Table 3 Most common adverse events occurring in ≥ 30% of patients receiving volasertib and azacitidine in Studies 1 (Part 1) and 2
n (%) | Study 1 Part 1 (n = 13) | Study 2 (n = 5) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
All | G1 | G2 | G3 | G4 | All | G1 | G2 | G3 | G4 | |
Injection site reaction | 0 | 0 | 0 | 0 | 0 | 5 (100) | 4 (80) | 1 (20) | 0 | 0 |
Thrombocytopenia | 10 (77) | 0 | 0 | 2 (15) | 8 (62) | 2 (40) | 0 | 0 | 2 (40) | 0 |
Neutropenia | 7 (54) | 0 | 1 (8) | 0 | 6 (46) | 1 (20) | 0 | 0 | 0 | 1 (20) |
Diarrhea | 6 (46) | 5 (39) | 0 | 1 (8) | 0 | 2 (40) | 2 (40) | 0 | 0 | 0 |
Decreased appetite | 6 (46) | 4 (31) | 2 (15) | 0 | 0 | 1 (20) | 0 | 1 (20) | 0 | 0 |
Rash | 6 (46) | 5 (39) | 1 (8) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Febrile neutropenia | 2 (15) | 0 | 0 | 2 (15) | 0 | 2 (40) | 0 | 0 | 2 (40) | 0 |
Pneumonia | 3 (23) | 0 | 1 (8) | 2 (15) | 0 | 2 (40) | 0 | 1 (20 | 1 (20) | 0 |
Pyrexia | 3 (23) | 3 (23) | 0 | 0 | 0 | 2 (40) | 2 (40) | 0 | 0 | 0 |
Pharyngitis | 0 | 0 | 0 | 0 | 0 | 2 (40) | 2 (40) | 0 | 0 | 0 |
White blood cell count decreased | 0 | 0 | 0 | 0 | 0 | 2 (40) | 0 | 0 | 1 (20) | 1 (20) |
Hypersensitivity | 0 | 0 | 0 | 0 | 0 | 2 (40) | 1 (20) | 1 (20) | 0 | 0 |
Fatigue | 5 (39) | 2 (15) | 3 (23) | 0 | 0 | 1 (20) | 1 (20) | 0 | 0 | 0 |
Constipation | 5 (39) | 4 (31) | 0 | 1 (8) | 0 | 1 (20) | 0 | 1 (20) | 0 | 0 |
Cough | 5 (39) | 5 (39) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Nausea | 5 (38) | 4 (31) | 1 (8) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Blood creatinine increased | 4 (31) | 2 (15) | 2 (15) | 0 | 0 | 0 | 1 (20) | 1 (20) | 0 | 0 |
Anemia | 4 (31) | 0 | 3 (23) | 1 (8) | 0 | 0 | 1 (20) | 0 | 0 | 1 (20) |
Vomiting | 4 (31) | 3 (23) | 1 (8) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Erythema | 4 (31) | 3 (23) | 1 (8) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Alopecia | 4 (31) | 4 (31) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |