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

Bayer

Status: Completed

Conditions: Venous Thrombosis and Pulmonary Embolism

Treatments: Drug: Rivaroxaban (Xarelto, BAY 59-7939)

Study type: Observational

Funder types: Industry

Identifiers

NCT02742623

XA1502 (Other Identifier)

18137

Details and patient eligibility

About

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

Enrollment: 528 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

528 participants in 1 patient group

Rivaroxaban

Description:

Female and male patients with active cancer and treated with rivaroxaban after a diagnosis of DVT/ and/or PE

Treatment:

Drug: Rivaroxaban (Xarelto, BAY 59-7939)