LAUSR

PURPOSE To highlight the comprehensive differences in adverse events (AEs) between abiraterone (ABI) and enzalutamide (ENZ) based on a big data dataset. MATERIALS AND METHODS We downloaded AE datasets of ABI and ENZ from the Food and Drug Administration Adverse Event Reporting System database. We used the Medical Dictionary for Regulatory Activities to treat each AE as a preferred term and grouped it into the System Organ Class (SOC). Logistic regression analyses were performed to compare ABI and ENZ. RESULTS In total, we extracted 59 680 datasets. After exclusion by criteria, we included 26015 reports on ENZ and 7507 on ABI. ENZ and ABI presented different toxicity profiles in most SOC. Overall, the reporting odds ratio indicated a higher incidence rate of serious AEs for ABI than ENZ. CONCLUSION In conclusion, our findings suggest that both drugs present a discrete and non-overlapping toxicity profile that varies by SOC and patient age. This dataset confirms, for the most part, what has been reported in clinical trials as well as true real-world reports.