Outcome Measures
death, bleeding, Thrombosis, thrombotic, respiratory or cardiovascular organ support
PULMONARY EMBOLISM, BLEEDING, MYOCARDIAL INFARCTION, DEEP VENOUS THROMBOSIS, THROMBOSIS, ISCHEMIC STROKE, SECONDARY, ARTERIAL EMBOLISM, EVENTS
The composite primary outcome was organ support–free days, an ordinal scale composed of survival to hospital discharge and, in survivors, the number of days free of intensive care–level respiratory or cardiovascular organ support during the index hospitalization, through day 21. Any death during the index hospitalization through 90 days was assigned the worst outcome (−1). This end point reflects both use of intensive care–level therapies and hospital survival, with higher values indicating better outcomes.A key secondary outcome was major thrombotic events or death (a composite of myocardial infarction, pulmonary embolism, ischemic stroke, systemic arterial embolism, and in-hospital death). Other secondary efficacy outcomes included survival to hospital discharge, survival without receipt of respiratory or cardiovascular organ support, and all thrombotic events (major thrombotic events plus deep venous thrombosis) or death. The primary safety outcome was major bleeding, as defined by the International Society on Thrombosis and Hemostasis. A secondary safety outcome was the composite of major bleeding or death. All reported bleeding and thrombotic events were adjudicated in an anonymized fashion by the clinical end points committee using consensus definitions (