Secondary endpoints
death
DISEASE PROGRESSION, SECONDARY
The secondary endpoints included DoR (defined as the time from the first documented evidence of CR or PR until documented disease progression or death from any cause); PFS (defined as the time from the first dose to disease progression or death from any cause, whichever occurred earlier); OS (defined as the time from the first dose of the study drug until death from any cause); and safety as assessed by the investigator. Safety assessments included change from baseline in physical examination findings, vital signs, AEs, laboratory values and cardiac assessments.