Intent-to-treat response and survival
| End point . | Arm A: G3139 . | Arm B: control . | P . |
|---|---|---|---|
| CR | .53 | ||
| Events/n | 135/254 | 142/252 | |
| Rate (95% CI) | 0.53 (0.47-0.59) | 0.56 (0.50-0.63) | |
| OS | .13* | ||
| Events/n | 228/254 | 237/252 | |
| Median (95% CI), mo | 9 (7.46-11.66) | 9 (7.82-10.78) | |
| 1-y rate (95% CI) | 0.43 (0.37-0.49) | 0.4 (0.34-0.46) | |
| 2-y rate (95% CI) | 0.22 (0.18-0.28) | 0.18 (0.14-0.23) | |
| EFS | .80 | ||
| Events/n | 234/254 | 241/252 | |
| Median (95% CI), mo | 3 (1.94-4.34) | 3 (2.56-5.49) | |
| 1-y rate (95% CI) | 0.22 (0.17-0.28) | 0.24 (0.19-0.30) | |
| 2-y rate (95% CI) | 0.13 (0.09-0.18) | 0.09 (0.06-0.14) | |
| DFS | .26 | ||
| Events/n | 116/135 | 130/142 | |
| Median (95% CI), mo | 8 (7.10-11.70) | 8 (6.90-10.51) | |
| 1-y rate (95% CI) | 0.4 (0.32-0.49) | 0.37 (0.30-0.46) | |
| 2-y rate (95% CI) | 0.24 (0.18-0.32) | 0.16 (0.11-0.24) | |
| Early death rate during first 30 d of induction therapy | .81 | ||
| All patients (95% CI) | 0.13 (0.09-0.18) | 0.12 (0.08-0.17) |
| End point . | Arm A: G3139 . | Arm B: control . | P . |
|---|---|---|---|
| CR | .53 | ||
| Events/n | 135/254 | 142/252 | |
| Rate (95% CI) | 0.53 (0.47-0.59) | 0.56 (0.50-0.63) | |
| OS | .13* | ||
| Events/n | 228/254 | 237/252 | |
| Median (95% CI), mo | 9 (7.46-11.66) | 9 (7.82-10.78) | |
| 1-y rate (95% CI) | 0.43 (0.37-0.49) | 0.4 (0.34-0.46) | |
| 2-y rate (95% CI) | 0.22 (0.18-0.28) | 0.18 (0.14-0.23) | |
| EFS | .80 | ||
| Events/n | 234/254 | 241/252 | |
| Median (95% CI), mo | 3 (1.94-4.34) | 3 (2.56-5.49) | |
| 1-y rate (95% CI) | 0.22 (0.17-0.28) | 0.24 (0.19-0.30) | |
| 2-y rate (95% CI) | 0.13 (0.09-0.18) | 0.09 (0.06-0.14) | |
| DFS | .26 | ||
| Events/n | 116/135 | 130/142 | |
| Median (95% CI), mo | 8 (7.10-11.70) | 8 (6.90-10.51) | |
| 1-y rate (95% CI) | 0.4 (0.32-0.49) | 0.37 (0.30-0.46) | |
| 2-y rate (95% CI) | 0.24 (0.18-0.32) | 0.16 (0.11-0.24) | |
| Early death rate during first 30 d of induction therapy | .81 | ||
| All patients (95% CI) | 0.13 (0.09-0.18) | 0.12 (0.08-0.17) |
One-sided P value.