TABLE 2.
Secondary Time-To-Event End Points (full analysis set)
| End point | Darolutamide + ADT (n = 446) | Placebo + ADT (n = 223) | Hazard Ratioa (95% CI) | ||
|---|---|---|---|---|---|
| Median, months | Events, No. (%) | Median, months | Events, No. (%) | ||
| Overall survival | NR | 103 (23.1) | NR | 60 (26.9) | 0.81 (0.59 to 1.12) |
| Time to initiation of subsequent systemic anticancer therapy | NR | 68 (15.2) | NR | 74 (33.2) | 0.40 (0.29 to 0.56) |
| Time to metastatic castration-resistant prostate cancer | NR | 154 (34.5) | 13.8 | 143 (64.1) | 0.40 (0.32 to 0.51) |
| Time to PSA progression | NR | 93 (20.9) | 16.8 | 108 (48.4) | 0.31 (0.23 to 0.41) |
| Time to pain progression | NR | 124 (27.8) | 29.9 | 79 (35.4) | 0.72 (0.54 to 0.96) |
Abbreviations: ADT, androgen-deprivation therapy; NR, not reached; PSA, prostate-specific antigen.
a
Hazard ratio and 95% CI are based on Cox regression model, stratified by visceral disease (present v absent) and prior local therapy (yes v no).