rpact: Confirmatory Adaptive Clinical Trial Design and Analysis
## [1] '2.0.3'

1 Working with objects

1.1 Create an example of all available rpact objects

## [PROGRESS] Stage results calculated [0.017 secs] 
## [PROGRESS] Conditional power calculated [0 secs] 
## [PROGRESS] Conditional rejection probabilities (CRP) calculated [0.001 secs] 
## [PROGRESS] Repeated confidence interval of stage 1 calculated [0.3291 secs] 
## [PROGRESS] Repeated confidence interval of stage 2 calculated [0.3959 secs] 
## [PROGRESS] Repeated confidence interval of stage 3 calculated [0.4039 secs] 
## [PROGRESS] Repeated confidence interval of stage 4 calculated [0.4159 secs] 
## [PROGRESS] Repeated confidence interval calculated [1.5459 secs] 
## [PROGRESS] Overall repeated p-values of stage 1 calculated [0.4199 secs] 
## [PROGRESS] Overall repeated p-values of stage 2 calculated [0.4249 secs] 
## [PROGRESS] Overall repeated p-values of stage 3 calculated [0.4159 secs] 
## [PROGRESS] Overall repeated p-values of stage 4 calculated [0.4209 secs] 
## [PROGRESS] Repeated p-values calculated [1.6815 secs] 
## [PROGRESS] Final p-value calculated [0.002 secs] 
## [PROGRESS] Final confidence interval calculated [0.0987 secs]

2 How to use R generic functions with rpact objects

2.1 Get field names of the object

##  [1] "kMax"                  "alpha"                
##  [3] "stages"                "informationRates"     
##  [5] "userAlphaSpending"     "criticalValues"       
##  [7] "stageLevels"           "alphaSpent"           
##  [9] "bindingFutility"       "tolerance"            
## [11] "typeOfDesign"          "beta"                 
## [13] "deltaWT"               "futilityBounds"       
## [15] "gammaA"                "gammaB"               
## [17] "optimizationCriterion" "sided"                
## [19] "betaSpent"             "typeBetaSpending"     
## [21] "userBetaSpending"      "power"                
## [23] "twoSidedPower"         "constantBoundsHP"
##  [1] "kMax"                     "alpha"                   
##  [3] "stages"                   "informationRates"        
##  [5] "userAlphaSpending"        "criticalValues"          
##  [7] "stageLevels"              "alphaSpent"              
##  [9] "bindingFutility"          "tolerance"               
## [11] "method"                   "alpha0Vec"               
## [13] "scale"                    "nonStochasticCurtailment"
## [15] "sided"                    "simAlpha"                
## [17] "iterations"               "seed"
##  [1] "nFixed"                 "shift"                 
##  [3] "inflationFactor"        "stages"                
##  [5] "information"            "power"                 
##  [7] "rejectionProbabilities" "futilityProbabilities" 
##  [9] "averageSampleNumber1"   "averageSampleNumber01" 
## [11] "averageSampleNumber0"
##  [1] "nMax"                "theta"               "averageSampleNumber"
##  [4] "calculatedPower"     "overallEarlyStop"    "earlyStop"          
##  [7] "overallReject"       "rejectPerStage"      "overallFutility"    
## [10] "futilityPerStage"
## [1] "designs"          "variedParameters"
## [1] "stages"             "groups"             "sampleSizes"       
## [4] "means"              "stDevs"             "overallSampleSizes"
## [7] "overallMeans"       "overallStDevs"
##  [1] "stages"                "overallTestStatistics"
##  [3] "overallPValues"        "overallMeans1"        
##  [5] "overallMeans2"         "overallStDevs1"       
##  [7] "overallStDevs2"        "overallSampleSizes1"  
##  [9] "overallSampleSizes2"   "testStatistics"       
## [11] "pValues"               "effectSizes"          
## [13] "thetaH0"               "direction"            
## [15] "normalApproximation"   "equalVariances"
##  [1] "stages"                               
##  [2] "informationRates"                     
##  [3] "criticalValues"                       
##  [4] "futilityBounds"                       
##  [5] "alphaSpent"                           
##  [6] "stageLevels"                          
##  [7] "effectSizes"                          
##  [8] "testStatistics"                       
##  [9] "pValues"                              
## [10] "testActions"                          
## [11] "thetaH0"                              
## [12] "thetaH1"                              
## [13] "assumedStDev"                         
## [14] "conditionalRejectionProbabilities"    
## [15] "nPlanned"                             
## [16] "allocationRatioPlanned"               
## [17] "pi1"                                  
## [18] "pi2"                                  
## [19] "conditionalPower"                     
## [20] "repeatedConfidenceIntervalLowerBounds"
## [21] "repeatedConfidenceIntervalUpperBounds"
## [22] "repeatedPValues"                      
## [23] "finalStage"                           
## [24] "finalPValues"                         
## [25] "finalConfidenceIntervalLowerBounds"   
## [26] "finalConfidenceIntervalUpperBounds"   
## [27] "medianUnbiasedEstimates"              
## [28] "normalApproximation"                  
## [29] "equalVariances"                       
## [30] "directionUpper"                       
## [31] "overallTestStatistics"                
## [32] "overallPValues"
##  [1] "normalApproximation"            "meanRatio"                     
##  [3] "thetaH0"                        "alternative"                   
##  [5] "stDev"                          "groups"                        
##  [7] "allocationRatioPlanned"         "optimumAllocationRatio"        
##  [9] "directionUpper"                 "nFixed"                        
## [11] "nFixed1"                        "nFixed2"                       
## [13] "informationRates"               "maxNumberOfSubjects"           
## [15] "maxNumberOfSubjects1"           "maxNumberOfSubjects2"          
## [17] "numberOfSubjects"               "numberOfSubjects1"             
## [19] "numberOfSubjects2"              "expectedNumberOfSubjectsH0"    
## [21] "expectedNumberOfSubjectsH01"    "expectedNumberOfSubjectsH1"    
## [23] "effect"                         "expectedNumberOfSubjects"      
## [25] "rejectPerStage"                 "overallReject"                 
## [27] "futilityPerStage"               "futilityStop"                  
## [29] "earlyStop"                      "criticalValuesEffectScale"     
## [31] "criticalValuesEffectScaleLower" "criticalValuesEffectScaleUpper"
## [33] "criticalValuesPValueScale"      "futilityBoundsEffectScale"     
## [35] "futilityBoundsPValueScale"
##  [1] "maxNumberOfSubjects"       "accrualTime"              
##  [3] "accrualIntensity"          "plannedEvents"            
##  [5] "pi1"                       "pi2"                      
##  [7] "median1"                   "median2"                  
##  [9] "directionUpper"            "dropoutRate1"             
## [11] "dropoutRate2"              "dropoutTime"              
## [13] "eventTime"                 "thetaH0"                  
## [15] "allocation1"               "allocation2"              
## [17] "minNumberOfEventsPerStage" "maxNumberOfEventsPerStage"
## [19] "conditionalPower"          "thetaH1"                  
## [21] "maxNumberOfIterations"     "kappa"                    
## [23] "piecewiseSurvivalTime"     "lambda1"                  
## [25] "lambda2"                   "hazardRatio"              
## [27] "iterations"                "analysisTime"             
## [29] "studyDuration"             "eventsPerStage"           
## [31] "expectedNumberOfEvents"    "eventsNotAchieved"        
## [33] "numberOfSubjects"          "numberOfSubjects1"        
## [35] "numberOfSubjects2"         "expectedNumberOfSubjects" 
## [37] "rejectPerStage"            "overallReject"            
## [39] "futilityPerStage"          "futilityStop"             
## [41] "earlyStop"                 "conditionalPowerAchieved" 
## [43] "seed"
##  [1] "piecewiseSurvivalTime"    "lambda1"                 
##  [3] "lambda2"                  "hazardRatio"             
##  [5] "pi1"                      "pi2"                     
##  [7] "median1"                  "median2"                 
##  [9] "eventTime"                "kappa"                   
## [11] "piecewiseSurvivalEnabled" "delayedResponseAllowed"  
## [13] "delayedResponseEnabled"
##  [1] "endOfAccrualIsUserDefined"                 
##  [2] "followUpTimeMustBeUserDefined"             
##  [3] "maxNumberOfSubjectsIsUserDefined"          
##  [4] "maxNumberOfSubjectsCanBeCalculatedDirectly"
##  [5] "absoluteAccrualIntensityEnabled"           
##  [6] "accrualTime"                               
##  [7] "accrualIntensity"                          
##  [8] "accrualIntensityRelative"                  
##  [9] "maxNumberOfSubjects"                       
## [10] "remainingTime"                             
## [11] "piecewiseAccrualEnabled"

2.1.1 Access data of a field

## [1] 3.069028 2.325888 1.977663 1.762694
## [1] 3.069028 2.325888 1.977663 1.762694

2.3 Show a summary of the object

## Interim analysis with a maximum of 4 looks (group sequential design):
## 
## Stage                                     1        2        3        4        
## Information rate                          25%      50%      75%      100%     
## Cumulative alpha spent                    0.0011   0.0105   0.0282   0.05     
## Cumulative power                          0.036    0.303    0.603    0.8      
## One-sided local significance level        0.0011   0.01     0.024    0.039    
## Efficacy boundary (Z-value scale)         3.069    2.326    1.978    1.763    
## Exit probability for efficacy (under H1)  0.0362   0.2664   0.3007   0.1966   
## Exit probability for efficacy (under H0)  0.00107  0.00945  0.01768  0.02179
## Interim analysis with a maximum of 4 looks (Fisher design):
## 
## Stage                               1        2        3        4        
## Information rate                    20%      50%      80%      100%     
## Cumulative alpha spent              0.0137   0.0206   0.0237   0.025    
## One-sided local significance level  0.0137   0.0137   0.0137   0.0137   
## Efficacy boundary (Z-value scale)   0.014    0.001    0        0
## This output summarizes the group sequential design characteristics specification.
## 
## Group sequential design characteristics:
##   Number of subjects fixed                     : 6.2 
##   Shift                                        : 6.4822 
##   Inflation factor                             : 1.0485 
##   Informations                                 : 1.6205, 3.2411, 4.8616, 6.4822 
##   Power                                        : 0.03625, 0.30265, 0.60337, 0.80000 
##   Rejection probabilities                      : 0.03625, 0.26640, 0.30072, 0.19663 
##   Futility probabilities                       : 0, 0, 0 
##   Ratio expected vs fixed sample size under H1 : 0.8015 
##   Ratio expected vs fixed sample size under a value between H0 and H1 : 0.9724 
##   Ratio expected vs fixed sample size under H0 : 1.0380 
## 
## 
## Technical summary of the design characteristics object of class "TrialDesignCharacteristics":
##   [g] Number of subjects fixed                 : 6.2 
##   [g] Shift                                    : 6.4822 
##   [g] Inflation factor                         : 1.0485 
##   [u] Stages                                   : 1, 2, 3, 4 
##   [g] Informations                             : 1.6205, 3.2411, 4.8616, 6.4822 
##   [g] Power                                    : 0.03625, 0.30265, 0.60337, 0.80000 
##   [g] Rejection probabilities                  : 0.03625, 0.26640, 0.30072, 0.19663 
##   [g] Futility probabilities                   : 0, 0, 0 
##   [g] Ratio expected vs fixed sample size under H1 : 0.8015 
##   [g] Ratio expected vs fixed sample size under a value between H0 and H1 : 0.9724 
##   [g] Ratio expected vs fixed sample size under H0 : 1.0380 
## 
## Legend:
##   u: user defined
##   >: derived value
##   d: default value
##   g: generated/calculated value
##   .: not applicable or hidden
## 
## Group sequential design characteristics table:
##           Information      Power Rejection probability
##   Stage 1    1.620541 0.03624538            0.03624538
##   Stage 2    3.241081 0.30264612            0.26640074
##   Stage 3    4.861622 0.60337036            0.30072424
##   Stage 4    6.482163 0.80000000            0.19662964
##           Futility probability
##   Stage 1         9.865876e-10
##   Stage 2         9.758407e-10
##   Stage 3         9.359906e-10
##   Stage 4                   NA
## This output summarizes the power and average sample size (ASN) specification.
## 
## Power and average sample size (ASN):
## 
## User defined parameters:
##   Effect                                       : 1 
## 
## Default parameters:
##   N_max                                        : 100 
## 
## Output:
##   Average sample sizes (ASN)                   : 25.7 
##   Power                                        : 1.0000 
##   Overall Early stop                           : 1 
##   Early stop [1]                               : 9.73e-01 
##   Early stop [2]                               : 2.67e-02 
##   Early stop [3]                               : 1.03e-06 
##   Early stop [4]                               : NA 
##   Overall reject                               : 1 
##   Reject per stage [1]                         : 9.73e-01 
##   Reject per stage [2]                         : 2.67e-02 
##   Reject per stage [3]                         : 1.02e-06 
##   Reject per stage [4]                         : 0.00e+00 
##   Overall futility                             : 0 
##   Futility stop per stage [1]                  : 0 
##   Futility stop per stage [2]                  : 0 
##   Futility stop per stage [3]                  : 0 
## 
## Legend:
##   [k]: values at stage k
## 
## 
## Technical summary of the power and average sample size (ASN) object:
##   [d] N_max                                    : 100 
##   [u] Effect                                   : 1 
##   [g] Average sample sizes (ASN)               : 25.7 
##   [g] Power                                    : 1.0000 
##   [g] Overall Early stop                       : 1 
##   [g] Early stop [1]                           : 9.73e-01 
##   [g] Early stop [2]                           : 2.67e-02 
##   [g] Early stop [3]                           : 1.03e-06 
##   [g] Early stop [4]                           : NA 
##   [g] Overall reject                           : 1 
##   [g] Reject per stage [1]                     : 9.73e-01 
##   [g] Reject per stage [2]                     : 2.67e-02 
##   [g] Reject per stage [3]                     : 1.02e-06 
##   [g] Reject per stage [4]                     : 0.00e+00 
##   [g] Overall futility                         : 0 
##   [g] Futility stop per stage [1]              : 0 
##   [g] Futility stop per stage [2]              : 0 
##   [g] Futility stop per stage [3]              : 0 
## 
## Legend:
##   u: user defined
##   >: derived value
##   d: default value
##   g: generated/calculated value
##   .: not applicable or hidden
## 
## Power and average sample size (ASN) table:
##      Stage   Early stop Reject per stage Futility stop per stage
## [1,]     1 9.732567e-01     9.732567e-01            9.865876e-10
## [2,]     2 2.674225e-02     2.674225e-02            9.755040e-10
## [3,]     3 1.025014e-06     1.024395e-06            6.188329e-10
## [4,]     4           NA     0.000000e+00                      NA
##         Length          Class           Mode 
##              3 TrialDesignSet             S4
## This output summarizes the dataset of means specification.
## 
## Dataset of means:
##   Stages                                       : 1, 1, 2, 2, 3, 3, 4, 4 
##   Treatment groups                             : 1, 2, 1, 2, 1, 2, 1, 2 
##   Sample sizes                                 : 22, 22, 11, 13, 22, 22, 11, 13 
##   Means                                        : 1.0, 1.4, 1.1, 1.5, 1.0, 3.0, 1.0, 2.5 
##   Standard deviations                          : 1.0, 1.0, 2.0, 2.0, 2.0, 2.0, 1.3, 1.3 
## 
## Calculated data:
##   Overall sample sizes                         : 22, 22, 33, 35, 55, 57, 66, 70 
##   Overall means                                : 1.000, 1.400, 1.033, 1.437, 1.020, 2.040, 1.017, 2.126 
##   Overall standard deviations                  : 1.000, 1.000, 1.381, 1.425, 1.639, 1.823, 1.579, 1.739 
## 
## 
## Technical summary of the dataset object of class"DatasetMeans":
##   [u] Stages                                   : 1, 1, 2, 2, 3, 3, 4, 4 
##   [u] Treatment groups                         : 1, 2, 1, 2, 1, 2, 1, 2 
##   [u] Sample sizes                             : 22, 22, 11, 13, 22, 22, 11, 13 
##   [u] Means                                    : 1.0, 1.4, 1.1, 1.5, 1.0, 3.0, 1.0, 2.5 
##   [u] Standard deviations                      : 1.0, 1.0, 2.0, 2.0, 2.0, 2.0, 1.3, 1.3 
##   [g] Overall sample sizes                     : 22, 22, 33, 35, 55, 57, 66, 70 
##   [g] Overall means                            : 1.000, 1.400, 1.033, 1.437, 1.020, 2.040, 1.017, 2.126 
##   [g] Overall standard deviations              : 1.000, 1.000, 1.381, 1.425, 1.639, 1.823, 1.579, 1.739 
## 
## Legend:
##   u: user defined
##   >: derived value
##   d: default value
##   g: generated/calculated value
##   .: not applicable or hidden
## 
## Dataset of means table:
##           Treatment group Sample size Mean Standard deviation
##   Stage 1               1          22  1.0                1.0
##   Stage 2               2          22  1.4                1.0
##   Stage 3               1          11  1.1                2.0
##   Stage 4               2          13  1.5                2.0
##   Stage 5               1          22  1.0                2.0
##   Stage 6               2          22  3.0                2.0
##   Stage 7               1          11  1.0                1.3
##   Stage 8               2          13  2.5                1.3
##           Overall sample size Overall mean Overall standard deviation
##   Stage 1                  22     1.000000                   1.000000
##   Stage 2                  22     1.400000                   1.000000
##   Stage 3                  33     1.033333                   1.381500
##   Stage 4                  35     1.437143                   1.425418
##   Stage 5                  55     1.020000                   1.639151
##   Stage 6                  57     2.040351                   1.822857
##   Stage 7                  66     1.016667                   1.578664
##   Stage 8                  70     2.125714                   1.738706
## This output summarizes the stage results of means specification.
## 
## Stage results of means:
## 
## User defined parameters:
##   Stages                                       : 1, 2, 3, 4 
## 
## Default parameters:
##   Theta H0                                     : 0 
##   Direction                                    : upper 
##   Normal approximation                         : FALSE 
##   Equal variances                              : TRUE 
## 
## Output:
##   Overall test statistics                      : -1.327, -1.185, -3.111, -3.887 
##   Overall p-values                             : 0.9041, 0.8799, 0.9988, 0.9999 
##   Overall means (1)                            : 1.000, 1.033, 1.020, 1.017 
##   Overall means (2)                            : 1.400, 1.437, 2.040, 2.126 
##   Overall standard deviations (1)              : 1.000, 1.381, 1.639, 1.579 
##   Overall standard deviations (2)              : 1.000, 1.425, 1.823, 1.739 
##   Overall sample sizes (1)                     : 22, 33, 55, 66 
##   Overall sample sizes (2)                     : 22, 35, 57, 70 
##   Test statistics                              : -1.327, -0.488, -3.317, -2.817 
##   p-values                                     : 0.9041, 0.6849, 0.9991, 0.9950 
##   Effect sizes                                 : -0.4000, -0.4038, -1.0204, -1.1090 
## 
## 
## Technical summary of the stage results object of class "StageResultsMeans":
## 
##   [u] Stages                                   : 1, 2, 3, 4 
##   [g] Overall test statistics                  : -1.327, -1.185, -3.111, -3.887 
##   [g] Overall p-values                         : 0.9041, 0.8799, 0.9988, 0.9999 
##   [g] Overall means (1)                        : 1.000, 1.033, 1.020, 1.017 
##   [g] Overall means (2)                        : 1.400, 1.437, 2.040, 2.126 
##   [g] Overall standard deviations (1)          : 1.000, 1.381, 1.639, 1.579 
##   [g] Overall standard deviations (2)          : 1.000, 1.425, 1.823, 1.739 
##   [g] Overall sample sizes (1)                 : 22, 33, 55, 66 
##   [g] Overall sample sizes (2)                 : 22, 35, 57, 70 
##   [g] Test statistics                          : -1.327, -0.488, -3.317, -2.817 
##   [g] p-values                                 : 0.9041, 0.6849, 0.9991, 0.9950 
##   [g] Effect sizes                             : -0.4000, -0.4038, -1.0204, -1.1090 
##   [d] Theta H0                                 : 0 
##   [d] Direction                                : upper 
##   [d] Normal approximation                     : FALSE 
##   [d] Equal variances                          : TRUE 
##   [.] Weights Fisher                           : 1.000, 1.000, 1.000, 1.000 
##   [.] Weights inverse normal                   : 0.500, 0.500, 0.500, 0.500 
##   [.] Inverse normal combination               : -1.305, -1.263, -2.826, -3.734 
##   [.] Fisher combination                       : 0.9041, 0.6192, 0.6186, 0.6155 
##   [?] Overall means                            :  
##   [?] Overall standard deviations              : 1.000, 1.404, 1.735, 1.663 
##   [?] Overall sample sizes                     :  
## 
## Legend:
##   u: user defined
##   >: derived value
##   d: default value
##   g: generated/calculated value
##   .: not applicable or hidden
## 
## Stage results of means table:
##           Overall test statistic Overall p-value Overall mean (1)
##   Stage 1              -1.326650       0.9041035         1.000000
##   Stage 2              -1.185099       0.8798860         1.033333
##   Stage 3              -3.111238       0.9988132         1.020000
##   Stage 4              -3.886959       0.9999205         1.016667
##           Overall mean (2) Overall standard deviation (1)
##   Stage 1         1.400000                       1.000000
##   Stage 2         1.437143                       1.381500
##   Stage 3         2.040351                       1.639151
##   Stage 4         2.125714                       1.578664
##           Overall standard deviation (2) Overall sample size (1)
##   Stage 1                       1.000000                      22
##   Stage 2                       1.425418                      33
##   Stage 3                       1.822857                      55
##   Stage 4                       1.738706                      66
##           Overall sample size (2) Test statistic   p-value Effect size
##   Stage 1                      22      -1.326650 0.9041035  -0.4000000
##   Stage 2                      35      -0.488194 0.6848785  -0.4038095
##   Stage 3                      57      -3.316625 0.9990567  -1.0203509
##   Stage 4                      70      -2.816504 0.9949743  -1.1090476
## This output summarizes the analysis results (group sequential design) specification.
## 
## Analysis results (group sequential design):
##   Stages                                       : 1, 2, 3, 4 
##   Information rates                            : 0.250, 0.500, 0.750, 1.000 
##   Critical values                              : 3.069, 2.326, 1.978, 1.763 
##   Futility bounds (non-binding)                : -Inf, -Inf, -Inf 
##   Cumulative alpha spending                    : 0.001074, 0.010527, 0.028206, 0.050000 
##   Stage levels                                 : 0.001074, 0.010012, 0.023983, 0.038976 
##   Effect sizes                                 : -0.4000, -0.4038, -1.0204, -1.1090 
##   Test statistics                              : -1.327, -0.488, -3.317, -2.817 
##   p-values                                     : 0.9041, 0.6849, 0.9991, 0.9950 
##   Overall test statistics                      : -1.327, -1.185, -3.111, -3.887 
##   Overall p-values                             : 0.9041, 0.8799, 0.9988, 0.9999 
##   Actions                                      : continue, continue, continue, accept 
##   Theta H0                                     : 0 
##   CRP                                          : 2.810e-03, 1.227e-04, 6.661e-16, NA 
##   Planned sample size                          : NA, NA, NA, NA 
##   Planned allocation ratio                     : 1 
##   Assumed effect                               : -1.109 
##   Assumed standard deviation                   : 1.663 
##   Conditional power                            : NA, NA, NA, NA 
##   RCIs (lower)                                 : -1.386, -1.216, -1.676, -1.616 
##   RCIs (upper)                                 : 0.5861, 0.4084, -0.3644, -0.6022 
##   Repeated p-values                            : >0.5, >0.5, >0.5, >0.5 
##   Final stage                                  : 4 
##   Final p-value                                : NA, NA, NA, 0.9999 
##   Final CIs (lower)                            : NA, NA, NA, -1.547 
##   Final CIs (upper)                            : NA, NA, NA, -0.6082 
##   Median unbiased estimate                     : NA, NA, NA, -1.078 
## 
## 
## Technical summary of the analysis results object of class "AnalysisResultsGroupSequential":
##   [u] Stages                                   : 1, 2, 3, 4 
##   [?] Information rates                        : 0.250, 0.500, 0.750, 1.000 
##   [?] Critical values                          : 3.069, 2.326, 1.978, 1.763 
##   [?] Futility bounds (non-binding)            : -Inf, -Inf, -Inf 
##   [?] Cumulative alpha spending                : 0.001074, 0.010527, 0.028206, 0.050000 
##   [?] Stage levels                             : 0.001074, 0.010012, 0.023983, 0.038976 
##   [?] Effect sizes                             : -0.4000, -0.4038, -1.0204, -1.1090 
##   [?] Test statistics                          : -1.327, -0.488, -3.317, -2.817 
##   [?] p-values                                 : 0.9041, 0.6849, 0.9991, 0.9950 
##   [?] Overall test statistics                  : -1.327, -1.185, -3.111, -3.887 
##   [?] Overall p-values                         : 0.9041, 0.8799, 0.9988, 0.9999 
##   [?] Actions                                  : continue, continue, continue, accept 
##   [?] Theta H0                                 : 0 
##   [?] CRP                                      : 2.810e-03, 1.227e-04, 6.661e-16, NA 
##   [?] Planned sample size                      : NA, NA, NA, NA 
##   [?] Planned allocation ratio                 : 1 
##   [?] Assumed effect                           : -1.109 
##   [?] Assumed standard deviation               : 1.663 
##   [?] Conditional power                        : NA, NA, NA, NA 
##   [?] RCIs (lower)                             : -1.386, -1.216, -1.676, -1.616 
##   [?] RCIs (upper)                             : 0.5861, 0.4084, -0.3644, -0.6022 
##   [?] Repeated p-values                        : >0.5, >0.5, >0.5, >0.5 
##   [?] Final stage                              : 4 
##   [?] Final p-value                            : NA, NA, NA, 0.9999 
##   [?] Final CIs (lower)                        : NA, NA, NA, -1.547 
##   [?] Final CIs (upper)                        : NA, NA, NA, -0.6082 
##   [?] Median unbiased estimate                 : NA, NA, NA, -1.078 
##   [?] pi (1)                                   :  
##   [?] pi (2)                                   :  
##   [?] Normal approximation                     : FALSE 
##   [?] Equal variances                          : TRUE 
##   [?] Direction upper                          : TRUE 
## 
## Legend:
##   u: user defined
##   >: derived value
##   d: default value
##   g: generated/calculated value
##   .: not applicable or hidden
## 
## Analysis results (group sequential design) table:
##           Information rate Critical value Futility bound (binding)
##   Stage 1 0.25             3.069028       -Inf                    
##   Stage 2 0.50             2.325888       -Inf                    
##   Stage 3 0.75             1.977663       -Inf                    
##   Stage 4 1.00             1.762694       <NA>                    
##           Cumulative alpha spending Stage level Effect size Test statistic
##   Stage 1 0.001073781               0.001073781 -0.4000000  -1.326650     
##   Stage 2 0.010526914               0.010012250 -0.4038095  -0.488194     
##   Stage 3 0.028205994               0.023983344 -1.0203509  -3.316625     
##   Stage 4 0.050000000               0.038976069 -1.1090476  -2.816504     
##           p-value   Overall test statistic Overall p-value Action  
##   Stage 1 0.9041035 -1.326650              0.9041035       continue
##   Stage 2 0.6848785 -1.185099              0.8798860       continue
##   Stage 3 0.9990567 -3.111238              0.9988132       continue
##   Stage 4 0.9949743 -3.886959              0.9999205       accept  
##           CRP          RCI (lower) RCI (upper) Repeated p-value
##   Stage 1 2.810091e-03 -1.386144    0.5861439  0.499999        
##   Stage 2 1.226756e-04 -1.216028    0.4084087  0.499999        
##   Stage 3 6.661338e-16 -1.676258   -0.3644440  0.499999        
##   Stage 4 <NA>         -1.615872   -0.6022231  0.499999        
##           Final p-value Final CI (lower) Final CI (upper)
##   Stage 1 <NA>          <NA>             <NA>            
##   Stage 2 <NA>          <NA>             <NA>            
##   Stage 3 <NA>          <NA>             <NA>            
##   Stage 4 0.9999205     -1.546886        -0.608249       
##           Median unbiased estimate
##   Stage 1 <NA>                    
##   Stage 2 <NA>                    
##   Stage 3 <NA>                    
##   Stage 4 -1.077568
## Interim analysis with a maximum of 4 looks, continuous endpoint (group sequential design):
## 
## Stage                                                                      1        2        3        4        
## Information rate                                                           25%      50%      75%      100%     
## Total sample size, Alternative = 0.2                                       163      488      975      1625     
## Total sample size, Alternative = 0.4                                       41       123      246      409      
## Total sample size, Alternative = 0.6                                       19       56       111      184      
## Total sample size, Alternative = 0.8                                       11       32       64       106      
## Total sample size, Alternative = 1                                         7        21       42       69       
## Cumulative alpha spent                                                     0.0011   0.0105   0.0282   0.05     
## Cumulative power                                                           0.036    0.303    0.603    0.8      
## One-sided local significance level                                         0.0011   0.01     0.024    0.039    
## Efficacy boundary (Z-value scale)                                          3.069    2.326    1.978    1.763    
## Efficacy boundary (approximate treatment effect scale), Alternative = 0.2  0.482    0.258    0.179    0.138    
## Efficacy boundary (approximate treatment effect scale), Alternative = 0.4  0.96     0.515    0.357    0.276    
## Efficacy boundary (approximate treatment effect scale), Alternative = 0.6  1.432    0.767    0.533    0.411    
## Efficacy boundary (approximate treatment effect scale), Alternative = 0.8  1.894    1.015    0.705    0.544    
## Efficacy boundary (approximate treatment effect scale), Alternative = 1    2.342    1.255    0.871    0.673    
## Exit probability for efficacy (under H1)                                   0.0362   0.2664   0.3007   0.1966   
## Exit probability for efficacy (under H0)                                   0.00107  0.00945  0.01768  0.02179
## Interim analysis with a maximum of 4 looks, simulation of a survival endpoint (group sequential design):
## 
## Stage                                      1        2        3        4        
## Information rate                           25%      50%      75%      100%     
## Cumulative number of events, pi (1) = 0.2  50       NA       NA       NA       
## Cumulative number of events, pi (1) = 0.3  50       NA       NA       NA       
## Cumulative number of events, pi (1) = 0.4  50       NA       NA       NA       
## Cumulative number of events, pi (1) = 0.5  50       NA       NA       NA       
## Analysis time under H1, pi (1) = 0.2       43       NA       NA       NA       
## Analysis time under H1, pi (1) = 0.3       35.3     NA       NA       NA       
## Analysis time under H1, pi (1) = 0.4       30       NA       NA       NA       
## Analysis time under H1, pi (1) = 0.5       26.2     NA       NA       NA       
## Cumulative alpha spent                     0.0011   0.0105   0.0282   0.05     
## Cumulative power                           0.036    0.303    0.603    0.8      
## One-sided local significance level         0.0011   0.01     0.024    0.039    
## Efficacy boundary (Z-value scale)          3.069    2.326    1.978    1.763    
## Exit probability for efficacy (under H1)   0.0362   0.2664   0.3007   0.1966   
## Exit probability for efficacy (under H0)   0.00107  0.00945  0.01768  0.02179
## This output summarizes the piecewise survival time specification.
## 
## Piecewise exponential survival times:
##    0 - < 6: 0.025
##    6 - < 9: 0.040
##    9 - <15: 0.015
##   15 - <21: 0.010
##       >=21: 0.007
## 
## Details:
## 
## User defined parameters:
##   Piecewise survival times                     : 0.00, 6.00, 9.00, 15.00, 21.00 
##   Lambda (2)                                   : 0.025, 0.040, 0.015, 0.010, 0.007 
##   Hazard ratio                                 : 0.800 
## 
## Default parameters:
##   Event time                                   : 12 
##   Kappa                                        : 1 
##   Delayed response allowed                     : FALSE 
## 
## Generated parameters:
##   Lambda (1)                                   : 0.0200, 0.0320, 0.0120, 0.0080, 0.0056 
##   Piecewise exponential survival enabled       : TRUE 
## 
## 
## Technical summary of the piecewise survival time object of class"PiecewiseSurvivalTime":
## 
##   [u] Piecewise survival times                 : 0.00, 6.00, 9.00, 15.00, 21.00 
##   [g] Lambda (1)                               : 0.0200, 0.0320, 0.0120, 0.0080, 0.0056 
##   [u] Lambda (2)                               : 0.025, 0.040, 0.015, 0.010, 0.007 
##   [u] Hazard ratio                             : 0.800 
##   [.] pi (1)                                   : NA 
##   [.] pi (2)                                   : NA 
##   [.] Median (1)                               : NA 
##   [.] Median (2)                               : NA 
##   [d] Event time                               : 12 
##   [d] Kappa                                    : 1 
##   [g] Piecewise exponential survival enabled   : TRUE 
##   [d] Delayed response allowed                 : FALSE 
##   [.] Delayed response enabled                 : FALSE 
## 
## Legend:
##   u: user defined
##   >: derived value
##   d: default value
##   g: generated/calculated value
##   .: not applicable or hidden
## 
## Piecewise survival time table:
##      Piecewise survival times Lambda (1) Lambda (2)
## [1,]                        0     0.0200      0.025
## [2,]                        6     0.0320      0.040
## [3,]                        9     0.0120      0.015
## [4,]                       15     0.0080      0.010
## [5,]                       21     0.0056      0.007
## This output summarizes the accrual time specification.
## 
## Accrual time and intensity:
##    0.00000 -  <12.00000: 15
##   12.00000 -  <13.00000: 21
##   13.00000 -  <14.00000: 27
##   14.00000 -  <15.00000: 33
##   15.00000 -  <16.00000: 39
##   16.00000 - <=40.44444: 45
## 
## Formula:
##   maxNumberOfSubjects = 1400 = 12 * 15 + 1 * 21 + 1 * 27 + 1 * 33 + 1 * 39 + 24.4444 * 45
## 
## Case (#5):
##   'maxNumberOfSubjects' and absolute accrual intensity are given, end of accrual* and 'followUpTime'** shall be calculated
##   Example: getAccrualTime(accrualTime = c(0, 6), accrualIntensity = c(22, 33), maxNumberOfSubjects = 1000)
## 
##   (*) Can be calculated directly.
##   (**) Cannot be calculated directly but with 'getSampleSizeSurvival' or 'getPowerSurvival'.
## 
## Details:
## 
## User defined parameters:
##   Accrual intensity                            : 15.0, 21.0, 27.0, 33.0, 39.0, 45.0 
##   Maximum number of subjects                   : 1400.0 
## 
## Default parameters: not available
## 
## Generated parameters:
##   End of accrual is user defined               : FALSE 
##   Follow-up time must be user defined          : FALSE 
##   Max number of subjects is user defined       : TRUE 
##   Max number of subjects can be calculated directly : TRUE 
##   Absolute accrual intensity is enabled        : TRUE 
##   Accrual time                                 : 0.00, 12.00, 13.00, 14.00, 15.00, 16.00, 40.44 
##   Remaining time                               : 24.44 
## 
## 
## Technical summary of the accrual time object of class"AccrualTime":
## 
##   [g] End of accrual is user defined           : FALSE 
##   [g] Follow-up time must be user defined      : FALSE 
##   [g] Max number of subjects is user defined   : TRUE 
##   [g] Max number of subjects can be calculated directly : TRUE 
##   [g] Absolute accrual intensity is enabled    : TRUE 
##   [g] Accrual time                             : 0.00, 12.00, 13.00, 14.00, 15.00, 16.00, 40.44 
##   [u] Accrual intensity                        : 15.0, 21.0, 27.0, 33.0, 39.0, 45.0 
##   [.] Accrual intensity (relative)             : NA 
##   [u] Maximum number of subjects               : 1400.0 
##   [g] Remaining time                           : 24.44 
##   [?] %piecewiseAccrualEnabled%                : TRUE 
## 
## Legend:
##   u: user defined
##   >: derived value
##   d: default value
##   g: generated/calculated value
##   .: not applicable or hidden
## 
## Accrual time table:
##      Accrual time Accrual intensity
## [1,]      0.00000                15
## [2,]     12.00000                21
## [3,]     13.00000                27
## [4,]     14.00000                33
## [5,]     15.00000                39
## [6,]     16.00000                45
## [7,]     40.44444                NA

2.4 Coerce object to data.frame: as.data.frame

##   Type of design Maximum # stages Stage Information rate
## 1             WT                4     1             0.25
## 2             WT                4     2             0.50
## 3             WT                4     3             0.75
## 4             WT                4     4             1.00
##   Significance level Type II error rate Two-sided power
## 1               0.05                0.2           FALSE
## 2               0.05                0.2           FALSE
## 3               0.05                0.2           FALSE
## 4               0.05                0.2           FALSE
##   Delta (Wang & Tsiatis) Test Tolerance Cumulative alpha spending
## 1                    0.1    1     1e-08               0.001073781
## 2                    0.1    1     1e-08               0.010526914
## 3                    0.1    1     1e-08               0.028205994
## 4                    0.1    1     1e-08               0.050000000
##   Critical value Stage level
## 1       3.069028 0.001073781
## 2       2.325888 0.010012250
## 3       1.977663 0.023983344
## 4       1.762694 0.038976069
##       Method Maximum # stages Stage Information rate Significance level
## 1 equalAlpha                4     1              0.2              0.025
## 2 equalAlpha                4     2              0.5              0.025
## 3 equalAlpha                4     3              0.8              0.025
## 4 equalAlpha                4     4              1.0              0.025
##   Alpha_0 Binding futility Test Tolerance Iterations
## 1     0.4             TRUE    1     1e-14          0
## 2     0.4             TRUE    1     1e-14          0
## 3     0.4             TRUE    1     1e-14          0
## 4      NA             TRUE    1     1e-14          0
##   Cumulative alpha spending Critical value Stage level    Scale
## 1                0.01366638   1.366638e-02  0.01366638 1.224745
## 2                0.02055086   8.921538e-04  0.01366638 1.224745
## 3                0.02372061   9.643023e-05  0.01366638 1.000000
## 4                0.02500000   2.151406e-05  0.01366638       NA
##   Non stochastic curtailment
## 1                      FALSE
## 2                      FALSE
## 3                      FALSE
## 4                      FALSE
##   Inflation factor Stage Information      Power Rejection probability
## 1          1.04846     1    1.620541 0.03624538            0.03624538
## 2          1.04846     2    3.241081 0.30264612            0.26640074
## 3          1.04846     3    4.861622 0.60337036            0.30072424
## 4          1.04846     4    6.482163 0.80000000            0.19662964
##   Futility probability Ratio expected vs fixed sample size under H1
## 1         9.865876e-10                                    0.8014789
## 2         9.758407e-10                                    0.8014789
## 3         9.359906e-10                                    0.8014789
## 4                   NA                                    0.8014789
##   Ratio expected vs fixed sample size under a value between H0 and H1
## 1                                                           0.9724133
## 2                                                           0.9724133
## 3                                                           0.9724133
## 4                                                           0.9724133
##   Ratio expected vs fixed sample size under H0
## 1                                     1.038026
## 2                                     1.038026
## 3                                     1.038026
## 4                                     1.038026
##   Stage Effect Average sample size (ASN) Power Overall Early stop
## 1     1      1                  25.66861     1                  1
## 2     2      1                  25.66861     1                  1
## 3     3      1                  25.66861     1                  1
## 4     4      1                  25.66861     1                  1
##     Early stop Overall reject Reject per stage Overall futility
## 1 9.732567e-01              1     9.732567e-01     2.580925e-09
## 2 2.674225e-02              1     2.674225e-02     2.580925e-09
## 3 1.025014e-06              1     1.024395e-06     2.580925e-09
## 4           NA              1     0.000000e+00     2.580925e-09
##   Futility stop per stage
## 1            9.865876e-10
## 2            9.755040e-10
## 3            6.188329e-10
## 4                      NA
##    Design number Type of design Maximum # stages Stage Information rate
## 1              1             WT                4     1             0.25
## 2              1             WT                4     2             0.50
## 3              1             WT                4     3             0.75
## 4              1             WT                4     4             1.00
## 5              2             WT                4     1             0.25
## 6              2             WT                4     2             0.50
## 7              2             WT                4     3             0.75
## 8              2             WT                4     4             1.00
## 9              3             WT                4     1             0.25
## 10             3             WT                4     2             0.50
## 11             3             WT                4     3             0.75
## 12             3             WT                4     4             1.00
##    Significance level Type II error rate Two-sided power
## 1                0.05                0.2           FALSE
## 2                0.05                0.2           FALSE
## 3                0.05                0.2           FALSE
## 4                0.05                0.2           FALSE
## 5                0.05                0.2           FALSE
## 6                0.05                0.2           FALSE
## 7                0.05                0.2           FALSE
## 8                0.05                0.2           FALSE
## 9                0.05                0.2           FALSE
## 10               0.05                0.2           FALSE
## 11               0.05                0.2           FALSE
## 12               0.05                0.2           FALSE
##    Delta (Wang & Tsiatis) Test Tolerance Cumulative alpha spending
## 1                     0.1    1     1e-08               0.001073781
## 2                     0.1    1     1e-08               0.010526914
## 3                     0.1    1     1e-08               0.028205994
## 4                     0.1    1     1e-08               0.050000000
## 5                     0.3    1     1e-08               0.006915859
## 6                     0.3    1     1e-08               0.020169238
## 7                     0.3    1     1e-08               0.035108439
## 8                     0.3    1     1e-08               0.050000000
## 9                     0.4    1     1e-08               0.012504953
## 10                    0.4    1     1e-08               0.026260600
## 11                    0.4    1     1e-08               0.038792487
## 12                    0.4    1     1e-08               0.050000000
##    Critical value Stage level
## 1        3.069028 0.001073781
## 2        2.325888 0.010012250
## 3        1.977663 0.023983344
## 4        1.762694 0.038976069
## 5        2.461604 0.006915859
## 6        2.142951 0.016058517
## 7        1.976032 0.024075572
## 8        1.865547 0.031052371
## 9        2.241250 0.012504953
## 10       2.091160 0.018256866
## 11       2.008067 0.022318106
## 12       1.951121 0.025521316
##   Stage Treatment group Sample size Mean Standard deviation
## 1     1               1          22  1.0                1.0
## 2     1               2          22  1.4                1.0
## 3     2               1          11  1.1                2.0
## 4     2               2          13  1.5                2.0
## 5     3               1          22  1.0                2.0
## 6     3               2          22  3.0                2.0
## 7     4               1          11  1.0                1.3
## 8     4               2          13  2.5                1.3
##   Overall sample size Overall mean Overall standard deviation
## 1                  22     1.000000                   1.000000
## 2                  22     1.400000                   1.000000
## 3                  33     1.033333                   1.381500
## 4                  35     1.437143                   1.425418
## 5                  55     1.020000                   1.639151
## 6                  57     2.040351                   1.822857
## 7                  66     1.016667                   1.578664
## 8                  70     2.125714                   1.738706
##   Stage Overall test statistic Overall p-value Overall mean (1)
## 1     1              -1.326650       0.9041035         1.000000
## 2     2              -1.185099       0.8798860         1.033333
## 3     3              -3.111238       0.9988132         1.020000
## 4     4              -3.886959       0.9999205         1.016667
##   Overall mean (2) Overall standard deviation (1)
## 1         1.400000                       1.000000
## 2         1.437143                       1.381500
## 3         2.040351                       1.639151
## 4         2.125714                       1.578664
##   Overall standard deviation (2) Overall sample size (1)
## 1                       1.000000                      22
## 2                       1.425418                      33
## 3                       1.822857                      55
## 4                       1.738706                      66
##   Overall sample size (2) Test statistic   p-value Effect size Theta H0
## 1                      22      -1.326650 0.9041035  -0.4000000        0
## 2                      35      -0.488194 0.6848785  -0.4038095        0
## 3                      57      -3.316625 0.9990567  -1.0203509        0
## 4                      70      -2.816504 0.9949743  -1.1090476        0
##   Direction Normal approximation Equal variance
## 1     upper                FALSE           TRUE
## 2     upper                FALSE           TRUE
## 3     upper                FALSE           TRUE
## 4     upper                FALSE           TRUE
##   Stage Information rate Critical value Futility bound (non-binding)
## 1     1             0.25       3.069028                         -Inf
## 2     2             0.50       2.325888                         -Inf
## 3     3             0.75       1.977663                         -Inf
## 4     4             1.00       1.762694                           NA
##   Cumulative alpha spending Stage level Effect size Test statistic
## 1               0.001073781 0.001073781  -0.4000000      -1.326650
## 2               0.010526914 0.010012250  -0.4038095      -0.488194
## 3               0.028205994 0.023983344  -1.0203509      -3.316625
## 4               0.050000000 0.038976069  -1.1090476      -2.816504
##     p-value Overall test statistic Overall p-value   Action          CRP
## 1 0.9041035              -1.326650       0.9041035 continue 2.810091e-03
## 2 0.6848785              -1.185099       0.8798860 continue 1.226756e-04
## 3 0.9990567              -3.111238       0.9988132 continue 6.661338e-16
## 4 0.9949743              -3.886959       0.9999205   accept           NA
##   Assumed standard deviation RCI (lower) RCI (upper) Repeated p-value
## 1                   1.662998   -1.386144   0.5861439         0.499999
## 2                   1.662998   -1.216028   0.4084087         0.499999
## 3                   1.662998   -1.676258  -0.3644440         0.499999
## 4                   1.662998   -1.615872  -0.6022231         0.499999
##   Final p-value Final CI (lower) Final CI (upper) Median unbiased estimate
## 1            NA               NA               NA                       NA
## 2            NA               NA               NA                       NA
## 3            NA               NA               NA                       NA
## 4     0.9999205        -1.546886        -0.608249                -1.077568
##    Stage Alternative Normal approximation Mean ratio Theta H0
## 1      1         0.2                FALSE      FALSE        0
## 2      1         0.4                FALSE      FALSE        0
## 3      1         0.6                FALSE      FALSE        0
## 4      1         0.8                FALSE      FALSE        0
## 5      1         1.0                FALSE      FALSE        0
## 6      2         0.2                FALSE      FALSE        0
## 7      2         0.4                FALSE      FALSE        0
## 8      2         0.6                FALSE      FALSE        0
## 9      2         0.8                FALSE      FALSE        0
## 10     2         1.0                FALSE      FALSE        0
## 11     3         0.2                FALSE      FALSE        0
## 12     3         0.4                FALSE      FALSE        0
## 13     3         0.6                FALSE      FALSE        0
## 14     3         0.8                FALSE      FALSE        0
## 15     3         1.0                FALSE      FALSE        0
## 16     4         0.2                FALSE      FALSE        0
## 17     4         0.4                FALSE      FALSE        0
## 18     4         0.6                FALSE      FALSE        0
## 19     4         0.8                FALSE      FALSE        0
## 20     4         1.0                FALSE      FALSE        0
##    Standard deviation Treatment group Planned allocation ratio
## 1                   1               2                        1
## 2                   1               2                        1
## 3                   1               2                        1
## 4                   1               2                        1
## 5                   1               2                        1
## 6                   1               2                        1
## 7                   1               2                        1
## 8                   1               2                        1
## 9                   1               2                        1
## 10                  1               2                        1
## 11                  1               2                        1
## 12                  1               2                        1
## 13                  1               2                        1
## 14                  1               2                        1
## 15                  1               2                        1
## 16                  1               2                        1
## 17                  1               2                        1
## 18                  1               2                        1
## 19                  1               2                        1
## 20                  1               2                        1
##    Information rate Max # subjects Max # subjects (1) Max # subjects (2)
## 1              0.25      649.63926          324.81963          324.81963
## 2              0.25      163.49107           81.74554           81.74554
## 3              0.25       73.48452           36.74226           36.74226
## 4              0.25       42.00708           21.00354           21.00354
## 5              0.25       27.46496           13.73248           13.73248
## 6              0.50      649.63926          324.81963          324.81963
## 7              0.50      163.49107           81.74554           81.74554
## 8              0.50       73.48452           36.74226           36.74226
## 9              0.50       42.00708           21.00354           21.00354
## 10             0.50       27.46496           13.73248           13.73248
## 11             0.75      649.63926          324.81963          324.81963
## 12             0.75      163.49107           81.74554           81.74554
## 13             0.75       73.48452           36.74226           36.74226
## 14             0.75       42.00708           21.00354           21.00354
## 15             0.75       27.46496           13.73248           13.73248
## 16             1.00      649.63926          324.81963          324.81963
## 17             1.00      163.49107           81.74554           81.74554
## 18             1.00       73.48452           36.74226           36.74226
## 19             1.00       42.00708           21.00354           21.00354
## 20             1.00       27.46496           13.73248           13.73248
##    # subjects Expected # subjects under H0 Expected # subjects under H0/H1
## 1  162.409815                    643.17426                       602.51988
## 2   40.872769                    161.86406                       151.63280
## 3   18.371130                     72.75323                        68.15457
## 4   10.501771                     41.58904                        38.96024
## 5    6.866239                     27.19163                        25.47288
## 6  324.819630                    643.17426                       602.51988
## 7   81.745537                    161.86406                       151.63280
## 8   36.742260                     72.75323                        68.15457
## 9   21.003541                     41.58904                        38.96024
## 10  13.732478                     27.19163                        25.47288
## 11 487.229445                    643.17426                       602.51988
## 12 122.618306                    161.86406                       151.63280
## 13  55.113391                     72.75323                        68.15457
## 14  31.505312                     41.58904                        38.96024
## 15  20.598717                     27.19163                        25.47288
## 16 649.639259                    643.17426                       602.51988
## 17 163.491074                    161.86406                       151.63280
## 18  73.484521                     72.75323                        68.15457
## 19  42.007082                     41.58904                        38.96024
## 20  27.464956                     27.19163                        25.47288
##    Expected # subjects under H1 Reject per stage Early stop
## 1                     496.60668       0.03624538  0.6033704
## 2                     124.97822       0.03624538  0.6033704
## 3                      56.17411       0.03624538  0.6033704
## 4                      32.11166       0.03624538  0.6033704
## 5                      20.99516       0.03624538  0.6033704
## 6                     496.60668       0.26640074  0.6033704
## 7                     124.97822       0.26640074  0.6033704
## 8                      56.17411       0.26640074  0.6033704
## 9                      32.11166       0.26640074  0.6033704
## 10                     20.99516       0.26640074  0.6033704
## 11                    496.60668       0.30072424  0.6033704
## 12                    124.97822       0.30072424  0.6033704
## 13                     56.17411       0.30072424  0.6033704
## 14                     32.11166       0.30072424  0.6033704
## 15                     20.99516       0.30072424  0.6033704
## 16                    496.60668       0.19662964  0.6033704
## 17                    124.97822       0.19662964  0.6033704
## 18                     56.17411       0.19662964  0.6033704
## 19                     32.11166       0.19662964  0.6033704
## 20                     20.99516       0.19662964  0.6033704
##    Critical value (effect scale) Local one-sided significance level
## 1                      0.4816424                        0.001073781
## 2                      0.9600942                        0.001073781
## 3                      1.4320657                        0.001073781
## 4                      1.8940857                        0.001073781
## 5                      2.3424559                        0.001073781
## 6                      0.2581058                        0.010012250
## 7                      0.5145018                        0.010012250
## 8                      0.7674250                        0.010012250
## 9                      1.0150154                        0.010012250
## 10                     1.2552910                        0.010012250
## 11                     0.1791908                        0.023983344
## 12                     0.3571945                        0.023983344
## 13                     0.5327872                        0.023983344
## 14                     0.7046776                        0.023983344
## 15                     0.8714898                        0.023983344
## 16                     0.1383155                        0.038976069
## 17                     0.2757147                        0.038976069
## 18                     0.4112529                        0.038976069
## 19                     0.5439333                        0.038976069
## 20                     0.6726938                        0.038976069
##    Stage pi (1) Max # subjects Accrual time Accrual intensity
## 1      1    0.2            100           12          8.333333
## 2      1    0.3            100           12          8.333333
## 3      1    0.4            100           12          8.333333
## 4      1    0.5            100           12          8.333333
## 5      2    0.2            100           12          8.333333
## 6      2    0.3            100           12          8.333333
## 7      2    0.4            100           12          8.333333
## 8      2    0.5            100           12          8.333333
## 9      3    0.2            100           12          8.333333
## 10     3    0.3            100           12          8.333333
## 11     3    0.4            100           12          8.333333
## 12     3    0.5            100           12          8.333333
## 13     4    0.2            100           12          8.333333
## 14     4    0.3            100           12          8.333333
## 15     4    0.4            100           12          8.333333
## 16     4    0.5            100           12          8.333333
##    Required planned events pi (2) Median (1) Median (2) Direction upper
## 1                       50    0.2   37.27540    37.2754            TRUE
## 2                      100    0.2   23.32030    37.2754            TRUE
## 3                      150    0.2   16.28299    37.2754            TRUE
## 4                      200    0.2   12.00000    37.2754            TRUE
## 5                       50    0.2   37.27540    37.2754            TRUE
## 6                      100    0.2   23.32030    37.2754            TRUE
## 7                      150    0.2   16.28299    37.2754            TRUE
## 8                      200    0.2   12.00000    37.2754            TRUE
## 9                       50    0.2   37.27540    37.2754            TRUE
## 10                     100    0.2   23.32030    37.2754            TRUE
## 11                     150    0.2   16.28299    37.2754            TRUE
## 12                     200    0.2   12.00000    37.2754            TRUE
## 13                      50    0.2   37.27540    37.2754            TRUE
## 14                     100    0.2   23.32030    37.2754            TRUE
## 15                     150    0.2   16.28299    37.2754            TRUE
## 16                     200    0.2   12.00000    37.2754            TRUE
##    Drop-out rate (1) Drop-out rate (2) Drop-out time Event time Theta H0
## 1                  0                 0            12         12        1
## 2                  0                 0            12         12        1
## 3                  0                 0            12         12        1
## 4                  0                 0            12         12        1
## 5                  0                 0            12         12        1
## 6                  0                 0            12         12        1
## 7                  0                 0            12         12        1
## 8                  0                 0            12         12        1
## 9                  0                 0            12         12        1
## 10                 0                 0            12         12        1
## 11                 0                 0            12         12        1
## 12                 0                 0            12         12        1
## 13                 0                 0            12         12        1
## 14                 0                 0            12         12        1
## 15                 0                 0            12         12        1
## 16                 0                 0            12         12        1
##    Allocation 1 Allocation 2 Conditional power Maximum # iterations Kappa
## 1             1            1                NA                 1000     1
## 2             1            1                NA                 1000     1
## 3             1            1                NA                 1000     1
## 4             1            1                NA                 1000     1
## 5             1            1                NA                 1000     1
## 6             1            1                NA                 1000     1
## 7             1            1                NA                 1000     1
## 8             1            1                NA                 1000     1
## 9             1            1                NA                 1000     1
## 10            1            1                NA                 1000     1
## 11            1            1                NA                 1000     1
## 12            1            1                NA                 1000     1
## 13            1            1                NA                 1000     1
## 14            1            1                NA                 1000     1
## 15            1            1                NA                 1000     1
## 16            1            1                NA                 1000     1
##    Lambda (1) Lambda (2) Hazard ratio Iterations Analysis time
## 1  0.01859530  0.0185953     1.000000       1000      42.95687
## 2  0.02972291  0.0185953     1.598410       1000      35.29897
## 3  0.04256880  0.0185953     2.289224       1000      29.97592
## 4  0.05776227  0.0185953     3.106284       1000      26.23859
## 5  0.01859530  0.0185953     1.000000          0            NA
## 6  0.02972291  0.0185953     1.598410          0            NA
## 7  0.04256880  0.0185953     2.289224          0            NA
## 8  0.05776227  0.0185953     3.106284          0            NA
## 9  0.01859530  0.0185953     1.000000          0            NA
## 10 0.02972291  0.0185953     1.598410          0            NA
## 11 0.04256880  0.0185953     2.289224          0            NA
## 12 0.05776227  0.0185953     3.106284          0            NA
## 13 0.01859530  0.0185953     1.000000          0            NA
## 14 0.02972291  0.0185953     1.598410          0            NA
## 15 0.04256880  0.0185953     2.289224          0            NA
## 16 0.05776227  0.0185953     3.106284          0            NA
##    Expected study duration # events by stage Expected # events
## 1                 0.000000                50              0.00
## 2                 3.061767                50              4.20
## 3                12.600565                50             20.75
## 4                21.096574                50             39.95
## 5                 0.000000                NA              0.00
## 6                 3.061767                NA              4.20
## 7                12.600565                NA             20.75
## 8                21.096574                NA             39.95
## 9                 0.000000                NA              0.00
## 10                3.061767                NA              4.20
## 11               12.600565                NA             20.75
## 12               21.096574                NA             39.95
## 13                0.000000                NA              0.00
## 14                3.061767                NA              4.20
## 15               12.600565                NA             20.75
## 16               21.096574                NA             39.95
##    Events not achieved # subjects Expected # subjects Reject per stage
## 1                0.000        100                 0.0            0.000
## 2                0.000        100                 8.4            0.084
## 3                0.000        100                41.5            0.415
## 4                0.000        100                79.9            0.799
## 5                1.000         NA                 0.0            0.000
## 6                0.916         NA                 8.4            0.000
## 7                0.585         NA                41.5            0.000
## 8                0.201         NA                79.9            0.000
## 9                0.000         NA                 0.0            0.000
## 10               0.000         NA                 8.4            0.000
## 11               0.000         NA                41.5            0.000
## 12               0.000         NA                79.9            0.000
## 13               0.000         NA                 0.0            0.000
## 14               0.000         NA                 8.4            0.000
## 15               0.000         NA                41.5            0.000
## 16               0.000         NA                79.9            0.000
##    Overall reject Futility stop per stage Futility stop Early stop
## 1           0.000                       0             0      0.000
## 2           0.084                       0             0      0.084
## 3           0.415                       0             0      0.415
## 4           0.799                       0             0      0.799
## 5           0.000                       0             0      0.000
## 6           0.084                       0             0      0.084
## 7           0.415                       0             0      0.415
## 8           0.799                       0             0      0.799
## 9           0.000                       0             0      0.000
## 10          0.084                       0             0      0.084
## 11          0.415                       0             0      0.415
## 12          0.799                       0             0      0.799
## 13          0.000                      NA             0      0.000
## 14          0.084                      NA             0      0.084
## 15          0.415                      NA             0      0.415
## 16          0.799                      NA             0      0.799
##         Seed
## 1  103083921
## 2  103083921
## 3  103083921
## 4  103083921
## 5  103083921
## 6  103083921
## 7  103083921
## 8  103083921
## 9  103083921
## 10 103083921
## 11 103083921
## 12 103083921
## 13 103083921
## 14 103083921
## 15 103083921
## 16 103083921
##   Piecewise survival times Lambda (1) Lambda (2) Hazard ratio Event time
## 1                        0     0.0200      0.025          0.8         12
## 2                        6     0.0320      0.040          0.8         12
## 3                        9     0.0120      0.015          0.8         12
## 4                       15     0.0080      0.010          0.8         12
## 5                       21     0.0056      0.007          0.8         12
##   Kappa Piecewise exponential survival enabled Delayed response allowed
## 1     1                                   TRUE                    FALSE
## 2     1                                   TRUE                    FALSE
## 3     1                                   TRUE                    FALSE
## 4     1                                   TRUE                    FALSE
## 5     1                                   TRUE                    FALSE
##   End of accrual is user defined Follow-up time must be user defined
## 1                          FALSE                               FALSE
## 2                          FALSE                               FALSE
## 3                          FALSE                               FALSE
## 4                          FALSE                               FALSE
## 5                          FALSE                               FALSE
## 6                          FALSE                               FALSE
## 7                          FALSE                               FALSE
##   Max number of subjects is user defined
## 1                                   TRUE
## 2                                   TRUE
## 3                                   TRUE
## 4                                   TRUE
## 5                                   TRUE
## 6                                   TRUE
## 7                                   TRUE
##   Max number of subjects can be calculated directly
## 1                                              TRUE
## 2                                              TRUE
## 3                                              TRUE
## 4                                              TRUE
## 5                                              TRUE
## 6                                              TRUE
## 7                                              TRUE
##   Absolute accrual intensity is enabled Accrual time Accrual intensity
## 1                                  TRUE      0.00000                15
## 2                                  TRUE     12.00000                21
## 3                                  TRUE     13.00000                27
## 4                                  TRUE     14.00000                33
## 5                                  TRUE     15.00000                39
## 6                                  TRUE     16.00000                45
## 7                                  TRUE     40.44444                NA
##   Max # subjects Remaining time piecewiseAccrualEnabled
## 1           1400       24.44444                    TRUE
## 2           1400       24.44444                    TRUE
## 3           1400       24.44444                    TRUE
## 4           1400       24.44444                    TRUE
## 5           1400       24.44444                    TRUE
## 6           1400       24.44444                    TRUE
## 7           1400       24.44444                    TRUE

2.5 Coerce object to data.frame: as.data.frame with argument ‘niceColumnNamesEnabled = FALSE’

##   typeOfDesign kMax stages informationRates alpha beta twoSidedPower
## 1           WT    4      1             0.25  0.05  0.2         FALSE
## 2           WT    4      2             0.50  0.05  0.2         FALSE
## 3           WT    4      3             0.75  0.05  0.2         FALSE
## 4           WT    4      4             1.00  0.05  0.2         FALSE
##   deltaWT sided tolerance  alphaSpent criticalValues stageLevels
## 1     0.1     1     1e-08 0.001073781       3.069028 0.001073781
## 2     0.1     1     1e-08 0.010526914       2.325888 0.010012250
## 3     0.1     1     1e-08 0.028205994       1.977663 0.023983344
## 4     0.1     1     1e-08 0.050000000       1.762694 0.038976069
##       method kMax stages informationRates alpha alpha0Vec bindingFutility
## 1 equalAlpha    4      1              0.2 0.025       0.4            TRUE
## 2 equalAlpha    4      2              0.5 0.025       0.4            TRUE
## 3 equalAlpha    4      3              0.8 0.025       0.4            TRUE
## 4 equalAlpha    4      4              1.0 0.025        NA            TRUE
##   sided tolerance iterations alphaSpent criticalValues stageLevels
## 1     1     1e-14          0 0.01366638   1.366638e-02  0.01366638
## 2     1     1e-14          0 0.02055086   8.921538e-04  0.01366638
## 3     1     1e-14          0 0.02372061   9.643023e-05  0.01366638
## 4     1     1e-14          0 0.02500000   2.151406e-05  0.01366638
##      scale nonStochasticCurtailment
## 1 1.224745                    FALSE
## 2 1.224745                    FALSE
## 3 1.000000                    FALSE
## 4       NA                    FALSE
##   inflationFactor stages information      power rejectionProbabilities
## 1         1.04846      1    1.620541 0.03624538             0.03624538
## 2         1.04846      2    3.241081 0.30264612             0.26640074
## 3         1.04846      3    4.861622 0.60337036             0.30072424
## 4         1.04846      4    6.482163 0.80000000             0.19662964
##   futilityProbabilities averageSampleNumber1 averageSampleNumber01
## 1          9.865876e-10            0.8014789             0.9724133
## 2          9.758407e-10            0.8014789             0.9724133
## 3          9.359906e-10            0.8014789             0.9724133
## 4                    NA            0.8014789             0.9724133
##   averageSampleNumber0
## 1             1.038026
## 2             1.038026
## 3             1.038026
## 4             1.038026
##   stages theta averageSampleNumber calculatedPower overallEarlyStop
## 1      1     1            25.66861               1                1
## 2      2     1            25.66861               1                1
## 3      3     1            25.66861               1                1
## 4      4     1            25.66861               1                1
##      earlyStop overallReject rejectPerStage overallFutility
## 1 9.732567e-01             1   9.732567e-01    2.580925e-09
## 2 2.674225e-02             1   2.674225e-02    2.580925e-09
## 3 1.025014e-06             1   1.024395e-06    2.580925e-09
## 4           NA             1   0.000000e+00    2.580925e-09
##   futilityPerStage
## 1     9.865876e-10
## 2     9.755040e-10
## 3     6.188329e-10
## 4               NA
##    designNumber typeOfDesign kMax stages informationRates alpha beta
## 1             1           WT    4      1             0.25  0.05  0.2
## 2             1           WT    4      2             0.50  0.05  0.2
## 3             1           WT    4      3             0.75  0.05  0.2
## 4             1           WT    4      4             1.00  0.05  0.2
## 5             2           WT    4      1             0.25  0.05  0.2
## 6             2           WT    4      2             0.50  0.05  0.2
## 7             2           WT    4      3             0.75  0.05  0.2
## 8             2           WT    4      4             1.00  0.05  0.2
## 9             3           WT    4      1             0.25  0.05  0.2
## 10            3           WT    4      2             0.50  0.05  0.2
## 11            3           WT    4      3             0.75  0.05  0.2
## 12            3           WT    4      4             1.00  0.05  0.2
##    twoSidedPower deltaWT sided tolerance  alphaSpent criticalValues
## 1          FALSE     0.1     1     1e-08 0.001073781       3.069028
## 2          FALSE     0.1     1     1e-08 0.010526914       2.325888
## 3          FALSE     0.1     1     1e-08 0.028205994       1.977663
## 4          FALSE     0.1     1     1e-08 0.050000000       1.762694
## 5          FALSE     0.3     1     1e-08 0.006915859       2.461604
## 6          FALSE     0.3     1     1e-08 0.020169238       2.142951
## 7          FALSE     0.3     1     1e-08 0.035108439       1.976032
## 8          FALSE     0.3     1     1e-08 0.050000000       1.865547
## 9          FALSE     0.4     1     1e-08 0.012504953       2.241250
## 10         FALSE     0.4     1     1e-08 0.026260600       2.091160
## 11         FALSE     0.4     1     1e-08 0.038792487       2.008067
## 12         FALSE     0.4     1     1e-08 0.050000000       1.951121
##    stageLevels
## 1  0.001073781
## 2  0.010012250
## 3  0.023983344
## 4  0.038976069
## 5  0.006915859
## 6  0.016058517
## 7  0.024075572
## 8  0.031052371
## 9  0.012504953
## 10 0.018256866
## 11 0.022318106
## 12 0.025521316
##   stages groups sampleSizes means stDevs overallSampleSizes overallMeans
## 1      1      1          22   1.0    1.0                 22     1.000000
## 2      1      2          22   1.4    1.0                 22     1.400000
## 3      2      1          11   1.1    2.0                 33     1.033333
## 4      2      2          13   1.5    2.0                 35     1.437143
## 5      3      1          22   1.0    2.0                 55     1.020000
## 6      3      2          22   3.0    2.0                 57     2.040351
## 7      4      1          11   1.0    1.3                 66     1.016667
## 8      4      2          13   2.5    1.3                 70     2.125714
##   overallStDevs
## 1      1.000000
## 2      1.000000
## 3      1.381500
## 4      1.425418
## 5      1.639151
## 6      1.822857
## 7      1.578664
## 8      1.738706
##   stages overallTestStatistics overallPValues overallMeans1 overallMeans2
## 1      1             -1.326650      0.9041035      1.000000      1.400000
## 2      2             -1.185099      0.8798860      1.033333      1.437143
## 3      3             -3.111238      0.9988132      1.020000      2.040351
## 4      4             -3.886959      0.9999205      1.016667      2.125714
##   overallStDevs1 overallStDevs2 overallSampleSizes1 overallSampleSizes2
## 1       1.000000       1.000000                  22                  22
## 2       1.381500       1.425418                  33                  35
## 3       1.639151       1.822857                  55                  57
## 4       1.578664       1.738706                  66                  70
##   testStatistics   pValues effectSizes thetaH0 direction
## 1      -1.326650 0.9041035  -0.4000000       0     upper
## 2      -0.488194 0.6848785  -0.4038095       0     upper
## 3      -3.316625 0.9990567  -1.0203509       0     upper
## 4      -2.816504 0.9949743  -1.1090476       0     upper
##   normalApproximation equalVariances
## 1               FALSE           TRUE
## 2               FALSE           TRUE
## 3               FALSE           TRUE
## 4               FALSE           TRUE
##   Stage Information rate Critical value Futility bound (non-binding)
## 1     1             0.25       3.069028                         -Inf
## 2     2             0.50       2.325888                         -Inf
## 3     3             0.75       1.977663                         -Inf
## 4     4             1.00       1.762694                           NA
##   Cumulative alpha spending Stage level Effect size Test statistic
## 1               0.001073781 0.001073781  -0.4000000      -1.326650
## 2               0.010526914 0.010012250  -0.4038095      -0.488194
## 3               0.028205994 0.023983344  -1.0203509      -3.316625
## 4               0.050000000 0.038976069  -1.1090476      -2.816504
##     p-value Overall test statistic Overall p-value   Action          CRP
## 1 0.9041035              -1.326650       0.9041035 continue 2.810091e-03
## 2 0.6848785              -1.185099       0.8798860 continue 1.226756e-04
## 3 0.9990567              -3.111238       0.9988132 continue 6.661338e-16
## 4 0.9949743              -3.886959       0.9999205   accept           NA
##   Assumed standard deviation RCI (lower) RCI (upper) Repeated p-value
## 1                   1.662998   -1.386144   0.5861439         0.499999
## 2                   1.662998   -1.216028   0.4084087         0.499999
## 3                   1.662998   -1.676258  -0.3644440         0.499999
## 4                   1.662998   -1.615872  -0.6022231         0.499999
##   Final p-value Final CI (lower) Final CI (upper) Median unbiased estimate
## 1            NA               NA               NA                       NA
## 2            NA               NA               NA                       NA
## 3            NA               NA               NA                       NA
## 4     0.9999205        -1.546886        -0.608249                -1.077568
##    stages alternative normalApproximation meanRatio thetaH0 stDev groups
## 1       1         0.2               FALSE     FALSE       0     1      2
## 2       1         0.4               FALSE     FALSE       0     1      2
## 3       1         0.6               FALSE     FALSE       0     1      2
## 4       1         0.8               FALSE     FALSE       0     1      2
## 5       1         1.0               FALSE     FALSE       0     1      2
## 6       2         0.2               FALSE     FALSE       0     1      2
## 7       2         0.4               FALSE     FALSE       0     1      2
## 8       2         0.6               FALSE     FALSE       0     1      2
## 9       2         0.8               FALSE     FALSE       0     1      2
## 10      2         1.0               FALSE     FALSE       0     1      2
## 11      3         0.2               FALSE     FALSE       0     1      2
## 12      3         0.4               FALSE     FALSE       0     1      2
## 13      3         0.6               FALSE     FALSE       0     1      2
## 14      3         0.8               FALSE     FALSE       0     1      2
## 15      3         1.0               FALSE     FALSE       0     1      2
## 16      4         0.2               FALSE     FALSE       0     1      2
## 17      4         0.4               FALSE     FALSE       0     1      2
## 18      4         0.6               FALSE     FALSE       0     1      2
## 19      4         0.8               FALSE     FALSE       0     1      2
## 20      4         1.0               FALSE     FALSE       0     1      2
##    allocationRatioPlanned informationRates maxNumberOfSubjects
## 1                       1             0.25           649.63926
## 2                       1             0.25           163.49107
## 3                       1             0.25            73.48452
## 4                       1             0.25            42.00708
## 5                       1             0.25            27.46496
## 6                       1             0.50           649.63926
## 7                       1             0.50           163.49107
## 8                       1             0.50            73.48452
## 9                       1             0.50            42.00708
## 10                      1             0.50            27.46496
## 11                      1             0.75           649.63926
## 12                      1             0.75           163.49107
## 13                      1             0.75            73.48452
## 14                      1             0.75            42.00708
## 15                      1             0.75            27.46496
## 16                      1             1.00           649.63926
## 17                      1             1.00           163.49107
## 18                      1             1.00            73.48452
## 19                      1             1.00            42.00708
## 20                      1             1.00            27.46496
##    maxNumberOfSubjects1 maxNumberOfSubjects2 numberOfSubjects
## 1             324.81963            324.81963       162.409815
## 2              81.74554             81.74554        40.872769
## 3              36.74226             36.74226        18.371130
## 4              21.00354             21.00354        10.501771
## 5              13.73248             13.73248         6.866239
## 6             324.81963            324.81963       324.819630
## 7              81.74554             81.74554        81.745537
## 8              36.74226             36.74226        36.742260
## 9              21.00354             21.00354        21.003541
## 10             13.73248             13.73248        13.732478
## 11            324.81963            324.81963       487.229445
## 12             81.74554             81.74554       122.618306
## 13             36.74226             36.74226        55.113391
## 14             21.00354             21.00354        31.505312
## 15             13.73248             13.73248        20.598717
## 16            324.81963            324.81963       649.639259
## 17             81.74554             81.74554       163.491074
## 18             36.74226             36.74226        73.484521
## 19             21.00354             21.00354        42.007082
## 20             13.73248             13.73248        27.464956
##    expectedNumberOfSubjectsH0 expectedNumberOfSubjectsH01
## 1                   643.17426                   602.51988
## 2                   161.86406                   151.63280
## 3                    72.75323                    68.15457
## 4                    41.58904                    38.96024
## 5                    27.19163                    25.47288
## 6                   643.17426                   602.51988
## 7                   161.86406                   151.63280
## 8                    72.75323                    68.15457
## 9                    41.58904                    38.96024
## 10                   27.19163                    25.47288
## 11                  643.17426                   602.51988
## 12                  161.86406                   151.63280
## 13                   72.75323                    68.15457
## 14                   41.58904                    38.96024
## 15                   27.19163                    25.47288
## 16                  643.17426                   602.51988
## 17                  161.86406                   151.63280
## 18                   72.75323                    68.15457
## 19                   41.58904                    38.96024
## 20                   27.19163                    25.47288
##    expectedNumberOfSubjectsH1 rejectPerStage earlyStop
## 1                   496.60668     0.03624538 0.6033704
## 2                   124.97822     0.03624538 0.6033704
## 3                    56.17411     0.03624538 0.6033704
## 4                    32.11166     0.03624538 0.6033704
## 5                    20.99516     0.03624538 0.6033704
## 6                   496.60668     0.26640074 0.6033704
## 7                   124.97822     0.26640074 0.6033704
## 8                    56.17411     0.26640074 0.6033704
## 9                    32.11166     0.26640074 0.6033704
## 10                   20.99516     0.26640074 0.6033704
## 11                  496.60668     0.30072424 0.6033704
## 12                  124.97822     0.30072424 0.6033704
## 13                   56.17411     0.30072424 0.6033704
## 14                   32.11166     0.30072424 0.6033704
## 15                   20.99516     0.30072424 0.6033704
## 16                  496.60668     0.19662964 0.6033704
## 17                  124.97822     0.19662964 0.6033704
## 18                   56.17411     0.19662964 0.6033704
## 19                   32.11166     0.19662964 0.6033704
## 20                   20.99516     0.19662964 0.6033704
##    criticalValuesEffectScale criticalValuesPValueScale
## 1                  0.4816424               0.001073781
## 2                  0.9600942               0.001073781
## 3                  1.4320657               0.001073781
## 4                  1.8940857               0.001073781
## 5                  2.3424559               0.001073781
## 6                  0.2581058               0.010012250
## 7                  0.5145018               0.010012250
## 8                  0.7674250               0.010012250
## 9                  1.0150154               0.010012250
## 10                 1.2552910               0.010012250
## 11                 0.1791908               0.023983344
## 12                 0.3571945               0.023983344
## 13                 0.5327872               0.023983344
## 14                 0.7046776               0.023983344
## 15                 0.8714898               0.023983344
## 16                 0.1383155               0.038976069
## 17                 0.2757147               0.038976069
## 18                 0.4112529               0.038976069
## 19                 0.5439333               0.038976069
## 20                 0.6726938               0.038976069
##    stages pi1 maxNumberOfSubjects accrualTime accrualIntensity
## 1       1 0.2                 100          12         8.333333
## 2       1 0.3                 100          12         8.333333
## 3       1 0.4                 100          12         8.333333
## 4       1 0.5                 100          12         8.333333
## 5       2 0.2                 100          12         8.333333
## 6       2 0.3                 100          12         8.333333
## 7       2 0.4                 100          12         8.333333
## 8       2 0.5                 100          12         8.333333
## 9       3 0.2                 100          12         8.333333
## 10      3 0.3                 100          12         8.333333
## 11      3 0.4                 100          12         8.333333
## 12      3 0.5                 100          12         8.333333
## 13      4 0.2                 100          12         8.333333
## 14      4 0.3                 100          12         8.333333
## 15      4 0.4                 100          12         8.333333
## 16      4 0.5                 100          12         8.333333
##    plannedEvents pi2  median1 median2 directionUpper dropoutRate1
## 1             50 0.2 37.27540 37.2754           TRUE            0
## 2            100 0.2 23.32030 37.2754           TRUE            0
## 3            150 0.2 16.28299 37.2754           TRUE            0
## 4            200 0.2 12.00000 37.2754           TRUE            0
## 5             50 0.2 37.27540 37.2754           TRUE            0
## 6            100 0.2 23.32030 37.2754           TRUE            0
## 7            150 0.2 16.28299 37.2754           TRUE            0
## 8            200 0.2 12.00000 37.2754           TRUE            0
## 9             50 0.2 37.27540 37.2754           TRUE            0
## 10           100 0.2 23.32030 37.2754           TRUE            0
## 11           150 0.2 16.28299 37.2754           TRUE            0
## 12           200 0.2 12.00000 37.2754           TRUE            0
## 13            50 0.2 37.27540 37.2754           TRUE            0
## 14           100 0.2 23.32030 37.2754           TRUE            0
## 15           150 0.2 16.28299 37.2754           TRUE            0
## 16           200 0.2 12.00000 37.2754           TRUE            0
##    dropoutRate2 dropoutTime eventTime thetaH0 allocation1 allocation2
## 1             0          12        12       1           1           1
## 2             0          12        12       1           1           1
## 3             0          12        12       1           1           1
## 4             0          12        12       1           1           1
## 5             0          12        12       1           1           1
## 6             0          12        12       1           1           1
## 7             0          12        12       1           1           1
## 8             0          12        12       1           1           1
## 9             0          12        12       1           1           1
## 10            0          12        12       1           1           1
## 11            0          12        12       1           1           1
## 12            0          12        12       1           1           1
## 13            0          12        12       1           1           1
## 14            0          12        12       1           1           1
## 15            0          12        12       1           1           1
## 16            0          12        12       1           1           1
##    conditionalPower maxNumberOfIterations kappa    lambda1   lambda2
## 1                NA                  1000     1 0.01859530 0.0185953
## 2                NA                  1000     1 0.02972291 0.0185953
## 3                NA                  1000     1 0.04256880 0.0185953
## 4                NA                  1000     1 0.05776227 0.0185953
## 5                NA                  1000     1 0.01859530 0.0185953
## 6                NA                  1000     1 0.02972291 0.0185953
## 7                NA                  1000     1 0.04256880 0.0185953
## 8                NA                  1000     1 0.05776227 0.0185953
## 9                NA                  1000     1 0.01859530 0.0185953
## 10               NA                  1000     1 0.02972291 0.0185953
## 11               NA                  1000     1 0.04256880 0.0185953
## 12               NA                  1000     1 0.05776227 0.0185953
## 13               NA                  1000     1 0.01859530 0.0185953
## 14               NA                  1000     1 0.02972291 0.0185953
## 15               NA                  1000     1 0.04256880 0.0185953
## 16               NA                  1000     1 0.05776227 0.0185953
##    hazardRatio iterations analysisTime studyDuration eventsPerStage
## 1     1.000000       1000     42.95687      0.000000             50
## 2     1.598410       1000     35.29897      3.061767             50
## 3     2.289224       1000     29.97592     12.600565             50
## 4     3.106284       1000     26.23859     21.096574             50
## 5     1.000000          0           NA      0.000000             NA
## 6     1.598410          0           NA      3.061767             NA
## 7     2.289224          0           NA     12.600565             NA
## 8     3.106284          0           NA     21.096574             NA
## 9     1.000000          0           NA      0.000000             NA
## 10    1.598410          0           NA      3.061767             NA
## 11    2.289224          0           NA     12.600565             NA
## 12    3.106284          0           NA     21.096574             NA
## 13    1.000000          0           NA      0.000000             NA
## 14    1.598410          0           NA      3.061767             NA
## 15    2.289224          0           NA     12.600565             NA
## 16    3.106284          0           NA     21.096574             NA
##    expectedNumberOfEvents eventsNotAchieved numberOfSubjects
## 1                    0.00             0.000              100
## 2                    4.20             0.000              100
## 3                   20.75             0.000              100
## 4                   39.95             0.000              100
## 5                    0.00             1.000               NA
## 6                    4.20             0.916               NA
## 7                   20.75             0.585               NA
## 8                   39.95             0.201               NA
## 9                    0.00             0.000               NA
## 10                   4.20             0.000               NA
## 11                  20.75             0.000               NA
## 12                  39.95             0.000               NA
## 13                   0.00             0.000               NA
## 14                   4.20             0.000               NA
## 15                  20.75             0.000               NA
## 16                  39.95             0.000               NA
##    expectedNumberOfSubjects rejectPerStage overallReject futilityPerStage
## 1                       0.0          0.000         0.000                0
## 2                       8.4          0.084         0.084                0
## 3                      41.5          0.415         0.415                0
## 4                      79.9          0.799         0.799                0
## 5                       0.0          0.000         0.000                0
## 6                       8.4          0.000         0.084                0
## 7                      41.5          0.000         0.415                0
## 8                      79.9          0.000         0.799                0
## 9                       0.0          0.000         0.000                0
## 10                      8.4          0.000         0.084                0
## 11                     41.5          0.000         0.415                0
## 12                     79.9          0.000         0.799                0
## 13                      0.0          0.000         0.000               NA
## 14                      8.4          0.000         0.084               NA
## 15                     41.5          0.000         0.415               NA
## 16                     79.9          0.000         0.799               NA
##    futilityStop earlyStop      seed
## 1             0     0.000 103083921
## 2             0     0.084 103083921
## 3             0     0.415 103083921
## 4             0     0.799 103083921
## 5             0     0.000 103083921
## 6             0     0.084 103083921
## 7             0     0.415 103083921
## 8             0     0.799 103083921
## 9             0     0.000 103083921
## 10            0     0.084 103083921
## 11            0     0.415 103083921
## 12            0     0.799 103083921
## 13            0     0.000 103083921
## 14            0     0.084 103083921
## 15            0     0.415 103083921
## 16            0     0.799 103083921
##   piecewiseSurvivalTime lambda1 lambda2 hazardRatio eventTime kappa
## 1                     0  0.0200   0.025         0.8        12     1
## 2                     6  0.0320   0.040         0.8        12     1
## 3                     9  0.0120   0.015         0.8        12     1
## 4                    15  0.0080   0.010         0.8        12     1
## 5                    21  0.0056   0.007         0.8        12     1
##   piecewiseSurvivalEnabled delayedResponseAllowed
## 1                     TRUE                  FALSE
## 2                     TRUE                  FALSE
## 3                     TRUE                  FALSE
## 4                     TRUE                  FALSE
## 5                     TRUE                  FALSE
##   endOfAccrualIsUserDefined followUpTimeMustBeUserDefined
## 1                     FALSE                         FALSE
## 2                     FALSE                         FALSE
## 3                     FALSE                         FALSE
## 4                     FALSE                         FALSE
## 5                     FALSE                         FALSE
## 6                     FALSE                         FALSE
## 7                     FALSE                         FALSE
##   maxNumberOfSubjectsIsUserDefined
## 1                             TRUE
## 2                             TRUE
## 3                             TRUE
## 4                             TRUE
## 5                             TRUE
## 6                             TRUE
## 7                             TRUE
##   maxNumberOfSubjectsCanBeCalculatedDirectly
## 1                                       TRUE
## 2                                       TRUE
## 3                                       TRUE
## 4                                       TRUE
## 5                                       TRUE
## 6                                       TRUE
## 7                                       TRUE
##   absoluteAccrualIntensityEnabled accrualTime accrualIntensity
## 1                            TRUE     0.00000               15
## 2                            TRUE    12.00000               21
## 3                            TRUE    13.00000               27
## 4                            TRUE    14.00000               33
## 5                            TRUE    15.00000               39
## 6                            TRUE    16.00000               45
## 7                            TRUE    40.44444               NA
##   maxNumberOfSubjects remainingTime piecewiseAccrualEnabled
## 1                1400      24.44444                    TRUE
## 2                1400      24.44444                    TRUE
## 3                1400      24.44444                    TRUE
## 4                1400      24.44444                    TRUE
## 5                1400      24.44444                    TRUE
## 6                1400      24.44444                    TRUE
## 7                1400      24.44444                    TRUE

2.6 Coerce object to matrix: as.matrix

##           Type of design Maximum # stages Stage Information rate
##   Stage 1 "WT"           "4"              "1"   "0.25"          
##   Stage 2 "WT"           "4"              "2"   "0.50"          
##   Stage 3 "WT"           "4"              "3"   "0.75"          
##   Stage 4 "WT"           "4"              "4"   "1.00"          
##           Significance level Type II error rate Two-sided power
##   Stage 1 "0.05"             "0.2"              "FALSE"        
##   Stage 2 "0.05"             "0.2"              "FALSE"        
##   Stage 3 "0.05"             "0.2"              "FALSE"        
##   Stage 4 "0.05"             "0.2"              "FALSE"        
##           Delta (Wang & Tsiatis) Test Tolerance Cumulative alpha spending
##   Stage 1 "0.1"                  "1"  "1e-08"   "0.001073781"            
##   Stage 2 "0.1"                  "1"  "1e-08"   "0.010526914"            
##   Stage 3 "0.1"                  "1"  "1e-08"   "0.028205994"            
##   Stage 4 "0.1"                  "1"  "1e-08"   "0.050000000"            
##           Critical value Stage level  
##   Stage 1 "3.069028"     "0.001073781"
##   Stage 2 "2.325888"     "0.010012250"
##   Stage 3 "1.977663"     "0.023983344"
##   Stage 4 "1.762694"     "0.038976069"
##           Method       Maximum # stages Stage Information rate
##   Stage 1 "equalAlpha" "4"              "1"   "0.2"           
##   Stage 2 "equalAlpha" "4"              "2"   "0.5"           
##   Stage 3 "equalAlpha" "4"              "3"   "0.8"           
##   Stage 4 "equalAlpha" "4"              "4"   "1.0"           
##           Significance level Alpha_0 Binding futility Test Tolerance
##   Stage 1 "0.025"            "0.4"   "TRUE"           "1"  "1e-14"  
##   Stage 2 "0.025"            "0.4"   "TRUE"           "1"  "1e-14"  
##   Stage 3 "0.025"            "0.4"   "TRUE"           "1"  "1e-14"  
##   Stage 4 "0.025"            NA      "TRUE"           "1"  "1e-14"  
##           Iterations Cumulative alpha spending Critical value Stage level 
##   Stage 1 "0"        "0.01366638"              "1.366638e-02" "0.01366638"
##   Stage 2 "0"        "0.02055086"              "8.921538e-04" "0.01366638"
##   Stage 3 "0"        "0.02372061"              "9.643023e-05" "0.01366638"
##   Stage 4 "0"        "0.02500000"              "2.151406e-05" "0.01366638"
##           Scale      Non stochastic curtailment
##   Stage 1 "1.224745" "FALSE"                   
##   Stage 2 "1.224745" "FALSE"                   
##   Stage 3 "1.000000" "FALSE"                   
##   Stage 4 NA         "FALSE"
##           Inflation factor Stage Information      Power
##   Stage 1          1.04846     1    1.620541 0.03624538
##   Stage 2          1.04846     2    3.241081 0.30264612
##   Stage 3          1.04846     3    4.861622 0.60337036
##   Stage 4          1.04846     4    6.482163 0.80000000
##           Rejection probability Futility probability
##   Stage 1            0.03624538         9.865876e-10
##   Stage 2            0.26640074         9.758407e-10
##   Stage 3            0.30072424         9.359906e-10
##   Stage 4            0.19662964                   NA
##           Ratio expected vs fixed sample size under H1
##   Stage 1                                    0.8014789
##   Stage 2                                    0.8014789
##   Stage 3                                    0.8014789
##   Stage 4                                    0.8014789
##           Ratio expected vs fixed sample size under a value between H0 and H1
##   Stage 1                                                           0.9724133
##   Stage 2                                                           0.9724133
##   Stage 3                                                           0.9724133
##   Stage 4                                                           0.9724133
##           Ratio expected vs fixed sample size under H0
##   Stage 1                                     1.038026
##   Stage 2                                     1.038026
##   Stage 3                                     1.038026
##   Stage 4                                     1.038026
##  Stage Effect Average sample size (ASN) Power Overall Early stop
##      1      1                  25.66861     1                  1
##      2      1                  25.66861     1                  1
##      3      1                  25.66861     1                  1
##      4      1                  25.66861     1                  1
##    Early stop Overall reject Reject per stage Overall futility
##  9.732567e-01              1     9.732567e-01     2.580925e-09
##  2.674225e-02              1     2.674225e-02     2.580925e-09
##  1.025014e-06              1     1.024395e-06     2.580925e-09
##            NA              1     0.000000e+00     2.580925e-09
##  Futility stop per stage
##             9.865876e-10
##             9.755040e-10
##             6.188329e-10
##                       NA
##       Design number Type of design Maximum # stages Stage Information rate
##  [1,] "1"           "WT"           "4"              "1"   "0.25"          
##  [2,] "1"           "WT"           "4"              "2"   "0.50"          
##  [3,] "1"           "WT"           "4"              "3"   "0.75"          
##  [4,] "1"           "WT"           "4"              "4"   "1.00"          
##  [5,] "2"           "WT"           "4"              "1"   "0.25"          
##  [6,] "2"           "WT"           "4"              "2"   "0.50"          
##  [7,] "2"           "WT"           "4"              "3"   "0.75"          
##  [8,] "2"           "WT"           "4"              "4"   "1.00"          
##  [9,] "3"           "WT"           "4"              "1"   "0.25"          
## [10,] "3"           "WT"           "4"              "2"   "0.50"          
## [11,] "3"           "WT"           "4"              "3"   "0.75"          
## [12,] "3"           "WT"           "4"              "4"   "1.00"          
##       Significance level Type II error rate Two-sided power
##  [1,] "0.05"             "0.2"              "FALSE"        
##  [2,] "0.05"             "0.2"              "FALSE"        
##  [3,] "0.05"             "0.2"              "FALSE"        
##  [4,] "0.05"             "0.2"              "FALSE"        
##  [5,] "0.05"             "0.2"              "FALSE"        
##  [6,] "0.05"             "0.2"              "FALSE"        
##  [7,] "0.05"             "0.2"              "FALSE"        
##  [8,] "0.05"             "0.2"              "FALSE"        
##  [9,] "0.05"             "0.2"              "FALSE"        
## [10,] "0.05"             "0.2"              "FALSE"        
## [11,] "0.05"             "0.2"              "FALSE"        
## [12,] "0.05"             "0.2"              "FALSE"        
##       Delta (Wang & Tsiatis) Test Tolerance Cumulative alpha spending
##  [1,] "0.1"                  "1"  "1e-08"   "0.001073781"            
##  [2,] "0.1"                  "1"  "1e-08"   "0.010526914"            
##  [3,] "0.1"                  "1"  "1e-08"   "0.028205994"            
##  [4,] "0.1"                  "1"  "1e-08"   "0.050000000"            
##  [5,] "0.3"                  "1"  "1e-08"   "0.006915859"            
##  [6,] "0.3"                  "1"  "1e-08"   "0.020169238"            
##  [7,] "0.3"                  "1"  "1e-08"   "0.035108439"            
##  [8,] "0.3"                  "1"  "1e-08"   "0.050000000"            
##  [9,] "0.4"                  "1"  "1e-08"   "0.012504953"            
## [10,] "0.4"                  "1"  "1e-08"   "0.026260600"            
## [11,] "0.4"                  "1"  "1e-08"   "0.038792487"            
## [12,] "0.4"                  "1"  "1e-08"   "0.050000000"            
##       Critical value Stage level  
##  [1,] "3.069028"     "0.001073781"
##  [2,] "2.325888"     "0.010012250"
##  [3,] "1.977663"     "0.023983344"
##  [4,] "1.762694"     "0.038976069"
##  [5,] "2.461604"     "0.006915859"
##  [6,] "2.142951"     "0.016058517"
##  [7,] "1.976032"     "0.024075572"
##  [8,] "1.865547"     "0.031052371"
##  [9,] "2.241250"     "0.012504953"
## [10,] "2.091160"     "0.018256866"
## [11,] "2.008067"     "0.022318106"
## [12,] "1.951121"     "0.025521316"
##           Stage Treatment group Sample size Mean Standard deviation
##   Stage 1     1               1          22  1.0                1.0
##   Stage 2     1               2          22  1.4                1.0
##   Stage 3     2               1          11  1.1                2.0
##   Stage 4     2               2          13  1.5                2.0
##   Stage 5     3               1          22  1.0                2.0
##   Stage 6     3               2          22  3.0                2.0
##   Stage 7     4               1          11  1.0                1.3
##   Stage 8     4               2          13  2.5                1.3
##           Overall sample size Overall mean Overall standard deviation
##   Stage 1                  22     1.000000                   1.000000
##   Stage 2                  22     1.400000                   1.000000
##   Stage 3                  33     1.033333                   1.381500
##   Stage 4                  35     1.437143                   1.425418
##   Stage 5                  55     1.020000                   1.639151
##   Stage 6                  57     2.040351                   1.822857
##   Stage 7                  66     1.016667                   1.578664
##   Stage 8                  70     2.125714                   1.738706
##           Stage Overall test statistic Overall p-value Overall mean (1)
##   Stage 1 "1"   "-1.326650"            "0.9041035"     "1.000000"      
##   Stage 2 "2"   "-1.185099"            "0.8798860"     "1.033333"      
##   Stage 3 "3"   "-3.111238"            "0.9988132"     "1.020000"      
##   Stage 4 "4"   "-3.886959"            "0.9999205"     "1.016667"      
##           Overall mean (2) Overall standard deviation (1)
##   Stage 1 "1.400000"       "1.000000"                    
##   Stage 2 "1.437143"       "1.381500"                    
##   Stage 3 "2.040351"       "1.639151"                    
##   Stage 4 "2.125714"       "1.578664"                    
##           Overall standard deviation (2) Overall sample size (1)
##   Stage 1 "1.000000"                     "22"                   
##   Stage 2 "1.425418"                     "33"                   
##   Stage 3 "1.822857"                     "55"                   
##   Stage 4 "1.738706"                     "66"                   
##           Overall sample size (2) Test statistic p-value     Effect size 
##   Stage 1 "22"                    "-1.326650"    "0.9041035" "-0.4000000"
##   Stage 2 "35"                    "-0.488194"    "0.6848785" "-0.4038095"
##   Stage 3 "57"                    "-3.316625"    "0.9990567" "-1.0203509"
##   Stage 4 "70"                    "-2.816504"    "0.9949743" "-1.1090476"
##           Theta H0 Direction Normal approximation Equal variance
##   Stage 1 "0"      "upper"   "FALSE"              "TRUE"        
##   Stage 2 "0"      "upper"   "FALSE"              "TRUE"        
##   Stage 3 "0"      "upper"   "FALSE"              "TRUE"        
##   Stage 4 "0"      "upper"   "FALSE"              "TRUE"
##           Stage Information rate Critical value
##   Stage 1 "1"   "0.25"           "3.069028"    
##   Stage 2 "2"   "0.50"           "2.325888"    
##   Stage 3 "3"   "0.75"           "1.977663"    
##   Stage 4 "4"   "1.00"           "1.762694"    
##           Futility bound (non-binding) Cumulative alpha spending
##   Stage 1 "-Inf"                       "0.001073781"            
##   Stage 2 "-Inf"                       "0.010526914"            
##   Stage 3 "-Inf"                       "0.028205994"            
##   Stage 4 NA                           "0.050000000"            
##           Stage level   Effect size  Test statistic p-value    
##   Stage 1 "0.001073781" "-0.4000000" "-1.326650"    "0.9041035"
##   Stage 2 "0.010012250" "-0.4038095" "-0.488194"    "0.6848785"
##   Stage 3 "0.023983344" "-1.0203509" "-3.316625"    "0.9990567"
##   Stage 4 "0.038976069" "-1.1090476" "-2.816504"    "0.9949743"
##           Overall test statistic Overall p-value Action     CRP           
##   Stage 1 "-1.326650"            "0.9041035"     "continue" "2.810091e-03"
##   Stage 2 "-1.185099"            "0.8798860"     "continue" "1.226756e-04"
##   Stage 3 "-3.111238"            "0.9988132"     "continue" "6.661338e-16"
##   Stage 4 "-3.886959"            "0.9999205"     "accept"   NA            
##           Assumed standard deviation RCI (lower) RCI (upper) 
##   Stage 1 "1.662998"                 "-1.386144" " 0.5861439"
##   Stage 2 "1.662998"                 "-1.216028" " 0.4084087"
##   Stage 3 "1.662998"                 "-1.676258" "-0.3644440"
##   Stage 4 "1.662998"                 "-1.615872" "-0.6022231"
##           Repeated p-value Final p-value Final CI (lower) Final CI (upper)
##   Stage 1 "0.499999"       NA            NA               NA              
##   Stage 2 "0.499999"       NA            NA               NA              
##   Stage 3 "0.499999"       NA            NA               NA              
##   Stage 4 "0.499999"       "0.9999205"   "-1.546886"      "-0.608249"     
##           Median unbiased estimate
##   Stage 1 NA                      
##   Stage 2 NA                      
##   Stage 3 NA                      
##   Stage 4 "-1.077568"
##       Stage Alternative Normal approximation Mean ratio Theta H0
##    1      1         0.2                    0          0        0
##    2      1         0.4                    0          0        0
##    3      1         0.6                    0          0        0
##    4      1         0.8                    0          0        0
##    5      1         1.0                    0          0        0
##    6      2         0.2                    0          0        0
##    7      2         0.4                    0          0        0
##    8      2         0.6                    0          0        0
##    9      2         0.8                    0          0        0
##    10     2         1.0                    0          0        0
##    11     3         0.2                    0          0        0
##    12     3         0.4                    0          0        0
##    13     3         0.6                    0          0        0
##    14     3         0.8                    0          0        0
##    15     3         1.0                    0          0        0
##    16     4         0.2                    0          0        0
##    17     4         0.4                    0          0        0
##    18     4         0.6                    0          0        0
##    19     4         0.8                    0          0        0
##    20     4         1.0                    0          0        0
##       Standard deviation Treatment group Planned allocation ratio
##    1                   1               2                        1
##    2                   1               2                        1
##    3                   1               2                        1
##    4                   1               2                        1
##    5                   1               2                        1
##    6                   1               2                        1
##    7                   1               2                        1
##    8                   1               2                        1
##    9                   1               2                        1
##    10                  1               2                        1
##    11                  1               2                        1
##    12                  1               2                        1
##    13                  1               2                        1
##    14                  1               2                        1
##    15                  1               2                        1
##    16                  1               2                        1
##    17                  1               2                        1
##    18                  1               2                        1
##    19                  1               2                        1
##    20                  1               2                        1
##       Information rate Max # subjects Max # subjects (1)
##    1              0.25      649.63926          324.81963
##    2              0.25      163.49107           81.74554
##    3              0.25       73.48452           36.74226
##    4              0.25       42.00708           21.00354
##    5              0.25       27.46496           13.73248
##    6              0.50      649.63926          324.81963
##    7              0.50      163.49107           81.74554
##    8              0.50       73.48452           36.74226
##    9              0.50       42.00708           21.00354
##    10             0.50       27.46496           13.73248
##    11             0.75      649.63926          324.81963
##    12             0.75      163.49107           81.74554
##    13             0.75       73.48452           36.74226
##    14             0.75       42.00708           21.00354
##    15             0.75       27.46496           13.73248
##    16             1.00      649.63926          324.81963
##    17             1.00      163.49107           81.74554
##    18             1.00       73.48452           36.74226
##    19             1.00       42.00708           21.00354
##    20             1.00       27.46496           13.73248
##       Max # subjects (2) # subjects Expected # subjects under H0
##    1           324.81963 162.409815                    643.17426
##    2            81.74554  40.872769                    161.86406
##    3            36.74226  18.371130                     72.75323
##    4            21.00354  10.501771                     41.58904
##    5            13.73248   6.866239                     27.19163
##    6           324.81963 324.819630                    643.17426
##    7            81.74554  81.745537                    161.86406
##    8            36.74226  36.742260                     72.75323
##    9            21.00354  21.003541                     41.58904
##    10           13.73248  13.732478                     27.19163
##    11          324.81963 487.229445                    643.17426
##    12           81.74554 122.618306                    161.86406
##    13           36.74226  55.113391                     72.75323
##    14           21.00354  31.505312                     41.58904
##    15           13.73248  20.598717                     27.19163
##    16          324.81963 649.639259                    643.17426
##    17           81.74554 163.491074                    161.86406
##    18           36.74226  73.484521                     72.75323
##    19           21.00354  42.007082                     41.58904
##    20           13.73248  27.464956                     27.19163
##       Expected # subjects under H0/H1 Expected # subjects under H1
##    1                        602.51988                    496.60668
##    2                        151.63280                    124.97822
##    3                         68.15457                     56.17411
##    4                         38.96024                     32.11166
##    5                         25.47288                     20.99516
##    6                        602.51988                    496.60668
##    7                        151.63280                    124.97822
##    8                         68.15457                     56.17411
##    9                         38.96024                     32.11166
##    10                        25.47288                     20.99516
##    11                       602.51988                    496.60668
##    12                       151.63280                    124.97822
##    13                        68.15457                     56.17411
##    14                        38.96024                     32.11166
##    15                        25.47288                     20.99516
##    16                       602.51988                    496.60668
##    17                       151.63280                    124.97822
##    18                        68.15457                     56.17411
##    19                        38.96024                     32.11166
##    20                        25.47288                     20.99516
##       Reject per stage Early stop Critical value (effect scale)
##    1        0.03624538  0.6033704                     0.4816424
##    2        0.03624538  0.6033704                     0.9600942
##    3        0.03624538  0.6033704                     1.4320657
##    4        0.03624538  0.6033704                     1.8940857
##    5        0.03624538  0.6033704                     2.3424559
##    6        0.26640074  0.6033704                     0.2581058
##    7        0.26640074  0.6033704                     0.5145018
##    8        0.26640074  0.6033704                     0.7674250
##    9        0.26640074  0.6033704                     1.0150154
##    10       0.26640074  0.6033704                     1.2552910
##    11       0.30072424  0.6033704                     0.1791908
##    12       0.30072424  0.6033704                     0.3571945
##    13       0.30072424  0.6033704                     0.5327872
##    14       0.30072424  0.6033704                     0.7046776
##    15       0.30072424  0.6033704                     0.8714898
##    16       0.19662964  0.6033704                     0.1383155
##    17       0.19662964  0.6033704                     0.2757147
##    18       0.19662964  0.6033704                     0.4112529
##    19       0.19662964  0.6033704                     0.5439333
##    20       0.19662964  0.6033704                     0.6726938
##       Local one-sided significance level
##    1                         0.001073781
##    2                         0.001073781
##    3                         0.001073781
##    4                         0.001073781
##    5                         0.001073781
##    6                         0.010012250
##    7                         0.010012250
##    8                         0.010012250
##    9                         0.010012250
##    10                        0.010012250
##    11                        0.023983344
##    12                        0.023983344
##    13                        0.023983344
##    14                        0.023983344
##    15                        0.023983344
##    16                        0.038976069
##    17                        0.038976069
##    18                        0.038976069
##    19                        0.038976069
##    20                        0.038976069
##       Stage pi (1) Max # subjects Accrual time Accrual intensity
##  [1,]     1    0.2            100           12          8.333333
##  [2,]     1    0.3            100           12          8.333333
##  [3,]     1    0.4            100           12          8.333333
##  [4,]     1    0.5            100           12          8.333333
##  [5,]     2    0.2            100           12          8.333333
##  [6,]     2    0.3            100           12          8.333333
##  [7,]     2    0.4            100           12          8.333333
##  [8,]     2    0.5            100           12          8.333333
##  [9,]     3    0.2            100           12          8.333333
## [10,]     3    0.3            100           12          8.333333
## [11,]     3    0.4            100           12          8.333333
## [12,]     3    0.5            100           12          8.333333
## [13,]     4    0.2            100           12          8.333333
## [14,]     4    0.3            100           12          8.333333
## [15,]     4    0.4            100           12          8.333333
## [16,]     4    0.5            100           12          8.333333
##       Required planned events pi (2) Median (1) Median (2) Direction upper
##  [1,]                      50    0.2   37.27540    37.2754               1
##  [2,]                     100    0.2   23.32030    37.2754               1
##  [3,]                     150    0.2   16.28299    37.2754               1
##  [4,]                     200    0.2   12.00000    37.2754               1
##  [5,]                      50    0.2   37.27540    37.2754               1
##  [6,]                     100    0.2   23.32030    37.2754               1
##  [7,]                     150    0.2   16.28299    37.2754               1
##  [8,]                     200    0.2   12.00000    37.2754               1
##  [9,]                      50    0.2   37.27540    37.2754               1
## [10,]                     100    0.2   23.32030    37.2754               1
## [11,]                     150    0.2   16.28299    37.2754               1
## [12,]                     200    0.2   12.00000    37.2754               1
## [13,]                      50    0.2   37.27540    37.2754               1
## [14,]                     100    0.2   23.32030    37.2754               1
## [15,]                     150    0.2   16.28299    37.2754               1
## [16,]                     200    0.2   12.00000    37.2754               1
##       Drop-out rate (1) Drop-out rate (2) Drop-out time Event time
##  [1,]                 0                 0            12         12
##  [2,]                 0                 0            12         12
##  [3,]                 0                 0            12         12
##  [4,]                 0                 0            12         12
##  [5,]                 0                 0            12         12
##  [6,]                 0                 0            12         12
##  [7,]                 0                 0            12         12
##  [8,]                 0                 0            12         12
##  [9,]                 0                 0            12         12
## [10,]                 0                 0            12         12
## [11,]                 0                 0            12         12
## [12,]                 0                 0            12         12
## [13,]                 0                 0            12         12
## [14,]                 0                 0            12         12
## [15,]                 0                 0            12         12
## [16,]                 0                 0            12         12
##       Theta H0 Allocation 1 Allocation 2 Conditional power
##  [1,]        1            1            1                NA
##  [2,]        1            1            1                NA
##  [3,]        1            1            1                NA
##  [4,]        1            1            1                NA
##  [5,]        1            1            1                NA
##  [6,]        1            1            1                NA
##  [7,]        1            1            1                NA
##  [8,]        1            1            1                NA
##  [9,]        1            1            1                NA
## [10,]        1            1            1                NA
## [11,]        1            1            1                NA
## [12,]        1            1            1                NA
## [13,]        1            1            1                NA
## [14,]        1            1            1                NA
## [15,]        1            1            1                NA
## [16,]        1            1            1                NA
##       Maximum # iterations Kappa Lambda (1) Lambda (2) Hazard ratio
##  [1,]                 1000     1 0.01859530  0.0185953     1.000000
##  [2,]                 1000     1 0.02972291  0.0185953     1.598410
##  [3,]                 1000     1 0.04256880  0.0185953     2.289224
##  [4,]                 1000     1 0.05776227  0.0185953     3.106284
##  [5,]                 1000     1 0.01859530  0.0185953     1.000000
##  [6,]                 1000     1 0.02972291  0.0185953     1.598410
##  [7,]                 1000     1 0.04256880  0.0185953     2.289224
##  [8,]                 1000     1 0.05776227  0.0185953     3.106284
##  [9,]                 1000     1 0.01859530  0.0185953     1.000000
## [10,]                 1000     1 0.02972291  0.0185953     1.598410
## [11,]                 1000     1 0.04256880  0.0185953     2.289224
## [12,]                 1000     1 0.05776227  0.0185953     3.106284
## [13,]                 1000     1 0.01859530  0.0185953     1.000000
## [14,]                 1000     1 0.02972291  0.0185953     1.598410
## [15,]                 1000     1 0.04256880  0.0185953     2.289224
## [16,]                 1000     1 0.05776227  0.0185953     3.106284
##       Iterations Analysis time Expected study duration # events by stage
##  [1,]       1000      42.95687                0.000000                50
##  [2,]       1000      35.29897                3.061767                50
##  [3,]       1000      29.97592               12.600565                50
##  [4,]       1000      26.23859               21.096574                50
##  [5,]          0            NA                0.000000                NA
##  [6,]          0            NA                3.061767                NA
##  [7,]          0            NA               12.600565                NA
##  [8,]          0            NA               21.096574                NA
##  [9,]          0            NA                0.000000                NA
## [10,]          0            NA                3.061767                NA
## [11,]          0            NA               12.600565                NA
## [12,]          0            NA               21.096574                NA
## [13,]          0            NA                0.000000                NA
## [14,]          0            NA                3.061767                NA
## [15,]          0            NA               12.600565                NA
## [16,]          0            NA               21.096574                NA
##       Expected # events Events not achieved # subjects Expected # subjects
##  [1,]              0.00               0.000        100                 0.0
##  [2,]              4.20               0.000        100                 8.4
##  [3,]             20.75               0.000        100                41.5
##  [4,]             39.95               0.000        100                79.9
##  [5,]              0.00               1.000         NA                 0.0
##  [6,]              4.20               0.916         NA                 8.4
##  [7,]             20.75               0.585         NA                41.5
##  [8,]             39.95               0.201         NA                79.9
##  [9,]              0.00               0.000         NA                 0.0
## [10,]              4.20               0.000         NA                 8.4
## [11,]             20.75               0.000         NA                41.5
## [12,]             39.95               0.000         NA                79.9
## [13,]              0.00               0.000         NA                 0.0
## [14,]              4.20               0.000         NA                 8.4
## [15,]             20.75               0.000         NA                41.5
## [16,]             39.95               0.000         NA                79.9
##       Reject per stage Overall reject Futility stop per stage
##  [1,]            0.000          0.000                       0
##  [2,]            0.084          0.084                       0
##  [3,]            0.415          0.415                       0
##  [4,]            0.799          0.799                       0
##  [5,]            0.000          0.000                       0
##  [6,]            0.000          0.084                       0
##  [7,]            0.000          0.415                       0
##  [8,]            0.000          0.799                       0
##  [9,]            0.000          0.000                       0
## [10,]            0.000          0.084                       0
## [11,]            0.000          0.415                       0
## [12,]            0.000          0.799                       0
## [13,]            0.000          0.000                      NA
## [14,]            0.000          0.084                      NA
## [15,]            0.000          0.415                      NA
## [16,]            0.000          0.799                      NA
##       Futility stop Early stop      Seed
##  [1,]             0      0.000 103083921
##  [2,]             0      0.084 103083921
##  [3,]             0      0.415 103083921
##  [4,]             0      0.799 103083921
##  [5,]             0      0.000 103083921
##  [6,]             0      0.084 103083921
##  [7,]             0      0.415 103083921
##  [8,]             0      0.799 103083921
##  [9,]             0      0.000 103083921
## [10,]             0      0.084 103083921
## [11,]             0      0.415 103083921
## [12,]             0      0.799 103083921
## [13,]             0      0.000 103083921
## [14,]             0      0.084 103083921
## [15,]             0      0.415 103083921
## [16,]             0      0.799 103083921
##      Piecewise survival times Lambda (1) Lambda (2) Hazard ratio
## [1,]                        0     0.0200      0.025          0.8
## [2,]                        6     0.0320      0.040          0.8
## [3,]                        9     0.0120      0.015          0.8
## [4,]                       15     0.0080      0.010          0.8
## [5,]                       21     0.0056      0.007          0.8
##      Event time Kappa Piecewise exponential survival enabled
## [1,]         12     1                                      1
## [2,]         12     1                                      1
## [3,]         12     1                                      1
## [4,]         12     1                                      1
## [5,]         12     1                                      1
##      Delayed response allowed
## [1,]                        0
## [2,]                        0
## [3,]                        0
## [4,]                        0
## [5,]                        0
##      End of accrual is user defined Follow-up time must be user defined
## [1,]                              0                                   0
## [2,]                              0                                   0
## [3,]                              0                                   0
## [4,]                              0                                   0
## [5,]                              0                                   0
## [6,]                              0                                   0
## [7,]                              0                                   0
##      Max number of subjects is user defined
## [1,]                                      1
## [2,]                                      1
## [3,]                                      1
## [4,]                                      1
## [5,]                                      1
## [6,]                                      1
## [7,]                                      1
##      Max number of subjects can be calculated directly
## [1,]                                                 1
## [2,]                                                 1
## [3,]                                                 1
## [4,]                                                 1
## [5,]                                                 1
## [6,]                                                 1
## [7,]                                                 1
##      Absolute accrual intensity is enabled Accrual time Accrual intensity
## [1,]                                     1      0.00000                15
## [2,]                                     1     12.00000                21
## [3,]                                     1     13.00000                27
## [4,]                                     1     14.00000                33
## [5,]                                     1     15.00000                39
## [6,]                                     1     16.00000                45
## [7,]                                     1     40.44444                NA
##      Max # subjects Remaining time piecewiseAccrualEnabled
## [1,]           1400       24.44444                       1
## [2,]           1400       24.44444                       1
## [3,]           1400       24.44444                       1
## [4,]           1400       24.44444                       1
## [5,]           1400       24.44444                       1
## [6,]           1400       24.44444                       1
## [7,]           1400       24.44444                       1

System: rpact 2.0.3, R version 3.5.3 (2019-03-11), platform: x86_64-w64-mingw32

To cite package ‘rpact’ in publications use:

Gernot Wassmer and Friedrich Pahlke (2019). rpact: Confirmatory Adaptive Clinical Trial Design and Analysis. R package version 2.0.3. https://CRAN.R-project.org/package=rpact

 

Creative Commons License
This work by Gernot Wassmer and Friedrich Pahlke is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.