The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration

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/s40264-024-01423-7

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The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration

Published in Drug Safety • May 7, 2024

Authors:

Michele Fusaroli

Francesco Salvo

Bernard Bégaud

Abstract

In pharmacovigilance, disproportionality analyses based on individual case safety reports are widely used to detect safety signals. Unfortunately, publishing disproportionality analyses lacks specific guidelines, often leading to incomplete and ambiguous reporting, and carries the risk of incorrect ...

Subject

Pharmacovigilance

Medicine

Context (archaeology)

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