Table 3.

Most frequent treatment-related AEs occurring in 10% patients on q3w schedule

0.2 mg/kg (n = 3)0.4 mg/kg (n = 3)0.8 mg/kg (n = 3)1.6 mg/kg (n = 3)2.4 mg/kg (n = 36)2.8 mg/kg (n = 6)All patients (N = 54)
GradeAnyG3/4AnyG3/4AnyG3/4AnyG3/4AnyG3/4AnyG3/4AnyG3/4
Any patient with AE12229115339 (72%)14 (26%)
Fatigue1111735125 (46%)4 (7%)
Nausea111214 (26%)
Diarrhea183112 (22%)1 (2%)
Alopecia9211 (20%)
Peripheral neuropathya1161210 (19%)1 (2%)
Anorexia426 (11%)
Pyrexia426 (11%)

NOTE: Additional grade 3/4 AEs not included in the table above includes the following: at 2.4 mg/kg: neutropenia (grade 3) × 1 and (grade 4) ×1; AST elevated (grade 3) × 3; ALT elevated (grade 3); hyperglycemia (grade 3); gastroparesis (grade 3); urinary tract infection (grade 3); infusion-related reaction (grade 3); pulmonary embolism (grade 3); leukopenia (grade 3) ×1; neutrophil count decrease (grade 3) ×1; at 2.8 mg/kg: neutropenia (grade 3); hyperglycemia (grade 3); hyponatremia (grade 3); hypophosphatemia (grade 3).

  • aPeripheral neuropathy SMQ terms: peripheral sensory neuropathy, peripheral neuropathy, burning sensation, hypoesthesia, muscular weakness, and paresthesia.