The final way to add a Signal/Inquiry/Request is via the Case Series Analysis (CSA) tool within Evidex Data & Analytics. CSA allows users to select their own criteria to produce an aggregated FAERS data output across more than 35 fields to customize their search, including: One or more drugs, indications, drug classes, or mechanism of action; adverse event terms from any level of the MedDRA hierarchy; Patient demographic info; Patient outcomes; Drug Dosages; Dates, etc.
CSA enables users to:
Perform individual case review and adjudication with comprehensive tracking functionality
Create custom disproportionality reports for a custom set of preferred terms
Create a snapshot of results as of that day and time they were run
Email results directly from the tool or attach them to a Signal, Inquiry, or Action in Evidex Signal Management
Or, from any other page in Evidex, click on “Custom Analytics” near the top right corner of the screen and then select “Case Series Analysis.”
This brings users to the Search page where they can enter criteria for a custom case series analysis. Mandatory items to input are shown in red, which include entering in one or more drugs, indications, mechanisms of action, or drug classes.
To select a drug, start typing in the “Drug Criteria 1” box, then click on the matching drug name of interest. Here, users can also select the role code for the selected product(s) – Primary suspect, Secondary Suspect, Concomitant, or Interacting.
Select one or more drugs by typing in the active ingredient (generic name) or brand name. Choose the "OR" icon to search across multiple drugs to pull data from (I.e. the patient was taking Invokana OR Glyxambi OR Jardiance), or the "AND" icon to run a search on a combination of medications (I.e. the patients were taking Invokana AND Metformin). Clicking on the “Show additional fields” box expands the criteria users can choose from, including Dose amount, NDA#, Route of administration, etc.
Next, type in and select adverse events (AEs) if desired, from any level of the MedDRA hierarchy. Further criteria selections can be made by expanding the Source Information, Patient Information, Outcome Information, Date Information, or Condition Information sections.
Case Review
To view the output, click on the Case Review tab. This tab allows users to:
Flag cases to include/exclude in data mining outputs
Perform individual case review & adjudication with comprehensive tracking functionality
Add annotations on any field within a case report
Share results via email or attach to/create a new Signal, Inquiry or Action in ESM
Under the Data Mining column, users can begin reviewing cases and choose to either include or exclude them from the data mining outputs to see how eliminating certain cases affects the statistical analyses for their case series. Selections are “Not Reviewed” (default setting), “Include”, and “Exclude”. Selecting “Exclude” will remove that case from the analyses on the rest of the data tabs to the right. Red warning text appear as soon as a user selects “exclude” for any case to notify of this.
The Case Series flag is to be used in conjunction with the data grid header filters. Setting this flag only affects the Case Review tab, not any of the other tabs. Using the quick-filter header on this data column allows reviewers to quickly see which cases they’ve chosen to include or exclude in their Case Series.
The Status flag shows the current Reviewer Status for each case. Here, reviewers can show whether they have reviewed certain cases, why they may have been excluded, etc. during quarterly or monthly reviews. The options seen here are customizable for users to choose from. Default settings are shown, but these can be edited by accessing
Tools --> Utilities --> Add/Edit Case profile Status options from the top of any Evidex page.
Users can also add comments to a case by clicking the edit icon. This opens up a comment box and gives users the option to share the comment with everyone within their organization, just specific users, or private/not shared.
Further, reviewers can choose to make annotations on any field within a case report. Edit icons are shown next to every piece of data in the columns; this allows reviewers to add notes on any field within a case that they are reviewing. Note that all annotations will be viewable by all users within a user’s organization.
Lastly, these results are shareable via email, attachable to any Signal, Inquiry, Request, Review, or Action within ESM, or downloadable in .csv or pdf formats. Users can name their output, associate it with an existing record, or create a new Signal, Inquiry, Request, Review, or Action related to the analysis.
Attaching to an Existing ESM Record allows users to search for and select an existing record.
Attaching to a New ESM Record allows users to create a new Signal, Inquiry, Request, Review, or Action related to the analysis.
Attaching to an ESM Action allows users to select a Signal, and then select an Action related to that Signal which the analysis will be attached to.
PT Details
The PT Details tab features statistical values for ROR, PRR, and Chi-squared analytics. The Stats table shows these values across the entire results set, while the lower PT Details table shows the analytics broken up by each adverse event. Users can Export Result Options from this page as they could for the Case Review tab. Users can also choose to add a new Signal, Inquiry, or Request via the “Add to ESM” column.
FAERS Outcomes
The FAERS Outcomes tab shows the number of cases reporting each outcome type, as well as the percentage of those cases compared to the total number of patient cases which matched the search criteria.
Manage Snapshots
Lastly, the Manage Snapshots tab allows reviewers to create point-in-time snapshots of results that can be viewed any time in the future. These results will not change when the database is updated. This can be used to compare results over time.
This tab shows all snapshots created by a users’ organization. Users can only delete or rename their own snapshots.
When creating a snapshot, Evidex will generate and save results for the Case Review tab, PT Details tab, and Outcomes tab.
