{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,9]],"date-time":"2026-05-09T08:10:52Z","timestamp":1778314252226,"version":"3.51.4"},"reference-count":23,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,5,6]],"date-time":"2026-05-06T00:00:00Z","timestamp":1778025600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Oncol Pharm Pract"],"abstract":"<jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>This study aimed to characterize FAERS reports of immune-mediated upper gastrointestinal (GI) toxicities associated with immune checkpoint inhibitors and to explore disproportional reporting patterns across ICI classes and treatment regimens.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Input data were downloaded from the public release of the FDA database including time period between January 1 2016, and December 31, 2024. 132 patients with upper-GI toxicity were included. Categorical variables were compared using either the chi-square test or Fisher's exact test. To evaluate the potential association between ICIs and specific upper-GI toxicity events of interest, a disproportionality analysis was conducted using the Reporting Odds Ratio (ROR) method. A signal was considered statistically significant when the lower bound of the 95% confidence interval for the ROR exceeded 1.0.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Anti-PD-1 agents showed higher disproportional reporting of upper-GI toxicities compared to anti-PD-L1 (p\u2009=\u20090.001, ROR = 3.83 95% CI: 1.53\u201315.23). A higher proportion of hospitalization among reported cases were observed in patients treated with concurrent chemotherapy, compared to those did not receive chemotherapy (ROR = 2.5; 95% CI: 1.05\u20135.921; p\u2009=\u20090.045).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Anti-PD-1 therapy showed a stronger reporting signal for upper-GI toxicity than anti-PD-L1 therapy in FAERS, although the number of anti-PD-L1 cases was small. Concurrent chemotherapy was associated with a higher proportion of hospitalization among reported cases. These findings are exploratory and hypothesis-generating.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10781552261447836","type":"journal-article","created":{"date-parts":[[2026,5,6]],"date-time":"2026-05-06T13:35:26Z","timestamp":1778074526000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Immune-Mediated upper gastrointestinal toxicities reported With immune checkpoint inhibitors: An analysis of the food and drug administration adverse event reporting system (FAERS)"],"prefix":"10.1177","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8263-0692","authenticated-orcid":false,"given":"Emir","family":"Cerme","sequence":"first","affiliation":[{"name":"Cerrahpa\u015fa Faculty of Medicine, Department of Internal Medicine, Division of Medical Oncology, Istanbul University-Cerrahpa\u015fa, Istanbul, 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