Event-free survival. Events were treatment discontinuation for AEs or SAEs, failure, progression to AP or BP, or death, whichever came first. At 36 months, the actuarial proportion of patients who were alive and event-free was 62% (95 CI, 56%-68%) in the high-dose arm (HDA) and 66% (95% CI, 61%-71%) in the standard-dose arm. P = .89, log-rank test.