959 / 1266
Adverse Events
•
Most common AE class
–
Skin and subcutaneous tissue disorders 25 (93%) patients
•
Most common AE terms
–
Pyrexia 14 (52%) patients
–
Fatigue 12 (44%) patients
–
Vomiting 12 (44%) patients
–
Headache 11 (41%) patients
•
Dose-limiting toxicity (1 event)
–
Grade 3 transient maculopapular rash at 4.5 mg/kg/day
dose
•
Patient remains on study at reduced dose (3.75 mg/kg/day)
113