OpenVigil - open analysis tools for pharmacovigilance data
OpenVigil 1 and 2 are software packages to analyse
pharmacovigilance 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).
Currently, analyses of FDA AERS (LAERS & FAERS)
pharmacovigilance data are available. Analyses include
disproportionality analyses like the Proportional Reporting Ratio (PRR, a measurement of disproportionality). Results can be viewed, sorted
and filtered in the webbrowser or saved via CSV for further analyses in
statistical software packages. For registered users, direct SQL database access enables advanced queries.
OpenVigil aims at integrating
FDA AERS and other pharmacolovigilance sources to
pharmacoepidemiological data like prescription data.
There are live installations of both versions of OpenVigil available
at Kiel university:
OpenVigil 2: http://www.is.informatik.uni-kiel.de:8503/OpenVigil/search/
(currently requires prior registration, please email us!)
OpenVigil 1: http://www.uni-kiel.de/pharmacology/pvt/openvigil.php
(development version at: http://www.uni-kiel.de/pharmacology/pvt/openvigil-current.php)
OpenVigil 1 is useful for validating results on raw FDA data. OpenVigil 2 is the successor of OpenVigil 1 and uses cleansed FDA
AERS data. For scientific research, do not use OpenVigil 1 but
only version 2!
You can download OpenVigil 1 (and soon OpenVigil 2) at sourceforge:
The project is maintained by Dr. R. Böhm, Institute of Experimental
and Clinical Pharmacology, UKSH Kiel, <firstname.lastname@example.org>
and Prof. H.J. Klein, Institut für Informatik, Christian Albrechts
University, Kiel, <email@example.com>