Table 7.
Summary of adverse events occurring in ≥10% patients (safety set)
| Adverse events | Patients (N = 132) | |
|---|---|---|
| Grade 1–2 | Grade ≥3 | |
| Hematologic, n (%) | ||
| Leukopenia | 5 (3.8) | 90 (68.1) |
| Thrombocytopenia | 3 (2.3) | 81 (61.4) |
| Neutropenia | 2 (1.5) | 71 (53.8) |
| Anemia | 7 (5.3) | 57 (43.2) |
| Non-hematologic, n (%) | ||
| Alanine aminotransferase increased | 25 (18.9) | 3 (2.3) |
| Upper respiratory tract infection | 31 (23.5) | 14 (10.6) |
| Lung infection | 20 (15.2) | 13 (9.8) |
| Pneumonia | 9 (6.8) | 15 (11.4) |
All observed toxicities were to be graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE), version 3.0, 2008 [41]
Safety analysis set included all patients who received at least 1 dose of decitabine