ArticleFrontiers in pharmacology2024
The reporting of disproportionality analysis in pharmacovigilance: spotlight on the READUS-PV guideline.
Article in Frontiers in pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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Who cites it
15 citing papers in PubMed.
- Disproportionality analysis of drug-associated tinnitus safety signals: a 43-year pharmacovigilance study.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Empirical-Null Calibration Challenges Comparative CNS Safety Signals for Androgen-Receptor Pathway Inhibitors: A FAERS Re-Analysis.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Ocrelizumab-induced colitis: VigiBase disproportionality analysis, case reports and literature review.British journal of clinical pharmacology · 2026Review
- Comparative Analysis of L-Carnitine and Coenzyme QNutrients · 2026Article
- Immune checkpoint inhibitor-related myotoxicity in lung cancer: a decade-long real-world pharmacovigilance analysis of the FAERS database.Frontiers in pharmacology · 2026Article
- Immune checkpoint inhibitor-related thyroid dysfunction during treatment of lung cancer: a disproportionality analysis based on the FDA adverse event reporting system.Frontiers in immunology · 2026Article
- Synergistic toxicity and clinical prioritization of docetaxel combined with nintedanib for non-small cell lung cancer: a real-world safety analysis using the FAERS database.Frontiers in oncology · 2026Article
- Pharmacovigilance assessment of drug-induced aplastic anemia: analysis of the FDA adverse event reporting system.International journal of clinical pharmacy · 2025Article
- Advances in Computational Drug Repurposing, Driver Genes, and Therapeutics in Lung Adenocarcinoma.Biomolecules · 2025Review
- Osimertinib-related myotoxicity: a disproportionality analysis of the FDA adverse event reporting system.BMC cancer · 2025Article
- Possible Association Between Concomitant Use of SSRIs with NSAIDs and an Increased Risk of Adverse Events Among People with Depressive Disorders: Data Mining of FDA Adverse Event Reporting System.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Article
- Real-World Safety Profile of Proton Pump Inhibitors in Infants as Reported in the FDA Adverse Event Reporting System (FAERS): Tiny Tummies, Key Decisions.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Exploring the complexities of disproportionality analysis in pharmacovigilance: reflections on the READUS-PV guideline and a call to action.Frontiers in pharmacology · 2025Article
- Safety of Dual Orexin Receptor Antagonist Daridorexant: A Disproportionality Analysis of Publicly Available FAERS Data.Pharmaceuticals (Basel, Switzerland) · 2024Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Disproportionality analyses are the most-commonly used study design used in the post-marketing phase to detect suspected adverse drug reactions in individual case safety reports. Recent years have witnessed an exponential increase in published articles on disproportionality analyses, thanks to publicly accessible databases. Unfortunately, this trend was accompanied by concerns on lack of transparency and misinterpretation of results, both generating unjustified alarm and diluting true signals into overwhelming noise. The READUS-PV guideline for reporting disproportionality analysis was developed to tackle this emerging issue. In this perspective article, we describe the rationale behind the development of the READUS-PV guideline, the first collaborative initiative to harmonize the reporting of disproportionality analyses. The adoption of the checklists will assist researchers, regulators, and reviewers in the reporting, assessment, and publication of disproportionality analyses. Acknowledging the challenges ahead of effective implementation, we advocate for a global endorsement by Pharmacology Journals. A wide dissemination of the READUS-PV guideline is crucial to foster transparency and reproducibility of pharmacovigilance research, supporting an effective exploitation of disproportionality analysis among other irreplaceable post-marketing research tools to ensure drug safety.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.