Efficacy and safety assessments
Cancer
ADVERSE EVENT, EVENTS, CANCER
The primary endpoints of the BYOND study have been previously reported [Efficacy was evaluated by standard criteria [Treatment-emergent AEs (TEAEs), serious AEs, and laboratory evaluations were assessed up to 28 days after last dose. Events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v.4.0. The frequency and characteristics of AEs of special interest were analyzed by selecting Medical Dictionary for Regulatory Activities (MedDRA) system organ class high-level group, high-level and preferred terms, and standardized MedDRA queries to generate TEAE clusters (Supplementary Methods).PROs were assessed using the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) quality of life questionnaire at baseline, every 3 months for the first year, and every 6 months during years 2, 3, and 4 of treatment [