Exploration of adverse event profiles for glofitamab: A disproportionality analysis using the FDA adverse event reporting system.

ABSTRACT:

Background

Glofitamab offers a promising option for the treatment of diffuse large B-cell lymphoma. It is crucial to gather comprehensive safety information of glofitamab through large-scale post market monitoring.

Methods

This study conducted a comprehensive analysis of glofitamab-related adverse events (AEs) based on FDA Adverse Event Reporting System database. Four disproportionality analysis methods were employed to mining the significant signals. The clinical characteristics of all AE and cytokine release syndrome reports were analyzed. Sensitivity analyses were performed to exam the potential bias. The differences in AE signals among different subgroups were investigated.

Results

A total of 641 reports and 1,542 AEs with glofitamab were identified. Cytokine rele

SUBMITTER: Zhou M 

PROVIDER: S-EPMC12585042 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature