DARWIN EU® – Incidence rates of venous thromboembolic events in patients with selected cancers

Study type

• Study topic:
  Disease /health condition
• Study topic, other:
  Cancer, thromboembolism
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Bone cancer

  Breast cancer

  Colorectal cancer

  Leukaemia

  Lymphoma

  Ovarian cancer

  Hepatic cancer

  Prostate cancer

  Endometrial cancer

  Skin cancer

  Gastrooesophageal cancer

  Pulmonary embolism

  Pelvic venous thrombosis

  Hepatic vein thrombosis

  Retinal vein thrombosis

  Disseminated intravascular coagulation
• Additional medical condition(s):
  Brain cancer, Kidney cancer, Lung cancer, Melanoma, Pancreatic cancer, Venous thromboembolism, Splanchnic vein thrombosis

Population studied

• Short description of the study population:
  The study population will include all individuals aged 18 years and above with a primary diagnosis of selected cancers in the study period. Cancer types will include bone, brain, breast, colorectal, corpus uteri, kidney, leukemia and lymphoma, liver, lung, melanoma, esophageal, ovary, pancreas, prostate, and stomach. ; ; Only patients with the first and one cancer diagnosis (except non-melanoma skin cancer) will be included. ; Patients with prior cancer diagnosis (except non-melanoma skin cancer) will be excluded to make sure the outcomes are related to a single primary cancer type of interest patient and also to avoid possible misclassification of second primary cancer and metastatic disease from previously diagnosed primary cancer. ; ; Cancer cases and thromboembolic events will be identified using appropriate computable phenotyping algorithms. Conditions in the OMOP CDM use the Systematised Nomenclature of Medicine (SNOMED) as the standard vocabulary for diagnosis codes. ; ; For cancer diagnoses, the International Classification of Diseases for Oncology, 3rd Edition (ICD-O-3) will also be considered. Algorithms to reproduce cancer phenotypes will be shown along with the study results.
• 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:
  This will be a population-level descriptive epidemiology and patient-level characterisation study.
• Main study objective:
  1. To estimate the incidence rates of thromboembolic events in patients newly diagnosed with each type of selected cancers stratified by country/database, age group, sex, study period (2016-2019 and 2020-2022), and cancer stage one and two years after cancer diagnosis.; ; 2. To characterise cancer patients in terms of demographics, comorbidities and concomitant medication before and at the time of diagnosis, as well as medications and procedures received in the first 90 days after cancer diagnosis.;
• Setting:
  This study will use routinely collected health data from 10 databases from 8 European countries.
• Outcomes:
  Conditions of interest included the following thromboembolic events: ; • Deep vein thrombosis (DVT) ; • Pulmonary embolisms (PE) ; • Venous thromboembolism (VTE, composite of DVT and PE) ; • Pelvic venous thrombosis (PVT) ; • Splanchnic vein thrombosis (SVT), including hepatic and extra-hepatic vein thrombosis ; • Retinal vein thrombosis (RVT), including retinal central vein thrombosis ; • Disseminated intravascular coagulation (DIC)
• Summary results:
  CONCLUSION ; In this large multinational cohort study, which incorporated data from nine data sources across eight countries in Europe, we estimated the incidence of thromboembolic events among patients with selected cancers. PE and VTE were the most frequently observed thromboembolic events. The highest incidence rates of thromboembolic events were seen in patients with lung, brain, ovarian, and gastrointestinal cancers, particularly pancreatic, oesophageal, and stomach cancers and lowest in melanoma, prostate, and breast cancer. Finally, the characterisation of cancer patients provided insights into prevalent comorbidities and concomitant medication use across cancer types, suggesting differences in cancer patient profiles.