ReviewJournal of the American Medical Informatics Association : JAMIA2016
Use of data mining at the Food and Drug Administration.
Review in Journal of the American Medical Informatics Association : JAMIA, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 76 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
76 citing papers in PubMed, 3 syntheses or guidelines pooled it, 143 citations in OpenAlex.
- Characterization of the Safety Profile of the Triple Monoamine Reuptake Inhibitor Dasotraline Based on Clinical Trial Data and Disproportionality Analyses of Four Related Pharmacological Classes Using Real-World Data from the FDA Adverse Event Reporting System.Clinical drug investigation · 2026Pooled it
- A systematic analysis and data mining of opioid-related adverse events submitted to the FAERS database.Experimental biology and medicine (Maywood, N.J.) · 2023Pooled it
- Hyponatremia Following Antipsychotic Treatment: In Silico Pharmacodynamics Analysis of Spontaneous Reports From the US Food and Drug Administration Adverse Event Reporting System Database and an Updated Systematic Review.The international journal of neuropsychopharmacology · 2021Pooled it
- Interstitial lung disease associated with antiandrogen agents: a pharmacovigilance study based on FDA adverse event reporting system.International urology and nephrology · 2026Article
- Exploring the impacts of type 2 diabetes and metformin use on Parkinson's disease: Mendelian randomization analysis and a national cohort study.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026Article
- Drug-Induced Noninfectious Myocarditis/Pericarditis: A Real-World Pharmacovigilance Study Using the FAERS Database.Cardiovascular toxicology · 2026Article
- Signal Detection Using Change Point Analysis to Identify Safety Signals from Spontaneous Reports in Aortic Stent Grafts in Japan.Journal of medical systems · 2026Article
- Drug-induced neutropenia: A comprehensive pharmacovigilance study of the FAERS database.Medicine · 2026Article
- Drug-associated deep vein thrombosis: a disproportionality analysis of the FDA adverse event reporting system (FAERS) database.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Real-world safety assessment of burosumab: a pharmacovigilance study utilizing the FDA adverse event reporting system.Orphanet journal of rare diseases · 2026Article
- Design Principles for Interactive Dashboards in Drug Safety Surveillance: Design Science Research.JMIR medical informatics · 2026Article
- Characterizing the FDA Adverse Event Reporting System (FAERS) as a Network to Improve Pattern Discovery.Drug safety · 2026Article
- Mapping adverse events and monitoring priorities for trastuzumab deruxtecan use in metastatic breast cancer.International journal of surgery (London, England) · 2026Article
- Evaluation of the Relationship between Vesicular Monoamine Transporter 2 (VMAT2) Inhibition and Neurologic Adverse Events in Approved Drugs.ACS pharmacology & translational science · 2026Article
- Detection of drug-induced acute respiratory distress syndrome risk signals in FAERS: a real-world pharmacovigilance study.Frontiers in medicine · 2026Article
- Drug-induced intestinal obstruction: insights from the FDA Adverse Event Reporting System.Therapeutic advances in drug safety · 2026Article
- Evaluation of Abuse Deterrent Formulations of Oxycodone Products: Real-World Data from an Enriched Population of Substance Users Assessed with the Addiction Severity Index-Multimedia Version (ASI-MVJournal of pain research · 2026Article
- Muscle toxicity reports in FAERS: a disproportionality analysis with focus on rhabdomyolysis and cross-database assessment.Frontiers in pharmacology · 2026Article
- A Vanished Association Between Proton Pump Inhibitors and Clostridioides Difficile Infection After Minimizing Bias.Journal of clinical medicine · 2025Article
- Analysis of infection-related adverse events induced by proton pump inhibitors based on the FAERS and JADER databases.Medicine · 2025Article
16 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
30 authors at 7 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThis article summarizes past and current data mining activities at the United States Food and Drug Administration (FDA). TARGET AUDIENCE: We address data miners in all sectors, anyone interested in the safety of products regulated by the FDA (predominantly medical products, food, veterinary products and nutrition, and tobacco products), and those interested in FDA activities. SCOPE: Topics include routine and developmental data mining activities, short descriptions of mined FDA data, advantages and challenges of data mining at the FDA, and future directions of data mining at the FDA.
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.