Safety assessment.
ADVERSE EVENTS, NERVOUS SYSTEM DISORDER
Safety and tolerability assessments included monitoring adverse events (AEs), vital signs, 12-lead electrocardiograms (ECG), physical examinations, body weight, and clinical laboratory evaluations. Clinical laboratory samples were collected after a fasting period of ≥4 h and analyzed for clinical chemistry, hematology, urinalysis, and coagulation.The severity of all the AEs was graded by using the NCI CTCAE version 4.0. The intensity of the AE was graded as mild, moderate, or severe. Any severe or very severe AEs that occurred during the study were categorized under the CTCAE severe category. Dose escalation was to be stopped based on predefined dose escalation stopping rules, which were either two participants with study drug-related grade 3/4 AE or one participant with study drug-related SAE, a possibility of an inappropriate safety risk, or two participants experiencing study drug-related grade 2 AE classified as nervous system disorder.