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. Author manuscript; available in PMC: 2022 Feb 1.
Published in final edited form as: Contemp Clin Trials. 2020 Dec 9;101:106244. doi: 10.1016/j.cct.2020.106244

Table 3.

Hypothetical Example 1. Conjunctive probability at each analysis and conjunctive power when the BH procedure is used.

Correlation Boundary function combination Stopping probability (%) at each analysis (month) Conjunctive power (%)
36 (l =1) 48 (l =2) 60 (l =3)
0.3 (a) OBF-OBF 1.31 36.23 40.16 77.71
(b) OBF-POC 3.88 36.00 36.56 76.43
(c) POC-OBF 7.14 39.98 24.09 71.20
(d) POC-POC 21.35 27.79 21.02 70.17
0.5 (a) OBF-OBF 1.37 36.41 39.95 77.73
(b) OBF-POC 3.96 36.13 36.40 76.48
(c) POC-OBF 7.32 40.00 23.92 71.24
(d) POC-POC 21.59 27.74 20.91 70.24
0.8 (a) OBF-OBF 1.58 36.94 39.31 77.83
(b) OBF-POC 4.20 36.53 35.94 76.67
(c) POC-OBF 7.90 40.06 23.40 71.36
(d) POC-POC 22.35 27.56 20.55 70.46

The accrual duration is τA =36 months and follow-up duration is common for MACE and CVD-or-HHF, τf1=τf2=τf=24 months. The HR is ψ1 =0.85 for MACE and ψ2 =0.80 for CVD-or-HHF. The proportion of survivors after the follow-up duration is common for MACE and CVD-or HHF S1(1)(60)=S2(1)(60)=85%. Three analyses at 36, 48 and 60 months are planned for MACE and CVD-or HHF. The correlation is assumed to be ρ =0.3, 0.5 and 0.8. The conjunctive probability at each analysis and conjunctive power are calculated under a sample size of 14,466 with S1(1)(60)=85%, which provides at least 80% power to detect 15% reduction in the HR for MACE at the 1.25% significance level by a one-sided logrank test in the fixed-sample design.