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| ID | Type | Description | Link |
|---|---|---|---|
| XA1502 | Other Identifier | Company internal |
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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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This study aims to collect patient reported outcomes and assess treatment satisfaction in active cancer patients treated with rivaroxaban for VTE (venous thromboembolism).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivaroxaban | Female and male patients with active cancer and treated with rivaroxaban after a diagnosis of DVT/ and/or PE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto, BAY 59-7939) | Drug | Treatment with rivaroxaban for DVT and/ or PE and/ or prevention of recurrent DVT and PE according to local label |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment satisfaction burden score (ACTS) | Patient reported treatment satisfaction will be assessed with regard to the Anti-Clot Treatment Scale (ACTS) burden score for the use of rivaroxaban for treatment of acute deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in patients with active cancer changing to this therapy. | At 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Preferences regarding the attributes of the anticoagulation medication options LMWH, VKA, rivaroxaban using DCE survey | Discrete Choice Experiment (DCE) based preference of patients for rivaroxaban versus other anticoagulants in a semi-structured telephone interview LMWH: Low Molecular Weight Heparin; VKA: Vitamin K Antagonist | Between 4 weeks and 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Female and male patients with active cancer and a diagnosis of DVT/ and/or PE after the decision for treatment with rivaroxaban
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Australia | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34877446 | Result | Maraveyas A, Beyer-Westendorf J, Lee AY, Mantovani LG, De Sanctis Y, Abdelgawwad K, Fatoba S, Bach M, Cohen AT. Cancer-Associated ThrOmboSIs - Patient-Reported OutcoMes With RivarOxaban (COSIMO) - Baseline characteristics and clinical outcomes. Res Pract Thromb Haemost. 2021 Nov 30;5(8):e12604. doi: 10.1002/rth2.12604. eCollection 2021 Dec. | |
| 30186045 |
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| Change of ACTS score over time | To assess patient reported outcomes by means of the Anti-Clot Treatment Scale (ACTS) questionnaire | At 3 months and 6 months |
| Patient's quality of life using the FACIT-Fatigue questionnaire | To assess patient reported outcomes on quality of life using the FACIT-Fatigue questionnaire (Functional Assessment of Chronic Illness Therapy) | Up to 6 months |
| Type of index VTE (venous thromboembolism) event | At baseline |
| Date of index VTE event | At baseline |
| Type (trade name) of initial anticoagulation treatment | At baseline |
| Duration of initial anticoagulation treatment | At baseline |
| Reason for drug switch to rivaroxaban | Menu items: patient choice, physician choice, side effects, other | At baseline |
| Planned duration of anticoagulation with rivaroxaban | At baseline |
| Actual duration of anticoagulation with rivaroxaban | Up to 6 months |
| Dosage of rivaroxaban | Up to 6 months |
| Reason for any potential dose adjustments during course of treatment with rivaroxaban | Menu items: side effects, intervention, other | Up to 6 months |
| Reasons for any switch from rivaroxaban treatment | Menu items: patient choice, physician choice, side effects, other | Up to 6 months |
| Reasons for permanent cessation of rivaroxaban treatment | Menu items: patient choice, physician choice, side effects, other | Up to 6 months |
| TNM Staging (Clinical characteristics of cancer disease) | Assessment according to TNM (Tumor, Lymph Node and Metastases) classification. TNM is developed and maintained by the Union for International Cancer Control (UICC) | At baseline |
| Primary site of cancer (Clinical characteristics of cancer disease) | Following Medical Dictionary for Regulatory Activities (MedDRA) coding system | At baseline |
| Type of bleeding events | Up to 6 months |
| Number of bleeding events | Up to 6 months |
| Type of thromboembolic events | Up to 6 months |
| Number of thromboembolic events | Up to 6 months |
| Multiple Locations |
| Belgium |
| Multiple Locations | Canada |
| Multiple Locations | Denmark |
| Multiple Locations | France |
| Multiple Locations | Germany |
| Multiple Locations | Italy |
| Multiple Locations | Netherlands |
| Multiple Locations | Spain |
| Multiple Locations | United Kingdom |
| Cohen AT, Maraveyas A, Beyer-Westendorf J, Lee AYY, Mantovani LG, Bach M; COSIMO Investigators. COSIMO - patients with active cancer changing to rivaroxaban for the treatment and prevention of recurrent venous thromboembolism: a non-interventional study. Thromb J. 2018 Sep 4;16:21. doi: 10.1186/s12959-018-0176-2. eCollection 2018. |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D011655 | Pulmonary Embolism |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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