Study outcomes and endpoints
death, TTD
ADVERSE EVENTS, EVENTS
The effectiveness and safety data were collected at the treatment visit (every 6 weeks) and termination visit (30 days post last dose). The outcomes included investigator-assessed response rate, PFS, time-to-treatment discontinuation (TTD) and safety profile. This study only collected the incidence of protocol-defined adverse events (AEs), including serious adverse events (SAEs), AEs of special interest (ILD or pneumonitis-like events and QTs prolongation events), and AEs leading to dose modification or discontinuation or death.