A Study of Degarelix in Taiwanese Patients With Prostate Cancer

Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168

Time frame · From Day 28 to Day 168

Kaplan-Meier estimates of the cumulative probability of testosterone levels below castrate level (\<= 0.5 ng/mL) from Day 28 to Day 168 and the associated two-sided 95% confidence interval (CI) was based on log-log transformation, Greenwood's formula, and asymptotic maximum likelihood theory. The primary objective was met if the lower limit of this two-sided 95% CI was ≥90%. The definition of the primary endpoint was the Day 28 to Day 168 cumulative probability of testosterone levels below castrate levels (≤0.5 ng/mL). Only patients with a testosterone value on Day 28 and after were included in this analysis. Patients who did not experience a testosterone suppression (≤0.5 ng/mL) were censored at the time of last available testosterone measurement. The full analysis set (FAS) results were considered primary, whereas the corresponding per protocol (PP) analysis served as the sensitivity analysis.

Proportion of Participants With Testosterone at Castrate Level (<= 0.5 ng/mL) at Day 3

Time frame · Day 3

Proportion of participants with testosterone at castrate level (\<= 0.5 ng/mL) at Day 3

Percentage Change in Serum Prostate Specific Antigen (PSA) Levels From Baseline (Day 0) to Day 28

Time frame · From Day 0 to Day 28

Percentage change in serum prostate specific antigen (PSA levels from Baseline (Day 0) to Day 28

Cumulative Probability of no PSA Failure

Time frame · Day 0, Day 7, Day 28, Day 112, Day 140, Daý 168

The time to PSA failure was defined as the days from first dosing (scheduled trial days) where an increase in serum PSA of ≥50% from nadir and at least 5 ng/mL measured on two consecutive occasions at least two weeks apart was noted. The second occasion was the time point of meeting the criterion. The Kaplan-Meier estimate and associated 95% CI were provided.