Table 2.
Approximate required numbers of total patients for screening trials with PFS rate (at a specified time) endpoints, using the binomial proportion test
| Error rates | PFS Rates (at a given time point, with equivalent hazard ratios )) | |||
|---|---|---|---|---|
| 20% vs. 35% ()=1.53) |
20% vs. 40% ()=1.76) |
40% vs. 55% ()=1.53) |
40% vs. 60% ()=1.79) |
|
| (α,β)=(10%,10%) | 256 | 156 | 316 | 182 |
| (α,β)=(10%,20%) or (20%,10%) |
184 | 112 | 224 | 132 |
| (α,β)=(20%,20%) | 126 | 78 | 150 | 90 |
Note: Calculations were carried out using nQueryAdvisor 5.0 software (Statistical Solutions, Saugus, MA) based on methods given in Fleiss et al [27] with 1-sided α