ArticleScientific data2014
A time-indexed reference standard of adverse drug reactions.
Article in Scientific data, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers.
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
34 citing papers in PubMed.
- Contrastive learning of adverse events to provide effective and interpretable vector representations for machine-assisted pharmacovigilance.Briefings in bioinformatics · 2026Article
- Development and validation of a MedDRA-based signal detection construct for drug-induced neurobehavioral impairment.Therapeutic advances in drug safety · 2026Article
- Recommendations to Enable Broader Use of Real-World Evidence to Inform Decision-Making Throughout Pharmacovigilance Signal Management.Pharmacoepidemiology and drug safety · 2025Review
- Artificial Intelligence: Applications in Pharmacovigilance Signal Management.Pharmaceutical medicine · 2025Review
- Development of a Drug Safety Signal Detection Reference Set Using Japanese Safety Information.Therapeutic innovation & regulatory science · 2025Article
- Across preclinical and clinical platforms, approved and investigational psychiatric drugs share pathways and associate with similar molecular functions.Frontiers in drug discovery · 2025Article
- Preclinical side effect prediction through pathway engineering of protein interaction network models.CPT: pharmacometrics & systems pharmacology · 2024Article
- Exploring the impact of design criteria for reference sets on performance evaluation of signal detection algorithms: The case of drug-drug interactions.Pharmacoepidemiology and drug safety · 2023Article
- Early Detection of Adverse Drug Reaction Signals by Association Rule Mining Using Large-Scale Administrative Claims Data.Drug safety · 2023Article
- A Data-Driven Reference Standard for Adverse Drug Reaction (RS-ADR) Signal Assessment: Development and Validation.Journal of medical Internet research · 2022Article
- Detecting early safety signals of infliximab using machine learning algorithms in the Korea adverse event reporting system.Scientific reports · 2022Article
- Artificial Intelligence Based on Machine Learning in Pharmacovigilance: A Scoping Review.Drug safety · 2022Article
- From random to predictive: a context-specific interaction framework improves selection of drug protein-protein interactions for unknown drug pathways.Integrative biology : quantitative biosciences from nano to macro · 2022Article
- A reference set of clinically relevant adverse drug-drug interactions.Scientific data · 2022Article
- Cardiovascular Toxicities of Antiangiogenic Tyrosine Kinase Inhibitors: A Retrospective, Pharmacovigilance Study.Targeted oncology · 2021Article
- The Use of Social Media in Detecting Drug Safety-Related New Black Box Warnings, Labeling Changes, or Withdrawals: Scoping Review.JMIR public health and surveillance · 2021Article
- Combining Social Media and FDA Adverse Event Reporting System to Detect Adverse Drug Reactions.Drug safety · 2020Article
- Retrofitting Vector Representations of Adverse Event Reporting Data to Structured Knowledge to Improve Pharmacovigilance Signal Detection.AMIA ... Annual Symposium proceedings. AMIA Symposium · 2020Article
- Machine Learning for Detection of Safety Signals From Spontaneous Reporting System Data: Example of Nivolumab and Docetaxel.Frontiers in pharmacology · 2020Article
- Recommendations for the Use of Social Media in Pharmacovigilance: Lessons from IMI WEB-RADR.Drug safety · 2019Article
Corrections and comments
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Authors and funding
12 authors.
Funding
Abstract
Undetected adverse drug reactions (ADRs) pose a major burden on the health system. Data mining methodologies designed to identify signals of novel ADRs are of deep importance for drug safety surveillance. The development and evaluation of these methodologies requires proper reference benchmarks. While progress has recently been made in developing such benchmarks, our understanding of the performance characteristics of the data mining methodologies is limited because existing benchmarks do not support prospective performance evaluations. We address this shortcoming by providing a reference standard to support prospective performance evaluations. The reference standard was systematically curated from drug labeling revisions, such as new warnings, which were issued and communicated by the US Food and Drug Administration in 2013. The reference standard includes 62 positive test cases and 75 negative controls, and covers 44 drugs and 38 events. We provide usage guidance and empirical support for the reference standard by applying it to analyze two data sources commonly mined for drug safety surveillance.
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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.