ReviewDrug safety2024
Detection Algorithms for Simple Two-Group Comparisons Using Spontaneous Reporting Systems.
Review in Drug safety, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 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
13 citing papers in PubMed, 23 citations in OpenAlex.
- Theoretical Framework and Key Considerations for Time-to-Onset Analysis in Spontaneous Reporting Systems.Drug safety · 2026Review
- Levofloxacin-associated tendon disorders: Sex-, age-, and route-specific disproportionality analysis using FAERS and JADER.PloS one · 2026Article
- Post-market safety profile and suicide risk signals of vortioxetine: a real-world pharmacovigilance study.Frontiers in pharmacology · 2026Article
- Risk factors for drug-related gastrointestinal ulcer:a retrospective pharmacovigilance study.Frontiers in pharmacology · 2026Article
- Article
- A comprehensive study on drug-related Raynaud's phenomenon based on the FDA adverse event reporting system.Scientific reports · 2025Article
- Is it appropriate to conduct a disproportionality analysis using a spontaneous reporting database to investigate whether drug-related adverse events are dose-dependent?Frontiers in pharmacology · 2025Article
- Post marketing safety assessment of the novel postpartum depression drug, Zuranolone: evidence from real-world pharmacovigilance analysis based on the FDA adverse event reporting system.Frontiers in psychiatry · 2025Article
- Exploring Novel Adverse Events of Nefecon.Kidney international reports · 2024Article
- Correspondence on 'Cardiovascular toxicities associated with bispecific T-cell engager therapy' by SayedJournal for immunotherapy of cancer · 2024Article
- Adverse event profile of albumin-bound paclitaxel: a real-world pharmacovigilance analysis.Frontiers in pharmacology · 2024Article
- Adverse events associated with herbal medicine products reported in the Korea Adverse Event Reporting System from 2012 to 2021.Frontiers in pharmacology · 2024Article
- Tumor lysis syndrome signal with the combination of encorafenib and binimetinib for malignant melanoma: a pharmacovigilance study using data from the FAERS database.Frontiers in pharmacology · 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
2 authors at 1 institution in 1 country.
Funding
Abstract
Medical science has often used adult males as the standard to establish pathological conditions, their transitions, diagnostic methods, and treatment methods. However, it has recently become clear that sex differences exist in how risk factors contribute to the same disease, and these differences also exist in the efficacy of the same drug. Furthermore, the elderly and children have lower metabolic functions than adult males, and the results of clinical trials on adult males cannot be directly applied to these patients. Spontaneous reporting systems have become an important source of information for safety assessment, thereby reflecting drugs' actual use in specific populations and clinical settings. However, spontaneous reporting systems only register drug-related adverse events (AEs); thus, they cannot accurately capture the total number of patients using these drugs. Therefore, although various algorithms have been developed to exploit disproportionality and search for AE signals, there is no systematic literature on how to detect AE signals specific to the elderly and children or sex-specific signals. This review describes signal detection using data mining, considering traditional methods and the latest knowledge, and their limitations.
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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.