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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)