ArticleDrug safety2024
The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration.
Article in Drug safety, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 223 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
223 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Fluoroquinolones and the risk of panic attacks: a systematic review and disproportionality analysis using individual case safety reports from the FDA Adverse Event Reporting System (FAERS) database.The Journal of antimicrobial chemotherapy · 2026Pooled it
- Comprehensive safety analysis of adverse events associated with eptinezumab in migraine treatment.Scientific reports · 2025Pooled it
- The quantity, reliability, transparency, reporting, and interpretation of pharmacovigilance signal detection studies in pregnancy: a meta-epidemiological study.European journal of clinical pharmacology · 2025Pooled it
- Cardiovascular Toxicity Associated With Bispecific Antibodies in Hematological Malignancies: A Comprehensive Pharmacovigilance Analysis.American journal of hematology · 2026Article
- Pharmacovigilance signals for congenital heart disease related to drug exposure: A disproportionality analysis based on the FAERS database.American heart journal plus : cardiology research and practice · 2026Article
- Differential signal strength of male sexual dysfunction associated with antidepressants: a disproportionality analysis of FAERS database.Sexual medicine · 2026Article
- Signal Detection of Adverse Events Associated with PCSK9 Inhibitors: A Nationwide Sequence Symmetry and Combined Worldwide Disproportionality Analysis.Drug safety · 2026Article
- Adverse event reporting patterns of selective serotonin reuptake inhibitors (SSRIs): disproportionality analysis using the European spontaneous reporting system.European archives of psychiatry and clinical neuroscience · 2026Article
- Interpreting Positive and Inverse Disproportionality Signals in Spontaneous Reporting Systems: A Claim-Strength Framework with Direction-Aware Evaluation.Drug safety · 2026Review
- Is teriparatide linked to osteosarcoma? A disproportionality analysis of the FAERS database.Pharmacological reports : PR · 2026Article
- Disproportionality analysis to investigate fatal adverse events with immune checkpoint inhibitors: Proceed with extreme caution.Proceedings of the National Academy of Sciences of the United States of America · 2026Article
- Reply to Revol et al.: Interpreting fatality-reporting signals in checkpoint immunotherapy.Proceedings of the National Academy of Sciences of the United States of America · 2026Article
- Drugs associated with retroperitoneal fibrosis: assessment of the 1969-2025 Food and Drug Administration (FDA) pharmacovigilance database.Pharmacological reports : PR · 2026Article
- QT Prolongation, Ventricular Arrhythmia, and Cardiac Arrest Signals During Ceftriaxone Co-therapy with Individual Proton Pump Inhibitors: A Multidatabase Study.Cardiovascular toxicology · 2026Article
- Sexual Safety Signals of Common Antidiabetic Drugs: Insights From FAERS Disproportionality Analysis.Andrology · 2026Article
- Association between SGLT2 inhibitors and reporting of phimosis/paraphimosis: a comparative pharmacovigilance analysis of the WHO database.Acta diabetologica · 2026Article
- Redundant pharmacovigilance disproportionality analyses: Navigating between Scylla and Charybdis.Headache · 2026Article
- Response to "Redundant pharmacovigilance disproportionality analyses: Navigating between Scylla and Charybdis".Headache · 2026Article
- Potential association of cluster headache with certain COVID-19 vaccines: An assessment from the pharmacovigilance databases.Headache · 2026Article
- Post-marketing safety monitoring of sodium-glucose cotransporter 2 inhibitors for diabetes in cats: a pharmacovigilance study based on the FDA ADAE database.Journal of veterinary internal medicine · 2026Article
163 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
34 authors.
Funding
No grant is acknowledged in the PubMed record.
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 conclusions when data are not placed in the correct context. The REporting of A Disproportionality analysis for drUg Safety signal detection using individual case safety reports in PharmacoVigilance (READUS-PV) statement was developed to address this issue by promoting transparent and comprehensive reporting of disproportionality studies. While the statement paper explains in greater detail the procedure followed to develop these guidelines, with this explanation paper we present the 14 items retained for READUS-PV guidelines, together with an in-depth explanation of their rationale and bullet points to illustrate their practical implementation. Our primary objective is to foster the adoption of the READUS-PV guidelines among authors, editors, peer reviewers, and readers of disproportionality analyses. Enhancing transparency, completeness, and accuracy of reporting, as well as proper interpretation of their results, READUS-PV guidelines will ultimately facilitate evidence-based decision making in pharmacovigilance.
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Identifiers
What Socratic holds
Registered trials
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 Socratic graph.