Table I.
λ2 | APPLE1 | True t*2 = 3 months | True t* = 9 months | ||
---|---|---|---|---|---|
|
|||||
Mis-specified tm5 = 6 | PW-Logrank3 tm = 6 (%) | S-Logrank4 (%) | PW-Logrank tm = 6 (%) | S-Logrank (%) | |
0.6 | 260 | 79 | 76 | 56 | 40 |
0.64 | 335 | 79 | 76 | 56 | 41 |
0.68 | 441 | 78 | 76 | 57 | 42 |
0.72 | 599 | 78 | 76 | 57 | 42 |
0.78 | 1025 | 77 | 76 | 58 | 43 |
The sample size calculated using APPLE is based on the target power at 80%, the proportion of subjects who can survive beyond the delayed phase at p = 70%, total accrual duration A = 1 year, total study duration τ = 3 years, and Type I error rate α = 0.05.
t*: True hazard ratio changing time.
PW-Logrank: Piecewise weighted log-rank test.
S-Logrank: Regular log-rank test.
tm: mis-specified hazard ratio changing time.