Table 4.
Hypothetical Example 2. Statistical information fraction and critical values
| Endpoint | Statistical information fraction at τl;, critical boundary function | Calendar time τl; (in months) at lth analysis | |||
|---|---|---|---|---|---|
| 24 (l =1) | 36 (l =2) | 48 (l =3) | 60 (l =4) | ||
| PFS | 0.6511 | 1.0 | |||
| OBF | 2.5444 | 1.9898 | |||
| POC | 2.0798 | 2.2427 | |||
| OS | 0.4157 | 0.7053 | 0.8866 | 1.0 | |
| OBF | 3.2860 | 2.4353 | 2.1703 | 2.0647 | |
| POC | 2.2122 | 2.3083 | 2.3708 | 2.4142 | |
The significance level is α = 2.5%. The accrual duration is τA =24 months and the follow-up duration is months for PFS and months for OS. The HRs 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.