A Disproportionality Analysis of Immune Checkpoint Inhibitors in Combination With Platinum‐Based Agents Using the FDA Adverse Event Reporting System Database

ABSTRACT Objective Immune checkpoint inhibitors (ICIs) combined with platinum‐based compounds are commonly used in the treatment of certain malignant tumors. This study aims to analyze adverse events (AEs) associated with the combination therapy of ICIs and platinum‐based compounds by using the FAERS database. Methods This study retrieved relevant adverse event (AE) data from the FAERS database (2008–2024) and conducted a retrospective analysis of the collected AEs. Multiple disproportionality analysis algorithms were employed, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi‐item Gamma Poisson Shrinker (MGPS). Results Analysis of 28,585 reports identified 27 significant SOC‐level signals, strongest for hematological (ROR = 6.3), endocrine (ROR = 14.3), and hepatobiliary disorders (ROR = 4.49). Key PTs included malignant neoplasm progression (ROR = 16), febrile neutropenia (ROR = 15.31), and myocarditis (ROR = 16.3). 45.5% of AEs occurred within 1 month (median onset: 38 days). Combination therapy showed lower rates vs. monotherapy for malignancy progression and nephrotoxicity, but higher neurotoxicity (628 neuropathy cases). Conclusion The combination exhibits distinct early‐onset toxicities (early‐onset hematological/endocrine/hepatic) and novel risks (neuropathy/myocarditis/leukemia), necessitating enhanced initial monitoring and subgroup‐specific management.