DARWIN EU® - Time to onset of thromboembolic events in adults with selected types of cancer

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Population studied

• Short description of the study population:
  Objective 1; Inclusion criteria; • First diagnosis of a selected cancer (index date) between 01/01/2016 and 31/12/2022 (inclusion period); • Age ≥18 years at cancer diagnosis; • Minimum of 365 days of available history before the cancer diagnosis date; • Cancer diagnosis date ≥365 days prior to end of data availability of the data source; Exclusion criteria; • History of any cancer diagnosis ever before the selected cancer diagnosis date; ; Objective 2; Inclusion criteria; • The subset of the cohort for objective 1 who experienced the outcome (i.e., thromboembolic event) during follow-up.; The study design to address objective 1, including assessment windows, is visualised in Figure 1. For objective 2, we will include the subset of the cohort of adults with cancer that experienced a thromboembolic event during follow-up.;
• 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)

Study design details

• Study design:
  A cohort study will be conducted.
• Main study objective:
  1. To estimate the thromboembolism-free survival within 5 years of the first cancer diagnosis in adults with each type of selected cancer, overall and stratified by age group, sex, and study subperiod.; 2. To estimate the median time from the first cancer diagnosis to onset of thromboembolic events in individuals with thromboembolic events with each type of selected cancer, overall and stratified by age group, sex, and study subperiod.;