This is a multicentric, phase IV study. In this study patients that are receiving an antineoplastic treatment and that have been diagnosed with venous thromboembolism will receive edoxaban as per clinical practice. Edoxaban will be administered according to summary of product characteristics. Patients will receive 6 to 12 months of treatment with edoxaban administered orally. The thromboembolic event will be monitored as per local clinical practice. In this study patients will be evaluated at baseline, at the beginning of therapy with edoxaban, after 1 month (+/- 7 days), after 3, 6 and 12 months (+/- 3 weeks). During these visits, patients will be provided of a diary in which they should report drug intake and interruptions and quality of life questionnaires.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Every patient will receive every day edoxaban orally once a day. Edoxaban therapy will start after at least 5 days of lead-in with low-molecular-weight heparin, as per clinical practice. Edoxaban will be administered at dosage of 60 mg/day. In case of patients with body weight ≤60kg or with renal failure (creatinine clearance between 15 and 50 ml/min) or that are treated with P-gp inhibitors (cyclosporine, dronedarone, erythomycin, ketoconazole), dosage will be 30 mg/day. Patients will be treated for 6 up to 12 months with edoxaban, as per medical decision.
Presidio Ospedaliero SS. Antonio e Biagio
Alessandria, Italy
Istituto Tumori di Bari
Bari, Italy
Azienda Ospedalier Spedali Civili di Brescia
Brescia, Italy
Ospedale S.Giacomo
Castelfranco Veneto, Italy
ARNAS Garibaldi
Catania, Italy
Istituti Ospitalieri di Cremona
Cremona, Italy
Ospedale di Faenza
Faenza, Italy
Ospedale Civile di Guastalla
Guastalla, Italy
Ospedale Mater Salutis
Legnago, Italy
Istituto Nazionale dei Tumori di Milano
Milan, Italy
...and 8 more locations
Evaluate the impact of edoxaban related adverse events on antineoplastic therapy
Percentage of antineoplastic therapy delays/interruption due to ADR related to edoxaban (bleeding, hepatobiliary toxicity, renal toxicity, anemia, hypersensitivity reactions).
Time frame: 24 months
Quality of life questionnaire
Quality of life will be evaluated using validate quality of life questionnaires.
Time frame: 24 months
Evaluate the compliance to Edoxaban treatment
For every patient the number of edoxaban tables used will be assessed and compared with the prescribed dose.
Time frame: 24 months
Evaluate the safety of edoxaban treatment
The adverse event severity grading scale for the National Cancer Institute Common Terminology for Adverse Events, Version 4.0 (NCI CTCAE v4.0) will be used for assessing adverse event severity.
Time frame: 24 months
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