Table 1.
Baseline characteristics of patients in COU-AA-301 and COU-AA-302
| Baseline characteristic | COU-AA-301 (N = 1195) |
COU-AA-302 (N = 1088) |
|---|---|---|
| Median age, yr (range) | 69 (39–95) | 70 (44–95) |
| Gleason score at initial diagnosis (n) | 1047 | 996 |
| ≤7, n (%) | 502 (48) | 479 (48) |
| ≥8, n (%) | 545 (52) | 517 (52) |
| Extent of disease (n) | 1190 | 1086 |
| Bone, n (%) | 1066 (90) | 884 (81) |
| Bone only, n (%) | 474 (40) | 541 (50) |
| Soft tissue or node, n (%) | 709 (60) | 538 (50) |
| Other, n (%) | 60 (5) | 11 (1) |
| Median time from initial diagnosis to first dose, yr (range) | 6.02 (0.17–25.01) | 5.3 (0–28) |
| Median weight, kg (range) | 82.6 (39.2–203.3) | 87.5 (45.3–168.3) |
| Median PSA, ng/ml (range) | 131.4 (0.4–10114) | 39.51 (0–6606.4) |
| Median hemoglobin, g/dl (range) | 11.8 (7.2–16.5) | 13.1 (7–16.6) |
| Median lactate dehydrogenase, IU/l (range) | 227 (84–5125) | 185 (60–871) |
| Median alkaline phosphatase, IU/l (range) | 134 (20–4896) | 91 (21–3056) |