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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.
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