Table 1.

Adverse events

Dose level (μg/kg)Total
13103050100
No. exposed patients5 (3)4 (2)5 (2)9 (4)4 (2)2 (1)29 (14)
Fatigue1 (1)473 (1)1 (1)16 (3)
Pyrexia22 (1)64115 (1)
Nausea3224 (1)2215 (1)
Headache31251113
Rash213219
Myalgia1269
Vomiting1113219
Pruritus11158
Anorexia13 (1)228 (1)
Influenza-like illness21328
Diarrhea122117
Chills12317
Toxicity
    Lymphopenia(1)(1)(4)(1)(7)
    Neutropenia(2)(1)(3)
    Leukopenia(1)(1)(2)
    Anemia(1)(1)(2)
    Thrombocytopenia(2)(2)
    Increased GGT(1)(1)(1)(2)(5)
    Increased ALT(2)(2)(4)
    Increased AST(1)(2)(3)
    Hypofibrinogenemia(1)(1)(1)(3)
    Hyponatremia(1)(1)(2)
    Hyperkalemia(1)(1)(2)
    Increased ALP(1)(1)
    Hyperbilirubinia(1)(1)
    Hyperuricemia(1)(1)
  • NOTE: Number of patients with most frequently reported adverse events across the dose levels and with the number of patients with CTCAE severity grade 3 or higher is in parenthesis. Laboratory abnormalities were only reported as adverse events if they were CTCAE grade 3 or higher and therefore given in parenthesis.

    Abbreviations: GGT, γ-glutamyl transpeptidase; ALP, alkalinephosphate.