Safety assessment of obinutuzumab: Real-world adverse event analysis based on the FAERS and JADER databases from 2013 to 2025.

ABSTRACT:

Background

Obinutuzumab is the first glycosylated type II anti-CD20 monoclonal antibody for the treatment of lymphocytic leukemia and follicular lymphoma. This research aimed to identify significant and unexpected adverse events (AEs) associated with obinutuzumab by utilizing data from the US Food and Drug Administration's Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report (JADER) databases, with the intention of providing a reference for the safe and rational clinical use of the drug.

Research design and methods

The reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayesian geometric average (EBGM) were employed to analyze the AEs of obinutuzumab using the regi

SUBMITTER: Li X 

PROVIDER: S-EPMC12513595 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature