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 months for PFS and 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 for PFS and 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.