Skip to main content

Advertisement

Table 3 Calculation of non-inferiority margins based on 14 eligible studies

From: Derivation of the non-inferiority margin for the evaluation of direct oral anticoagulants in the treatment of venous thromboembolism

Measure of association Odds ratio (95% CI) Risk ratio (95% CI)
Point estimate of current standard of care vs placebo, ‘no treatment’ or ‘less intensive treatment’ 0.18 (0.14−0.25) 0.19 (0.12−0.28)
Reversed point estimate of current standard of care vs placebo, ‘no treatment’ or ‘less intensive treatment’ 5.56 (4.00−7.14) 5.26 (3.57−8.33)
Non-inferiority margins Odds ratio based on arithmetic/geometric scale Risk ratio based on arithmetic/geometric scale
Limit for no preserved effect 4.00/4.00 3.57/3.57
Threshold for preservation of 50% of effect 2.50/2.00 2.29/1.89
Threshold for preservation of 66% of effect 2.00/1.60 1.86/1.54
Threshold for preservation of 75% of effect 1.75/1.41 1.64/1.37
Threshold for preservation of 100% of effect* 1.00/1.00 1.00/1.00
  1. *Superiority versus current standard of care.
  2. CI: confidence interval.