Table 2.
Summary of trial scenarios explored
| Parameter | Values considered |
|---|---|
| Accrual | Constant rate of 16 per week (required accrual) |
| Constant rate of 5 per week (slow accrual) | |
| Ramp-up (slow initially, increasing over course of study) | |
| Time to outcome | Uniform between 48 and 72 weeks |
| Control response | 0.1 |
| Treatment response | 0.05, 0.06, 0.07, 0.08, 0.09, 0.10 |
| Superiority threshold | 0.95, 0.955, 0.96, 0.965, 0.97 |
| Success threshold | 1, 0.975, 0.95, 0.925, 0.9, 0.8 |
| Futility threshold | 0, 0.025, 0.05, 0.075, 0.1, 0.2 |