Safety signals of zolbetuximab in gastric or gastroesophageal junction adenocarcinoma: a comprehensive analysis of the FDA adverse event reporting system (FAERS) data - Summary - MDSpire
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Safety signals of zolbetuximab in gastric or gastroesophageal junction adenocarcinoma: a comprehensive analysis of the FDA adverse event reporting system (FAERS) data
To analyze the post-marketing adverse events of zolbetuximab using the FDA Adverse Event Reporting System (FAERS).
Approach:
Data Extraction: Adverse event reports from FAERS (Q1 2024 – Q3 2025) were analyzed, focusing on reports where zolbetuximab was the primary suspect.
Disproportionality Analysis: Four algorithms (ROR, PRR, IC, and EBGM) were employed to detect potential safety signals.
Time-to-Onset Analysis: The time-to-onset for adverse events was also evaluated.
Key Findings:
A total of 676 reports were analyzed based on disproportionality analysis.
Known gastrointestinal and metabolic disorders were confirmed through the analysis.
Several unlabeled adverse events were identified, including gastritis, protein-losing gastroenteropathy, peripheral edema, compression fracture, and vascular pain.
The median time-to-onset for adverse events was 0 days, with 82.9% occurring within the first 30 days.
Interpretation:
Limitations:
The analysis is based on spontaneous reporting data, which may be subject to underreporting and reporting bias.
The findings are hypothesis-generating and require further validation in clinical and real-world studies.
