{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T17:38:14Z","timestamp":1791999494516,"version":"4.4.0"},"reference-count":27,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2025,5,1]],"date-time":"2025-05-01T00:00:00Z","timestamp":1746057600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2025,5,1]],"date-time":"2025-05-01T00:00:00Z","timestamp":1746057600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2025,5,1]],"date-time":"2025-05-01T00:00:00Z","timestamp":1746057600000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-017"},{"start":{"date-parts":[[2025,5,1]],"date-time":"2025-05-01T00:00:00Z","timestamp":1746057600000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-037"},{"start":{"date-parts":[[2025,5,1]],"date-time":"2025-05-01T00:00:00Z","timestamp":1746057600000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-012"},{"start":{"date-parts":[[2025,5,1]],"date-time":"2025-05-01T00:00:00Z","timestamp":1746057600000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-029"},{"start":{"date-parts":[[2025,5,1]],"date-time":"2025-05-01T00:00:00Z","timestamp":1746057600000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-004"}],"funder":[{"DOI":"10.13039\/100022416","name":"Center for Drug Evaluation and Research","doi-asserted-by":"publisher","award":["75F40121C00185"],"award-info":[{"award-number":["75F40121C00185"]}],"id":[{"id":"10.13039\/100022416","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100022416","name":"Center for Drug Evaluation and Research","doi-asserted-by":"publisher","award":["2U01FD005942-03"],"award-info":[{"award-number":["2U01FD005942-03"]}],"id":[{"id":"10.13039\/100022416","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100022416","name":"Center for Drug Evaluation and Research","doi-asserted-by":"publisher","award":["75F40119C10084"],"award-info":[{"award-number":["75F40119C10084"]}],"id":[{"id":"10.13039\/100022416","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100007880","name":"Johns Hopkins University","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007880","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100008935","name":"Center of Excellence in Regulatory Science and Innovation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008935","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000038","name":"U.S. Food and Drug Administration","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000038","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Journal of Biomedical Informatics"],"published-print":{"date-parts":[[2025,5]]},"DOI":"10.1016\/j.jbi.2025.104824","type":"journal-article","created":{"date-parts":[[2025,4,4]],"date-time":"2025-04-04T14:49:32Z","timestamp":1743778172000},"page":"104824","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":12,"special_numbering":"C","title":["Deduplicating the FDA adverse event reporting system with a novel application of network-based grouping"],"prefix":"10.1016","volume":"165","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5434-1420","authenticated-orcid":false,"given":"Kory","family":"Kreimeyer","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan","family":"Spiker","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-9505-945X","authenticated-orcid":false,"given":"Oanh","family":"Dang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suranjan","family":"De","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1609-7420","authenticated-orcid":false,"given":"Robert","family":"Ball","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taxiarchis","family":"Botsis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"issue":"6","key":"10.1016\/j.jbi.2025.104824_b0005","doi-asserted-by":"crossref","first-page":"1243","DOI":"10.1002\/cpt.1948","article-title":"Postmarketing Safety-Related Regulatory Actions for New Therapeutic Biologics Approved in the United States 2002-2014: Similarities and Differences With New Molecular Entities","volume":"108","author":"Bulatao","year":"2020","journal-title":"Clin. Pharmacol. Ther."},{"issue":"2","key":"10.1016\/j.jbi.2025.104824_b0010","doi-asserted-by":"crossref","first-page":"169","DOI":"10.1007\/s40264-021-01142-3","article-title":"Sources of Evidence Triggering and Supporting Safety-Related Labeling Changes: A 10-Year Longitudinal Assessment of 22 New Molecular Entities Approved in 2008 by the US Food and Drug Administration","volume":"45","author":"Croteau","year":"2022","journal-title":"Drug Saf."},{"issue":"3","key":"10.1016\/j.jbi.2025.104824_b0015","doi-asserted-by":"crossref","first-page":"302","DOI":"10.1002\/pds.3395","article-title":"Evaluation of FDA safety-related drug label changes in 2010","volume":"22","author":"Lester","year":"2013","journal-title":"Pharmacoepidemiol. Drug Saf."},{"issue":"2","key":"10.1016\/j.jbi.2025.104824_b0020","doi-asserted-by":"crossref","first-page":"390","DOI":"10.1002\/cpt.944","article-title":"Postmarket Safety Outcomes for New Molecular Entity (NME) Drugs Approved by the Food and Drug Administration Between 2002 and 2014","volume":"104","author":"Pinnow","year":"2018","journal-title":"Clin. Pharmacol. Ther."},{"issue":"1","key":"10.1016\/j.jbi.2025.104824_b0025","doi-asserted-by":"crossref","first-page":"21","DOI":"10.2165\/00002018-200831010-00003","article-title":"Methods for causality assessment of adverse drug reactions: a systematic review","volume":"31","author":"Agbabiaka","year":"2008","journal-title":"Drug Saf."},{"key":"10.1016\/j.jbi.2025.104824_b0030","unstructured":"FDA, Best Practices for FDA Staff in the Postmarketing Safety Surveillance of Human Drug and Biological Products. 2024."},{"issue":"5","key":"10.1016\/j.jbi.2025.104824_b0035","doi-asserted-by":"crossref","first-page":"365","DOI":"10.1007\/s40264-017-0509-2","article-title":"Causality Assessment in Pharmacovigilance: Still a Challenge","volume":"40","author":"Ralph Edwards","year":"2017","journal-title":"Drug Saf."},{"issue":"7","key":"10.1016\/j.jbi.2025.104824_b0040","doi-asserted-by":"crossref","first-page":"845","DOI":"10.1002\/sim.8447","article-title":"An evaluation of statistical approaches to postmarketing surveillance","volume":"39","author":"Ding","year":"2020","journal-title":"Stat. Med."},{"issue":"6","key":"10.1016\/j.jbi.2025.104824_b0045","doi-asserted-by":"crossref","first-page":"551","DOI":"10.2165\/00002018-200730060-00009","article-title":"'Extreme duplication' in the US FDA Adverse Events Reporting System database","volume":"30","author":"Hauben","year":"2007","journal-title":"Drug Saf."},{"issue":"8","key":"10.1016\/j.jbi.2025.104824_b0050","doi-asserted-by":"crossref","first-page":"1140","DOI":"10.1002\/pds.5265","article-title":"More extreme duplication in the U.S. FDA FAERS database and a suggested check point for disproportionality analysis","volume":"30","author":"Hauben","year":"2021","journal-title":"Pharmacoepidemiol. Drug Saf."},{"issue":"3","key":"10.1016\/j.jbi.2025.104824_b0055","doi-asserted-by":"crossref","first-page":"387","DOI":"10.1002\/pds.5555","article-title":"More extreme duplication in FDA Adverse Event Reporting System detected by literature reference normalization and fuzzy string matching","volume":"32","author":"Hung","year":"2023","journal-title":"Pharmacoepidemiol. Drug Saf."},{"issue":"4","key":"10.1016\/j.jbi.2025.104824_b0060","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2023-081990","article-title":"Navigating duplication in pharmacovigilance databases: a scoping review","volume":"14","author":"Kiguba","year":"2024","journal-title":"BMJ Open"},{"issue":"2","key":"10.1016\/j.jbi.2025.104824_b0065","doi-asserted-by":"crossref","first-page":"56","DOI":"10.1139\/cjpp-2024-0078","article-title":"Analysis of literature-derived duplicate records in the FDA Adverse Event Reporting System (FAERS) database","volume":"103","author":"Han","year":"2025","journal-title":"Can. J. Physiol. Pharmacol."},{"issue":"3","key":"10.1016\/j.jbi.2025.104824_b0070","article-title":"A Standardized Dataset of a Spontaneous Adverse Event Reporting System","volume":"10","author":"Khaleel","year":"2022","journal-title":"Healthcare (Basel)"},{"key":"10.1016\/j.jbi.2025.104824_b0075","unstructured":"FDA. FDA Adverse Event Reporting System (FAERS) Electronic Submissions \u2013 E2B(R3) Standards. July 19, 2024]; Available from: https:\/\/www.fda.gov\/drugs\/questions-and-answers-fdas-adverse-event-reporting-system-faers\/fda-adverse-event-reporting-system-faers-electronic-submissions-e2br3-standards."},{"issue":"7","key":"10.1016\/j.jbi.2025.104824_b0080","doi-asserted-by":"crossref","first-page":"543","DOI":"10.1007\/s40264-017-0548-8","article-title":"The Power of the Case Narrative - Can it be Brought to Bear on Duplicate Detection?","volume":"40","author":"Noren","year":"2017","journal-title":"Drug Saf."},{"issue":"4","key":"10.1016\/j.jbi.2025.104824_b0085","doi-asserted-by":"crossref","first-page":"249","DOI":"10.1007\/s40264-014-0146-y","article-title":"Performance of probabilistic method to detect duplicate individual case safety reports","volume":"37","author":"Tregunno","year":"2014","journal-title":"Drug Saf."},{"key":"10.1016\/j.jbi.2025.104824_b0090","series-title":"ITNG 2022 19th International Conference on Information Technology-New Generations","article-title":"Graph-based hierarchical record clustering for unsupervised entity resolution","author":"Ebeid","year":"2012"},{"issue":"9","key":"10.1016\/j.jbi.2025.104824_b0095","doi-asserted-by":"crossref","first-page":"905","DOI":"10.1007\/s40264-020-00945-0","article-title":"Information Visualization Platform for Postmarket Surveillance Decision Support","volume":"43","author":"Spiker","year":"2020","journal-title":"Drug Saf."},{"key":"10.1016\/j.jbi.2025.104824_b0100","doi-asserted-by":"crossref","DOI":"10.3389\/fdsfr.2022.918897","article-title":"Increased confidence in deduplication of drug safety reports with natural language processing of narratives at the us food and drug administration","volume":"2","author":"Kreimeyer","year":"2022","journal-title":"Front. Drug Saf. Regul."},{"issue":"7","key":"10.1016\/j.jbi.2025.104824_b0105","doi-asserted-by":"crossref","first-page":"571","DOI":"10.1007\/s40264-017-0523-4","article-title":"Using Probabilistic Record Linkage of Structured and Unstructured Data to Identify Duplicate Cases in Spontaneous Adverse Event Reporting Systems","volume":"40","author":"Kreimeyer","year":"2017","journal-title":"Drug Saf."},{"key":"10.1016\/j.jbi.2025.104824_b0110","doi-asserted-by":"crossref","first-page":"354","DOI":"10.1016\/j.jbi.2016.07.023","article-title":"Decision support environment for medical product safety surveillance","volume":"64","author":"Botsis","year":"2016","journal-title":"J. Biomed. Inform."},{"issue":"2","key":"10.1016\/j.jbi.2025.104824_b0115","doi-asserted-by":"crossref","first-page":"144","DOI":"10.3414\/ME14-01-0066","article-title":"Can Natural Language Processing Improve the Efficiency of Vaccine Adverse Event Report Review?","volume":"55","author":"Baer","year":"2016","journal-title":"Methods Inf. Med."},{"key":"10.1016\/j.jbi.2025.104824_b0120","doi-asserted-by":"crossref","first-page":"78","DOI":"10.1016\/j.jbi.2016.06.006","article-title":"A new algorithmic approach for the extraction of temporal associations from clinical narratives with an application to medical product safety surveillance reports","volume":"62","author":"Wang","year":"2016","journal-title":"J. Biomed. Inform."},{"issue":"23","key":"10.1016\/j.jbi.2025.104824_b0125","doi-asserted-by":"crossref","first-page":"8577","DOI":"10.1073\/pnas.0601602103","article-title":"Modularity and community structure in networks","volume":"103","author":"Newman","year":"2006","journal-title":"PNAS"},{"issue":"6","key":"10.1016\/j.jbi.2025.104824_b0130","article-title":"Finding community structure in very large networks. Physical Review E\u2014Statistical, Nonlinear, and Soft Matter","volume":"70","author":"Clauset","year":"2004","journal-title":"Physics"},{"issue":"6","key":"10.1016\/j.jbi.2025.104824_b0135","doi-asserted-by":"crossref","first-page":"735","DOI":"10.1080\/14740338.2021.1897566","article-title":"Analysis of completeness for spontaneous reporting of disease-modifying therapies in multiple sclerosis","volume":"20","author":"Araujo","year":"2021","journal-title":"Expert Opin. Drug Saf."}],"container-title":["Journal of Biomedical Informatics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S153204642500053X?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S153204642500053X?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,11,7]],"date-time":"2025-11-07T21:00:15Z","timestamp":1762549215000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S153204642500053X"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,5]]},"references-count":27,"alternative-id":["S153204642500053X"],"URL":"https:\/\/doi.org\/10.1016\/j.jbi.2025.104824","relation":{},"ISSN":["1532-0464"],"issn-type":[{"value":"1532-0464","type":"print"}],"subject":[],"published":{"date-parts":[[2025,5]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Deduplicating the FDA adverse event reporting system with a novel application of network-based grouping","name":"articletitle","label":"Article Title"},{"value":"Journal of Biomedical Informatics","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.jbi.2025.104824","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2025 Elsevier Inc. All rights are reserved, including those for text and data mining, AI training, and similar technologies.","name":"copyright","label":"Copyright"}],"article-number":"104824"}}