Table 2.
TRAE | Total (N=34) | All AEs | Guadecitabine dose level | All AEs | All AEs | |||
Escalation | All AEs | Escalation | Expansion | |||||
45 mg/m2 (N=6) | 30 mg/m2 (N=8) | 30 mg/m2 (N=20) | ||||||
Grade | ≥Grade 3 | ≥Grade 3 | ≥Grade 3 | ≥Grade 3 | ||||
Any TRAE | 18 (53%) | 53 | 6 (100%) | 16 | 5 (62.5%) | 10 | 8 (40%) | 27 |
Neutropaenia | 13 | 20 | 4 | 6 | 3 | 5 | 6 | 9 |
Fatigue | 0 | 6 | 0 | 1 | 0 | 1 | 0 | 4 |
Febrile Neutropaenia | 4 | 4 | 2 | 2 | 1 | 1 | 1 | 1 |
Anemia | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 3 |
Nausea | 0 | 4 | 0 | 1 | 0 | 0 | 0 | 3 |
Thrombocytopaenia | 0 | 3 | 0 | 2 | 0 | 0 | 0 | 1 |
Anemia | 0 | 2 | 0 | 0 | 0 | 1 | 1 | 1 |
Cough | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 2 |
Diarrhea | 1 | 2 | 0 | 0 | 1 | 2 | 0 | 0 |
Fever | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 1 |
Injection site reaction | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 1 |
Rash | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 1 |
Vomiting | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 1 |
AEs, adverse events; TRAE, treatment related AEs.