Observational Studies in Cancer Associated Thrombosis for Rivaroxaban in SwEden (OSCAR-SE)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (B01AA03) warfarin

  warfarin

  (B01AB01) heparin

  heparin

  (B01AE07) dabigatran etexilate

  dabigatran etexilate

  (B01AF01) rivaroxaban

  rivaroxaban

  (B01AF02) apixaban

  apixaban

  (B01AF03) edoxaban

  edoxaban
• Medical condition to be studied:
  Embolism venous

Population studied

• Short description of the study population:
  The study population comprised of patients aged 18 years or older diagnosed with cancer of a subsequent venous thromboembolism (VTE) identified from the Swedish registries for the period of January 1, 2013 to December 31, 2020.; Inclusion criteria:; • a resident in Sweden of 18+ years of age; • a Swedish Person Identification Number; • a diagnosis of cancer (ICD10 = C00-C97) in the Swedish Cancer registry during 2013-2019 and a diagnosis of VTE subsequent to the cancer diagnosis.; ; Exclusion criteria:; • a diagnosis of atrial fibrillation, total hip or knee replacement or acute coronary syndrome (for evaluation of treatment patterns) before the date of VTE diagnosis; • a dispensed prescription for any OAC before the date of VTE diagnosis; • a cancer diagnosis associated with high bleeding risk (see listed diagnoses to be included)
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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:
  Patients with venous thromboembolism
• Estimated number of subjects:
  15000

Study design details

• Main study objective:
  - To estimate the risk of recurrent VTE, major bleeding and all-cause death in individuals with cancer - To describe the anticoagulation treatments for VTE - To estimate the risk of a recurrent VTE, major bleeding and all-cause death - To compare incidence rates of recurrent VTE, major bleeding and death in subjects treated with rivaroxaban versus LMWH, and NOACs versus LMWH
• Outcomes:
  - Recurrence of VTE - Major bleedings - All-cause death - Choice of anticoagulation treatments for VTE - Duration of anticoagulation treatments for VTE - Recurrence of VTE with different treatment types of LMWH, VKA and NOAC - Major bleedings with different treatment types of LMWH, VKA and NOAC - All-cause death with different treatment types of LMWH, VKA and NOAC
• Data analysis plan:
  Descriptive statistics, incidence rates and Cox proportional hazards regression models.