Table 4.

Most frequent treatment-related AEs occurring in 10% patients on weekly schedule

0.8 mg/kg (n = 3)1 mg/kg (n = 7)1.2 mg/kg (n = 7)All patients (N = 17)
GradeAnyG3/4AnyG3/4AnyG3/4AnyG3/4
Any patient with AE3726216 (94%)4 (24%)
Diarrhea1315 (29%)
Peripheral neuropathya1135 (29%)
Fatigue224 (24%)
Anemia1.213 (17%)1 (6%)
Hoarse voice33 (18%)
Nausea213 (18%)
Vomiting213 (18%)
Anorexia112 (12%)
Neutropenia212 (12%)
Pyrexia112 (12%)

NOTE: Additional grade 3/4–related AEs not included in the table above include rash (G3; 1.0 mg/kg), white blood cell count decreased (grade 3; 1.0 mg/kg), ileus (grade 3; 1.2 mg/kg), and bacterial peritonitis (grade 3; 1.2 mg/kg).

  • aPeripheral neuropathy SMQ terms: peripheral neuropathy, peripheral sensory neuropathy, and paresthesia.