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A class for simulation results rates in multi-arm designs.

Details

Use getSimulationMultiArmRates() to create an object of this type.

Fields

maxNumberOfIterations

The number of simulation iterations. 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.

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.

conditionalPower

The conditional power at each stage of the trial. Is a numeric vector of length 1 containing a value between 0 and 1.

iterations

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

futilityPerStage

The per-stage probabilities of stopping the trial for futility. Is a numeric matrix.

futilityStop

In simulation results data set: indicates whether trial is stopped for futility or not.

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.

plannedSubjects

Determines the number of cumulated (overall) subjects when the interim stages are planned. For two treatment arms, is the number of subjects for both treatment arms. For multi-arm designs, refers to the number of subjects per selected active arm. Is a numeric vector of length kMax containing whole numbers.

maxNumberOfSubjects

The maximum number of subjects for power calculations. Is a numeric vector.

calcSubjectsFunction

An optional function that can be entered to define how sample size is recalculated. By default, recalculation is performed with conditional power with specified minNumberOfSubjectsPerStage and maxNumberOfSubjectsPerStage.

expectedNumberOfSubjects

The expected number of subjects under specified alternative.

activeArms

The number of active treatment arms to be compared with control. Is a numeric vector of length 1 containing a whole number.

effectMatrix

The matrix of effect sizes with activeArms columns and number of rows reflecting the different situations to consider.

typeOfShape

The shape of the dose-response relationship over the treatment groups. Is a character vector of length 1.

piMaxVector

The range of assumed probabilities for the treatment group with highest response for "linear" and "sigmoidEmax" model.

piControl

The assumed probability in the control arm for simulation and under which the sample size recalculation is performed. Is a numeric vector of length 1 containing a value between 0 and 1.

piH1

The assumed probability in the active treatment arm(s) under which the sample size recalculation is performed. Is a numeric vector of length 1 containing a value between 0 and 1.

piControlH1

The assumed probability in the reference group, for which the conditional power was calculated. Is a numeric vector of length 1 containing a value between 0 and 1.

gED50

The ED50 of the sigmoid Emax model. Only necessary if typeOfShape = "sigmoidEmax" has been specified. Is a numeric vector of length 1.

slope

The slope of the sigmoid Emax model, if typeOfShape = "sigmoidEmax" Is a numeric vector of length 1.

intersectionTest

The multiple test used for intersection hypotheses in closed systems of hypotheses. Is a character vector of length 1.

adaptations

Indicates whether or not an adaptation takes place at interim k. Is a logical vector of length kMax minus 1.

typeOfSelection

The way the treatment arms or populations are selected at interim. Is a character vector of length 1.

effectMeasure

Criterion for treatment arm/population selection, either based on test statistic ("testStatistic") or effect estimate ("effectEstimate"). Is a character vector of length 1.

successCriterion

Defines when the study is stopped for efficacy at interim. "all" stops the trial if the efficacy criterion has been fulfilled for all selected treatment arms/populations, "atLeastOne" stops if at least one of the selected treatment arms/populations is shown to be superior to control at interim. Is a character vector of length 1.

epsilonValue

Needs to be specified if typeOfSelection = "epsilon". Is a numeric vector of length 1.

rValue

Needs to be specified if typeOfSelection = "rBest". Is a numeric vector of length 1.

threshold

The selection criterion: treatment arm/population is only selected if effectMeasure exceeds threshold. Either a single numeric value or a numeric vector of length activeArms referring to a separate threshold condition for each treatment arm.

selectArmsFunction

An optional function that can be entered to define how treatment arms are selected.

earlyStop

The probability to stopping the trial either for efficacy or futility. Is a numeric vector.

selectedArms

The selected arms in multi-armed designs.

numberOfActiveArms

The number of active arms in a multi-armed design. Is a numeric matrix.

rejectAtLeastOne

The probability to reject at least one of the (multiple) hypotheses. Is a numeric vector.

rejectedArmsPerStage

The simulated number of rejected arms per stage.

successPerStage

The simulated success probabilities per stage where success is defined by user. Is a numeric matrix.

sampleSizes

The sample sizes for each group and stage. Is a numeric vector of length number of stages times number of groups containing whole numbers.

conditionalPowerAchieved

The calculated conditional power, under the assumption of observed or assumed effect sizes. Is a numeric matrix.