• A prespecified pooling of data from trials comparing apixaban with the same enoxaparin regimen (40 mg daily;
    ADVANCE-2 and ADVANCE-3) was conducted to evaluate whether the treatment had a statistically significant
    different effect (P <.10) across various subgroups, including BMI and body weight
  • Subgroups for BMI were initially defined in the statistical analysis plan as ≤28, 28 to 33, and >33 kg/m2. For the
    subanalysis, the BMI subgroups were divided into the following: BMI <25 kg/m2, BMI 25 to 29 kg/m2, and BMI
    ≥30 kg/m2, respectively; and body weight subgroups were divided into <60 kg and >60 kg
  • The prespecified outcome measure for efficacy in the subgroup analysis was major VTE
  • Major VTE was defined as the composite of adjudicated symptomatic or asymptomatic proximal DVT (popliteal,
    femoral, or iliac-vein thrombosis), nonfatal PE, and VTE-related death during the intended treatment period (i.e.,
    within 2 days after the last dose of the study drug, or within 14 days [ADVANCE-2] or 38 days [ADVANCE-3] after
    the first dose of the study drug, whichever was later)
  • The prespecified outcome measures for bleeding were major bleeding, and the composite of major bleeding and
    CRNM bleeding