Feasibility and safety
| . | Observation group (N = 60) . | Azacitidine group (N = 56) . |
|---|---|---|
| Transfusion requirements | ||
| RBC (median/mean), units | 0/1 | 0/1 |
| No. of patients receiving no RBC | 55 (92%) | 48 (86%) |
| Platelets, median/mean | 0/1 | 0/1 |
| Patients receiving no platelets, n | 56 (93%) | 48 (86%) |
| Nights in hospital | ||
| Median/mean | 0/1 | 0/2 |
| Patients without nights in hospital, n | 55 (92%) | 48 (86%) |
| AEs | ||
| Median | 1 | 2 |
| AE ≥2 grade (total), n | 449 | 510 |
| Patients with SAEs | ||
| 0 SAE | 56 (93%) | 42 (75%) |
| 1 SAE | 4 (7%) | 11 (20%) |
| 2 SAE | 2 (3%) | |
| 3 SAE | 1 (2%) |
| . | Observation group (N = 60) . | Azacitidine group (N = 56) . |
|---|---|---|
| Transfusion requirements | ||
| RBC (median/mean), units | 0/1 | 0/1 |
| No. of patients receiving no RBC | 55 (92%) | 48 (86%) |
| Platelets, median/mean | 0/1 | 0/1 |
| Patients receiving no platelets, n | 56 (93%) | 48 (86%) |
| Nights in hospital | ||
| Median/mean | 0/1 | 0/2 |
| Patients without nights in hospital, n | 55 (92%) | 48 (86%) |
| AEs | ||
| Median | 1 | 2 |
| AE ≥2 grade (total), n | 449 | 510 |
| Patients with SAEs | ||
| 0 SAE | 56 (93%) | 42 (75%) |
| 1 SAE | 4 (7%) | 11 (20%) |
| 2 SAE | 2 (3%) | |
| 3 SAE | 1 (2%) |
RBC, red blood cells.