Pharmacovigilance study of the frequency of gastrointestinal ulceration reports associated with immune checkpoint inhibitors: insights from the FDA adverse event reporting system.

ABSTRACT:

Background

Immune checkpoint inhibitors (ICIs) have revolutionized the treatment landscape for cancer, yet they are linked to immune-related adverse events (AEs), one of which includes gastrointestinal ulceration (GU). The objective of this study was to evaluate the reporting frequency of GU reported in connection with ICIs by utilizing data from the United States (U.S.) Food and Drug Administration Adverse Event Reporting System (FAERS).

Materials and methods

AEs pertaining to GU attributed to ICIs were extracted from the U.S. FAERS database for the time frame spanning from the fourth quarter of 2018 to the fourth quarter of 2024. A disproportionality analysis was performed employing the reporting odds ratio (ROR) and information component (IC), accompanied by 95% confidenc

SUBMITTER: Lei L 

PROVIDER: S-EPMC12646910 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature