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OpenVigil - open tools for data-mining and analysis of pharmacovigilance data

Quick access:
Search drugs and adverse events with OpenVigil 2! Search drugs and adverse events with OpenVigil FDA! Calculate 2x2 contingency tables!
Documentation:
Welcome About Pharmacovigilance How to use OpenVigil
Technical docs and other resources Further Literature News & project roadmap

What is OpenVigil?

OpenVigil 1 and 2 are software packages to analyse pharmacovigilance (adverse drug event) data. There are several national and international databases of so called spontaneous adverse event reports, e.g., the U.S. american FDA Adverse Event Reporting System (AERS, mostly domestic data) or the WHO Uppsala Monitoring Centre (international). Currently, analyses of FDA AERS (LAERS & FAERS) pharmacovigilance data are available. In addition to U.S. american data, we have also imported German pharmcovigilance data. Data mining features include highly configurable search criteria filters and output filters. Analyses include disproportionality analyses for signal detection like Proportional Reporting Ratio (PRR) calculations. Results can be viewed, sorted and filtered in the webbrowser or saved for further analyses in statistical software packages. Both projects aim at integrating these and other pharmacolovigilance sources to pharmacoepidemiological data like prescription data. OpenVigil 2 is designed for complete case analyses.
OpenVigilFDA is a front-end to the openFDA-interface which is being developed by the FDA since 2014. It allows extraction of the latest reports. Due to technical limitations, the beta-version status and the ongoing changes to the API of openFDA, OpenVigil 2 is more stable and superior for analyses of disproportionality. OpenVigilFDA provides available case analysis, e.g., some records are not complete but still considered.

Where can I access OpenVigil?

US americal pharmacovigilance data analysis options There are live installations with U.S. american FDA pharmacovigilance data of both versions of OpenVigil with FDA AERS data and OpenVigilFDA freely available

IMPORTANT INFORMATION FOR ACCESSING OPENVIGIL 2! OpenVigil 2.1-MedDRA-v24 (data 2004Q1-2024Q4): http://ov2.h2876314.stratoserver.net/OV2


OpenVigil FDA: http://ovfda.h2876314.stratoserver.net

Where can I download OpenVigil?

You can download the PHP-sources/executables of OpenVigil 1, OpenVigilFDA and OpenVigil 2.1-MedDRA at sourceforge: http://sourceforge.net/projects/openvigil/

Who can be contacted about this project?

The project is maintained by Dr. Ruwen Böhm, specialist for clinical pharmacology, Department of Radiotherapy, University Hospital Schleswig-Holstein (UKSH), Campus Kiel, and SocraTec R&D GmbH, Erfurt, and Prof. Dr. Hans-Joachim Klein, computer scientist, independend researcher, Kiel. We can be reached at <openvigil@pharmakologie.uni-kiel.de>

Legalese

The OpenVigil project follows the HONcode (Health On The Net) and was certified in november 2015. All software uses browser cookies. Cookies are used for the captchas and to store previous queries as convenience for the user (OpenVigilFDA only). Users are not tracked. Emails sent to the projects members are treated confidentially and are neither systematically saved nor used for statistics. Access of all webpages/programs is logged, including your IP address. You can contact us if you wish to see or delete this data.
Cf. the installation overview pages for date of last changes to programs or databases and version numbers and the cave-at documents for general pitfalls.
All software uses brand names which are not specifically identified (e.g., by using ®). Cf. the documentation to understand the difference between drug name and brand name and to learn which output does contain brand names. The authors declare no conflicts of interested as they have no financial or other relation to any of the producers.
Responsible for this website (Impressum / Betreiber der Website): Dr. med. Ruwen Böhm, Institut für Experimentelle und Klinisch Pharmakologie, UKSH Kiel, Hospitalstr. 4, 24105 Kiel, Germany. Tel. +49 431 500 30414, <ruwen.boehm@pharmakologie.uni-kiel.de>.
The project is funded by public funding via the Christian Albrechts University (CAU) of Kiel, Germany. There is no funding via advertisements.
The OpenVigil project does not produce or gather any of the pharmacovigilance data itself but is dependent on external data sources.
Our software is being developed for physicians, pharmacists and scientists. Due to the origin and nature of the data and the ongoing work on our programs, all results should be considered unvalidated. Especially, any findings must not be used uncritically for therapy changes or legal proceedings. However, these data are well usable for hypothesis generation.
This page was last changed on 2025-03-20.