Fixed design, two-arm trial with time-to-event
outcome (Lachin and Foulkes, 1986).
Study duration (fixed): Ts=2
Accrual duration (fixed): Tr=0.5
Uniform accrual: entry="unif"
Control median: log(2)/lambda1=3.5
Experimental median: log(2)/lambda2=6.9
Censoring median: log(2)/eta=6.9
Control failure rate: lambda1=0.2
Experimental failure rate: lambda2=0.1
Censoring rate: eta=0.1
Power: 100*(1-beta)=90%
Type I error (1-sided): 100*alpha=2.5%
Equal randomization: ratio=1
Sample size based on hazard ratio=0.5 (type="rr")
Sample size (computed): n=430
Events required (computed): nEvents=91
Fixed design, two-arm trial with time-to-event
outcome (Lachin and Foulkes, 1986).
Study duration (fixed): Ts=2
Accrual duration (fixed): Tr=0.5
Exponential accrual: entry="expo"
Accrual shape parameter: gamma=1
Control median: log(2)/lambda1=3.5
Experimental median: log(2)/lambda2=6.9
Censoring median: log(2)/eta=6.9
Control failure rate: lambda1=0.2
Experimental failure rate: lambda2=0.1
Censoring rate: eta=0.1
Power: 100*(1-beta)=90%
Type I error (1-sided): 100*alpha=2.5%
Equal randomization: ratio=1
Sample size based on hazard ratio=0.5 (type="rr")
Sample size (computed): n=426
Events required (computed): nEvents=91
Fixed design, two-arm trial with time-to-event
outcome (Lachin and Foulkes, 1986).
Study duration (fixed): Ts=2
Accrual duration (fixed): Tr=0.5
Exponential accrual: entry="expo"
Accrual shape parameter: gamma=1
Control median: log(2)/lambda1=3.5
Experimental median: log(2)/lambda2=6.9
Censoring only at study end (eta=0)
Control failure rate: lambda1=0.2
Experimental failure rate: lambda2=0.1
Censoring rate: eta=0
Power: 100*(1-beta)=90%
Type I error (1-sided): 100*alpha=2.5%
Randomization (Exp/Control): ratio=1.25
Sample size based on hazard ratio=0.5 (type="rr")
Sample size (computed): n=400
Events required (computed): nEvents=89
Fixed design, two-arm trial with time-to-event
outcome (Lachin and Foulkes, 1986).
Study duration (fixed): Ts=2
Accrual duration (fixed): Tr=0.5
Exponential accrual: entry="expo"
Accrual shape parameter: gamma=1
Control median: log(2)/lambda1=3.5
Experimental median: log(2)/lambda2=6.9
Censoring only at study end (eta=0)
Control failure rate: lambda1=0.2
Experimental failure rate: lambda2=0.1
Censoring rate: eta=0
Power: 100*(1-beta)=90%
Type I error (1-sided): 100*alpha=2.5%
Randomization (Exp/Control): ratio=0.8
Sample size based on hazard ratio=0.5 (type="rr")
Sample size (computed): n=396
Events required (computed): nEvents=94
risk ratio (type = rr) with approximate computation
Fixed design, two-arm trial with time-to-event
outcome (Lachin and Foulkes, 1986).
Study duration (fixed): Ts=2
Accrual duration (fixed): Tr=0.5
Uniform accrual: entry="unif"
Control median: log(2)/lambda1=3.5
Experimental median: log(2)/lambda2=6.9
Censoring median: log(2)/eta=0.1
Control failure rate: lambda1=0.2
Experimental failure rate: lambda2=0.1
Censoring rate: eta=6.9
Power: 100*(1-beta)=90%
Type I error (1-sided): 100*alpha=2.5%
Equal randomization: ratio=1
Sample size based on hazard ratio=0.5 (type="rr")
Sample size (computed): n=4308
Events required (computed): nEvents=92
risk difference (type = rd) with approximate computation
Fixed design, two-arm trial with time-to-event
outcome (Lachin and Foulkes, 1986).
Study duration (fixed): Ts=2
Accrual duration (fixed): Tr=0.5
Uniform accrual: entry="unif"
Control median: log(2)/lambda1=3.5
Experimental median: log(2)/lambda2=6.9
Censoring only at study end (eta=0)
Control failure rate: lambda1=0.2
Experimental failure rate: lambda2=0.1
Censoring rate: eta=0
Power: 100*(1-beta)=90%
Type I error (1-sided): 100*alpha=2.5%
Equal randomization: ratio=1
Sample size based on risk difference=0.1 (type="rd")
Sample size based on H1 variance only: approx=TRUE
Sample size (computed): n=416
Events required (computed): nEvents=95
risk difference (type = rd) with approx set to FALSE
Fixed design, two-arm trial with time-to-event
outcome (Lachin and Foulkes, 1986).
Study duration (fixed): Ts=2
Accrual duration (fixed): Tr=0.5
Uniform accrual: entry="unif"
Control median: log(2)/lambda1=3.5
Experimental median: log(2)/lambda2=6.9
Censoring only at study end (eta=0)
Control failure rate: lambda1=0.2
Experimental failure rate: lambda2=0.1
Censoring rate: eta=0
Power: 100*(1-beta)=90%
Type I error (1-sided): 100*alpha=2.5%
Equal randomization: ratio=1
Sample size based on risk difference=0.1 (type="rd")
Sample size based on H0 and H1 variance: approx=FALSE
Sample size (computed): n=414
Events required (computed): nEvents=94
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