OpenVigilFDA is a web-based user interface to the FDA Adverse Event Reporting System (AERS) database for extraction and analysis of drug/adverse event safety reports
using the openFDA online-API. This data is helpful for generating hypotheses for new adverse drug reactions,
drug-drug-interactions and safety comparisons. openFDA aims at providing a clean and curated access to the underlying AERS and can count
reports stratified to an extraction condition. Results are used by OpenVigilFDA for statistics and reported to the user via HTML or several other outputs.
For more information and for citation please refer to Böhm R, von Hehn L, Herdegen T, Klein HJ, Bruhn O, Petri H, Höcker J. OpenVigil FDA - Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications. PLoS One. 2016 Jun 21;11(6):e0157753. PMID: 27326858 http://dx.plos.org/10.1371/journal.pone.0157753
OpenVigilFDA DESCRIPTION An pharmacovigilance tool to extract and analyse FDA adverse event reporting system (AERS) data using the openFDA API for accessing the FDA drug-event-database with the additional openFDA drugmapping and duplicate detection functionality. Special analysis scenarios are available: For Clinicians/GPs: Which drug is most likely associated with a newly occuring adverse event of a patient? For pharmacology scientists: Generate hypotheses of drug-drug-interactions or comparisons within drug-class: Extract and analyse frequencies of one adverse event with either drug or the combination. LIMITATIONS Mapping names of pharmaceutical products to an active substance is a still not sufficently resolved issue in pharmacovigilance and -epidemiology. Mapping tools exist (cf. openvigil.sf.net ) but fail to achieve a complete mapping. The FDA reports the mapping quantity to be 86% (cf. https://open.fda.gov/drug/event/reference/ ). Note that openFDA is currently under development by the FDA and thus the qualitiy of the data will be subject to change. Please be sure to read and understand all relevant cave-at-documents and disclaimers: http://openvigil.sourceforge.net/doc/openvigil-cave-at-v2.html http://open.fda.gov/license record meta.last_updated and meta.disclaimer which is currently "openFDA is a beta research project and not for clinical use. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated." AUTHOR: Ruwen Boehm, firstname.lastname@example.org LICENSE AND DISCLAIMER for this script: GNU Public License v2 (GPLv2) LICENSE AND DISCLAIMER for the data and preprocessing: FDA, see openFDA result meta.disclaimer VERSION HISTORY 2016-07-07: OpenVigilFDA v1.0.2 release - confidence interval in 2x2 output for ROR - lower bounds or RRR in list outputs - citation information 2016-02-04: OpenVigilFDA v1.0.1 released - Legends for tables added, nomenclature improved - added UNII for user-input 2015-10-19: OpenVigilFDA v1.0 final released - inclusion of date and time of analysis in overview and last line on page 2015-10-01: OpenVigilFDA v1.0 release candidate 5 - Changes to the API access methods (timeout etc.) - bug fixes to contingency table calculations (wrong calculation of cell "de") 2015-09-14: OpenVigilFDA v1.0 release candidate 4 - More fixes to Elastic/Lucenne communication - Added receivedate to background correction - Successful validation against openFDA demos and RR_D 2015-31-08: OpenVigilFDA v1.0 release candidate 3 - Fixes to Elastic/Lucenne communication 2015-28-08: OpenVigilFDA v1.0 release candidate 2 - bug fixes (missing apostrophes, delta_both formula, EPC/MoA/CI... - confounders extended; calculation can be skipped 2015-08-25: OpenVigilFDA v1.0 release candidate 1 released - bug fixes, GUI improvements - Confounder calculations - external dictionaries for MedDRA, USAN, INN, drug classes EPC etc. 2015-08-13: OpenVigilFDA v0.5-testing-snapshot released - GUI improvements - store custom queries in cookie - error reporting, graceful handling of UNDEF values - background definition for all queries - various bug fixes - TODO: Fix or circumvent readmeddrapt(.exact) issue 2015-08-07: OpenVigilFDA v0.4-testing-snapshot released - bug fixes: ROR is now ok, several PRR changed to RRR - further improvements to GUI 2015-08-05: Project name changes to "OpenVigilFDA" v0.3 - bug fixes (TODO: ROR) - optimizations (numbextractor()-function) (TODO: recursive numbextractor()) - TODO: Excel output, better GUI/Help 2015-08-03: v0.1-testing released first public release for testing and bug-hunting features: - report browser - disproportionality analyses for -- drug-event and -- 2drugs-event - reverse analysis - free query construction - exporters to HTML, JSON, XML, CSV HOW TO INSTALL This program does not depend on any databases etc. except - a webserver with - a PHP installation Copy it to the document (htdocs) folder of your webserver, e.g. MHTTPD: cp openvigilfda-0.3.php /var/www/default/ APACHE linux/bsd/osx: cp openvigilfda-0.3.php /var/www/ APACHE windows: copy openvigilfda-0.3.php C:\Apache\htdocs and link to it in the HTML on your website. This script uses cURL, SimpleXML and gd as special sub-installations. However, gd is optional, and everything else appears to belong to the latest PHP version 5 standard installation. HOW TO USE Use a webbrowser to access the script, e.g., http://localhost/openvigilfda-1.0.php or our installation at Christian Albrechts university, Kiel, Germany: (testing preview/later:stable) http://www.uni-kiel.de/pharmacology/pvt/openvigilfda.php (current snapshot) http://www.uni-kiel.de/pharmacology/pvt/openvigilfda-current.php