{"title":"Calibrated AI approach to pharmacovigilance using FAERS","authors":"Zhouzhou Chu, Sherry Yun Wang","doi":"10.1038/s41746-026-03273-2","DOIUrl":null,"url":null,"abstract":"We developed a transparent, calibrated AI framework using 242,312 FAERS reports on GLP-1 receptor agonists to predict adverse event seriousness. All models achieved strong discrimination, with area under the receiver operating characteristic curve (ROC-AUC)ranging from 0.877 to 0.930, and post hoc calibration improved probability reliability. Frequently reported gastrointestinal events showed low predictive importance, whereas dosing/administration, injection-site, and pancreatic events were among the strongest predictors, highlighting a disconnect between reporting frequency and predictive importance for reporter-classified seriousness.","PeriodicalId":19349,"journal":{"name":"NPJ Digital Medicine","volume":"37 1","pages":""},"PeriodicalIF":18.0000,"publicationDate":"2026-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"NPJ Digital Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1038/s41746-026-03273-2","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}
引用次数: 0
Abstract
We developed a transparent, calibrated AI framework using 242,312 FAERS reports on GLP-1 receptor agonists to predict adverse event seriousness. All models achieved strong discrimination, with area under the receiver operating characteristic curve (ROC-AUC)ranging from 0.877 to 0.930, and post hoc calibration improved probability reliability. Frequently reported gastrointestinal events showed low predictive importance, whereas dosing/administration, injection-site, and pancreatic events were among the strongest predictors, highlighting a disconnect between reporting frequency and predictive importance for reporter-classified seriousness.
期刊介绍:
npj Digital Medicine is an online open-access journal that focuses on publishing peer-reviewed research in the field of digital medicine. The journal covers various aspects of digital medicine, including the application and implementation of digital and mobile technologies in clinical settings, virtual healthcare, and the use of artificial intelligence and informatics.
The primary goal of the journal is to support innovation and the advancement of healthcare through the integration of new digital and mobile technologies. When determining if a manuscript is suitable for publication, the journal considers four important criteria: novelty, clinical relevance, scientific rigor, and digital innovation.