The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement

Fusaroli, Michele; Salvo, Francesco; Bégaud, Bernard; M. Alshammari, Thamir; Bate, Andrew; Battini, Vera; Brueckner, Andreas; Candore, Gianmario; Carnovale, Carla; Crisafulli, Salvatore; Maria Cutroneo, Paola; Dolladille, Charles; Drici, Milou‐Daniel; Faillie, Jean‐Luc; Goldman, Adam; Hauben, Manfred; Teresa Herdeiro, María; Mahaux, Olivia; Manlik, Katrin; Montastruc, François; Noguchi, Yoshihiro; Niklas Norén, G.; Noseda, Roberta; Onakpoya, Igho; Pariente, Alexandre; Poluzzi, Elisabetta; Salem, Myriam; Sartori, Daniele; TH Trinh, Nhung; Tuccori, Marco; van Hunsel, Florence; van Puijenbroek, Eugène; Raschi, Emanuel; Khouri, Charles

doi:10.1007/s40264-024-01421-9

Public

The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement

Published in Drug Safety • May 7, 2024

Authors:

Michele Fusaroli

Francesco Salvo

Bernard Bégaud

Abstract

BACKGROUND AND AIM: Disproportionality analyses using reports of suspected adverse drug reactions are the most commonly used quantitative methods for detecting safety signals in pharmacovigilance. However, their methods and results are generally poorly reported in published articles and existing gui...

Subject

Pharmacovigilance

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Medicine

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