Endpoints
PD, death
DISEASE PROGRESSION, ADVERSE EVENT, ADVERSE EVENTS, DISEASE, DISEASE
The primary endpoint was PFS, which was the time elapsed from the start of therapy to first disease progression as judged by the investigators or per imaging findings or death. Secondary endpoints encompassed OS, ORR, disease control rate (DCR), and safety. OS represented the time elapsed from the start of therapy to death. Objective Response Rate (ORR) was defined as (CR + PR) / (CR + PR + SD + PD) × 100%, and Disease Control Rate (DCR) was defined as (CR + PR + SD) / (CR + PR + SD + PD) × 100%. Treatment-emergent adverse events (TEAEs) were evaluated on the basis of the Common Terminology Criteria for Adverse Events (CTCAE) 4.0.