Table 3.
All secondary endpoints seen in each group (ITT analysis set).
| Abiraterone (n = 157) | Prednisone (n = 156) | p-Value and HR (95%CI) | |
|---|---|---|---|
| Time to initiation of cytotoxic chemotherapy, stratified analysis | |||
| Event, n (%) | 1 (0.6) | 2 (1.3) | |
| Censored, n (%) | 156 (99.4) | 154 (98.7) | 0.3908 0.361 (0.032, 4.069) |
| Range, month | (1.0+, 11.1+) | (0.7+, 11.2+) | |
| 6-month event-free rate, % (95%CI) | 100 (100, 100) | 98.5 (94.0, 99.6) | |
| Time to pain intensity progression, stratified analysis | |||
| Event, n (%) | 10 (6.4) | 15 (9.6) | |
| Censored, n (%) | 147 (93.6) | 141 (90.4) | |
| 25th percentile, month (95%CI) | NE (NE, NE) | NE (6.47, NE) | 0.2228 0.608 (0.272, 1.363) |
| Range, month | (0.0+, 11.1+) | (0.0+, 11.1+) | |
| 6-month event-free rate, % (95%CI) | 92.1 (85.5, 95.8) | 87.7 (76.8, 93.7) | |
| Time to pain interference progression, stratified analysis | |||
| Event, n (%) | 31 (19.7) | 42 (26.9) | |
| Censored, n (%) | 126 (80.3) | 114 (73.1) | |
| 25th percentile (95%CI) | 5.59 (2.79, NE) | 2.83 (1.91, 4.57) | 0.0481 0.620 (0.384, 1.000) |
| Median, month (95%CI) | NE (8.35, NE) | 7.79 (5.55, NE) | |
| 75th percentile, month (95%CI) | NE (8.35, NE) | NE (NE, NE) | |
| Range, month | (0.0+, 11.1+) | (0.0+, 11.1+) | |
| 6-month event-free rate, % (95%CI) | 73.7 (63.3, 81.6) | 60.8 (48.8, 70.8) | |
| Time to deterioration in ECOG PS grade from 0–1 to ≥2, stratified analysis | |||
| Event, n (%) | 5 (3.2) | 13 (8.3) | |
| Censored, n (%) | 152 (96.8) | 143 (91.7) | |
| 25th percentile, month (95%CI) | NE (NE, NE) | NE (5.55, NE) | 0.0274 0.328 (0.116, 0.928) |
| Range, month | (0.0+, 11.1+) | (0.0+, 11.1+) | |
| 6-month event-free rate, % (95%CI) | 95.1 (88.3,98.0) | 81.5 (67.0,90.1) | |
| Time to analgesic progression, stratified analysis | |||
| Event, n (%) | 5 (3.2) | 7 (4.5) | |
| Censored, n (%) | 152 (96.8) | 149 (95.5) | |
| 25th percentile, month (95%CI) | NE (7.43, NE) | NE (NE, NE) | 0.3860 0.599 (0.186, 1.929) |
| Range, month | (0.0+, 11.1+) | (0.0+, 11.1+) | |
| 6-month event-free rate, % (95%CI) | 96.4 (90.4, 98.7) | 92.4 (83.6, 96.5) | |
+, censored observation; HR, hazard ratio; ITT, intent to treat; NE, not estimable.
p value is from a log-rank test stratified by region (Asia or Europe) and ECOG PS grade (0 or 1). HR from stratified proportional hazards model. HR < 1 favors abiraterone.