total number and rate of each event type experienced by patients in the Treatment and Control groups, respectively. Odds Ratios with 95% Confidence Intervals, as well as p-values are also displayed. Treatment Group counts and calculations are based on all trial arms where the intervention was the drug shown in the given drug profile (i.e. Invokana or canagliflozin). Control Group counts and calculations are based on all trial arms which include a standard to compare to the Treatment Group. Details on Statistical Measures calculations can be found in the Statistical Measures section below.
Clicking on the “Compare” drop-down menu allows users to navigate to the Clinical data tab for the linked Mechanism, Indication, and Drug Class Comparison pages related to the given drug.
Green boxes indicate the Group with the lowest rate and red boxes indicate the Group with the highest rate for a given measure.
For “Treat rate” and “Ctrl rate” columns, green boxes indicate the lowest rate and red boxes indicate the highest rate for the given adverse event.
The Adverse Event Counts by Trial, Arm, Event Type table displays rates of events for individual arms across all trials, by default. Users can click on the three-lined menu in the upper right corner of the table to export data and make column display selections. To choose which trials to pull data from and create a Custom Pooled Analysis, users can click on the blue “Clinical Evidence Filter” button (circled in black below).
Green boxes indicate the trial arm with the lowest rate for the given measure for the given trial, and red boxes indicate the trial arm with the highest rate for the given measure for the given trial.
Once criteria from the Clinical Evidence Filter are selected, only trials/arms matching those criteria will be displayed within this sub-tab, and the summary data within the Comparative Adverse Event Rates data table will also be recalculated based on a user’s selections. These criteria selections will not be saved after a user navigates to a different sub-tab or page within Evidex.
Criteria selections include: Trial Design features, Population Characteristics, Treatments administered, Studies, and Duration. For this sub-tab, the “Events” filter is greyed out as it does not apply. Users can click the boxes next to the criteria they desire, then hit the blue “Search” button to apply those criteria. To close the Filter without applying selected criteria, click the yellow “Cancel” button.
To clear the search criteria, hit the red “Clear Filter” button near the top right corner of the data table.
