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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 5.

Hypothetical Example 2. Stopping probability at each analysis and conjunctive power when the FS procedure is used.

Correlation Boundary function combination Stopping probability (%) at each analysis (month) Conjunctive power (%)
24 (l =1) 36 (l =2) 48 (l =3) 60 (l =4)
0.3 (a) OBF-OBF 4.52 36.62 19.92 10.53 71.59
(b) OBF-POC 20.31 19.89 9.95 15.13 65.29
(c) POC-OBF 5.60 35.69 19.23 8.97 69.49
(d) POC-POC 25.90 19.21 9.44 9.25 63.79
0.5 (a) OBF-OBF 5.06 37.39 20.18 10.10 72.73
(b) OBF-POC 21.88 20.14 10.10 14.27 66.39
(c) POC-OBF 6.01 36.65 19.49 8.68 70.82
(d) POC-POC 27.20 19.54 9.58 8.83 65.15
0.8 (a) OBF-OBF 6.12 38.92 20.98 9.22 75.25
(b) OBF-POC 25.39 21.05 10.56 11.65 68.65
(c) POC-OBF 6.68 38.65 20.41 8.12 73.87
(d) POC-POC 29.95 20.61 10.07 7.47 68.11

The accrual duration is τA =24 months and the follow-up duration is τf1=12 months for PFS and τf2=36 months for OS. The HR is ψ1 =0.65 for PFS and ψ2 =0.70 for OS. The proportion of survivors after the follow-up duration is S1(1)(36)=6.0% for PFS and S2(1)(60)=7.0% for OS. Two analyses at 24 and 36 months for PFS and up to four analyses at 24, 36, 48 or 60 months for OS are planned. A correlation is assumed to be ρ =0.3, 0.5 and 0.8. The conjunctive probability at each anal and conjunctive power are calculated under a sample size of 304, which provides at least 80% power to detect 30% reduction in the HR for OS at the 2.5% significance level by a one-sided logrank test in the fixed-sample design.