Statistical analysis methods
The completion rate of each PRO questionnaire was summarized as a percentage out of the number of randomized patients who were expected at that visit; patients expected at each post-baseline visit were those who remained on randomized treatment and had not progressed, switched treatment, died, or withdrawn from the study for any other reasons at that visit.The MDASI-CML, EQ-5D-5L VAS, and WPAI-CML were summarized at baseline and at each subsequent visit descriptively using means and standard deviation. The PGIC-CML was summarized as proportions of patients who reported improvement, no change, or worsening at each visit.To compare the difference between treatment arms in changes from baseline over time in PRO scores up to week 48 (longitudinal analysis), a mixed-effects model for repeated measures (MMRM) was conducted, which adjusts for repeated assessments per patient over time as well as baseline PRO score and covariates [The consistency of the longitudinal analysis results (changes over time and difference between treatments) was explored for the following pre-specified subgroups of patients based on key demographic variables and TKI treatment history: sex, race, age, reason for prior TKI discontinuation, and number of prior TKI lines of therapy.