Table 1.
Baseline Demographic and Clinical Characteristics of the Patients.*
| Characteristic | Abiraterone Acetate (N = 797) |
Placebo (N = 398) |
|---|---|---|
| Age | ||
| Median (range) — yr | 69 (42–95) | 69 (39–90) |
| ≥75 yr — no. of patients/total no. (%) | 220/797 (28) | 111/397 (28) |
| Disease location — no. of patients/total no. (%) | ||
| Bone | 709/797 (89) | 357/397 (90) |
| Node | 361/797 (45) | 164/397 (41) |
| Liver | 90/797 (11) | 30/397 (8) |
| BPI-SF score for pain† | ||
| No. of patients | 792 | 394 |
| Median score (range) | 3.0 (0–10) | 3.0 (0–10) |
| No. of previous cytotoxic chemotherapy regimens — no. of patients/total no. (%) | ||
| 1 | 558/797 (70) | 275/398 (69) |
| 2 | 239/797 (30) | 123/398 (31) |
| ECOG performance status — no. of patients/total no. (%) | ||
| 0 or 1 | 715/797 (90) | 353/398 (89) |
| 2 | 82/797 (10) | 45/398 (11) |
| Prostate-specific antigen | ||
| No. of patients | 788 | 393 |
| Median (range) — ng/ml | 128.8 (0.4–9253.0) | 137.7 (0.6–10114.0) |
*
See Table 2 in the Supplementary Appendix for more baseline demographic and clinical characteristics.
†
The Brief Pain Inventory–Short Form (BPI-SF) rates pain on a scale of 0 to 10, with 0 to 3 indicating that clinically significant pain is absent and 4 to 10 indicating that clinically significant pain is present. The scores shown are for the worst pain over the previous 24 hours.