Table 2.

Treatment-relateda AEs by severity, according to CTCAE criteria

Cohorts 1–5, 0.5–15 mg/kg QW (n = 37)Cohorts 6–7, 30–45 mg/kg Q3W (n = 6)
AE, n (%)Grade 1/2Grade 3/4Grade 1/2Grade 3/4
Fatigue10 (27)01 (17)1 (17)
Decreased appetite9 (24)01 (17%)0
Nausea7 (19)01 (17)0
Diarrhea5 (14)02 (33)0
Anemia5 (14)000
Vomiting3 (8)01 (17)0
Rash2 (5)01 (17)0
Pruritus1 (3)02 (33)0
Myalgia2 (5)000
Leukopenia2 (5)000
Thrombocytopenia2 (5)000
Abdominal pain2 (5)000
Stomatitis002 (33)0
Increased alkaline phosphatase1 (3)01 (17)0
Constipation1 (3)000
Dry mouth1 (3)000
Peripheral edema1 (3)000
Pyrexia1 (3)000
Thirst1 (3)000
Increased serum creatinine1 (3)000
Increased growth hormone1 (3)000
Increased insulin1 (3)000
Decreased weight1 (3)000
Hypocalcemia1 (3)000
Hypomagnesemia1 (3)000
Hypophosphatemia1 (3)000
Back pain1 (3)000
Somnolence1 (3)000
Exertional dyspnea1 (3)000
Pneumothorax1 (3)000
Alopecia1 (3)000
Early satiety001 (17)0
Hypoglycemia01 (3)00
Systolic hypertension1 (3)000
  • aRelated is defined as possibly, probably, or definitely related to study drug.