Table 2.
Progression-free and overall survival analysis (from time of study randomization)
| Outcome | Observation | CC-486 |
|---|---|---|
| Confirmed progression-free survival | ||
| N at risk | 25 | 23a |
| N events | 16 | 18 |
| Median (95% CI) | 8.9 (3.4, 24.6) | 9.2 (4.1, 20.9) |
| 1-year PFS, % (95% CI) | 50% (27%, 69%) | 38% (18%, 58%) |
| Hazard ratio (95% CI) | 0.94 (0.46, 1.87) | |
| P value | P = 0.85 | |
| Progression-free survival including clinical assessments | ||
| N at risk | 25 | 23a |
| N events | 19 | 19 |
| Median (95% CI) | 6.2 (3.2, 18.7) | 9.17 (2.5, 20.9) |
| 1-year PFS, % (95% CI) | 43% (23%, 63%) | 37% (17%, 56%) |
| Hazard ratio (95% CI) | 0.83 (0.42, 1.59) | |
| P value | P = 0.57 | |
| Overall survival | ||
| N at risk | 25 | 24 |
| N events | 14 | 15 |
| Median (95% CI) | 26.4 (17.8, 46.7) | 33.8 (12.8, 47.6) |
| 2-year OS, % (95% CI) | 61% (36%, 78%) | 50% (28%, 69%) |
| Hazard ratio | 0.98 (0.46, 2.05) | |
| P value | P = 0.96 |
aOne patient randomized to CC-486 was found to have progressive disease prior to start of treatment and was thus not included in the PFS analyses