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

Reporting guideline provided for?
(i.e. exactly what the authors state in the paper)
Reporting of disproportionality analyses.
Full bibliographic reference Fusaroli M, Salvo F, Begaud B, AlShammari TM, Bate A, Battini V, Brueckner A, Candore G, Carnovale C, Crisafulli S, Cutroneo PM, Dolladille C, Drici MD, Faillie JL, Goldman A, Hauben M, Herdeiro MT, Mahaux O, Manlik K, Montastruc F, Noguchi Y, Norén GN, Noseda R, Onakpoya IJ, Pariente A, Poluzzi E, Salem M, Sartori D, Trinh NTH, Tuccori M, van Hunsel F, van Puijenbroek E, Raschi E, Khouri C. The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement. Drug Saf. 2024;47(6):575-584.
Language English
PubMed ID 38713346
Relevant URLs
(full-text if available)
Access the READUS-PV checklist and the READUS-PV checklist for abstracts.
Explanation and elaboration papers
Fusaroli M, Salvo F, Begaud B, AlShammari TM, Bate A, Battini V, Brueckner A, Candore G, Carnovale C, Crisafulli S, Cutroneo PM, Dolladille C, Drici MD, Faillie JL, Goldman A, Hauben M, Herdeiro MT, Mahaux O, Manlik K, Montastruc F, Noguchi Y, Norén GN, Noseda R, Onakpoya IJ, Pariente A, Poluzzi E, Salem M, Sartori D, Trinh NTH, Tuccori M, van Hunsel F, van Puijenbroek E, Raschi E, Khouri C. The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration. Drug Saf. 2024;47(6):585-599. PMID: 38713347

 
Reporting guideline website URL http://www.readus-statement.org/
Reporting guideline acronym READUS-PV
Study design Observational studies
Clinical area Pharmaceutical medicine, Public health
Applies to the whole report or to individual sections of the report? Abstract, Whole report
Record last updated on June 12, 2024

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