| Population |
Description |
Dutasteride (N=4015) |
Placebo (N=4126) |
| Biopsy |
Patients in the REDUCE trial who had a negative prostate biopsy upon entry into the study, who received at least 1 dose of study treatment, and who had at least 1 post-baseline biopsy |
3 305 |
3 424 |
| North America |
All patients in biopsy population who were participating through investigational sites in the US, Canada, and Puerto Rico |
810
(24.5%) |
844
(24.6%) |
| Baseline PSA < 4.9 ng/mL |
All patients in the biopsy population who had baseline PSA < 4.9 ng/mL |
1 095
(33.1%) |
1 173
(34.3%) |
| Baseline PSA ≥ 4.9 and < 6.8 ng/mL |
All patients in the biopsy population who had a baseline PSA ≥ 4.9 and < 6.8 ng/mL |
1 121
(33.9%) |
1 138
(33.2%) |
| Baseline PSA ≥ 6.8 ng/mL |
All patients in the biopsy population who had a baseline PSA ≥ 6.8 ng/mL |
1 086
(32.9%) |
1 105
(32.3%) |
PSA = prostate-specific antigen; REDUCE = Reduction by Dutasteride of Prostate Cancer Events; US = United States.
aPatients in the population subgroups defined by baseline PSA do not total to 100% because 3 and 8 patients in the dutasteride and placebo groups, respectively, had
missing baseline PSA measures. |