Analysis Results Enrichment Fisher

Description

Class for enrichment analysis results based on a Fisher combination test design.

Details

This object cannot be created directly; use getAnalysisResults with suitable arguments to create the multi-arm analysis results of a Fisher combination test 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.

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.

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.

conditionalPowerSimulated

The simulated conditional power, under the assumption of observed or assumed effect sizes.

iterations

The number of iterations used for simulations. Is a numeric vector of length 1 containing a whole number.

seed

The seed used for random number generation. Is a numeric vector of length 1.

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.