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.
Table 2: Analysis Populationsa.