Once logged in to Evidex, users can type in the universal search bar to access different pages Select a category from the drop-down menu to search by Drug name (brand or generic), Vaccine name, drug company, indication/disease, drug class, mechanism of action, adverse event, drug/adverse event pair, or clinical trial ID or description.
We'll first review how the individual Drug Pages are set up.
Overview Tab
The Overview tab for Drug Pages consists of two main sub-tabs: Summary, and Source Comparison.
Summary Sub-Tab
The Summary sub-tab includes key statistics including the drug’s FDA approval date and the Data Complete Through date, showing the most recent FAERS update quarter & VAERS weekly update. You can view the number of Clinical Trials that Advera’s analyst team has aggregated from clinicaltrials.gov as well.
Users can click on hyperlinks to Evidex data pages for the drug’s Lead or Partner Companies, Drug Classes, Mechanisms of Action (MoA), Indications (both FDA-approved, and those still going through clinical trials, where applicable), Active RxSignals. Sections for Boxed Warnings, Warnings and Precautions, and REMS (Risk Evaluation Mitigation Strategy) are also displayed on this sub-tab, all sourced from the drug’s most recent FDA-approved label/package insert. EU label data is also mined by Advera’s analyst team. Drug Classes are mapped using the Anatomical Therapeutic Chemical (ATC) codes to level 3. The primary resource used for mapping drugs to Indications and Drug Classes is the Veterans Health Administration National Drug File – Reference Terminology (VHA NDF-RT).
A blue “NDA” tag next to a company name indicates that the company is listed as a New Drug Application holder for the drug. A grey “ANDA” tag next to a company name indicates the company is listed as an Abbreviated New Drug Application holder (or generic manufacturer) for the drug. A “BLA” tag next to a company name indicates the company is listed as a Biologic License Applicant holder. All of these mappings are sourced from Drugs@FDA.
Clicking the blue “Show All” button anywhere on this sub-tab will expand the list a user is viewing. Users can download a PDF of the Summary sub-tab by clicking the red “View PDF” button. Drop-down “Compare” icons throughout Evidex make comparisons between other drugs with the same Mechanism of Action, Indication, or Drug Class quick and easy.
Scrolling down further, users can view summary Clinical Data in the Overall Safety table. Clicking on the “View All Clinical Data” blue text will link users to the Evidex Clinical Safety Summary tab for that drug.
The Overall Safety table shows aggregated rates of Serious Adverse Events, Other (non-serious) Adverse Events, and Discontinuation across all Clinical Trials in Evidex for Treatment (all trial arms where the drug users are viewing was given to patients) and Control (all trial arms where other drugs or placebo were given to patients) groups. Clicking on a Group term will take users to the Evidex Clinical Safety Summary tab for that drug.
Rates are calculated by taking the number of patients experiencing the given event in the given group and dividing by the total number of patients in the given group.
For more information on how Odds Ratios (OR) and p-values are calculated, see the Clinical Trials Data Module section. In general, an odds ratio of above 1 shows that the rate being measured (i.e. the Serious Adverse Event Rate) is higher in the treatment group versus the control group across all clinical trials captured in Evidex.The red highlighting reflects a higher than 1 odds ratio (OR) while the green highlighting reflects an OR lower than 1.When the p value is less than 0.05, that Odds Ratio is statistically significant and is highlighted in red when it is below that threshold.
Under Specific Risks, the four tables show the top Medical Dictionary for Regulatory Activities (MedDRA) System Organ Classes (SOCs) and Preferred Term (PT) Adverse Events (AEs) for both Serious and Non-Serious events, sorted in descending order by top 5 Treatment Rate. Specific adverse event rates are only shown in this section if their Odds Ratio is above 1.
Clicking on an SOC will take users to the Evidex Clinical Adverse Events tab. Clicking on a Serious Adverse Event (SAE) or AE term will take users to the given Drug/Adverse Event Analysis page within Evidex.
Green “L” tags indicate the PT AE is Labeled or listed on the drug’s FDA-approved prescribing information/package insert, while red “NL” tags indicate the PT AE is Not Labeled. Red “RX” tags indicated the AE is an Active RxSignal. Yellow “WL” icons indicate the AE is a Watchlist RxSignal. Green “NA” icons indicate the AE is not triggering an Active or Watchlist RxSignal.
Under FAERS Data, Unlabeled Serious Risks meet the following criteria: 1) Adverse events are not listed on the drug’s most recent FDA-approved label/package insert; 2) Adverse events are on the Important Medical Event (IME) Serious list; 3) Disease-related status of the event is either “Potential” or “No”; 4) “Death” as an adverse event is excluded from these tables. Sort order is showing top 5 MedDRA PT AEs, by descending primary suspect case count in FAERS database as of the latest quarter. Labeled Serious Risks meet the same criteria, except the table includes only labeled events. Clicking “show all” will expand the list of preferred terms in this section.
Clicking on the blue text of the Adverse Event term will take users to the given Drug/Adverse Event Analysis page within Evidex.