{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T18:59:56Z","timestamp":1790449196448,"version":"4.1.0"},"reference-count":48,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2022,11,24]],"date-time":"2022-11-24T00:00:00Z","timestamp":1669248000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["82060577"],"award-info":[{"award-number":["82060577"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Medicine"],"published-print":{"date-parts":[[2023,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Although arrhythmias have been reported in patients treated with immune checkpoint inhibitors (ICIs), the association between arrhythmias and ICIs has not been thoroughly evaluated in real\u2010world studies. We aimed to describe the major features of ICI\u2010related arrhythmic events and identify the factors that contributed to death.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A disproportionality analysis was performed using data from the Food and Drug Administration Adverse Event Reporting System (FAERS) database from January 2011 to December 2021. Reporting odds ratios (RORs), proportional reporting ratio and information component were used to assess whether adverse arrhythmic events were associated with ICIs. The clinical characteristics of patients with ICI\u2010associated arrhythmias were compared with fatal and non\u2010fatal arrhythmias. The time to onset (TTO), fatality rates of arrhythmic events were also investigated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>We identified a total of 1945 cases of ICI\u2010related arrhythmic events. Men (64.78%) were identified significantly more frequently than women (28.84%). The median age was 68\u2009years ([interquartile range, IQR] 60\u201375\u2009years). Anti\u2010programmed cell death\u20101 (PD\u20101) and anti\u2010programmed cell death ligand\u20101 (PD\u2010L1) were associated with adverse arrhythmic events, corresponding to ROR 1.11 (95% confidence interval [CI] 1.05\u20131.17) and ROR 1.34 (95% CI 1.20\u20131.49), respectively. However, anti\u2010cytotoxic T\u2010lymphocyte associated protein 4 or combination immunotherapy did not appear to be associated with arrhythmic events. Atrial fibrillation (<jats:italic>N<\/jats:italic> \u00a0=\u00a0576, 0.62%), cardiac arrest (<jats:italic>N<\/jats:italic> \u00a0=\u00a0284, 0.31%), tachycardia (<jats:italic>N<\/jats:italic> \u00a0=\u00a0175, 0.19%) were the most common adverse arrhythmic events. Sudden death and complete atrioventricular block are adverse events that are significantly associated with ICI\u2010related arrhythmic events and have strong signal intensity. The TTO of cases that resulted in death (30\u2009days [IQR] 11\u201373.75) was significantly earlier than that of cases that did not result in death (33\u2009days [IQR 10.5\u201388.5], <jats:italic>p<\/jats:italic> \u00a0=\u00a00.003). ICI\u2010related arrhythmic events were severe with death occurring in 507 (26.07%) of 1945 arrhythmias cases.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Treatment with PD\u20101\/PD\u2010L1 may cause arrhythmic events, which are severe and tend to occur early on during treatment. It is important to identify ICI\u2010related arrhythmias as early as possible, and to manage them appropriately.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cam4.5438","type":"journal-article","created":{"date-parts":[[2022,11,25]],"date-time":"2022-11-25T07:40:05Z","timestamp":1669362005000},"page":"6637-6648","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":34,"title":["Arrhythmic events associated with immune checkpoint inhibitors therapy: A real\u2010world study based on the Food and Drug Administration Adverse Event Reporting System database"],"prefix":"10.1002","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6002-0781","authenticated-orcid":false,"given":"Yunwei","family":"Liu","sequence":"first","affiliation":[{"name":"Department of Oncology The Second Affiliated Hospital of Nanchang University  Nanchang Jiangxi China"},{"name":"Jiangxi Key Laboratory of Clinical Translational Cancer Research The Second 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