
Study End Points

bleeding
BLEEDING, BLEEDING
The first part of the trial determined short-term efficacy and safety at 50% accrual, as previously describedPart 2 primary end points include duration of PLT-R and long-term safety and tolerability. Secondary end points include (1) difference in time to response (time from starting treatment to time of achievement PLT-R); (2) frequency of PLT transfusions during the treatment and follow-up periods; (3) duration of PLT transfusion independence; (4) incidence and severity of bleeding using the WHO Bleeding Scale