Table 3.
Adverse events.
| Monotherapy | Combination therapy | |||
|---|---|---|---|---|
| Grade 1–2 | Grade 3–4 | Grade 1–2 | Grade 3–4 | |
| Neutropenia | 81 (31.0) | 41 (15.7) | 80 (27.9) | 106 (36.9) |
| Anemia | 68 (26.1) | 19 (7.3) | 113 (39.4) | 54 (18.8) |
| Thrombocytopenia | 82 (31.4) | 30 (11.5) | 93 (32.4) | 91 (31.7) |
| Fatigue | 89 (34.1) | 16 (6.1) | 167 (58.2) | 89 (31.0) |
| Fever | 31 (11.9) | 0 (0) | 58 (20.2) | 7 (2.4) |
| Nausea/vomiting | 59 (22.6) | 3 (1.1) | 99 (34.5) | 4 (1.4) |
| Diarrhea | 35 (13.4) | 2 (0.8) | 44 (15.3) | 3 (1.0) |
| Prolonged QTc period | 6 (2.3) | 1 (0.4) | 8 (2.8) | 0 (0) |
| Thromboembolism | 2 (0.8) | 0 (0) | 14 (4.9) | 0 (0) |
| Elevated ALT | 16 (6.1) | 4 (1.5) | 40 (13.9) | 2 (0.7) |
| Elevated AST | 14 (5.4) | 5 (1.9) | 29 (10.1) | 4 (1.4) |
| Elevated Creatinine | 7 (2.7) | 0 (0) | 11 (3.8) | 1 (0.3) |
| Proteinuria | 8 (3.1) | 0 (0) | 13 (4.5) | 0 (0) |
ALT, alanine transaminase; AST, aspartate transaminase; QTc, QT interval corrected by heart rate.