Evaluation of Anticoagulants among Venous Thromboembolism Patients with Active Cancer: Pooled Analysis from Claims Databases

Study type

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

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  APIXABAN

  LOW MOLECULAR WEIGHT HEPARIN SODIUM

  WARFARIN
• Medical condition to be studied:
  Venous thrombosis

Population studied

• 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:
  Renal impaired

  Hepatic impaired
• Estimated number of subjects:
  8000

Study design details

• Main study objective:
  1: Compare demographic/clinical characteristics of VTE pts w/active cancer prescribed apixaban, LMWH, or warfarin2: Evaluate treatment patterns among VTE pts w/active cancer prescribed apixaban, LMWH, or warfarin.3: Compare the risk of MB, CRNM bleeding & recurrent VTE <6 months & using all available follow-up period among VTE pts w/active cancer prescribed apixaban, LMWH, or warfarin.
• Data analysis plan:
  Means, medians, and standard deviations will be provided for continuous variables. Numbers and percentages will be provided for dichotomous and polychotomous variables. Bivariate comparisons of baseline characteristics and outcomes measures will be provided. Inverse probability treatment weighting (IPTW) will be used to balance treatment cohorts. Appropriate tests (eg, t-test, chi-square test) will be used based on the distribution of the measure. The cumulative incidence rate for clinical outcomes (major bleeding, CRNM bleeding, and recurrent VTE) will be calculated. Cox proportional hazard ratio model will be used to evaluate the risk of clinical outcomes (MB, CRNM bleeding, recurrent VTE). Data analysis will be executed using statistical software SAS version 9.3/9.4.