One-sided group sequential design with
90 % power and 2.5 % Type I Error.
Sample
Size
Analysis Ratio* Z Nominal p Spend
1 0.205 3.25 0.0006 0.0006
2 0.409 2.99 0.0014 0.0013
3 0.614 2.69 0.0036 0.0028
4 0.819 2.37 0.0088 0.0063
5 1.023 2.03 0.0214 0.0140
Total 0.0250
++ alpha spending:
Hwang-Shih-DeCani spending function with gamma = -4.
* Sample size ratio compared to fixed design with no interim
Boundary crossing probabilities and expected sample size
assume any cross stops the trial
Upper boundary (power or Type I Error)
Analysis
Theta 1 2 3 4 5 Total E{N}
0.0000 0.0006 0.0013 0.0028 0.0063 0.0140 0.025 1.0197
3.2415 0.0370 0.1512 0.2647 0.2699 0.1771 0.900 0.7366
Group sequential design sample size for time-to-event outcome
with sample size 22. The analysis plan below shows events
at each analysis.
Symmetric two-sided group sequential design with
90 % power and 2.5 % Type I Error.
Spending computations assume trial stops
if a bound is crossed.
Sample
Size
Analysis Ratio* Z Nominal p Spend
1 0.205 3.25 0.0006 0.0006
2 0.409 2.99 0.0014 0.0013
3 0.614 2.69 0.0036 0.0028
4 0.819 2.37 0.0088 0.0063
5 1.023 2.03 0.0214 0.0140
Total 0.0250
++ alpha spending:
Hwang-Shih-DeCani spending function with gamma = -4.
* Sample size ratio compared to fixed design with no interim
Boundary crossing probabilities and expected sample size
assume any cross stops the trial
Upper boundary (power or Type I Error)
Analysis
Theta 1 2 3 4 5 Total E{N}
0.0000 0.0006 0.0013 0.0028 0.0063 0.0140 0.025 1.0160
3.2415 0.0370 0.1512 0.2647 0.2699 0.1771 0.900 0.7366
Lower boundary (futility or Type II Error)
Analysis
Theta 1 2 3 4 5 Total
0.0000 6e-04 0.0013 0.0028 0.0063 0.014 0.025
3.2415 0e+00 0.0000 0.0000 0.0000 0.000 0.000
Symmetric two-sided group sequential design with
90 % power and 2.5 % Type I Error.
Spending computations assume trial stops
if a bound is crossed.
Sample
Size
Analysis Ratio* Z Nominal p Spend
1 0.205 3.25 0.0006 0.0006
2 0.409 2.99 0.0014 0.0013
3 0.614 2.69 0.0036 0.0028
4 0.819 2.37 0.0088 0.0063
5 1.023 2.03 0.0214 0.0140
Total 0.0250
++ alpha spending:
Hwang-Shih-DeCani spending function with gamma = -4.
* Sample size ratio compared to fixed design with no interim
Boundary crossing probabilities and expected sample size
assume any cross stops the trial
Upper boundary (power or Type I Error)
Analysis
Theta 1 2 3 4 5 Total E{N}
0.0000 0.0006 0.0013 0.0028 0.0063 0.0140 0.025 1.0160
3.2415 0.0370 0.1512 0.2647 0.2699 0.1771 0.900 0.7366
Lower boundary (futility or Type II Error)
Analysis
Theta 1 2 3 4 5 Total
0.0000 6e-04 0.0013 0.0028 0.0063 0.014 0.025
3.2415 0e+00 0.0000 0.0000 0.0000 0.000 0.000
Asymmetric two-sided group sequential design with
90 % power and 2.5 % Type I Error.
Spending computations assume trial stops
if a bound is crossed.
Sample
Size ----Lower bounds---- ----Upper bounds-----
Analysis Ratio* Z Nominal p Spend+ Z Nominal p Spend++
1 0.214 -0.92 0.1777 0.0077 3.25 0.0006 0.0006
2 0.428 -0.07 0.4727 0.0115 2.99 0.0014 0.0013
3 0.641 0.66 0.7440 0.0171 2.69 0.0036 0.0028
4 0.855 1.32 0.9058 0.0256 2.37 0.0089 0.0063
5 1.069 1.97 0.9755 0.0381 1.97 0.0245 0.0140
Total 0.1000 0.0250
+ lower bound beta spending (under H1):
Hwang-Shih-DeCani spending function with gamma = -2.
++ alpha spending:
Hwang-Shih-DeCani spending function with gamma = -4.
* Sample size ratio compared to fixed design with no interim
Boundary crossing probabilities and expected sample size
assume any cross stops the trial
Upper boundary (power or Type I Error)
Analysis
Theta 1 2 3 4 5 Total E{N}
0.0000 0.0006 0.0013 0.0028 0.0063 0.0140 0.025 0.5636
3.2415 0.0397 0.1610 0.2743 0.2677 0.1573 0.900 0.7306
Lower boundary (futility or Type II Error)
Analysis
Theta 1 2 3 4 5 Total
0.0000 0.1777 0.3135 0.2708 0.1527 0.0602 0.975
3.2415 0.0077 0.0115 0.0171 0.0256 0.0381 0.100
Asymmetric two-sided group sequential design with
90 % power and 2.5 % Type I Error.
Upper bound spending computations assume
trial continues if lower bound is crossed.
----Lower bounds---- ----Upper bounds-----
Analysis N Z Nominal p Spend+ Z Nominal p Spend++
1 177 -0.90 0.1836 0.0077 3.25 0.0006 0.0006
2 353 -0.04 0.4853 0.0115 2.99 0.0014 0.0013
3 529 0.69 0.7563 0.0171 2.69 0.0036 0.0028
4 705 1.36 0.9131 0.0256 2.37 0.0088 0.0063
5 882 2.03 0.9786 0.0381 2.03 0.0214 0.0140
Total 0.1000 0.0250
+ lower bound beta spending (under H1):
Hwang-Shih-DeCani spending function with gamma = -2.
++ alpha spending:
Hwang-Shih-DeCani spending function with gamma = -4.
Boundary crossing probabilities and expected sample size
assume any cross stops the trial
Upper boundary (power or Type I Error)
Analysis
Theta 1 2 3 4 5 Total E{N}
0.0000 0.0006 0.0013 0.0028 0.0062 0.0117 0.0226 458.0
0.1146 0.0417 0.1679 0.2806 0.2654 0.1444 0.9000 595.2
Lower boundary (futility or Type II Error)
Analysis
Theta 1 2 3 4 5 Total
0.0000 0.1836 0.3201 0.2700 0.1477 0.0559 0.9774
0.1146 0.0077 0.0115 0.0171 0.0256 0.0381 0.1000
Asymmetric two-sided group sequential design with
90 % power and 2.5 % Type I Error.
Spending computations assume trial stops
if a bound is crossed.
Sample
Size ----Lower bounds---- ----Upper bounds-----
Analysis Ratio* Z Nominal p Spend+ Z Nominal p Spend++
1 0.205 -1.44 0.0751 0.0751 3.25 0.0006 0.0006
2 0.410 -0.98 0.1627 0.1120 2.99 0.0014 0.0013
3 0.615 -0.47 0.3207 0.1670 2.69 0.0036 0.0028
4 0.821 0.21 0.5833 0.2492 2.37 0.0088 0.0063
5 1.026 2.02 0.9785 0.3717 2.02 0.0215 0.0140
Total 0.9750 0.0250
+ lower bound spending (under H0):
Hwang-Shih-DeCani spending function with gamma = -2.
++ alpha spending:
Hwang-Shih-DeCani spending function with gamma = -4.
* Sample size ratio compared to fixed design with no interim
Boundary crossing probabilities and expected sample size
assume any cross stops the trial
Upper boundary (power or Type I Error)
Analysis
Theta 1 2 3 4 5 Total E{N}
0.0000 0.0006 0.0013 0.0028 0.0063 0.0140 0.025 0.7719
3.2415 0.0372 0.1517 0.2652 0.2698 0.1761 0.900 0.7349
Lower boundary (futility or Type II Error)
Analysis
Theta 1 2 3 4 5 Total
0.0000 0.0751 0.1120 0.1670 0.2492 0.3717 0.975
3.2415 0.0018 0.0009 0.0009 0.0023 0.0942 0.100
Asymmetric two-sided group sequential design with
90 % power and 2.5 % Type I Error.
Upper bound spending computations assume
trial continues if lower bound is crossed.
Sample
Size ----Lower bounds---- ----Upper bounds-----
Analysis Ratio* Z Nominal p Spend+ Z Nominal p Spend++
1 0.205 -1.44 0.0751 0.0751 3.25 0.0006 0.0006
2 0.411 -0.98 0.1627 0.1120 2.99 0.0014 0.0013
3 0.616 -0.47 0.3207 0.1671 2.69 0.0036 0.0028
4 0.821 0.21 0.5834 0.2492 2.37 0.0088 0.0063
5 1.027 2.03 0.9786 0.3718 2.03 0.0214 0.0140
Total 0.9751 0.0250
+ lower bound spending (under H0):
Hwang-Shih-DeCani spending function with gamma = -2.
++ alpha spending:
Hwang-Shih-DeCani spending function with gamma = -4.
* Sample size ratio compared to fixed design with no interim
Boundary crossing probabilities and expected sample size
assume any cross stops the trial
Upper boundary (power or Type I Error)
Analysis
Theta 1 2 3 4 5 Total E{N}
0.0000 0.0006 0.0013 0.0028 0.0063 0.0140 0.0249 0.7726
3.2415 0.0372 0.1519 0.2654 0.2697 0.1757 0.9000 0.7353
Lower boundary (futility or Type II Error)
Analysis
Theta 1 2 3 4 5 Total
0.0000 0.0751 0.1120 0.1671 0.2492 0.3718 0.9751
3.2415 0.0018 0.0009 0.0009 0.0023 0.0942 0.1000
One-sided group sequential design with
90 % power and 2.5 % Type I Error.
Analysis N Z Nominal p Spend
1 3 3.25 0.0006 0.0006
2 5 2.99 0.0014 0.0013
3 8 2.69 0.0036 0.0028
4 10 2.37 0.0088 0.0063
5 13 2.03 0.0214 0.0140
Total 0.0250
++ alpha spending:
Hwang-Shih-DeCani spending function with gamma = -4.
Boundary crossing probabilities and expected sample size
assume any cross stops the trial
Upper boundary (power or Type I Error)
Analysis
Theta 1 2 3 4 5 Total E{N}
0.0000 0.0006 0.0013 0.0028 0.0063 0.0140 0.025 12.2
0.9357 0.0370 0.1512 0.2647 0.2699 0.1771 0.900 8.8
Symmetric two-sided group sequential design with
98.5 % power and 5 % Type I Error.
Spending computations assume trial stops
if a bound is crossed.
Sample
Size
Analysis Ratio* Z Nominal p Spend
1 300 2.77 0.0028 0.0028
2 600 2.23 0.0127 0.0114
3 860 1.68 0.0462 0.0357
Total 0.0500
++ alpha spending:
Hwang-Shih-DeCani spending function with gamma = -4.
* Sample size ratio compared to fixed design with no interim
Boundary crossing probabilities and expected sample size
assume any cross stops the trial
Upper boundary (power or Type I Error)
Analysis
Theta 1 2 3 Total E{N}
0.0000 0.0028 0.0114 0.0357 0.05 850.8823
3.8149 1.0000 0.0000 0.0000 1.00 300.0000
Lower boundary (futility or Type II Error)
Analysis
Theta 1 2 3 Total
0.0000 0.0028 0.0114 0.0357 0.05
3.8149 0.0000 0.0000 0.0000 0.00
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