NCT02555878.

Trial name or title	Efficacy and safety of rivaroxaban prophylaxis compared with placebo in ambulatory cancer patients initiating systemic cancer therapy and at high risk for venous thromboembolism
Methods	Multicentre, randomised, double‐blind (participant, caregiver, investigator), placebo‐controlled, parallel‐group superiority study
Participants	Patients with histologically confirmed solid malignancy including but not limited to: pancreas, lung, stomach, colon, rectum, bladder, breast, ovary, renal, or lymphoma (haematologic), with locally advanced or metastatic disease who have a Khorana thromboembolic risk score ≥ 2
Interventions	Intervention: rivaroxaban 10 mg tablet orally once daily for 180 days Control: placebo
Outcomes	Primary efficacy outcome: symptomatic and incidental lower extremity proximal DVT, symptomatic upper extremity DVT, symptomatic non‐fatal PE, incidental PE, VTE‐related death Primary safety outcome: major bleeding Secondary outcomes: symptomatic VTE and VTE‐related deaths, all‐cause mortality, clinically relevant non‐major bleeding, minor bleeding, any bleeding adverse events, and serious adverse events
Starting date	September 2015
Contact information	Janssen Research & Development, LLC Clinical Trial
Notes	ClinicalTrials.gov identifier: NCT02555878

DVT: deep vein thrombosis
 HIT: heparin‐induced thrombocytopenia
 IV: intravenous
 LMWH: low molecular weight heparin
 PE: pulmonary embolism
 RCT: randomised controlled trial
 sc: subcutaneous
 VTE: venous thromboembolism