Bleeding complications
| . | Control . | Intervention . |
|---|---|---|
| ITT analysis | ||
| Transfusion-treatment periods, n | 279 | 277 |
| Primary end point | ||
| WHO grade 2, 3 or 4 bleeding, n (%)* | 143 (51) | 150 (54) |
| Days from randomization to first grade 2, 3, or 4 bleeding, median (IQR), n | 5 (2-8) | 5.5 (2-9) |
| Days with grade 2, 3, or 4 bleeding, median (IQR), %† | 3 (0-14) | 5 (0-15) |
| Days with grade 2, 3, or 4 bleeding, median (IQR), n | 1 (0-2) | 1 (0-2) |
| Highest grade of bleeding, n (%) | ||
| None or grade 1 | 136 (49) | 127 (46) |
| Grade 2 | 131 (47) | 139 (50) |
| Grade 3 | 6 (2) | 5 (2) |
| Grade 4 | 6 (2) | 6 (2) |
| Per-protocol analysis | ||
| Transfusion-treatment periods, n | 220 | 205 |
| Primary end point | ||
| WHO grade 2, 3, or 4 bleeding, n (%)‡ | 97 (44) | 107 (52) |
| Days from first transfusion to first grade 2, 3, or 4 bleeding, median (IQR), n | 3 (1-5) | 3 (1-5) |
| Days with grade 2, 3, or 4 bleeding, median (IQR), § | 0 (0-15) | 4 (0-17) |
| Days with grade 2, 3, or 4 bleeding, median (IQR) n | 0 (0-2) | 1 (0-2) |
| Highest grade of bleeding, n (%) | ||
| None or grade 1 | 123 (56) | 98 (48) |
| Grade 2 | 87 (40) | 102 (50) |
| Grade 3 | 4 (2) | 2 (1) |
| Grade 4 | 6 (3) | 3 (2) |
| . | Control . | Intervention . |
|---|---|---|
| ITT analysis | ||
| Transfusion-treatment periods, n | 279 | 277 |
| Primary end point | ||
| WHO grade 2, 3 or 4 bleeding, n (%)* | 143 (51) | 150 (54) |
| Days from randomization to first grade 2, 3, or 4 bleeding, median (IQR), n | 5 (2-8) | 5.5 (2-9) |
| Days with grade 2, 3, or 4 bleeding, median (IQR), %† | 3 (0-14) | 5 (0-15) |
| Days with grade 2, 3, or 4 bleeding, median (IQR), n | 1 (0-2) | 1 (0-2) |
| Highest grade of bleeding, n (%) | ||
| None or grade 1 | 136 (49) | 127 (46) |
| Grade 2 | 131 (47) | 139 (50) |
| Grade 3 | 6 (2) | 5 (2) |
| Grade 4 | 6 (2) | 6 (2) |
| Per-protocol analysis | ||
| Transfusion-treatment periods, n | 220 | 205 |
| Primary end point | ||
| WHO grade 2, 3, or 4 bleeding, n (%)‡ | 97 (44) | 107 (52) |
| Days from first transfusion to first grade 2, 3, or 4 bleeding, median (IQR), n | 3 (1-5) | 3 (1-5) |
| Days with grade 2, 3, or 4 bleeding, median (IQR), § | 0 (0-15) | 4 (0-17) |
| Days with grade 2, 3, or 4 bleeding, median (IQR) n | 0 (0-2) | 1 (0-2) |
| Highest grade of bleeding, n (%) | ||
| None or grade 1 | 123 (56) | 98 (48) |
| Grade 2 | 87 (40) | 102 (50) |
| Grade 3 | 4 (2) | 2 (1) |
| Grade 4 | 6 (3) | 3 (2) |
IQR, interquartile range.
Difference is 3 percentage points, 95% CI (−6 to 11), P = .012 for noninferiority. After correcting for stratification factors (center, diagnosis AML/non-AML, and treatment phase conventional/stem cell), the difference is 1 percentage point, 95% CI (−6 to 9), P = .002 for noninferiority.
P = .535 for superiority of mean percentages.
Difference is 8 percentage points, 95% CI (−2 to 18), P = .19 for noninferiority. After correcting for stratification factors (center, diagnosis AML/non-AML, and treatment phase conventional/stem cell), the difference is 10 percentage points, 95% CI (1-19), P = .29 for noninferiority.
P = .538 for superiority of mean percentages.