ArticleJournal of biomedical semantics2014
Standardizing adverse drug event reporting data.
Article in Journal of biomedical semantics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.
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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
22 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Computational Advances in Drug Safety: Systematic and Mapping Review of Knowledge Engineering Based Approaches.Frontiers in pharmacology · 2019Pooled it
- Hypophosphatemia as a Potential Class Effect of Histone Deacetylase Inhibitors: Evidence from Disproportionality Analysis and Mendelian Randomization Analysis of Drug Targets.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Cardiovascular Safety of COVID-19 Treatments: A Disproportionality Analysis of Adverse Event Reports from the WHO VigiBase.Infectious diseases and therapy · 2025Article
- Safety profile of lanreotide: a retrospective post-marketing pharmacovigilance study based on the real-world data from FAERS database.Endocrine · 2025Article
- Aioli: Standardising Drugs in the FDA Adverse Event Reporting System (FAERS) to RxNorm and Anatomical Therapeutic Chemical (ATC) Codes.Pharmacoepidemiology and drug safety · 2025Article
- A Real-world Pharmacovigilance Study Of FDA Adverse Event Reporting System (FAERS) Events For Gender Of Voriconazole Drugs.Drug research · 2025Article
- Long-term hepatobiliary disorder associated with trastuzumab emtansine pharmacovigilance study using the FDA Adverse Event Reporting System database.Scientific reports · 2024Article
- Using electronic health records for clinical pharmacology research: Challenges and considerations.Clinical and translational science · 2024Review
- Adverse drug events associated with linezolid administration: a real-world pharmacovigilance study from 2004 to 2023 using the FAERS database.Frontiers in pharmacology · 2024Article
- Identifying Herbal Adverse Events From Spontaneous Reporting Systems Using Taxonomic Name Resolution Approach.Bioinformatics and biology insights · 2020Article
- ADEpedia-on-OHDSI: A next generation pharmacovigilance signal detection platform using the OHDSI common data model.Journal of biomedical informatics · 2019Article
- Three-Component Mixture Model-Based Adverse Drug Event Signal Detection for the Adverse Event Reporting System.CPT: pharmacometrics & systems pharmacology · 2018Article
- DMTO: a realistic ontology for standard diabetes mellitus treatment.Journal of biomedical semantics · 2018Article
- Detecting Pharmacovigilance Signals Combining Electronic Medical Records With Spontaneous Reports: A Case Study of Conventional Disease-Modifying Antirheumatic Drugs for Rheumatoid Arthritis.Frontiers in pharmacology · 2018Article
- Ontology-based systematical representation and drug class effect analysis of package insert-reported adverse events associated with cardiovascular drugs used in China.Scientific reports · 2017Article
- Development of an automated assessment tool for MedWatch reports in the FDA adverse event reporting system.Journal of the American Medical Informatics Association : JAMIA · 2017Article
- Proton Pump Inhibitors and the Risk for Fracture at Specific Sites: Data Mining of the FDA Adverse Event Reporting System.Scientific reports · 2017Article
- Discovering adverse drug events combining spontaneous reports with electronic medical records: a case study of conventional DMARDs and biologics for rheumatoid arthritis.AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science · 2017Article
- A curated and standardized adverse drug event resource to accelerate drug safety research.Scientific data · 2016Article
- Systematic Analysis of Adverse Event Reports for Sex Differences in Adverse Drug Events.Scientific reports · 2016Article
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.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe Adverse Event Reporting System (AERS) is an FDA database providing rich information on voluntary reports of adverse drug events (ADEs). Normalizing data in the AERS would improve the mining capacity of the AERS for drug safety signal detection and promote semantic interoperability between the AERS and other data sources. In this study, we normalize the AERS and build a publicly available normalized ADE data source. The drug information in the AERS is normalized to RxNorm, a standard terminology source for medication, using a natural language processing medication extraction tool, MedEx. Drug class information is then obtained from the National Drug File-Reference Terminology (NDF-RT) using a greedy algorithm. Adverse events are aggregated through mapping with the Preferred Term (PT) and System Organ Class (SOC) codes of Medical Dictionary for Regulatory Activities (MedDRA). The performance of MedEx-based annotation was evaluated and case studies were performed to demonstrate the usefulness of our approaches.
resultsOur study yields an aggregated knowledge-enhanced AERS data mining set (AERS-DM). In total, the AERS-DM contains 37,029,228 Drug-ADE records. Seventy-one percent (10,221/14,490) of normalized drug concepts in the AERS were classified to 9 classes in NDF-RT. The number of unique pairs is 4,639,613 between RxNorm concepts and MedDRA Preferred Term (PT) codes and 205,725 between RxNorm concepts and SOC codes after ADE aggregation.
conclusionsWe have built an open-source Drug-ADE knowledge resource with data being normalized and aggregated using standard biomedical ontologies. The data resource has the potential to assist the mining of ADE from AERS for the data mining research community.
Identifiers
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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.