Inhibitor Prevention Trial: power simulations
| Simulation condition . | Noninferiority . | Superiority . | ||||
|---|---|---|---|---|---|---|
| Design scenario . | Design 1 . | Design 2 . | Design 3 . | Design 1 . | Design 2 . | Design 3 . |
| No. borrowed | 0 | 40 | 80 | 0 | 40 | 80 |
| Random allocation* | 1:1 | 1:3 | 1:3 | 1:1 | 1:3 | 1:3 |
| Equivalent, % | 23.9 | 26.5 | 31.8 | |||
| 5% superior, % | 42.4 | 55.4 | 63.2 | 11.9 | 9.3 | 11.9 |
| 10% superior, % | 65.9 | 83.9 | 89.1 | 25.4 | 28.8 | 36.2 |
| Simulation condition . | Noninferiority . | Superiority . | ||||
|---|---|---|---|---|---|---|
| Design scenario . | Design 1 . | Design 2 . | Design 3 . | Design 1 . | Design 2 . | Design 3 . |
| No. borrowed | 0 | 40 | 80 | 0 | 40 | 80 |
| Random allocation* | 1:1 | 1:3 | 1:3 | 1:1 | 1:3 | 1:3 |
| Equivalent, % | 23.9 | 26.5 | 31.8 | |||
| 5% superior, % | 42.4 | 55.4 | 63.2 | 11.9 | 9.3 | 11.9 |
| 10% superior, % | 65.9 | 83.9 | 89.1 | 25.4 | 28.8 | 36.2 |
With Design Scenario 2, there is between 26.5% and 83.9% power for the noninferiority test, with 66 subjects and α = 0.05. In addition, there is between 9.3% and 28.8% power for the superiority testing.
ELOCTATE/emicizumab.