{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,14]],"date-time":"2026-06-14T16:55:01Z","timestamp":1781456101587,"version":"3.54.1"},"reference-count":48,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2026,6,13]],"date-time":"2026-06-13T00:00:00Z","timestamp":1781308800000},"content-version":"vor","delay-in-days":39,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"National Cancer Institute of the National Institutes of Health","award":["P30CA042014"],"award-info":[{"award-number":["P30CA042014"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,5,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment, but their clinical benefit is limited by the onset of immune-related adverse events (irAEs). Real-world pharmacovigilance data, such as the FDA\u2019s Adverse Event Reporting System (FAERS) database, offer the scale needed to better characterize and understand these toxicities. However, extracting cohorts and normalizing complex fields requires expertise in data preprocessing, technical terminology harmonization, and programming.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>We curated an oncology-specific FAERS dataset of ICI-treated cases (2012Q4-2025Q3), standardized tumor, drug, and adverse event fields, deduplicated reports, and generated a flat-file resource (N\u2009=\u200971\u00a0175 irAE cases). To broaden accessibility, we developed a large language model (LLM)-powered analytics assistant that translates natural language queries into executable Python code for cohort filtering, visualization, and statistical testing. Our system also leverages retrieval-augmented generation (RAG) to return clinical guideline-grounded responses to questions about irAEs and their management for research purposes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>We benchmarked the system on curated tasks (question intent classification, TableQA, statistics, plotting) using multiple LLMs and report model- and task-specific performance metrics. As a case study, the platform recovered established irAE trends including differences in irAE patterns between anti-CTLA-4 treatment and other immunotherapy regimens and tumor-specific differences in irAE profiles following anti-PD-1 treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>Our results show that LLM-driven analytics can reliably translate natural-language queries into reproducible analyses, though model choice affects accuracy across tasks.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This platform provides a transparent, user-friendly approach for exploring real-world immunotherapy safety data to support hypothesis generation, candidate biomarker identification, and irAE risk assessment in immuno-oncology.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/jamiaopen\/ooag094","type":"journal-article","created":{"date-parts":[[2026,5,22]],"date-time":"2026-05-22T11:53:20Z","timestamp":1779450800000},"source":"Crossref","is-referenced-by-count":0,"title":["irAE.AI: AI-powered exploration of real-world immune-related adverse events"],"prefix":"10.1093","volume":"9","author":[{"given":"Gabriela","family":"Fort","sequence":"first","affiliation":[{"name":"Huntsman Cancer Institute, University of Utah , Salt Lake City, UT, 84112,","place":["United States"]},{"name":"Department of Oncological Sciences, University of Utah , Salt Lake City, UT, 84112,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Stone","sequence":"additional","affiliation":[{"name":"Huntsman Cancer Institute, University of Utah , Salt Lake City, UT, 84112,","place":["United States"]},{"name":"Department of Oncological Sciences, University of Utah , Salt Lake City, UT, 84112,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ching-Nung","family":"Lin","sequence":"additional","affiliation":[{"name":"Huntsman Cancer Institute, University of Utah , Salt Lake City, UT, 84112,","place":["United States"]},{"name":"Department of Oncological Sciences, University of Utah , Salt Lake City, UT, 84112,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arabella","family":"Young","sequence":"additional","affiliation":[{"name":"Huntsman Cancer Institute, University of Utah , Salt Lake City, UT, 84112,","place":["United States"]},{"name":"Department of Pathology, University of Utah , Salt Lake City, UT, 84112,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2955-8369","authenticated-orcid":false,"given":"Aik Choon","family":"Tan","sequence":"additional","affiliation":[{"name":"Huntsman Cancer Institute, University of Utah , Salt Lake City, UT, 84112,","place":["United States"]},{"name":"Department of Oncological Sciences, University of Utah , Salt Lake City, UT, 84112,","place":["United States"]},{"name":"Department of Biomedical Informatics, University of Utah , Salt Lake City, UT, 84112,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,6,12]]},"reference":[{"key":"2026061321194262000_ooag094-B1","doi-asserted-by":"publisher","first-page":"139","DOI":"10.1016\/j.ejca.2015.11.016","article-title":"Immune-related adverse events with immune checkpoint blockade: a comprehensive review","volume":"54","author":"Michot","year":"2016","journal-title":"Eur J Cancer"},{"key":"2026061321194262000_ooag094-B2","doi-asserted-by":"publisher","first-page":"158","DOI":"10.1056\/NEJMra1703481","article-title":"Immune-related adverse events associated with immune checkpoint blockade","volume":"378","author":"Postow","year":"2018","journal-title":"N Engl J Med"},{"issue":"3","key":"2026061321194262000_ooag094-B3","doi-asserted-by":"publisher","first-page":"e006398","DOI":"10.1136\/jitc-2022-006398","article-title":"Society for Immunotherapy of Cancer (SITC) consensus definitions for immune checkpoint inhibitor-associated immune-related adverse events (irAEs) terminology","volume":"11","author":"Naidoo","year":"2023","journal-title":"J Immunother Cancer"},{"key":"2026061321194262000_ooag094-B4","doi-asserted-by":"publisher","first-page":"4073","DOI":"10.1200\/JCO.21.01440","article-title":"Management of immune-related adverse events in patients treated with immune checkpoint inhibitor therapy: ASCO guideline update","volume":"39","author":"Schneider","year":"2021","journal-title":"J Clin Oncol"},{"key":"2026061321194262000_ooag094-B5","doi-asserted-by":"publisher","first-page":"230","DOI":"10.6004\/jnccn.2020.0012","article-title":"NCCN guidelines insights: management of immunotherapy-related toxicities, version 1.2020","volume":"18","author":"Thompson","year":"2020","journal-title":"J Natl Compr Canc Netw"},{"key":"2026061321194262000_ooag094-B6","doi-asserted-by":"publisher","first-page":"51","DOI":"10.1038\/s41416-024-02887-1","article-title":"Cancer and treatment specific incidence rates of immune-related adverse events induced by immune checkpoint inhibitors: a systematic review","volume":"132","author":"Jayathilaka","year":"2025","journal-title":"Br J Cancer"},{"key":"2026061321194262000_ooag094-B7","doi-asserted-by":"publisher","first-page":"415","DOI":"10.1093\/oncolo\/oyae012","article-title":"Exploring the landscape of immune checkpoint inhibitor-induced adverse events through big data mining of pan-cancer clinical trials","volume":"29","author":"Fadlullah","year":"2024","journal-title":"Oncologist"},{"key":"2026061321194262000_ooag094-B8","doi-asserted-by":"publisher","first-page":"551","DOI":"10.2165\/00002018-200730060-00009","article-title":"Extreme duplication\u2019 in the US FDA adverse events reporting system database","volume":"30","author":"Hauben","year":"2007","journal-title":"Drug Saf"},{"key":"2026061321194262000_ooag094-B9","doi-asserted-by":"publisher","first-page":"1119","DOI":"10.1007\/s40264-025-01560-7","article-title":"An evaluation of duplicate adverse event reports characteristics in the food and drug administration adverse event reporting system","volume":"48","author":"Janiczak","year":"2025","journal-title":"Drug Saf"},{"key":"2026061321194262000_ooag094-B10","doi-asserted-by":"publisher","first-page":"160026","DOI":"10.1038\/sdata.2016.26","article-title":"A curated and standardized adverse drug event resource to accelerate drug safety research","volume":"3","author":"Banda","year":"2016","journal-title":"Sci Data"},{"key":"2026061321194262000_ooag094-B11","doi-asserted-by":"publisher","DOI":"10.3390\/healthcare10030420","article-title":"A standardized dataset of a spontaneous adverse event reporting system","volume":"10","author":"Khaleel","year":"2022","journal-title":"Healthcare (Basel)"},{"key":"2026061321194262000_ooag094-B12","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1080\/14740338.2025.2588634","article-title":"Utility and limitations of the FDA adverse events reporting system public dashboard for safety analyses: a case study with vesicular monoamine transporter 2 inhibitors","author":"McIntyre","year":"2025","journal-title":"Expert Opin Drug Saf"},{"key":"2026061321194262000_ooag094-B13","doi-asserted-by":"publisher","first-page":"135","DOI":"10.1007\/s11060-020-03687-2","article-title":"Neuroimmunological adverse events associated with immune checkpoint inhibitor: a retrospective, pharmacovigilance study using FAERS database","volume":"152","author":"Mikami","year":"2021","journal-title":"J Neurooncol"},{"key":"2026061321194262000_ooag094-B14","doi-asserted-by":"publisher","first-page":"1631273","DOI":"10.3389\/fimmu.2025.1631273","article-title":"Evaluating the toxicity profile of combination immune checkpoint inhibitors: a disproportionality analysis of real-world adverse events from the FDA adverse event reporting system for tremelimumab, durvalumab, ipilimumab, and nivolumab","volume":"16","author":"Li","year":"2025","journal-title":"Front Immunol"},{"key":"2026061321194262000_ooag094-B15","doi-asserted-by":"publisher","first-page":"15597","DOI":"10.3389\/jpps.2025.15597","article-title":"Refined pharmacovigilance assessment of immune checkpoint inhibitors-related bullous pemphigoid: a multi-methodological approach utilizing FAERS database","volume":"28","author":"Wang","year":"2025","journal-title":"J Pharm Pharm Sci"},{"key":"2026061321194262000_ooag094-B16","author":"Fang","year":"2024"},{"key":"2026061321194262000_ooag094-B17","doi-asserted-by":"publisher","author":"Sui","DOI":"10.1145\/3616855.3635752"},{"key":"2026061321194262000_ooag094-B18","doi-asserted-by":"publisher","first-page":"10315","DOI":"10.18653\/v1\/2025.findings-acl.538","article-title":"TableLLM: Enabling tabular data manipulation by LLMs in real office usage scenarios","author":"Zhang","year":"2025","journal-title":"Assoc Comput Linguist"},{"key":"2026061321194262000_ooag094-B19","doi-asserted-by":"publisher","author":"Wu","DOI":"10.1145\/3654992"},{"key":"2026061321194262000_ooag094-B20","doi-asserted-by":"publisher","volume-title":"Sci Data","author":"Song","DOI":"10.1038\/s41597-026-06731-4"},{"key":"2026061321194262000_ooag094-B21","doi-asserted-by":"publisher","author":"Wu","DOI":"10.1609\/aaai.v39i24.34739"},{"key":"2026061321194262000_ooag094-B22","doi-asserted-by":"publisher","volume-title":"EBioMedicine","author":"Bejan","DOI":"10.1016\/j.ebiom.2026.106227"},{"key":"2026061321194262000_ooag094-B23","doi-asserted-by":"publisher","first-page":"4134","DOI":"10.1200\/JCO.24.00326","article-title":"Enhancing precision in detecting severe immune-related adverse events: comparative analysis of large language models and international classification of disease codes in patient records","volume":"42","author":"Sun","year":"2024","journal-title":"J Clin Oncol"},{"key":"2026061321194262000_ooag094-B24","doi-asserted-by":"publisher","first-page":"243","DOI":"10.2147\/POR.S468253","article-title":"Detection of patient-level immunotherapy-related adverse events (irAEs) from clinical narratives of electronic health records: a high-sensitivity artificial intelligence model","volume":"15","author":"Zitu","year":"2024","journal-title":"Pragmat Obs Res"},{"key":"2026061321194262000_ooag094-B25","doi-asserted-by":"publisher","DOI":"10.1136\/jitc-2023-008599","article-title":"Use of artificial intelligence chatbots in clinical management of immune-related adverse events","volume":"12","author":"Burnette","year":"2024","journal-title":"J Immunother Cancer"},{"key":"2026061321194262000_ooag094-B26","doi-asserted-by":"publisher","first-page":"1930","DOI":"10.1038\/s41591-023-02448-8","article-title":"Large language models in medicine","volume":"29","author":"Thirunavukarasu","year":"2023","journal-title":"Nat Med"},{"key":"2026061321194262000_ooag094-B27","first-page":"9459","author":"Lewis"},{"key":"2026061321194262000_ooag094-B28","author":"Gao","year":"2023"},{"key":"2026061321194262000_ooag094-B29","doi-asserted-by":"publisher","first-page":"129","DOI":"10.1093\/jamia\/ocae284","article-title":"Oncointerpreter.ai enables interactive, personalized summarization of cancer diagnostics data","volume":"32","author":"Tripathi","year":"2025","journal-title":"J Am Med Inform Assoc"},{"key":"2026061321194262000_ooag094-B30","doi-asserted-by":"publisher","first-page":"e2500071","DOI":"10.1200\/CCI-25-00071","article-title":"Enhancing Patient-Trial matching with large language models: a scoping review of emerging applications and approaches","volume":"9","author":"Chen","year":"2025","journal-title":"JCO Clin Cancer Inform"},{"key":"2026061321194262000_ooag094-B31","doi-asserted-by":"publisher","first-page":"109","DOI":"10.2165\/00002018-199920020-00002","article-title":"The medical dictionary for regulatory activities (MedDRA)","volume":"20","author":"Brown","year":"1999","journal-title":"Drug Saf"},{"key":"2026061321194262000_ooag094-B32","doi-asserted-by":"publisher","author":"He","DOI":"10.1609\/aaai.v38i16.29777"},{"key":"2026061321194262000_ooag094-B33","doi-asserted-by":"publisher","volume-title":"ACM Trans Intell Syst Technol","author":"Naveed","DOI":"10.1145\/3744746"},{"key":"2026061321194262000_ooag094-B34","author":"Chen","year":"2021"},{"key":"2026061321194262000_ooag094-B35","author":"Jimenez","year":"2023"},{"key":"2026061321194262000_ooag094-B36","author":"Cao","year":"2026"},{"key":"2026061321194262000_ooag094-B37","author":"Qwen Team"},{"key":"2026061321194262000_ooag094-B38","author":"Qwen Team"},{"issue":"2","key":"2026061321194262000_ooag094-B39","doi-asserted-by":"publisher","first-page":"346","DOI":"10.1109\/TBDATA.2025.3618474","article-title":"The Faiss library","volume":"12","author":"Douze","year":"2025","journal-title":"IEEE Trans Big Data"},{"key":"2026061321194262000_ooag094-B40","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1145\/3703155","article-title":"A survey on hallucination in large language models: principles, taxonomy, challenges, and open questions","volume":"43","author":"Huang","year":"2025","journal-title":"ACM Trans Inf Syst"},{"key":"2026061321194262000_ooag094-B41","author":"Tauman Kalai","year":"2025"},{"key":"2026061321194262000_ooag094-B42","doi-asserted-by":"publisher","first-page":"2377","DOI":"10.1093\/annonc\/mdx286","article-title":"Tumour- and class-specific patterns of immune-related adverse events of immune checkpoint inhibitors: a systematic review","volume":"28","author":"Khoja","year":"2017","journal-title":"Ann Oncol"},{"key":"2026061321194262000_ooag094-B43","doi-asserted-by":"publisher","first-page":"405","DOI":"10.12998\/wjcc.v7.i4.405","article-title":"Immune checkpoint inhibitor-induced colitis: a comprehensive review","volume":"7","author":"Som","year":"2019","journal-title":"World J Clin Cases"},{"key":"2026061321194262000_ooag094-B44","doi-asserted-by":"publisher","first-page":"639","DOI":"10.1002\/ijc.32132","article-title":"A systematic review of adverse events in randomized trials assessing immune checkpoint inhibitors","volume":"145","author":"Arnaud-Coffin","year":"2019","journal-title":"Int J Cancer"},{"key":"2026061321194262000_ooag094-B45","doi-asserted-by":"publisher","first-page":"110414","DOI":"10.1016\/j.intimp.2023.110414","article-title":"Recent advances in immune checkpoint inhibitor-induced type 1 diabetes mellitus","volume":"122","author":"Liao","year":"2023","journal-title":"Int Immunopharmacol"},{"key":"2026061321194262000_ooag094-B46","doi-asserted-by":"publisher","first-page":"313","DOI":"10.1146\/annurev-med-050219-034237","article-title":"Autoimmune endocrinopathies: an emerging complication of immune checkpoint inhibitors","volume":"72","author":"Quandt","year":"2021","journal-title":"Annu Rev Med"},{"key":"2026061321194262000_ooag094-B47","doi-asserted-by":"publisher","first-page":"221","DOI":"10.1200\/CCI.20.00108","article-title":"OncoTree: a cancer classification system for precision oncology","volume":"5","author":"Kundra","year":"2021","journal-title":"JCO Clin Cancer Inform"},{"key":"2026061321194262000_ooag094-B48","doi-asserted-by":"publisher","first-page":"e2500323","DOI":"10.1200\/CCI-25-0032341802246","article-title":"Leveraging artificial intelligence for Immune Checkpoint Inhibitor safety: a scoping review of current applications","volume":"10","author":"Yiu","year":"2026","journal-title":"JCO Clin Cancer Inform"}],"container-title":["JAMIA Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/jamiaopen\/article-pdf\/9\/3\/ooag094\/68522379\/ooag094.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jamiaopen\/article-pdf\/9\/3\/ooag094\/68522379\/ooag094.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,14]],"date-time":"2026-06-14T16:08:46Z","timestamp":1781453326000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/jamiaopen\/article\/doi\/10.1093\/jamiaopen\/ooag094\/8707580"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5,5]]},"references-count":48,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2026,5,5]]}},"URL":"https:\/\/doi.org\/10.1093\/jamiaopen\/ooag094","relation":{},"ISSN":["2574-2531"],"issn-type":[{"value":"2574-2531","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2026,6]]},"published":{"date-parts":[[2026,5,5]]},"article-number":"ooag094"}}