Clinical trialPhase 3Completed

A Study to Evaluate the Efficacy and Safety of Rivaroxaban Venous Thromboembolism (VTE) Prophylaxis in Ambulatory Cancer Participants

Efficacy and Safety of Rivaroxaban Prophylaxis Compared With Placebo in Ambulatory Cancer Patients Initiating Systemic Cancer Therapy and at High Risk for Venous Thromboembolism

NCT02555878 ↗ ClinicalTrials.gov, retrieved 5 November 2026

Outcome: Outcome unknown
Phase: Phase 3
Status: Completed
Study type: Interventional
Start: 11 September 2015
Expected end: 24 August 2018
Enrollment: 841 participants
Sites: 151
Primary outcomes: Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components); Percentage of Participants With Time to the First Occurrence of Major Bleeding Events as Defined by International Society of Thrombosis and Haemostasis (ISTH)
Sponsor: Industry
Results posted: 2019-09-12
Last update: 12 September 2019

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Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) [Up to Day 180]. Number, Percentage of participants. Primary efficacy composite endpoint: Placebo (n=421): 8.79; Rivaroxaban 10 mg (n=420): 5.95. Symptomatic lower extremity proximal DVT: Placebo (n=421): 1.90; Rivaroxaban 10 mg (n=420): 2.14. Symptomatic lower extremity distal DVT: Placebo (n=421): 1.19; Rivaroxaban 10 mg (n=420): 0.48. Symptomatic upper extremity DVT: Placebo (n=421): 1.43; Rivaroxaban 10 mg (n=420): 0.95. Symptomatic non-fatal PE: Placebo (n=421): 1.19; Rivaroxaban 10 mg (n=420): 1.19. Asymptomatic lower extremity proximal DVT: Placebo (n=421): 2.61; Rivaroxaban 10 mg (n=420): 0.95. Incidental PE: Placebo (n=421): 2.38; Rivaroxaban 10 mg (n=420): 1.43. VTE-related death: Placebo (n=421): 0.71; Rivaroxaban 10 mg (n=420): 0.24. Analysis, Placebo vs Rivaroxaban 10 mg: Hazard Ratio (HR) 0.66 (95% CI 0.40 to 1.09); p== 0.101; Log Rank; superiority. Analysis, Placebo vs Rivaroxaban 10 mg: Hazard Ratio (HR) 1.12 (95% CI 0.43 to 2.91); p== 0.814; Log Rank; superiority. Analysis, Placebo vs Rivaroxaban 10 mg: Hazard Ratio (HR) 0.40 (95% CI 0.08 to 2.07); p== 0.260; Log Rank; superiority. Analysis, Placebo vs Rivaroxaban 10 mg: Hazard Ratio (HR) 0.67 (95% CI 0.19 to 2.39); p== 0.538; Log Rank; superiority. Analysis, Placebo vs Rivaroxaban 10 mg: Hazard Ratio (HR) 1.02 (95% CI 0.29 to 3.52); p== 0.977; Log Rank; superiority. Analysis, Placebo vs Rivaroxaban 10 mg: Hazard Ratio (HR) 0.35 (95% CI 0.11 to 1.11); p== 0.063; Log Rank; superiority. Analysis, Placebo vs Rivaroxaban 10 mg: Hazard Ratio (HR) 0.59 (95% CI 0.21 to 1.62); p== 0.301; Log Rank; superiority. Analysis, Placebo vs Rivaroxaban 10 mg: Hazard Ratio (HR) 0.33 (95% CI 0.03 to 3.18); p== 0.314; Log Rank; superiority.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Percentage of Participants With Time to the First Occurrence of Major Bleeding Events as Defined by International Society of Thrombosis and Haemostasis (ISTH) [From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)]. Number, Percentage of participants. Placebo (n=404): 0.99; Rivaroxaban 10 mg (n=405): 1.98. Analysis, Placebo vs Rivaroxaban 10 mg: Hazard Ratio (HR) 1.96 (95% CI 0.59 to 6.49); p== 0.265; Log Rank; superiority.