Evaluation of the Safety and Effectiveness of Anticoagulants Among Sub-Groups of Venous Thromboembolism Patients (VTE Subgroups)

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
• 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)
• Estimated number of subjects:
  5000

Study design details

• Main study objective:
  Describe and compare, among VTE patients overall and in key subgroups of patients who were prescribed apixaban or warfarin, the following:1. demographic and clinical characteristics 2. rate of MB and CRNM bleeding 3. rate of recurrent VTE
• 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. Appropriate tests (eg, t-test, chi-square test) will be used based on the distribution of the measure. Kaplan-Meier survival curves will be generated to illustrate the time to first MB, CRNM bleeding, and recurrent VTE events. The cumulative incidence rate for clinical outcomes will be calculated. Inverse probability treatment weighting (IPTW) will be used to balance patient characteristics when comparing outcomes among different cohorts. Cox proportional hazards models will be used to compare the time to recurrent VTE, MB, and CRNM bleeding between apixaban and warfarin cohorts after IPTW. Data analysis will be executed using statistical software SAS version 9.3/9.4