AnalysisResultsEnrichmentInverseNormal {rpact} | R Documentation |

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

This object cannot be created directly; use `getAnalysisResults`

with suitable arguments to create the enrichment analysis results of an inverse normal design.

`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.

[Package *rpact* version 4.0.0 Index]