In the edoxaban and enoxaparin groups , major bleeding occurred in 4/354 ( 1.1 % ) versus 1/349 ( 0.3 % ) patients ( P = 0.373 ) ; major or CRNM bleeding occurred in 22/354 ( 6.2 % ) versus 13/349 ( 3.7 % ) patients ( P = 0.129 ) , respectively .