{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T06:06:59Z","timestamp":1789020419407,"version":"build-2803163510"},"reference-count":30,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T00:00:00Z","timestamp":1788998400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Pharmacol."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Zolbetuximab has an established upper gastrointestinal tolerability profile, but the broader post-marketing spectrum of gastric mucosal events and findings related to albumin, protein loss, and fluid balance remains incompletely characterized.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We conducted an indication-restricted, report-level US Food and Drug Administration Adverse Event Reporting System (FAERS) analysis from 2024 Q1 through 2026 Q1, comparing 597 zolbetuximab reports with 1,231 pooled nivolumab\/pembrolizumab reports. Reporting odds ratios (RORs) were used for primary screening, with five contextual reporting backgrounds, adjusted Firth models, and chemotherapy-, drug-role-, geographic-, calendar-time-, and submission-channel analyses. Time to onset and co-reporting were summarized descriptively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Among 1,041 screened preferred terms, 58 met the ROR criterion and 48 were clinically retained. The findings clustered into three groups: upper gastrointestinal and intake-related findings, gastric mucosal findings, and findings related to albumin, protein loss, and fluid balance. The eight\n                      <jats:italic>post hoc<\/jats:italic>\n                      focus preferred terms (PTs) retained support across all five backgrounds and the principal adjusted analyses. Gastritis was reported in 22 zolbetuximab\n                      <jats:italic>versus<\/jats:italic>\n                      1 pooled PD-1 report (ROR 32.07, 95% CI 6.12\u2013167.97), hypoalbuminemia in 72\n                      <jats:italic>versus<\/jats:italic>\n                      3 (ROR 48.43, 95% CI: 16.49\u2013142.24), and protein-losing gastroenteropathy (PLE) in 10\n                      <jats:italic>versus<\/jats:italic>\n                      2 (ROR 8.79, 95% CI: 2.21\u201335.04). Japan accounted for 83.8% of zolbetuximab reports, with limited support outside Japan.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The analysis reinforced established upper gastrointestinal findings. Gastritis and findings related to albumin, protein loss, and fluid balance require clinical confirmation, while protein-losing gastroenteropathy was reported sparsely. Overall, the results characterize reporting disproportionality in an early, Japan-dominant setting, not incidence or comparative clinical risk.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fphar.2026.1887849","type":"journal-article","created":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T05:31:24Z","timestamp":1789018284000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Zolbetuximab-associated adverse event reporting signals in gastric cancer: a FAERS disproportionality analysis"],"prefix":"10.3389","volume":"17","author":[{"given":"Jingshun","family":"Zhang","sequence":"first","affiliation":[{"name":"Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Chongqing Medical University","place":["Chongqing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhuo","family":"Zhen","sequence":"additional","affiliation":[{"name":"Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Chongqing Medical University","place":["Chongqing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhijun","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Chongqing Medical University","place":["Chongqing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peng","family":"Zhu","sequence":"additional","affiliation":[{"name":"Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Chongqing Medical University","place":["Chongqing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,9,10]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"169","DOI":"10.6004\/jnccn.2025.0022","article-title":"Gastric cancer, version 2.2025, NCCN clinical practice guidelines in oncology","volume":"23","author":"Ajani","year":"2025","journal-title":"J. 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