COSIMO – patients with active cancer changing to rivaroxaban for the treatment and prevention of recurrent venous thromboembolism: a non-interventional study

Table 2 Inclusion and exclusion criteria for the COSIMO study

Inclusion criteria	Exclusion 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)	Contraindicated for rivaroxaban
Patients who have been treated with SOC anticoagulation (LMWH/VKA) for treatment of DVT and/or PE (index venous thromboembolic event), and/or prevention of recurrent DVT and PE for ≥4 weeks prior to inclusion in the study	Experienced an index VTE despite chronic anticoagulant therapy
Decision taken to start rivaroxaban for the treatment of DVT and/or PE and/or the prevention of recurrent DVT and/or PE	Receiving apixaban, edoxaban or dabigatran or any investigational drug as initial therapy for index VTE
ECOG performance status score of 0, 1 or 2	Participating in a clinical study using investigational drugs^a
Provided informed consent
Available for follow-up with a life expectancy >6 months

^aExcept as part of an investigational oncology trial
DVT deep vein thrombosis, ECOG Eastern Cooperative Oncology Group, LMWH low molecular weight heparin, PE pulmonary embolism, SOC standard of care, VKA vitamin K antagonist, VTE venous thromboembolism

ISSN: 1477-9560