Page 15 - PACE: Advanced Prostate Cancer Consensus

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)

Grade Grade Grade Grade Grade Grade
Selected AE, %
All ≥3 All ≥3 All ≥3 All ≥3 All ≥3 All ≥3

Fracture 12 3 7 1 − − − − 4.2 0.9 3.6 0.9

Dizziness 9 1 6 0 10 <1 4 0 4.5 0.2 4.0 0.2
Hypothyroidism 8 0 2 0 − − − − 0.2 0 0 0

Mental impairment disorders 5 0 3 0 5 <1 2 0 0.9 0 1.7 0

0.2 0.3 0.2 0.2 0.2
Seizure 0 0 0 0 0 0 0
(n = 2) (n = 3) (n = 2) (n = 2) (n = 1)
Rash 24 5 6 <1 − − − − 2.9 0.1 0.9 0
Fall 16 2 9 1 11 1 4 1 4.2 0.8 4.7 0.7

Fatigue 30.4 0.9 21.1 0.3 33 3 14 1 15.8 0.6 11.4 1.1
Major cardiovascular event 5.9 - 3 - 5 4 3 2 5.0 2.2 3.4 0.4

*These are not head-to-head comparisons
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.