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

ABSTRACT:

Introduction

The vigiGrade completeness score established in VigiBase, the worldwide ADR database, measures the completeness of information provided in the structured format of each ADR report. Currently, no such measurement is implemented in the European ADR database EudraVigilance. The aim of our study was to adjust the algorithm of the vigiGrade completeness score to the structure of the ADR reports from EudraVigilance (=Vigi4Eudra-score).

Materials and methods

An R script was developed to semi-automatically assess the completeness of structured information provided in the ADR reports extracted from EudraVigilance. The script was applied to four different datasets. We compared the values achieved by the Vigi4Eudra-score to those of the vigiGrade completeness score per ADR

SUBMITTER: Christ P 

PROVIDER: S-EPMC12935194 | biostudies-literature | 2026

REPOSITORIES: biostudies-literature