Table 1.
Demographic and Baseline Characteristics
| Characteristic | Placebo (N= 474) | Atrasentan (N= 467) |
|---|---|---|
| Age, years | ||
| Mean | 73.4 | 73.9 |
| SD | 7.79 | 7.81 |
| Median | 74.0 | 75.0 |
| Range | 48.0–93.0 | 47.0–92.0 |
|
| ||
| Race, number of patients (%) | ||
| White | 447 (94.3) | 420 (89.9) |
| Black | 23 (4.9) | 27 (5.8) |
| Other | 4 (0.8) | 20 (4.2) |
|
| ||
| Karnofsky Performance Score, number of patients (%) | ||
| 100 | 331 (69.8) | 326 (69.8) |
| 90 | 115 (24.3) | 109 (23.3) |
| 80 | 24 (5.1) | 23 (4.9) |
| ≤70 | 4 (0.8) | 8 (1.7) |
| Missing | 0 (0) | 1 (0.2) |
|
| ||
| Enrollment by regions, number of patients (%) | ||
| US | 189 (39.9) | 191 (40.9) |
| Non-US | 285 (60.1) | 276 (59.1) |
|
| ||
| Time since initial diagnosis, years | (N = 473) | (N = 467) |
| Mean | 7.2 | 7.5 |
| SD | 3.86 | 4.03 |
| Median | 6.9 | 7.1 |
| Range | 0.9–23.4 | 0.9–22.9 |
|
| ||
| PSA, ng/mL | (N = 474) | (N = 467) |
| Mean | 29.8 | 28.9 |
| SD | 60.16 | 54.64 |
| Median | 13.1 | 13.1 |
| Range | 0.8–672.2 | 1.2–732.9 |
|
| ||
| BALP, ng/mL | (N = 455) | (N = 446) |
| Mean | 14.3 | 14.4 |
| SD | 8.02 | 7.73 |
| Median | 13.2 | 14.1 |
| Range | 2.1–79.0 | 2.4–58.4 |
|
| ||
| Total Gleason score | (N = 401) | (N = 390) |
| Mean | 7.1 | 6.9 |
| SD | 1.43 | 1.62 |
| Median | 7.0 | 7.0 |
| Range | 2.0–10.0 | 2.0–10.0 |