Safety data on Black patients from ARANOTE

Safety Profile in Black Men

Key Themes:

• Overall safety profile was comparable between Black men and the general study population.
• Major adverse events showed similar patterns and frequencies.
• There was a slightly higher discontinuation rate in Black men, but it was not statistically significant.
• Small sample size was noted as a limitation for safety comparison.

Key Points for Physicians:

• A similar adverse event profile can be anticipated in Black patients.
• There was no evidence of race-specific toxicity concerns.
• The nonsignificant difference in discontinuation rates should be interpreted with caution due to small numbers.

Notable Insights: The comparable safety profile addresses important questions about potential race-based differences in drug tolerability that might impact treatment recommendations.

Clinical Significance: Safety data support equitable treatment recommendations without race-based concerns regarding the adverse effect profile of darolutamide.