Safety assessments
treatment-emergent adverse events, TEAEs, Cancer
BLOOD, ADVERSE EVENT, CANCER
Safety was assessed by the incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, and mean changes from baseline in clinical laboratory values at each scheduled visit. Blood for clinical laboratory values was collected at screening (up to Day −14), at 72 h post-dose, and on Days 14, 28, and 35. Medical Dictionary for Regulatory Activities (MedDRA) version 17.0 was used to classify all TEAEs by system organ class and preferred term; severity was classified with National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.