Study Outcomes
bleeding, Thrombosis, death, DVT
BLEEDING, THROMBOSIS, DVT, EVENTS, DRUG ALLERGY
The primary outcome was a composite of any DVT (proximal and distal as well as asymptomatic and symptomatic) or objectively confirmed PE. Secondary outcomes were the incidence of DVT (asymptomatic and symptomatic) during treatment and follow-up and all-cause mortality during the follow-up period (within 28 ± 2 days after surgery). Postoperative morbidity was also recorded by using the Clavien-Dindo classification.The main safety outcome was the incidence of major bleeding defined by the International Society on Thrombosis and Hemostasis (ISTH; bleeding leading to transfusion or a decrease in the hemoglobin level of ≥2 g/dL [to convert to grams per liter, multiply by 10]) during the intervention and observation periods. Secondary safety end points were the percentages of patients with ISTH-defined clinically relevant nonmajor bleeding, cardiovascular events, drug allergy and drug sensitivity, and death.