Table 2.
Treatment-emergent adverse events of grade 3 or 4 in at least 10% of patients in any group (2009 clinical cutoff) [16]
| Adverse event, n (%) | TC (control) | Decitabine (n = 238) | ||
|---|---|---|---|---|
| Supportive care (n = 29) | Cytarabine (n = 208) | Total TC (n = 237) | ||
| Any grade 3 or 4 adverse event | 16 (55) | 188 (90) | 204 (86) | 221 (93) |
| Thrombocytopenia | 4 (14) | 73 (35) | 77 (32) | 95 (40) |
| Anemia | 4 (14) | 56 (27) | 60 (25) | 80 (34) |
| Febrile neutropenia | 0 | 51 (25) | 51 (22) | 76 (32) |
| Neutropenia | 1 (3) | 41 (20) | 42 (18) | 76 (32) |
| Leukopenia | 0 | 20 (10) | 20 (8) | 47 (20) |
| Pneumonia | 4 (14) | 39 (19) | 43 (18) | 51 (21) |
| Bronchopneumonia | 3 (10) | 9 (4) | 12 (5) | 10 (4) |
| Disease progression | 2 (7) | 46 (22) | 48 (20) | 43 (18) |
| General physical health deterioration | 5 (17) | 33 (16) | 38 (16) | 30 (13) |
| Pyrexia | 3 (10) | 17 (8) | 20 (8) | 24 (10) |
| Hypokalemia | 5 (17) | 19 (9) | 24 (10) | 27 (11) |
| Dyspnea | 3 (10) | 11 (5) | 14 (6) | 16 (7) |
TC patient’s choice of treatment with physician’s advice