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 | 
G grade