Table 2.

Adverse events.

Treatment-emergent AEs in ≥5% of patientsTreatment-related grade 3 or grade 4 AEs
Preferred term, n (%)0.05–0.5 mg/kg, n = 210.6 mg/kg, n = 110.75 mg/kg, n = 120.9 mg/kg, n = 3Total, N = 470.05–0.5 mg/kg, n = 210.6 mg/kg, n = 110.75 mg/kg, n = 120.9 mg/kg, n = 3Total, N = 47
Any event20 (95.2)11 (100)12 (100)3 (100)46 (97.9)3 (14.3)4 (36.4)8 (66.7)2 (66.7)17 (36.2)
Nausea15 (71.4)5 (45.5)10 (83.3)3 (100)33 (70.2)0001 (33.3)1 (2.1)
Fatigue10 (47.6)4 (36.4)9 (75.0)3 (100)26 (55.3)01 (9.1)001 (2.1)
Vomiting9 (42.9)6 (54.5)5 (41.7)2 (66.7)22 (46.8)00000
AST increased5 (23.8)5 (45.5)8 (66.7)2 (66.7)20 (42.6)3 (14.3)3 (27.3)3 (25.0)1 (33.3)10 (21.3)
Diarrhea4 (19.0)5 (45.5)8 (66.7)3 (100)20 (42.6)001 (8.3)2 (66.7)3 (6.4)
ALT increased4 (19.0)5 (45.5)8 (66.7)2 (66.7)19 (40.4)2 (9.5)2 (18.2)2 (16.7)1 (33.3)7 (14.9)
Decreased appetite4 (19.0)4 (36.4)9 (75.0)1 (33.3)18 (38.3)00000
Alopecia04 (36.4)6 (50.0)2 (66.7)12 (25.5)00000
Constipation5 (23.8)4 (36.4)2 (16.7)1 (33.3)12 (25.5)00000
Weight decreased6 (28.6)1 (9.1)3 (25.0)2 (66.7)12 (25.5)00000
Abdominal pain2 (9.5)1 (9.1)6 (50.0)1 (33.3)10 (21.3)00000
ALP increased3 (14.3)4 (36.4)1 (8.3)2 (66.7)10 (21.3)2 (9.5)0002 (4.3)
Dehydration2 (9.5)3 (27.3)3 (25.0)2 (66.7)10 (21.3)001 (8.3)01 (2.1)
Dyspnea1 (4.8)1 (9.1)4 (33.3)2 (66.7)8 (17.0)00000
Hypokalemia01 (9.1)4 (33.3)3 (100)8 (17.0)001 (8.3)01 (2.1)
Urinary tract infection1 (4.8)2 (18.2)4 (33.3)1 (33.3)8 (17.0)00000
Blood bilirubin increased2 (9.5)2 (18.2)01 (33.3)5 (10.6)1 (4.8)1 (9.1)01 (33.3)3 (6.4)
Neuropathy peripheral01 (9.1)2 (16.7)03 (6.4)01 (9.1)1 (8.3)02 (4.3)
Peripheral sensory neuropathy2 (9.5)01 (8.3)03 (6.4)001 (8.3)01 (2.1)