Figure 2.

PSA response, best percentage change from baseline for Arm B (PSA-assessable analysis set). The −50% reference line represents 50% reduction of PSA in best percentage change from baseline. PSA₅₀ response was defined as the proportion of patients achieving a ≥50% decrease in PSA from baseline to the lowest post-baseline PSA, confirmed by a consecutive PSA ≥3 weeks later. If there was a PSA decline from baseline, progression was defined as the date of the first PSA increase (i.e. both ≥25% and ≥2 ng/ml above the nadir) and was confirmed by a second value ≥3 weeks later, even if within 12 weeks. If there was no PSA decline from baseline, progression was defined as a ≥25% increase and a ≥2 ng/ml increase from baseline beyond 12 weeks. Best percentage change from baseline in PSA is the maximum percentage reduction from baseline or the minimum percentage increase from baseline in the absence of a reduction. PSA, prostate-specific antigen; PSA₅₀, proportion of patients achieving a ≥ 50% decrease in PSA from baseline to the lowest post-baseline PSA; QD, once daily; Q3W, every 3 weeks.