Primary End Point and Sample Size Derivation
hemorrhage
ADVERSE EVENTS, HEMORRHAGE
The primary end point was treatment-associated grade 4 hemorrhage or treatment-associated grade 5 adverse events in the first year after the start of treatment. The trial used a Fleming 2-stage design with 14 and 42 patients in the first and second stage (0.14 one-sided α and 83% power; acceptable and unacceptable rates of 5% and 15%, respectively); more details were given in the initial publication.