Table 5.
Overall survival analysis: unadjusted and adjusted results
| Analysis | Treatment | No. patients with events | Median (95% CI) time to event (months) | HR (95% CI) |
|---|---|---|---|---|
| Unadjusted ITT | Enzalutamide | 241 | 32.36 (30.09–NYR) | 0.71 (0.60–0.84) |
| Placebo | 299 | 30.19 (27.96–NYR) | ||
| Two-stage method | ||||
| Gamma AF without recensoringa | Enzalutamide | 241 | 32.36 (30.09–NYR) | 0.66 (0.57–0.81) |
| Placebo | 299 | 28.71 (26.87–NYR) | ||
| Gamma AF with recensoring | Enzalutamide | 198 | NYR | 0.62 (0.47–0.81) |
| Placebo | 216 | NYR | ||
| Weibull AF without recensoring | Enzalutamide | 241 | 31.47 (30.09–NYR) | 0.69 (0.58–0.83) |
| Placebo | 299 | 30.00 (26.87–NYR) | ||
| Weibull AF with recensoring | Enzalutamide | 106 | NYR | 0.65 (0.45–0.80) |
| Placebo | 222 | NYR | ||
| IPCW method | 0.63 (0.52–0.75) | |||
aPreferred approach for two-stage method
AF Acceleration factor, CI confidence interval, HR hazard ratio, IPCW inverse probability of censoring weights, ITT intention to treat, NYR not yet reached