Frontiers in pharmacology
Zolbetuximab-associated adverse event reporting signals in gastric cancer: a FAERS disproportionality analysis
By Zhang J, Zhen Z, Li Z and 1 others.
Abstract
Background
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.
Methods
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.
