Table 5.

Application of two-stage strategy to Phase III trial in metastatic breast cancer for clinical irrelevance factors (CIFs). Confidence intervals were computed using the Hochberg procedure described in section 2.3, with an overall one-sided α = 0.05.

CIF	99th percentile of CI Upper Bound	Average Audit Size
log(1.0)= 0	−0.016	0.28
log(0.9)=−0.11	−0.112	0.37
log(0.8)=−0.22	−0.227	0.54
log(0.7)=−0.36	−0.358	0.80