Statistical analysis
EVENT
Time-to-event endpoints (excluding OS) were estimated using cumulative incidence, adjusting for the competing risk of treatment discontinuation without the event. OS was estimated using the Kaplan–Meier method. Two-sided 95% confidence interval (CI) for response rate was determined using the exact binomial method. For Kaplan–Meier yearly probability estimates, two-sided 95% CI was based on Greenwood’s formula using a log(-log) transformation. All other data were summarized descriptively unless otherwise stated. All patients who received at least one dose of study drug (full analysis set) were included in the safety and PRO analyses.This analysis was based on the final database lock, ≥3 years after the last enrolled patient; 90% of patients with Ph+ CP CML had a follow-up of 4 years or had already permanently discontinued.