Pharmacovigilance

An analytical tool that helps mine millions of adverse events reported to FDA for analysis of information on drug side effects and safety signals. Its interactive and intuitive interface assists users in identifying relationships between many facets of reported adverse events by presenting a summary view for the search query along with a detailed view of the adverse event case.

SEARCH

• All Fields: The 'All Fields' search queries all sections of the adverse event data.  The entity specific vocabularies are also searched for the extraction (from the title of the event and entity specific fields), normalization and synonym expansion.  This search behavior is designed for broad coverage without sacrificing the relevance of results.

• Indication: This entity specific search field queries the 'Indication' field of the adverse event case.  Indication refers to a disease, disorder, syndrome, illness, or injury.

• Product: This entity specific search field queries the 'Product' field of the adverse event case. Product refers to drugs, biologics, surgical procedures, radiologic procedures, devices, behavioral treatments, process-of-care changes, preventive care, etc.

• Manufacturer: This entity specific search field queries the 'Manufacturer' field of the adverse event case. Manufacturer refers to the manufacturer/reporter of the adverse event case.

• Reactions: This entity specific search field queries the 'Reaction' field of the adverse event case. Reaction refers to an adverse reaction described in the event.

• Include Synonyms: A synonym term could be a word/phrase that means similar to its preferred term. When 'Include synonyms' (the default) is selected the synonym expansion behavior from thesaurus gets activated. The system will process the search term against all its synonyms and display the preferred term in the application. De-selection of the 'Include Synonyms' option will query only the search term and display its preferred term in the application.

RESULTS

Results for search query are summarized in two views under separate tabs: Overview (facet/chart panel) and Adverse Events table view.

The Overview is a summary view of the search results and contains a selection of interactive charts and facet panels.

• Indications: The 'Indications' panel lists the preferred terminology based on the relevant adverse events cases retrieved for the search query.  Corresponding to each indication, a count of adverse events cases retrieved is displayed.  The MeSH thesaurus (from the National Library of Medicine) is being used for normalization, synonym expansion and hierarchical structure of indication names. The application uses only the following MeSH descriptors: Diseases [C] and Mental Disorders [F03].

• Products: The 'Products' panel lists all the drug names from adverse event cases retrieved for the search query.  Corresponding to each product, a count of adverse events cases retrieved is displayed.  Products extraction is limited to drugs of both chemical and biological type.  The CRN intervention vocabulary and ChemIDPlus vocabulary (from the National Library of Medicine) are being used for normalization and synonym expansion of drugs names.

• Manufacturers: The 'Manufacturer' panel lists the company names which holds the IND/ANDA of a product retrieved for the search query.  Corresponding to each manufacturer name, a count of adverse events cases retrieved is displayed. The CRN organization vocabulary is being used for normalization and synonym expansion of the Manufacturer names.

• Reactions: The 'Reaction' Panel list all the adverse reaction events from adverse event cases retrieved for the search query.  Corresponding to each reaction name, a count of adverse events cases retrieved is displayed. FDA is using the MedDRA ‘Preferred Term’ level terminology to report the adverse event reaction.

  • Country: The 'Country' panel displays a world map based on the number of adverse events cases reporting the country as the address or the country where the event occurred. Rolling the mouse over country will indicate the name of the country along with the number of events reported for that country. This map can be flipped to display a tabular view of the country information.

• Outcome Chart: The 'Outcome Chart' panel displays the reported patient health outcomes following adverse events in a bar chart format. In the outcome chart the adverse event outcomes are grouped based on the FDA date and is distributed over the past 10 years.

All the above described panels have interactive filtering capability.  Thus facet/chart panel allows users to further explore and refine the query by inclusion & /exclusion* of meta data from these panels.  Clicking left mouse button on one of the data value in a facet panel returns a subset of the results that match your query and contains the selected data value.  The selected data value in a facet panel gets highlighted in green. Clicking right  mouse button on one of the data value in a facet panel returns a subset of the results that match your query excluding the selected data value.  The selected data value in a facet panel gets highlighted in red. Multiple rows can be selected by holding down the Control key while clicking on the data values with-in the facet.  Boolean logic can be added to the interactive filtering capability by selecting AND or OR from the top right of the respective panel view.  Selected data values for inclusion &/exclusion appears as breadcrumbs and can be individually removed from the breadcrumb panel.  Multiple selections within a facet panel can be removed by clicking the filter icon which appears on the panel.

*The capability of excluding of meta-data is currently available for the facet panels (Indications, Products, Manufacturers, Reactions) only. 

The Adverse Events view is a detailed view of the adverse event cases in a tabular format extracted by the application for the query results in a chronological order of FDA received date. The table displays the first 500 of the most relevant adverse event cases retrieved by the query. The default columns displayed are:

• 1. Case: The number for identifying an FDA Adverse Event Reporting System (FAERS) Case. A case consists of one or more Individual Safety Reports (ISRs).

  2. ISR: Individual Safety Report, a unique number for identifying an FAERS report. It describes an adverse experience for a patient or subject.

  3. Products: It is the name of a valid medicinal product (Temis is further normalizing the product names using the CHEMID and in-house developed vocabulary.

  4. Indications: Patient indication (FDA is using the MedDRA ‘Preferred Term’ level terminology and is further normalized using MeSH thesaurus).

  5. Adverse Reaction: Adverse reaction describing the event (FDA is using the MedDRA ‘Preferred Term’ level terminology).

  6. Manufacturer: Company which holds the IND/ANDA of a product, This data is further normalized using in-house developed vocabulary.

  7. Outcome: Patient health outcome following an adverse event.

  8. Role: Code for the drug’s reported role in the event.

  9. Occupation: Initial reporter’s type of occupation.

  10. Initial/Follow up: Code for initial or follow up status of the report, as reported by the manufacturer.

  11. Report: The type of report submitted. Expedited reports are an indicator of serious adverse event reports submitted to the FDA.

  12. FDA Date: Date when FDA received the report (Year-Month-Day).