rpact (version 4.2.0)

SimulationResultsRates: Class for Simulation Results Rates

Description

A class for simulation results rates.

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.

riskRatio

Specifies if the sample size for one-sided testing of H0: pi1 / pi2 = thetaH0 has been calculated. Is a logical vector of length 1.

thetaH0

The difference or assumed effect under H0. Is a numeric vector of length 1.

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.

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.

groups

The group numbers. Is a numeric vector.

pi1H1

The assumed probability in the active treatment group for two-group designs, or the assumed probability for a one treatment group design, for which the conditional power was calculated. Is a numeric vector of length 1 containing a value between 0 and 1.

pi2H1

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

effect

The effect for randomly creating normally distributed responses. Is a numeric vector of length kMax.

earlyStop

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

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.

overallReject

The overall rejection probability. Is a numeric vector.

rejectPerStage

The probability to reject a hypothesis per stage of the trial. Is a numeric matrix.

conditionalPowerAchieved

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

Details

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

SimulationResultsRates is the basic class for

• SimulationResultsRates,

• SimulationResultsMultiArmRates, and

• SimulationResultsEnrichmentRates.