Analysis of Adverse Reactions of Pembrolizumab in Ovarian Cancer Treatment: A Pharmacovigilance Study Based on the FAERS Database

The purpose of this study is to systematically evaluate the safety characteristics of PD-1 inhibiting pembrolizumab in the treatment of ovarian cancer by analyzing data from the FDA Adverse Event Reporting System (FAERS), providing a basis for clinical risk management and personalized monitoring. Method: Extract adverse event (AE) reports related to pembrolizumab in ovarian cancer from FAERS database from Q1 2015 to Q4 2024. Signal detection was performed using disproportionate analysis methods (including ratio to odds ratio/OR, ratio to odds ratio/PRR), Bayesian belief propagation neural network (BCPNN), and multiple gamma Poisson constrictors (MGPS), and systematic organ classification (SOC) and preferred language (PT) statistics were performed based on MedDRA terminology. A total of 318 valid AE reports were included, with the age group mainly concentrated between 18-64.5 years old (28.30%), followed by 65-85 years old (24.21%); The weight is mainly concentrated between 50-100 kg (18.85%), followed by<50 kg (2.20%). The main clinical outcome was hospitalization (25.47%), followed by fatal events (17.92%). 44 cases were recorded to have onset time, with approximately 45.5% (20 cases) occurring between 0-30 days after medication. Screening high-risk signals involves endocrine disorders, musculoskeletal toxicity, respiratory system and gastrointestinal toxicity, etc. Conclusion: This study identified common signals of pembrolizumab related adverse events (AEs) in ovarian cancer based on the FAERS database, such as cardiovascular system, endocrine system diseases, musculoskeletal system, respiratory system, and gastrointestinal digestive system, as well as other meaningful AEs reports. These findings provide key evidence for risk stratification and safety monitoring in clinical practice, emphasizing the need to be vigilant for specific organs during the 0-30 day window of treatment.