Table 3.

Patient incidence of treatment-related AEs

Dose group, mg/kga
0.51.5361020All patients
Preferred termb, n (%)n = 3n = 3n = 4n = 3n = 4n = 8N = 25
Patients reporting any treatment-related AEs1 (33)2 (67)3 (75)3 (100)4 (100)6 (75)19 (76)
 Grade 3002 (50)c1 (33)d2 (50)e2 (25)f7 (28)
Treatment-related AEs in >5% of patients
 Periorbital edema01 (33)3 (75)2 (67)3 (75)2 (25)11 (44)
 AST increased001 (25)2 (67)2 (50)2 (25)7 (28)
 Fatigue01 (33)2 (50)02 (50)1 (13)6 (24)
 Nausea01 (33)001 (25)2 (25)4 (16)
 Blood alkaline phosphatase increased001 (25)2 (67)003 (12)
 Vision blurred001 (25)01 (25)1 (13)3 (12)
 Decreased appetite01 (33)1 (25)0002 (8)
 Hypertension001 (25)01 (25)02 (8)
 Lacrimation increased001 (25)01 (25)02 (8)
 Mucosal inflammation01 (33)0001 (13)2 (8)
 Peripheral edema001 (25)01 (25)02 (8)
 Vomiting000002 (25)2 (8)
  • aDosing schedule was once weekly for 0.5 mg/kg and every 2 weeks for other groups.

  • bAEs were coded using Medical Dictionary for Regulatory Activities version 17.0 and graded using Common Terminology Criteria for Adverse Events version 4.0.

  • cOne patient each for AST increased and hypertension.

  • dOne patient with AST increased.

  • eOne patient each for AST increased and periorbital edema.

  • fOne patient each for AST increased and bilateral deafness.