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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 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 J1(τl)/J1(τ2) 0.6511 1.0
OBF 2.5444 1.9898
POC 2.0798 2.2427
OS J2(τl)/J1(τ4) 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 τf1=12 months for PFS and τf2=36 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 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.