A Non-interventional Study on Xarelto for Treatment of Venous Thromboembolism (VTE) and Prevention of Recurrent VTE in Patients With Active Cancer

• Status: Completed
• Trial end date: 2019-03-28
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to collect patient reported outcomes and assess treatment satisfaction in active cancer patients treated with rivaroxaban for VTE (venous thromboembolism).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Collaborator: Janssen Research & Development, LLC
• Treatments: Rivaroxaban

Criteria

Inclusion Criteria:

• Adult female and male patients with active cancer other than fully treated basal-cell or squamous-cell carcinoma of the skin (active cancer defined as the diagnosis or treatment of cancer in the previous < 6 months or recurrent or metastatic cancer)

• Patients that have been treated with standard of care anticoagulation (Low Molecular Weight Heparin / Vitamin K Antagonist) for treatment of DVT and/ or PE (index VTE event) and/ or prevention of recurrent DVT and PE for at least 4 weeks prior to inclusion in the study

• Patients for whom the decision was made to start rivaroxaban for treatment of DVT and/ or PE and/ or prevention of recurrent DVT and PE

• Patients with Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2

• Patients who are willing to participate in this study (signed informed consent)

• Patients who are available for follow-up with a life expectancy >6 months

Exclusion Criteria:

• The contra-indications according to the local marketing authorization must be considered

• Patients who developed an index VTE event despite chronic anticoagulant therapy

• Patients receiving apixaban, edoxaban or dabigatran or any investigational drug as the initial therapy for the index VTE event

• Patients participating in an investigational program with interventions outside of routine clinical practice with exception of oncology investigational trials