Assessing Full Benefit of Rivaroxaban Prophylaxis in High-Risk Ambulatory Patients with Cancer: Thromboembolic Events in the Randomized CASSINI Trial

841 adult ambulatory patients (outpatients) with a solid tumor or lymphoma, locally advanced or metastatic disease, baseline Khorana score ≥2, and expected survival >6 months, starting a new systemic regimen within 1 week. Excluded: primary brain tumors or known brain metastases, ECOG performance status ≥3, active bleeding or at risk for bleeding, and DVT on baseline screening.

Rivaroxaban 10 mg orally once daily for 180 (±3) days

Matching placebo orally once daily for 180 (±3) days

Total thromboembolic endpoint (composite of symptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, asymptomatic lower extremity proximal DVT, symptomatic nonfatal PE, incidental PE, VTE-related death, confirmed arterial thromboembolism [myocardial infarction, ischemic stroke, and systemic arterial embolism], visceral thromboembolism, and asymptomatic/screen-detected lower extremity distal DVT) up to day 180composite