Table 4. CASSINI study endpoints.
| Efficacy | |
|---|---|
| Primary | • Composite of time from randomization to first occurrence of symptomatic, lower-extremity, proximal DVT; asymptomatic, lower-extremity, proximal DVT; symptomatic, upper-extremity DVT; symptomatic, nonfatal PE; incidental PE; or VTE-related death during the 180-d (±3 d), double-blind treatment period |
| Key secondary | • Symptomatic VTE events |
| • VTE-related deaths | |
| • All-cause mortality | |
| Other | • Time from randomization to first occurrence of individual components of the composite primary efficacy endpoint |
| • Confirmed fatal/non-fatal arterial thromboembolism events | |
| • Confirmed fatal/non-fatal visceral VTE events | |
| • Composite of symptomatic, lower-extremity, proximal DVT; asymptomatic, lower-extremity, proximal DVT; symptomatic, upper-extremity DVT; symptomatic, non-fatal PE; incidental PE; and all-cause mortality | |
| Safety | |
| Primary | • Time to a major bleeding event as defined by the ISTH |
| Secondary | • Percentages of clinically relevant non-major bleeding, minor bleeding and any bleeding |
| Exploratory | |
| • Inflammation and hypercoagulability biomarkers (e.g., D-dimer, P-selectin and tissue factor) | |
| • Pharmacokinetics and exposure response to rivaroxaban | |
| • Health care resource utilization | |
Abbreviations: DVT, deep-vein thrombosis; ISTH, International Society on Thrombosis and Haemostasis; PE, pulmonary embolism; VTE, venous thromboembolism.