Time to event group sequential design with HR= 0.5
Equal randomization: ratio=1
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 31 -0.24 0.4056 0.0148 3.01 0.0013 0.0013
2 62 0.94 0.8267 0.0289 2.55 0.0054 0.0049
3 93 2.00 0.9772 0.0563 2.00 0.0228 0.0188
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 Total E{N}
0.0000 0.0013 0.0049 0.0171 0.0233 54.2
0.3481 0.1412 0.4403 0.3185 0.9000 68.6
Lower boundary (futility or Type II Error)
Analysis
Theta 1 2 3 Total
0.0000 0.4056 0.4290 0.1420 0.9767
0.3481 0.0148 0.0289 0.0563 0.1000
T n Events HR futility HR efficacy
IA 1 43.16196 43.16196 30.92271 1.090 0.339
IA 2 74.71327 74.71327 61.84542 0.787 0.523
Final 105.74376 105.24376 92.76813 0.660 0.660
Accrual rates:
Stratum 1
0-105.24 1
Control event rates (H1):
Stratum 1
0-Inf 0.12
Censoring rates:
Stratum 1
0-Inf 0
Time to event group sequential design with HR= 0.5
Non-inferiority design with null HR= 1.5
Equal randomization: ratio=1
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 13 -0.24 0.4056 0.0148 3.01 0.0013 0.0013
2 25 0.94 0.8267 0.0289 2.55 0.0054 0.0049
3 38 2.00 0.9772 0.0563 2.00 0.0228 0.0188
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 Total E{N}
0.0000 0.0013 0.0049 0.0171 0.0233 21.7
0.5506 0.1412 0.4403 0.3185 0.9000 27.4
Lower boundary (futility or Type II Error)
Analysis
Theta 1 2 3 Total
0.0000 0.4056 0.4290 0.1420 0.9767
0.5506 0.0148 0.0289 0.0563 0.1000
T n Events HR futility HR efficacy
IA 1 22.69529 22.69529 12.35900 1.718 0.271
IA 2 36.59355 36.59355 24.71799 1.027 0.539
Final 49.56349 49.06349 37.07699 0.778 0.778
Accrual rates:
Stratum 1
0-49.06 1
Control event rates (H1):
Stratum 1
0-Inf 0.12
Censoring rates:
Stratum 1
0-Inf 0
Time to event group sequential design with HR= 0.5
Equal randomization: ratio=1
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.
----Lower bounds---- ----Upper bounds-----
Analysis N Z Nominal p Spend+ Z Nominal p Spend++
1 27 0.16 0.5618 0.0500 3.16 0.0008 0.0008
2 54 0.76 0.7769 0.0207 2.82 0.0024 0.0022
3 80 1.34 0.9092 0.0159 2.42 0.0078 0.0059
4 107 1.86 0.9685 0.0134 1.86 0.0315 0.0161
Total 0.1000 0.0250
+ lower bound beta spending (under H1):
Kim-DeMets (power) spending function with rho = 0.5.
++ 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 Total E{N}
0.0000 0.0008 0.0022 0.0059 0.0160 0.0249 44.8
0.3489 0.0877 0.3127 0.3489 0.1507 0.9000 68.0
Lower boundary (futility or Type II Error)
Analysis
Theta 1 2 3 4 Total
0.0000 0.5618 0.2498 0.1184 0.0451 0.9751
0.3489 0.0500 0.0207 0.0159 0.0134 0.1000
T n Events HR futility HR efficacy
IA 1 12.24228 75.4103 26.62788 0.942 0.294
IA 2 18.97078 116.8567 53.25576 0.812 0.462
IA 3 25.02728 147.8358 79.88364 0.742 0.582
Final 36.00000 147.8358 106.51151 0.697 0.697
Accrual rates:
Stratum 1
0-24 6.16
Control event rates (H1):
Stratum 1
0-Inf 0.12
Censoring rates:
Stratum 1
0-Inf 0.02
Time to event group sequential design with HR= 0.5
Equal randomization: ratio=1
One-sided group sequential design with
90 % power and 2.5 % Type I Error.
Analysis N Z Nominal p Spend
1 23 3.16 0.0008 0.0008
2 45 2.82 0.0024 0.0022
3 67 2.44 0.0074 0.0059
4 89 2.01 0.0220 0.0161
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 Total E{N}
0.0000 0.0008 0.0022 0.0059 0.0161 0.025 87.8
0.3489 0.0644 0.2507 0.3480 0.2369 0.900 65.1
T n Events HR efficacy
IA 1 12.24228 62.33412 22.01059 0.261
IA 2 18.97078 96.59366 44.02119 0.428
IA 3 25.02728 122.20099 66.03178 0.549
Final 36.00000 122.20099 88.04237 0.651
Accrual rates:
Stratum 1
0-24 5.09
Control event rates (H1):
Stratum 1
0-Inf 0.12
Censoring rates:
Stratum 1
0-Inf 0.02
Time to event group sequential design with HR= 0.5
Randomization (Exp/Control): ratio= 0.6
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.
----Lower bounds---- ----Upper bounds-----
Analysis N Z Nominal p Spend+ Z Nominal p Spend++
1 30 0.16 0.5618 0.0500 3.16 0.0008 0.0008
2 59 0.76 0.7769 0.0207 2.82 0.0024 0.0022
3 88 1.34 0.9092 0.0159 2.42 0.0078 0.0059
4 117 1.86 0.9685 0.0134 1.86 0.0315 0.0161
Total 0.1000 0.0250
+ lower bound beta spending (under H1):
Kim-DeMets (power) spending function with rho = 0.5.
++ 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 Total E{N}
0.0000 0.0008 0.0022 0.0059 0.0160 0.0249 49.3
0.3329 0.0877 0.3127 0.3489 0.1507 0.9000 74.7
Lower boundary (futility or Type II Error)
Analysis
Theta 1 2 3 4 Total
0.0000 0.5618 0.2498 0.1184 0.0451 0.9751
0.3329 0.0500 0.0207 0.0159 0.0134 0.1000
T n Events HR futility HR efficacy
IA 1 12.04139 78.84331 29.24741 0.942 0.300
IA 2 18.73390 122.66381 58.49482 0.814 0.467
IA 3 24.77333 157.14461 87.74223 0.745 0.586
Final 36.00000 157.14461 116.98964 0.701 0.701
Accrual rates:
Stratum 1
0-24 6.55
Control event rates (H1):
Stratum 1
0-Inf 0.12
Censoring rates:
Stratum 1
0-Inf 0.02
Add the following code to your website.
For more information on customizing the embed code, read Embedding Snippets.