rpact: Confirmatory Adaptive Clinical Trial Design and Analysis

getData {rpact}R Documentation

Get Simulation Data


Returns the aggregated simulation data.





A SimulationResults object created by getSimulationMeans,
getSimulationRates, getSimulationSurvival, getSimulationMultiArmMeans,
getSimulationMultiArmRates, or getSimulationMultiArmSurvival.


This function can be used to get the aggregated simulated data from an simulation results object, for example, obtained by getSimulationSurvival. In this case, the data frame contains the following columns:

  1. iterationNumber: The number of the simulation iteration.

  2. stageNumber: The stage.

  3. pi1: The assumed or derived event rate in the treatment group.

  4. pi2: The assumed or derived event rate in the control group.

  5. hazardRatio: The hazard ratio under consideration (if available).

  6. analysisTime: The analysis time.

  7. numberOfSubjects: The number of subjects under consideration when the (interim) analysis takes place.

  8. eventsPerStage1: The observed number of events per stage in treatment group 1.

  9. eventsPerStage2: The observed number of events per stage in treatment group 2.

  10. eventsPerStage: The observed number of events per stage in both treatment groups.

  11. rejectPerStage: 1 if null hypothesis can be rejected, 0 otherwise.

  12. eventsNotAchieved: 1 if number of events could not be reached with observed number of subjects, 0 otherwise.

  13. futilityPerStage: 1 if study should be stopped for futility, 0 otherwise.

  14. testStatistic: The test statistic that is used for the test decision, depends on which design was chosen (group sequential, inverse normal, or Fisher combination test)'

  15. logRankStatistic: Z-score statistic which corresponds to a one-sided log-rank test at considered stage.

  16. conditionalPowerAchieved: The conditional power for the subsequent stage of the trial for selected sample size and effect. The effect is either estimated from the data or can be user defined with thetaH1 or pi1H1 and pi2H1.

  17. trialStop: TRUE if study should be stopped for efficacy or futility or final stage, FALSE otherwise.

  18. hazardRatioEstimateLR: The estimated hazard ratio, derived from the log-rank statistic.

A subset of variables is provided for getSimulationMeans, getSimulationRates, getSimulationMultiArmMeans,
getSimulationMultiArmRates, or getSimulationMultiArmSurvival.


Returns a data.frame.


results <- getSimulationSurvival(pi1 = seq(0.3,0.6,0.1), pi2 = 0.3, eventTime = 12, 
    accrualTime = 24, plannedEvents = 40, maxNumberOfSubjects = 200, 
    maxNumberOfIterations = 50)
data <- getData(results)

[Package rpact version 3.0.0 Index | www.rpact.org]