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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.