Table 2.
Preferred term | Dose level | |||
---|---|---|---|---|
2 mg/kg (N = 3) | 4 mg/kg (N = 13) | |||
All grades n (%) | Grades 3, 4 n (%) | All grades n (%) | Grades 3, 4 n (%) | |
Hematological toxicitiesb | ||||
Leukopenia | 3 (100 %) | 1 (33.3 %) | 13 (100 %) | 8 (61.5 %) |
Neutropenia | 3 (100 %) | 3 (100 %) | 12 (92.3 %) | 10 (76.9 %) |
Anemia | 3 (100 %) | 0 | 11 (84.6 %) | 1 (7.7 %) |
Thrombocytopenia | 2 (66.7 %) | 0 | 9 (69.2 %) | 1 (7.7 %) |
Non-hematological toxicities | ||||
Diarrhoea | 3 (100 %) | 0 | 12 (92.3 %) | 1 (7.7 %) |
Fatigue | 3 (100 %) | 0 | 12 (92.3 %) | 0 |
Decreased appetite | 2 (66.7 %) | 0 | 12 (92.3 %) | 0 |
Stomatitis | 2 (66.7 %) | 0 | 11 (84.6 %) | 2 (15.4 %) |
Dysphonia | 2 (66.7 %) | 0 | 11 (84.6 %) | 0 |
Nausea | 3 (100 %) | 0 | 11 (84.6 %) | 0 |
Epistaxis | 1 (33.3 %) | 0 | 10 (76.9 %) | 0 |
Hypertension | 0 | 0 | 8 (61.5 %) | 4 (30.8 %) |
Alopecia | 2 (66.7 %) | 0 | 8 (61.5 %) | 0 |
Vomiting | 3 (100 %) | 0 | 7 (53.8 %) | 0 |
Headache | 1 (33.3 %) | 0 | 6 (46.2 %) | 0 |
Nasopharyngitis | 1 (33.3 %) | 0 | 5 (38.5 %) | 0 |
Abdominal pain | 1 (33.3 %) | 0 | 5 (38.5 %) | 0 |
Constipation | 0 | 0 | 5 (38.5 %) | 0 |
Gingivitis | 0 | 0 | 5 (38.5 %) | 0 |
Pyrexia | 1 (33.3 %) | 0 | 4 (30.8 %) | 0 |
aEvents listed are those occurring in ≥4 patients at 4 mg/kg at any grade.
bBased on laboratory data.