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 ratesPFS Rates at a given time point (with equivalent hazard ratios Δ)
20% vs. 35% (1.53)20% vs. 40% (1.76)40% vs. 55% (1.53)40% vs. 60% (1.79)
(α,β) = (10%,10%)256156316182
(α,β) = (10%,20%) or (20%,10%)184112224132
(α,β) = (20%,20%)1267815090
  • NOTE: Calculations were carried out using nQueryAdvisor 5.0 software (Statistical Solutions) based on methods given in Fleiss et al. (27) with one-sided α.