COSIMO Cancer associated thrombosis - patient reported outcomes with rivaroxaban. A non-interventional study on patients changing to Xarelto® for treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in patients with active cancer

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Other
• If ‘other’, further details on the scope of the study:
  Patient reported outcomes
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (B01AF01) rivaroxaban

  rivaroxaban
• Medical condition to be studied:
  Venous thrombosis

  Pulmonary embolism

Population studied

• Short description of the study population:
  Female and male patients with active cancer and a diagnosis of DVT/ and/or PE were enrolled after the decision to start treatment with rivaroxaban has been made by the investigator.; ; Inclusion criteria was as follow:; 1. 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); 2. Patients that have been treated with standard of care anticoagulation (LMWH/VKA) 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; 3. 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; 4. Patients with Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2 (See Annex 3. For ECOG score details); 5. Patients who were willing to participate in this study (signed informed consent); 6. Patients who were available for follow-up with a life expectancy > 6 months
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Cancer patients
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  To assess patient reported treatment satisfaction 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.
• Outcomes:
  - Treatment satisfaction burden score Anti-Clot Treatment Scale (ACTS), - Preferences regarding the attributes of the anticoagulation medication options LMWH, VKA, rivaroxaban using DCE Survey- Change of ACTS score over time- Patient’s quality of life using the FACIT-Fatigue questionnaire - Type of index VTE (venous thromboembolism) Event(for more secondary outcome measures please visit www.clinicaltrials.gov)
• Data analysis plan:
  All variables will be analyzed descriptively with appropriate statistical methods: categorical variables by frequency tables (absolute and relative frequencies) and continuous variables by sample statistics (i.e. mean, standard deviation, minimum, median, quartiles and maximum). Continuous variables will be described by absolute value and as change from baseline per analysis time point, if applicable. The analyses for ACTS (Anti-Clot Treatment Scale) will be performed for the population which includes patients whose ACTS score at the time point for the target analysis, i.e. week 4, or months 3 and 6, is available. Other analyses will be performed for the population which includes patients receiving at least one dose of rivaroxaban. All details including calculated variables and proposed format and content of tables will be described in the Statistical Analysis Plan (SAP). SAP will be finalized before study database lock.