Table 2.

Treatment-related adverse events occurring in ≥20% of treated patients

No. of events (no. of patients)
Cohort 1, 0.1 mg/kg (n = 3)Cohort 2, 0.2 mg/kg (n = 3)Cohort 3, 0.4 mg/kg (n = 7)Cohort 4, 0.8 mg/kg (n = 3)Cohort 5, 1.6 mg/kg (n = 3)Cohort 6, 2.4 mg/kg (n = 3)Cohort 7, 3.6 mg/kg (n = 14)Cohort 8, 4.5 mg/kg (n = 4)All cohorts (N = 40)
Hypertension,* any grade00 (0)03 (2)2 (2)1 (1)8 (6)2 (1)16 (12)
    Grades 1–20003 (2)1 (1)1 (1)6 (5)2 (1)13 (10)
    Grades 3–400001 (1)02 (2)03 (3)
Elevated LDH, any grade001 (1)1 (1)04 (1)9 (6)16 (3)31 (12)
    Grades 1–2001 (1)001 (1)9 (6)14 (3)25 (11)
    Grades 3–40001 (1)03 (1)02 (2)6 (4)
Proteinuria, any grade00003 (1)2 (1)8 (4)8 (3)21 (9)
    Grades 1–200003 (1)2 (1)8 (4)8 (3)21 (9)
    Grades 3–4000000000
Elevated AST, any grade0000006 (6)5 (4)11 (10)
    Grades 1–20000006 (6)4 (4)10 (10)
    Grades 3–400000001 (1)1 (1)
Fatigue, any grade2 (1)0002 (1)08 (6)2 (1)13 (9)
    Grades 1–22 (1)0002 (1)08 (6)2 (1)13 (9)
    Grades 3–4000000000
Diarrhea, any grade00001 (1)1 (1)25 (6)027 (8)
    Grades 1–200001 (1)1 (1)25 (6)027 (8)
    Grades 3–4000000000
Vomiting, any grade00001 (1)1 (1)10 (5)2 (1)§14 (8)
    Grades 1–200001 (1)1 (1)10 (5)1 (1)13 (8)
    Grades 3–400000001 (1)1 (1)

Abbreviation: LDH, lactate dehydrogenase.

  • *Hypertension includes the preferred terms “hypertension” and “blood pressure increase.”

  • A single patient experienced all lactate dehydrogenase elevations of any grade reported for cohort 6.

  • Proteinuria includes proteinuria and protein urine.

  • §A single patient experienced all vomiting episodes of any grade reported for cohort 8.