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Table 9 FOCUS results of final analysis after early stopping at stage 1.

From: How do multi-stage, multi-arm trials compare to the traditional two-arm parallel group design – a reanalysis of 4 trials

one-sided sig. level A vs B A vs C A vs D A vs E Power for
at recruitment stop HR 95% CI HR 95% CI HR 95% CI HR 95% CI final analysis
0.5 0.93 (0.76–1.13) 0.88 (0.72–1.08) 0.96 (0.78–1.17) 1.03 (0.85–1.26) 90%
0.4 0.94 (0.78–1.14) 0.87 (0.72–1.05) 0.97 (0.81–1.18) 1.04 (0.86–1.25) > 90%
0.3 0.89 (0.74–1.06) 0.88 (0.73–1.05) 0.94 (0.79–1.13) 0.97 (0.81–1.16) > 90%
0.2 0.92 (0.77–1.09) 0.93 (0.78–1.10) 0.99 (0.84–1.17) 1.03 (0.87–1.22) > 90%
0.1 0.89 (0.76–1.04) 0.86 (0.73–1.00) 0.99 (0.85–1.15) 0.97 (0.83–1.13) > 90%
n/a – actual analysis 0.91 (0.81–1.06) 0.84 (0.73–0.96) 0.97 (0.85–1.11) 0.93 (0.81–1.06) n/a
  1. This analysis was carried out on mature data for the primary endpoint including only those patients recruited up to the time of the first stage analysis. HR – hazard ratio on primary outcome (overall survival), CI – 95% confidence interval around the hazard ratio, Power for final analysis – this was calculated for a targetted alternative of 0.73 (as specified in the protocol)
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