Table 3.

Summary of nonhematologic and hematologic toxicity (all cycles) presenting in two or more patients

Dose levels (patients)EventsA1 (3)A-1 (3)A-2 (3)A-3 (3)B1 (3)B2 (3)C1 (3)C2 (6)
AnyG3AnyG3AnyG3AnyG3AnyG3AnyG3AnyG3AnyG3
Nonhematologic
    Injection site reaction2333233333
    Nausea1813123422
    Vomiting17131234121*
    Fatigue1731123313
    ALT elevation1113322
    Edema101112311
    Hyperglycemia713111
    Lightheadedness621111
    Anorexia5113
    Diarrhea51112
    Hyponatremia511*31
    Abdominal pain4112
    Body odor41111
    Headache312
    Somnolence31111*
    Alopecia3111
    Flatulence/indigestion3111
    Constipation211
    Pruritis211
    Skin rash211
    Arthralgia211
    Hypokalemia211
    Hypoalbuminemia211
    Confusion2111
Hematologic
    Neutropenia113*3*1*1*1*2*2*2*+1
    Anemia921211121*+1
    Thrombocytopenia611211

Abbreviation: G3, Common Toxicity Criteria grade 3.

  • *Neutropenia and other grade 3 toxicities in cycle 1.