Signal mining and analysis of trifluridine/tipiracil adverse events based on real-world data from the FAERS database.

ABSTRACT:

Objective

The objective of this research is to scrutinize adverse events (AEs) linked to Trifluridine/Tipiracil (TFTD/TPI), using data from the FDA Adverse Event Reporting System (FAERS) database.

Methods

The AEs data related to TFTD/TPI were collected from the fourth quarter of 2015 through the fourth quarter of 2023. After normalizing the data, multiple signal quantification techniques including Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Bayesian approaches such as Bayesian Confidence Propagation Neural Network (BCPNN) and the Multi-item Gamma Poisson Shrinker (MGPS) were used for overall and subgroup analysis and visualization analyses were performed.

Results

From the FAERS database, we analyzed 13,520,073 reports, identifying 8,331 as primary

SUBMITTER: Hu Y 

PROVIDER: S-EPMC11301057 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature