Safety assessments
ADVERSE EVENTS
Safety and tolerability assessments included the recording of adverse events (AEs; evaluated according to CTCAE version 4.03), serious adverse events (SAEs), physical examinations, vital signs measurements, 12-lead electrocardiogram (ECG) assessments including heart rate, and PR, QRS, and QT intervals, clinical laboratory parameters, pregnancy testing, and ECOG performance status. Transthoracic echocardiography was performed at screening and at the end of the study. Concomitant medications were monitored throughout.