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Safety: Selected Adverse Events (SPARTAN,
PROSPER, ARAMIS)*
SPARTAN PROSPER ARAMIS
Safety
(%) APA PBO ENZA PBO DARO PBO
(n = 803) (n = 398) (n = 930) (n = 465) (n = 954) (n = 554)
AEs, any Grade 97 93 87 77 83 77
AEs, Grade ≥3 45 34 31 23 25 20
Serious AEs 25 23 24 18 25 20
AEs leading to 11 7 9 6 9 9
discontinuation
AEs associated with 1.2 0.3 3 1 3.9** 3.2
death on trial
*These are not head-to-head comparisons; **Described as Grade 5 adverse event in the NEJM publication
AE, adverse event
1. Smith MR, et al. N Engl J Med 2018;378:1408-1418; 2. Hussain M, et al. N Engl J Med 2018;378:2465-2474; 3. Fizazi K, et al. N Engl J Med 2019;380:1235-
1246 [Epub ahead of print]; 4. Xtandi Canadian Product Monograph; December 20, 2018. 5. Erleada Canadian Product Monograph; July 3, 2018.