Lessons to be learnt from real-world studies on immune-related adverse events with checkpoint inhibitors: a clinical perspective from pharmacovigilance
E Raschi, M Gatti, F Gelsomino, A Ardizzoni… - Targeted Oncology, 2020 - Springer
The advent of immune checkpoint inhibitors (ICIs) caused a paradigm shift both in drug
development and clinical practice; however, by virtue of their mechanism of action, the …
development and clinical practice; however, by virtue of their mechanism of action, the …
Pharmacovigilance studies without a priori hypothesis systematic review highlights inappropriate multiple testing correction procedures.
L Gaucher, P Sabatier, S Katsahian… - Journal of Clinical …, 2023 - Elsevier
Objective The purpose of this study was to systematically review the statistical methods used
in pharmacovigilance studies without a priori hypotheses. Study Design and Setting A …
in pharmacovigilance studies without a priori hypotheses. Study Design and Setting A …
Systematic analysis of drug-associated myocarditis reported in the World Health Organization pharmacovigilance database
While multiple pharmacological drugs have been associated with myocarditis, temporal
trends and overall mortality have not been reported. Here we report the spectrum and main …
trends and overall mortality have not been reported. Here we report the spectrum and main …
Case–non-case studies: principle, methods, bias and interpretation
JL Faillie - Therapies, 2019 - Elsevier
Case–non-case studies are among the methods used to assess drug safety by analyzing the
disproportionality of adverse drug reaction reports in pharmacovigilance databases. First …
disproportionality of adverse drug reaction reports in pharmacovigilance databases. First …
Promoting and protecting public health: how the European Union pharmacovigilance system works
A Santoro, G Genov, A Spooner, J Raine, P Arlett - Drug safety, 2017 - Springer
This article provides an overview of the European Union pharmacovigilance system
resulting from the rationalisation and strengthening delivered through the implementation of …
resulting from the rationalisation and strengthening delivered through the implementation of …
Disproportionality analysis for pharmacovigilance signal detection in small databases or subsets: recommendations for limiting false-positive associations
O Caster, Y Aoki, LM Gattepaille, B Grundmark - Drug Safety, 2020 - Springer
Introduction Uncovering safety signals through the collection and assessment of individual
case reports remains a core pharmacovigilance activity. Despite the widespread use of …
case reports remains a core pharmacovigilance activity. Despite the widespread use of …
Pharmacovigilance‐based drug repurposing: The search for inverse signals via OpenVigil identifies putative drugs against viral respiratory infections
R Böhm, C Bulin, V Waetzig, I Cascorbi… - British journal of …, 2021 - Wiley Online Library
Aims: Pharmacovigilance data are primarily used to identify adverse drug reactions by
screening for disproportionate reporting, ie more reports of certain combinations of adverse …
screening for disproportionate reporting, ie more reports of certain combinations of adverse …
Adverse drug reaction risks obtained from meta-analyses and pharmacovigilance disproportionality analyses are correlated in most cases
Objective We aimed at testing if a correlation between adverse drug reactions relative risks
estimated from meta-analyses and disproportionality analyses calculated from …
estimated from meta-analyses and disproportionality analyses calculated from …
Pharmacovigilance of sodium-glucose co-transporter-2 inhibitors: what a clinician should know on disproportionality analysis of spontaneous reporting systems
Abstract Sodium-glucose co-transporter-2 inhibitors (SGLT2-Is) have consistently
demonstrated a clinically significant reduction of cardiovascular mortality. However, their …
demonstrated a clinically significant reduction of cardiovascular mortality. However, their …
Potential cerebrovascular accident signal for risankizumab: a disproportionality analysis of the FDA adverse event reporting system (FAERS)
RH Woods - British Journal of Clinical Pharmacology, 2023 - Wiley Online Library
Aims The interleukin‐23 (IL‐23) inhibitor risankizumab was recently approved for the
treatment of moderate‐to‐severe plaque psoriasis in the United States. Low rates of …
treatment of moderate‐to‐severe plaque psoriasis in the United States. Low rates of …