ArticleEuropean journal of clinical pharmacology2014
Reducing the noise in signal detection of adverse drug reactions by standardizing the background: a pilot study on analyses of proportional reporting ratios-by-therapeutic area.
Article in European journal of clinical pharmacology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 3 of them syntheses that pooled it.
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
45 citing papers in PubMed, 3 syntheses or guidelines pooled it, 67 citations in OpenAlex.
- Safety of sulfamethoxazole-trimethoprim for the treatment of bacterial infection in outpatient settings: A systematic review and meta-analysis with active comparator disproportionality analysis.British journal of clinical pharmacology · 2025Pooled it
- Safety of sulfamethoxazole-trimethoprim for the treatment of bacterial infection in outpatient settings: A systematic review and meta-analysis with active comparator disproportionality analysis.British journal of clinical pharmacology · 2025Pooled it
- Adverse drug reactions of leukotriene receptor antagonists in children with asthma: a systematic review.BMJ paediatrics open · 2021Pooled it
- Comparative Pharmacovigilance Analysis of Selected Cardiotoxicity Signals Associated with Doxorubicin and Epirubicin Based on EudraVigilance Data.Journal of clinical medicine · 2026Article
- Digoxin Dosing Errors, Drug Interactions and Off-Label Risks: Insights from an EudraVigilance Disproportionality Analysis.Journal of clinical medicine · 2026Article
- Metabolic and Inflammatory Adverse Drug Reactions Associated with Amlodipine: A Descriptive and Disproportionality Analysis of EudraVigilance Reports.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Association of GnRH agonists with depression and suicide/self-injury: a FAERS pharmacovigilance study.Endocrine connections · 2026Article
- Charting and Sidestepping the Pitfalls of Disproportionality Analysis.Drug safety · 2026Review
- Exploring the Cardiovascular Safety Profile of Ibuprofen: Insights from EudraVigilance Database.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Inefficiency Rates of Biological Immunosuppressive Induction Agents Used in Organ Transplantation: A Pharmacovigilance Study.Journal of clinical medicine · 2025Article
- Article
- Birth defects reporting and the use of dydrogesterone: a disproportionality analysis from the World Health Organization pharmacovigilance database (VigiBase).Human reproduction open · 2025Article
- Exploring the complexities of disproportionality analysis in pharmacovigilance: reflections on the READUS-PV guideline and a call to action.Frontiers in pharmacology · 2025Article
- Real-Life Data on the Safety of Pasireotide in Acromegaly: Insights from EudraVigilance.Pharmaceuticals (Basel, Switzerland) · 2024Article
- The Descriptive and Disproportionality Assessment of EudraVigilance Database Reports on Capecitabine Induced Cardiotoxicity.Cancers · 2024Article
- Safety Profiles Related to Dosing Errors of Rapid-Acting Insulin Analogs: A Comparative Analysis Using the EudraVigilance Database.Biomedicines · 2024Article
- Drug-Drug Interactions of Selective Serotonin Reuptake Inhibitors: A Pharmacovigilance Study on Real-World Evidence from the EudraVigilance Database.Pharmaceuticals (Basel, Switzerland) · 2024Article
- Long-term hepatobiliary disorder associated with trastuzumab emtansine pharmacovigilance study using the FDA Adverse Event Reporting System database.Scientific reports · 2024Article
- Comparators in Pharmacovigilance: A Quasi-Quantification Bias Analysis.Drug safety · 2024Article
- A real-world pharmacovigilance study investigating the toxicities of histone deacetylase inhibitors.Annals of hematology · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeDisproportionality screening analysis is acknowledged as a tool for performing signal detection in databases of adverse drug reactions (ADRs), e.g., in the European Union (EU) Drug Authority setting. The purpose of this study was to explore the possibility of decreasing false-positive signals of disproportionate reporting (SDR) by calculating the proportional reporting ratio (PRR)-by-therapeutic area (TA), while still maintaining the ability to detect relevant SDRs.
methodsIn the EudraVigilance (EV) Database, output from PRR calculated with a restricted TA comparator background was compared in detail to output from conventional authority-setting PRR calculations for four drugs: bicalutamide, abiraterone, metformin, and vildagliptin, within the TAs of prostate gland disease and type 2 diabetes mellitus.
resultsADR reports per investigated drug ranged from 2,400 to 50,000. The PRR-TA's ability to detect true-positive SDRs (as acknowledged in approved labeling) was increased compared to the conventional PRR, and performed 8-31 % better than a recently proposed stricter EU-SDR definition. The PRR-TA removed false SDRs confounded by disease or disease spill-over by up to 63 %, while retaining/increasing the number of unclassified SDRs relevant for manual validation, and thereby improving the ratio between confounded SDRs (i.e., noise) and unclassified SDRs for all investigated drugs (possible signals).
conclusionsThe performance of the PRR was improved by background restriction with the PRR-TA method; the number of false-positive SDRs decreased, and the ability to detect true-positive SDRs increased, improving the signal-to-noise ratio. Further development and validation of the method is needed within other TAs and databases, and for disproportionality analysis methods.
Indexed as
Identifiers
What 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.