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. Author manuscript; available in PMC: 2025 Aug 25.
Published in final edited form as: Clin Trials. 2025 Aug 21;22(6):667–675. doi: 10.1177/17407745251358233

Table 4.

Simulation results for H0:p=0.1 and H1:p=0.3 with an additional trial in the second stage.

Data (n1, n2) Par Simon logit(0.1) logit(0.2) logit(0.3)
H0 (3, 21) p^ 0.14 (0.07) 0.10 (0.06) 0.11 (0.06) 0.11 (0.06)
FPR 0.05 0.09 0.09 0.09
PET 0.73 0.64 0.60 0.57
ESS 8.69 10.55 11.46 12.09
(6, 18) p^ 0.13 (0.07) 0.12 (0.07) 0.11 (0.06) 0.11 (0.06)
FPR 0.06 0.07 0.07 0.08
PET 0.53 0.63 0.60 0.58
ESS 14.43 12.70 13.25 13.64
(8, 16) p^ 0.12 (0.07) 0.12 (0.07) 0.13 (0.07) 0.12 (0.07)
FPR 0.07 0.07 0.07 0.07
PET 0.43 0.63 0.60 0.58
ESS 17.11 13.97 14.41 14.72
(9, 15) p^ 0.12 (0.06) 0.12 (0.07) 0.12 (0.07) 0.13 (0.07)
FPR 0.07 0.08 0.08 0.08
PET 0.39 0.62 0.59 0.58
ESS 18.19 14.72 15.11 15.36
H1 (3, 21) p^ 0.32 (0.09) 0.30 (0.10) 0.30 (0.10) 0.30 (0.10)
Power 0.63 0.88 0.89 0.89
(6, 18) p^ 0.31 (0.09) 0.30 (0.10) 0.30 (0.10) 0.30 (0.10)
Power 0.82 0.80 0.83 0.86
(8, 16) p^ 0.30 (0.09) 0.30 (0.10) 0.30 (0.10) 0.30 (0.10)
Power 0.86 0.84 0.84 0.85
(9, 15) p^ 0.30 (0.09) 0.30 (0.10) 0.30 (0.10) 0.30 (0.10)
Power 0.88 0.86 0.86 0.86

Note: logitπi=μ+vi, where vi~l(i4)N0,0.12+l(i=4)N0,0.32.

FPR = false positive rate; PET = probability of early termination; ESS=expected sample size