Treatment-related adverse events
| Continuous dosing cohort (n=30) | Intermittent dosing cohort (n=10) | |||
| All grades | Grade 3 or 4 | All grades | Grade 3 or 4 | |
| All events | 30 (100.0) | 8 (26.7) | 9 (90.0) | 2 (20.0) |
| Nausea | 4 (13.3) | 0 | 2 (20.0) | 0 |
| Vomiting | 4 (13.3) | 0 | 2 (20.0) | 0 |
| Fatigue | 14 (46.7) | 0 | 9 (90.0) | 0 |
| Headache | 8 (26.7) | 0 | 3 (30.0) | 0 |
| Hand-foot syndrome | 17 (56.7) | 2 (6.7) | 5 (50.0) | 0 |
| AST increased | 24 (80.0) | 3 (10.0) | 7 (70.0) | 1 (10.0) |
| ALT increased | 19 (63.3) | 0 | 7 (70.0) | 1 (10.0) |
| Blood bilirubin increased | 6 (20.0) | 0 | 1 (10.0) | 0 |
| Diarrhea | 6 (20.0) | 0 | 1 (10.0) | 0 |
| Hypertension | 11 (36.7) | 0 | 3 (30.0) | 0 |
| Hematochezia | 0 | 0 | 1 (10.0) | 0 |
| Anemia | 5 (16.7) | 0 | 2 (20.0) | 0 |
| Leukopenia | 9 (30.0) | 1 (3.3) | 3 (30.0) | 0 |
| Thrombocytopenia | 3 (10.0) | 0 | 1 (10.0) | 0 |
| Proteinuria | 16 (53.3) | 1 (3.3) | 5 (50.0) | 0 |
| Capillary hemangioma | 3 (10.0) | 0 | 3 (30.0) | 0 |
| Rash* | 9 (30) | 0 | 1 (10.0) | 0 |
| Gingival hemorrhage | 1 (3.3) | 0 | 2 (20.0) | 0 |
| Cough | 3 (10.0) | 0 | 1 (10.0) | 0 |
| Pneumonitis | 2 (6.7) | 1 (3.3) | 0 | 0 |
| Hypothyroidism†| 8 (26.7) | 0 | 1 (10.0) | 0 |
| Hyperthyroidism | 5 (16.7) | 0 | 0 | 0 |
Data are n (%).There were no grade 5 adverse events in both arms.
*Includes rash, rash papular, rash pustular, dermatitis acneiform, and drug eruption.
†Includes hypothyroidism and increased concentrations of thyroid-stimulating hormone in blood.
AST, aspartate aminotransferase.