Safety outcomes
DISEASE, ADVERSE EVENT
Safety endpoints included the occurrence of DLTs (any treatment-emergent adverse event [TEAE] which is ≥ Grade 3 and not attributable to the disease process assessed during cycles 0 and 1); AEs including TEAEs, treatment-related AEs (TRAEs), and serious AEs; and changes in standard clinical laboratory parameters, vital signs, electrocardiogram parameters (corrected QT [QTcF] and QRS intervals), physical examination (including ECOG-PS), echocardiogram and multi-gated acquisition scans (e.g., left ventricular ejection fraction [LVEF]), and ophthalmologic findings. Pulmonary assessments were conducted at the discretion of the investigators.AEs were coded and summarized by system organ class (SOC) and preferred term (PT) using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA) [