Tolerability of treatment per treatment arm
| Variable . | 10-d decitabine (n = 72) . | 10-d decitabine + ibrutinib (n = 72) . |
|---|---|---|
| Cycle 1, median | ||
| Nights in hospital | 13 | 17 |
| No. of RBC transfusions | 5 | 5 |
| No. of platelet transfusions | 3 | 3 |
| Cycle 2, median | ||
| Nights in hospital | 9 | 10 |
| No. of RBC transfusions | 4 | 4 |
| No. of platelet transfusions | 1 | 1 |
| Cycle 3, median | ||
| Nights in hospital | 0 | 0 |
| No. of RBC transfusions | 2 | 2 |
| No. of platelet transfusions | 0 | 0 |
| AEs, any, n (%) | ||
| Grade 2 | 50 (9) | 58 (11) |
| Grade 3 | 81 (14) | 92 (18) |
| Grade 4 | 30 (5) | 21 (4) |
| Patients with SAEs, n (%) | ||
| 0 SAE | 14 (19) | 9 (13) |
| 1 SAE | 25 (35) | 32 (44) |
| 2 SAEs | 12 (17) | 21 (29) |
| 3 SAEs | 13 (18) | 6 (8) |
| >3 SAEs | 8 (11) | 4 (6) |
| Variable . | 10-d decitabine (n = 72) . | 10-d decitabine + ibrutinib (n = 72) . |
|---|---|---|
| Cycle 1, median | ||
| Nights in hospital | 13 | 17 |
| No. of RBC transfusions | 5 | 5 |
| No. of platelet transfusions | 3 | 3 |
| Cycle 2, median | ||
| Nights in hospital | 9 | 10 |
| No. of RBC transfusions | 4 | 4 |
| No. of platelet transfusions | 1 | 1 |
| Cycle 3, median | ||
| Nights in hospital | 0 | 0 |
| No. of RBC transfusions | 2 | 2 |
| No. of platelet transfusions | 0 | 0 |
| AEs, any, n (%) | ||
| Grade 2 | 50 (9) | 58 (11) |
| Grade 3 | 81 (14) | 92 (18) |
| Grade 4 | 30 (5) | 21 (4) |
| Patients with SAEs, n (%) | ||
| 0 SAE | 14 (19) | 9 (13) |
| 1 SAE | 25 (35) | 32 (44) |
| 2 SAEs | 12 (17) | 21 (29) |
| 3 SAEs | 13 (18) | 6 (8) |
| >3 SAEs | 8 (11) | 4 (6) |
RBC, red blood cell; SAE, serious AE.