Endpoints and assessments
proteinuria, hemorrhages, Cancer
THROMBOEMBOLIC EVENT, FEBRILE NEUTROPENIA, ADVERSE EVENTS, BLOOD, GASTROINTESTINAL PERFORATION, PULMONARY HEMORRHAGE, HEMORRHAGES, EVENTS, HYPERTENSION, COMPLICATIONS, CANCER
The primary endpoint was the ORR at week 18 (ORRSecondary efficacy endpoints included: CIR‐assessed ORR at week 6 (ORRAll adverse events (AEs) and serious AEs were evaluated for assessment of safety. The National Cancer Institute Common Terminology Criteria for AE version 4.03 was used to grade the severity of treatment‐emergent AEs (TEAEs), which were defined as events that emerged during treatment (having been absent pretreatment or worsened relative to the pretreatment state) and with onset dates occurring between the first dosing day of study treatment, and until 28 days after the last dose of study treatment. Clinical laboratory results, electrocardiogram parameters, vital signs, and physical examinations were also assessed. AEs of special interest included anaphylactic reactions, arterial and venous thromboembolic events, febrile neutropenia, gastrointestinal perforations, hypertension, proteinuria, pulmonary hemorrhage, other hemorrhages, and wound healing complications. Blood samples were also collected throughout the study for pharmacokinetic (PK) analysis.