Signal mining and analysis of influencing factors for adverse events of Nivolumab and Cetuximab in the treatment of head and neck cancer based on the US FAERS database.

ABSTRACT:

Background

No prior research has directly compared adverse drug event (ADE) profiles of Nivolumab and Cetuximab in head and neck cancer (HNC) using the US FDA Adverse Event Reporting System (FAERS). The present study aims to evaluate ADE signal characteristics of both agents to inform clinical decision-making.

Methods

Data extracted from FAERS included patient baseline characteristics, which were summarized in a baseline table. Disproportionality analysis with reporting odds ratio (ROR) and Bayesian confidence propagation neural network (BCPNN) was applied to identify signals at the system organ class (SOC) and preferred term (PT) levels.

Results

For Nivolumab, three significant SOC-level signals were identified-benign/malignant tumors (including cysts/polyps), hepato

SUBMITTER: Tang Y 

PROVIDER: S-EPMC12605481 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature