Study assessments
ADVERSE EVENTS, REMISSION
The primary endpoint was the mean change from baseline in QTc. Secondary endpoints included assessment of PK parameters, adverse events (AEs), incidence of antidrug antibodies (ADAs)/neutralizing antibodies (NAbs), overall survival (OS), and response rate (CR/CRi) (see Supplementary methods in the Online Resource). Triplicate electrocardiograms were performed at screening, baseline, and before serial PK draws on each day of dosing, using a 12-lead (with a 10-s rhythm strip) tracing. Response of remission status (CR/CRi) was evaluated after each treatment cycle, per European LeukemiaNet (ELN) 2017 recommendations [