[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-0-en-105":3,"doc-seo-349409-105":59,"doc-detail-349409-en":130},{"code":4,"msg":5,"data":6},0,"success",[7,13,18,23,28,33,38,43,48,51,55],{"id":8,"doc_module":4,"doc_module_name":9,"category_name":10,"show_sort_weight":11,"slug":12},1,"Document","Story & Novel",90,"story-novel",{"id":14,"doc_module":4,"doc_module_name":9,"category_name":15,"show_sort_weight":16,"slug":17},2,"Literature",80,"literature",{"id":19,"doc_module":4,"doc_module_name":9,"category_name":20,"show_sort_weight":21,"slug":22},4,"Exam",70,"exam",{"id":24,"doc_module":4,"doc_module_name":9,"category_name":25,"show_sort_weight":26,"slug":27},5,"Comic",60,"comic",{"id":29,"doc_module":4,"doc_module_name":9,"category_name":30,"show_sort_weight":31,"slug":32},6,"Technology",50,"technology",{"id":34,"doc_module":4,"doc_module_name":9,"category_name":35,"show_sort_weight":36,"slug":37},7,"Healthcare",40,"healthcare",{"id":39,"doc_module":4,"doc_module_name":9,"category_name":40,"show_sort_weight":41,"slug":42},8,"Research & Report",30,"research-report",{"id":44,"doc_module":4,"doc_module_name":9,"category_name":45,"show_sort_weight":46,"slug":47},9,"Religion & Spirituality",20,"religion-spirituality",{"id":46,"doc_module":4,"doc_module_name":9,"category_name":49,"show_sort_weight":46,"slug":50},"World Cup","world-cup",{"id":52,"doc_module":4,"doc_module_name":9,"category_name":53,"show_sort_weight":52,"slug":54},10,"Lifestyle","lifestyle",{"id":56,"doc_module":4,"doc_module_name":9,"category_name":57,"show_sort_weight":24,"slug":58},19,"General","general",{"code":4,"msg":60,"data":61},"ok",{"site_id":62,"language":63,"slug":64,"title":65,"keywords":66,"description":67,"schema_data":68,"social_meta":123,"head_meta":125,"extra_data":127,"updated_unix":129},105,"en","ipilimumab-and-nivolumab-for-cancer-treatment-a-pharmacovigilance-study-based-on-the-fda-adverse-event-reporting-system-database","Ipilimumab and nivolumab for cancer treatment - a pharmacovigilance study based on the FDA adverse event reporting system database","","Cancer treatment with ipilimumab and nivolumab continues to expand, while safety concerns require ongoing signal monitoring. This study analyzed adverse drug event (ADE) signals and factors associated with reporting in FAERS for all cancers from Q1 2004 to Q4 2024. It examined report characteristics, cumulative ADE onset trends across age groups, and safety signals using disproportionality analysis. Results identified significant signals and age/weight-associated reporting factors, with adverse reaction onset showing a bimodal “early outbreak + persistent risk” pattern, emphasizing the need for heightened clinical vigilance and routine endocrinological monitoring.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":40,"@type":76,"position":81},"https://docshare.wps.com/document/research-report/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/ipilimumab-and-nivolumab-for-cancer-treatment-a-pharmacovigilance-study-based-on-the-fda-adverse-event-reporting-system-database/349409/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/ipilimumab-and-nivolumab-for-cancer-treatment-a-pharmacovigilance-study-based-on-the-fda-adverse-event-reporting-system-database/349409.png","ImageObject",300,407,{"name":92,"@type":93},"Ben ","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-09-24","2026-09-22",true,{"@type":102,"interactionType":103,"userInteractionCount":19},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"Which data source and time period were used to study safety signals for ipilimumab and nivolumab?","Question",{"text":112,"@type":113},"The analysis used the FDA Adverse Event Reporting System (FAERS) database, covering all cancers from the first quarter of 2004 through the fourth quarter of 2024.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"How did the study analyze adverse event onset timing across age groups?",{"text":117,"@type":113},"It investigated cumulative trends of ADE onset time across different age groups, finding a bimodal pattern characterized by “early concentrated outbreak + long-term persistent risk,” related to age.",{"name":119,"@type":110,"acceptedAnswer":120},"What safety categories and drug-related reactions showed stronger associations?",{"text":121,"@type":113},"The study reported stronger associations with colitis, adrenal insufficiency, malignant neoplasm progression, death, and intentional product use issues across the three drug groups.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},349409,1790147583,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":39,"category_name":40,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":19,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":139,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":144,"read_time":41},2336478951081,"https://ap-avatar.wpscdn.com/davatar_276721f389ce27ea32af1340a28f341c","TYPE Original Research PUBLISHED 18 June 2026  \nDOI 10.3389/fendo.2026.1786504  \nOPEN ACCESS  \nEDITED BY  \nIppazio Cosimo Antonazzo, University of Milan-Bicocca, Italy  \nREVIEWED BY  \nLukasz Chlewicki,  \nDechra Veterinary Products, United States Shanshan Xu,  \nCapital Medical University, China  \n*CORRESPONDENCE  \nXidan Hu  \n[yunduan702914@126.com](yunduan702914@126.com)[ ](yunduan702914@126.com)Min Zhang  \n[zhangmin800424@163.com](zhangmin800424@163.com)  \n†These authors have contributed equally to this work and share first authorship  \nRECEIVED 13 January 2026  \nREVISED 30 April 2026  \nACCEPTED 25 May 2026  \nPUBLISHED 18 June 2026  \nCITATION  \nLiu R, Xiang Y, Hu X, Zhang M, Wang L, Liu T, Wang X and Qian B (2026)  \nIpilimumab and nivolumab for cancer treatment: a pharmacovigilance study based on the FDA adverse event reporting system database.  \nFront. Endocrinol. 17:1786504 .  \ndoi: 10.3389/fendo.2026.1786504  \nCOPYRIGHT  \n© 2026 Liu, Xiang, Hu, Zhang, Wang, Liu, Wang and Qian. This is an open-access article distributed under the terms of the  \nCreative Commons Attribution License (CC BY) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.  \nIpilimumab and nivolumab for cancer treatment:  \na pharmacovigilance study based on the FDA adverse event reporting system database  \nRuming Liu 1†, Yaoyu Xiang 2†, Xidan Hu 1*, Min Zhang 1*, Lujie Wang 1, Tao Liu 3, Xi Wang 1 and Bin Qian 1  \n1 Department of Clinical Pharmacy, The First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China, 2 Department of Sports Medicine, The First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China, 3Organ Transplantation Center, The First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China  \nBackground: Cancer remains one of the leading is associated with of death globally. This study analyzed adverse drug event (ADE) signals and potential factors associated with reporting in ipilimumab and nivolumab-treated cancer data from the Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) database. Methods: This study collected ADEs associated with ipilimumab, nivolumab, and their combination therapy for all cancers from the first quarter of 2004 to the fourth quarter of 2024 through the FAERS database. It investigated the basic information of all adverse reaction reports, analyzed the cumulative trends of ADE onset time across different age groups, and mined safety signals significantly associated with the three drug groups via disproportionality analysis. Additionally, the study explored potential factors associated with reporting of these adverse reactions. Results: A total of 21,712,563 reports were included in this study as research subjects, among which there were 4,600, 36,556, and 10,862 adverse reaction reports for ipilimumab, nivolumab, and ipilimumab/nivolumab, respectively. Separate analysis of these three groups of drugs showed that the onset time of adverse reactions mostly exhibited a bimodal pattern characterized by “early concentrated outbreak + long-term persistent risk”, which was related to age. These three groups of drugs showed a stronger associated with colitis, adrenal insufficiency, malignant neoplasm progression, death, and intentional product use issues. Age and weight were identified as potential factors associated with reporting of adverse reactions related to these three groups of drugs. Conclusion: Based on the FAERS database, this study identifies significant pharmacovigilance signals and potential reporting-associated factors for ipilimumab, nivolumab, and their combination. Importantly, these findings represent hypothesis-generating signal detections rather than definit","cbCaihy0fuFt7PcE","https://ap.wps.com/l/cbCaihy0fuFt7PcE","pdf",3000511,12,"English","# Introduction\n## Background and epidemiology\n## Immunotherapy and study rationale\n## Data sources and methods\n## Results and key safety signals\n## Discussion, implications, and conclusions","[{\"question\":\"Which data source and time period were used to study safety signals for ipilimumab and nivolumab?\",\"answer\":\"The analysis used the FDA Adverse Event Reporting System (FAERS) database, covering all cancers from the first quarter of 2004 through the fourth quarter of 2024.\"},{\"question\":\"How did the study analyze adverse event onset timing across age groups?\",\"answer\":\"It investigated cumulative trends of ADE onset time across different age groups, finding a bimodal pattern characterized by “early concentrated outbreak + long-term persistent risk,” related to age.\"},{\"question\":\"What safety categories and drug-related reactions showed stronger associations?\",\"answer\":\"The study reported stronger associations with colitis, adrenal insufficiency, malignant neoplasm progression, death, and intentional product use issues across the three drug groups.\"}]","Ipilimumab and nivolumab for cancer treatment - a pharmacovigilance study based on the FDA adverse event reporting system database | PDF",1790083180]