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, 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 . 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 , 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.