Analysis | Value | Efficacy | Futility |
---|
IA1: 11% | Z | 3.47 | − 1.48 |
N: 1184 | p (1-sided) | 0.0003 | 0.9318 |
Events: 16 | HR at bound | 0.28 | 3.47 |
Year: 3 | P (cross) if HR = 1.63 | 0.0003 | 0.07 |
| P (cross) if HR = 1 | 0.0056 | 0.008 |
Final | Z | 1.96 | 1.96 |
N: 2100 | p (1-sided) | 0.025 | 0.025 |
Events: 140 | HR at bound | 1.17 | 1.17 |
Year: 10 | P (cross) if HR = 1.63 | 0.025 | 0.975 |
| P (cross) if HR = 1 | 0.800 | 0.200 |
- Asymmetric two-sided group sequential design with binding futility bound, 2 analyses, time-to-event outcome with sample size 2100 and 140 events required, 80% power, 2.5% (1-sided) type I error to detect a hazard ratio of 1 with a null hypothesis hazard ratio of 1.63. Enrollment and total study durations are assumed to be 5 and 10 years, respectively. Efficacy bounds derived using a Lan-DeMets O’Brien-Fleming approximation spending function. Futility bounds derived using a Lan-DeMets O’Brien-Fleming approximation spending function. 1A1 11% = 1st interim analysis done when 11% of the local recurrence events have been observed (information fraction)