ArticleDrug safety2018
A Critical Evaluation of Safety Signal Analysis Using Algorithmic Standardised MedDRA Queries.
Article in Drug safety, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.
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Who cites it
25 citing papers in PubMed.
- Trial
- Safety signals for drug-related respiratory depression: a disproportionality analysis of the FDA Adverse Event Reporting System (FAERS).Journal of thoracic disease · 2026Article
- Pharmacovigilance evaluation of somatrogon-associated adverse events in real-world databases.Endocrine connections · 2026Article
- Analysis of drug-induced pulmonary embolism risk based on the Food and Drug Administration Adverse Event Reporting System database.Journal of thoracic disease · 2026Article
- Real-world safety of satralizumab in neuromyelitis optica spectrum disorder: a FAERS-based risk stratification study.Journal of neurology · 2026Article
- Paradoxical psoriasis in pediatric tumor necrosis factor-α inhibitor therapy database.Pediatric research · 2026Article
- Characterizing the FDA Adverse Event Reporting System (FAERS) as a Network to Improve Pattern Discovery.Drug safety · 2026Article
- Comparative pharmacovigilance of non-benzodiazepine receptor agonists versus dual orexin receptor antagonists for insomnia in older adults.Frontiers in pharmacology · 2026Article
- Comparison of safety of lecanemab and donanemab: a real-world disproportionality analysis using the FDA adverse event reporting system.Frontiers in pharmacology · 2026Article
- Pharmacovigilance analysis of iodinated contrast media related respiratory adverse effects based on the FDA adverse event reporting system.Frontiers in pharmacology · 2026Article
- Risk factors for drug-related gastrointestinal ulcer:a retrospective pharmacovigilance study.Frontiers in pharmacology · 2026Article
- An interpretable machine learning framework for adverse drug reaction prediction from drug-target interactions.PloS one · 2026Article
- Triptorelin associated adverse events evaluated using FAERS pharmacovigilance data.Scientific reports · 2025Article
- Aggregation of Adverse Event Terms for Signal Detection and Labeling in Clinical Trials.Drug safety · 2025Article
- Safety evaluation of inotuzumab ozogamicin: a pharmacovigilance study based on the FAERS database.International journal of surgery (London, England) · 2025Article
- Medication Hazards and Outcome Patterns of Pediatric Drug-Associated Liver Injury in Taiwan: An Analysis of 1998-2017 Spontaneous Adverse Drug Reaction Reports.Drugs - real world outcomes · 2025Article
- A real-world pharmacovigilance study of adverse drug reactions associated with lecanemab and aducanumab based on WHO-VigiAccess and FAERS databases.Frontiers in pharmacology · 2025Article
- Adverse events associated with ustekinumab in Crohn's disease treatment: an analysis based on the FAERS database.Frontiers in medicine · 2025Article
- Post-marketing pharmacovigilance study of inclisiran: mining and analyzing adverse event data from the FDA Adverse Event Reporting System database.International journal of clinical pharmacy · 2024Article
- Data mining and safety analysis of dual orexin receptor antagonists (DORAs): a real-world pharmacovigilance study based on the FAERS database.Frontiers in pharmacology · 2024Article
Corrections and comments
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Authors and funding
2 authors.
Funding
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Abstract
introductionAlgorithmic Standardised MedDRA
objectivesOur objective was to characterise the performance of aSMQs with respect to their potential for double counting, the likelihood of events in aSMQ positive cases being clinically related, how frequently terms are used for algorithmically positive cases, and the face validity of positive cases based on the drug inducing events. We were also interested in what effect requiring symptoms to overlap temporally would have on performance.
methodsWe reviewed adverse event (AE) datasets of New Drug Applications and Biological License Applications and compiled a database including preferred terms and corresponding SMQs, SMQ term categories, AE start day, AE duration, drug name, and Anatomical Therapeutic Chemical class. Two reviewers independently determined if the algorithm was met and, if so, whether the broad terms overlapped temporally.
resultsA total of 107 marketing applications were reviewed, including 103,928 patients and 277,430 AEs. Use of algorithms condensed the number of AEs to between 5 and 8% and the incidence to about 1.5% relative to when the SMQs are used without the algorithm. Certain aSMQs exhibited a potential for overcounting. Requiring symptoms to temporally overlap helped to eliminate irrelevant cases.
conclusionsOur findings demonstrate that algorithmic and temporal assessment increased specificity of case retrieval, though the reduction in the number of terms or incidence seemed excessive for certain aSMQs. Evaluating the day of AE onset and duration improve specificity through identification of outlying events. Identification of drug classes known to cause the aSMQ's clinical condition provides face validity for this tool, yet detection of cases associated with novel classes may provide new understanding of these disorders. Improvements in some of the SMQ term lists may improve the performance of SMQs in general.
Indexed as
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30112728What 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.