Vigi4Eudra-score: Evaluation of the completeness of spontaneous adverse drug reaction reports in EudraVigilance

20260 citationsJournal Articlegold Open Access

Authors

Patrick Christ · Federal Institute for Drugs and Medical Devices

Diana Dubrall · Federal Institute for Drugs and Medical Devices

Dennis Lex · Federal Institute for Drugs and Medical Devices

Thomas Grüger · Federal Institute for Drugs and Medical Devices

Matthias Schmid · University Hospital Bonn

Bernhardt Sachs · Federal Institute for Drugs and Medical Devices

Abstract

We provide an R script to assess the completeness of information provided in the structured format of ADR reports from EudraVigilance, which may be useful for researchers, pharmaceutical companies, and regulatory authorities. Our use cases demonstrate its successful application.

Topics & Keywords

Pharmacovigilance and Adverse Drug Reactions Biomedical Text Mining and Ontologies Computational Drug Discovery Methods

UN Sustainable Development Goals

Good health and well-being

Publication Details

Published in: PLoS ONE

Volume 21, Issue 2, pp. e0343694-e0343694

DOI: 10.1371/journal.pone.0343694

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