SynthesisDrug safety2009
Defining 'signal' and its subtypes in pharmacovigilance based on a systematic review of previous definitions.
Synthesis in Drug safety, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 69 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
69 citing papers in PubMed.
- Linezolid-related Optic Nerve Disorders: Insight From a Pharmacovigilance Analysis of the US FDA Adverse Event Reporting System.Open forum infectious diseases · 2025Trial
- Safety Signals of GLP-1 Receptor Agonists: A Multi-Method Pharmacovigilance Analysis of FAERS (2018-2025) With Sensitivity-Stratified Prioritisation, Notoriety-Bias Assessment, and Cross-Database Validation.Diabetes, obesity & metabolism · 2026Article
- Agent-Specific Clinical Profiles of Antibiotic-Associated Encephalopathy: A Dual-Database Pharmacovigilance Study Using JADER and FAERS.Antibiotics (Basel, Switzerland) · 2026Article
- Medical Affairs in the Age of Complexity: From Scientific Support to Strategic Enterprise Integrator.Pharmaceutical medicine · 2026Review
- Optimising Pharmacovigilance Efficiency with MLIT (Machine Learning for Intelligent Triage): A Tool for Statistical Safety Alerts.Drug safety · 2026Article
- Attribution as a Conditional Reasoning Step in Multifactorial Risk Analysis and Decision-Making.Risk analysis : an official publication of the Society for Risk Analysis · 2026Article
- Safety evaluation of CD3×CD20 bispecific antibodies: a pharmacovigilance study using FDA adverse event reporting system.BMJ open · 2026Article
- Comparative disproportionality signals for methotrexate monotherapy versus methotrexate combined with hydroxychloroquine, leflunomide, or sulfasalazine in rheumatoid arthritis: newly highlighted signals evaluated using drug information safety profiles.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Strengthening Signal Detection in Pharmacovigilance by Using International Nonproprietary Name (INN) Stems.Drug safety · 2026Review
- Causal Inference Tools for Pharmacovigilance: Using Causal Graphs to Identify and Address Biases in Disproportionality Analysis.Drug safety · 2026Article
- Article
- The real-world safety evaluation of the selective NaV1.8 inhibitor suzetrigine: disproportionality analysis and flexible empirical bayes signals from FAERS with external triangulation.Frontiers in pharmacology · 2026Article
- Peripheral nervous system safety signals of antibody-drug conjugates: cross-database reproducibility and labeling gaps identified using FAERS, JADER, and CVARD.Frontiers in pharmacology · 2026Article
- Evaluation of dipeptidyl peptidase-4 inhibitor-associated gastrointestinal symptoms using the prescription claims database.Scientific reports · 2025Article
- Article
- Diabetic Ketoacidosis and the Use of New Hypoglycemic Groups: Real-World Evidence Utilizing the Food and Drug Administration Adverse Event Reporting System.Pharmaceuticals (Basel, Switzerland) · 2025Article
- A Retrospective Observational Study of Adverse Drug Reactions (ADR) Reported to ADR Monitoring Centre from 2010 to 2020.Current drug safety · 2025Observational
- Artificial intelligence in pharmacovigilance: advancing drug safety monitoring and regulatory integration.Therapeutic advances in drug safety · 2025Review
- Evaluating Triptan Safety in Pediatric Migraine Management: A Comprehensive Pharmacovigilance Analysis.Journal of pain research · 2025Article
- Investigating the Benefit-Risk Profile of Drugs: From Spontaneous Reporting Systems to Real-World Data for Pharmacovigilance.Methods in molecular biology (Clifton, N.J.) · 2025Article
9 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Having surveyed the etymology and previous definitions of the pharmacovigilance term 'signal', we propose a definition that embraces all the surveyed ideas, reflects real-world pharmacovigilance processes, and accommodates signals of both harmful and beneficial effects. The essential definitional features of a pharmacovigilance signal are (i) that it is based on one or more reports of an association between an intervention or interventions and an event or set of related events (e.g. a syndrome), including any type of evidence (clinical or experimental); (ii) that it represents an association that is new and important and has not been previously investigated and refuted; (iii) that it incites to action (verification and remedial action); (iv) that it does not encompass intervention-event associations that are not related to causality or risk with a specified degree of likelihood and scientific plausibility. Based on these features, we propose this definition of a signal of suspected causality: "information that arises from one or multiple sources (including observations and experiments), which suggests a new potentially causal association, or a new aspect of a known association, between an intervention and an event or set of related events, either adverse or beneficial, which would command regulatory, societal or clinical attention, and is judged to be of sufficient likelihood to justify verifiable and, when necessary, remedial actions." This defines an unverified signal; we have also defined term-- indeterminate, verified, and refuted signals--that qualify it in relation to verification. This definition and its accompanying flowchart should inform decision making in considering benefits and harms caused by pharmacological and nonpharmacological interventions.
Indexed as
Identifiers
19236117What OpenQuestion 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 OpenQuestion graph.