AnalysisResultsEnrichmentInverseNormal: Analysis Results Enrichment Inverse Normal
In rpact: Confirmatory Adaptive Clinical Trial Design and Analysis

AnalysisResultsEnrichmentInverseNormal

R Documentation

Analysis Results Enrichment Inverse Normal

Description

Class for enrichment analysis results based on a inverse normal design.

Details

This object cannot be created directly; use getAnalysisResults with suitable arguments to create the enrichment analysis results of an inverse normal design.

Fields

normalApproximation: Describes if a normal approximation was used when calculating p-values. Default for means is FALSE and TRUE for rates and hazard ratio. Is a logical vector of length 1.
directionUpper: Specifies the direction of the alternative, only applicable for one-sided testing. Default is TRUE which means that larger values of the test statistics yield smaller p-values. Is a logical vector of length 1.
thetaH0: The difference or assumed effect under H0. Is a numeric vector of length 1.
pi1: The assumed probability or probabilities in the active treatment group in two-group designs, or the alternative probability for a one-group design.
pi2: The assumed probability in the reference group for two-group designs. Is a numeric vector of length 1 containing a value between 0 and 1.
nPlanned: The sample size planned for each of the subsequent stages. Is a numeric vector of length kMax containing whole numbers.
allocationRatioPlanned: The planned allocation ratio (n1 / n2) for the groups. For multi-arm designs, it is the allocation ratio relating the active arm(s) to the control. Is a positive numeric vector of length 1.
thetaH1: The assumed effect under the alternative hypothesis. For survival designs, refers to the hazard ratio. Is a numeric vector.
assumedStDevs: Assumed standard deviations to calculate conditional power in multi-arm trials or enrichment designs. Is a numeric vector.
piTreatments: The assumed rates in the treatment groups for multi-arm and enrichment designs, i.e., designs with multiple subsets.
intersectionTest: The multiple test used for intersection hypotheses in closed systems of hypotheses. Is a character vector of length 1.
varianceOption: Defines the way to calculate the variance in multiple (i.e., >2) treatment arms or population enrichment designs when testing means. Available options for multiple arms: "overallPooled", "pairwisePooled", "notPooled". Available options for enrichment designs: "pooled", "pooledFromFull", "notPooled".
conditionalRejectionProbabilities: The probabilities of rejecting the null hypothesis at each stage, given the stage has been reached. Is a numeric vector of length kMax containing values between 0 and 1.
conditionalPower: The conditional power at each stage of the trial. Is a numeric vector of length 1 containing a value between 0 and 1.
repeatedConfidenceIntervalLowerBounds: The lower bound of the confidence intervals that are calculated at any stage of the trial. Is a numeric vector of length kMax.
repeatedConfidenceIntervalUpperBounds: The upper bound of the confidence interval that are calculated at any stage of the trial. Is a numeric vector of length kMax.
repeatedPValues: The p-values that are calculated at any stage of the trial. Is a numeric vector of length kMax containing values between 0 and 1.
piControls: The assumed rates in the control group for enrichment designs, i.e., designs with multiple subsets.
stratifiedAnalysis: For enrichment designs, typically a stratified analysis should be chosen. When testing means and rates, a non-stratified analysis can be performed on overall data. For survival data, only a stratified analysis is possible. Is a logical vector of length 1.