TrialDesignPlanRates: Trial Design Plan Rates
In rpact: Confirmatory Adaptive Clinical Trial Design and Analysis

TrialDesignPlanRates

R Documentation

Trial Design Plan Rates

Description

Trial design plan for rates.

Details

This object cannot be created directly; use getSampleSizeRates() with suitable arguments to create a design plan for a dataset of rates.

Fields

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.
conservative: Conservative sample size calculation enabled or not 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.
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.
optimumAllocationRatio: The allocation ratio that is optimum with respect to the overall sample size at given power. 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.
effect: The effect for randomly creating normally distributed responses. Is a numeric vector of length kMax.
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.
futilityStop: In simulation results data set: indicates whether trial is stopped for futility or not.
futilityPerStage: The per-stage probabilities of stopping the trial for futility. Is a numeric matrix.
earlyStop: The probability to stopping the trial either for efficacy or futility. Is a numeric vector.
expectedNumberOfSubjects: The expected number of subjects under specified alternative.
nFixed: The sample size in a fixed (one-stage) design. Is a positive numeric vector.
nFixed1: The sample size in treatment arm 1 in a fixed (one-stage) design. Is a positive numeric vector.
nFixed2: The sample size in treatment arm 2 in a fixed (one-stage) design. Is a positive numeric vector.
informationRates: The information rates (that must be fixed prior to the trial), default is (1:kMax) / kMax. Is a numeric vector of length kMax containing values between 0 and 1.
maxNumberOfSubjects: The maximum number of subjects for power calculations. Is a numeric vector.
maxNumberOfSubjects1: The maximum number of subjects in treatment arm 1. Is a numeric vector.
maxNumberOfSubjects2: The maximum number of subjects in treatment arm 2. Is a numeric vector.
numberOfSubjects: In simulation results data set: The number of subjects under consideration when the interim analysis takes place.
numberOfSubjects1: In simulation results data set: The number of subjects under consideration in treatment arm 1 when the interim analysis takes place.
numberOfSubjects2: In simulation results data set: The number of subjects under consideration in treatment arm 2 when the interim analysis takes place.
expectedNumberOfSubjectsH0: The expected number of subjects under H0. Is a numeric vector.
expectedNumberOfSubjectsH01: The expected number of subjects under a value between H0 and H1. Is a numeric vector.
expectedNumberOfSubjectsH1: The expected number of subjects under H1. Is a numeric vector.
criticalValuesEffectScale: The critical values for each stage of the trial on the effect size scale.
criticalValuesEffectScaleLower: The lower critical values for each stage of the trial on the effect size scale. Is a numeric matrix.
criticalValuesEffectScaleUpper: The upper critical values for each stage of the trial on the effect size scale. Is a numeric matrix.
criticalValuesPValueScale: The critical values for each stage of the trial on the p-value scale.
futilityBoundsEffectScale: The futility bounds for each stage of the trial on the effect size scale. Is a numeric matrix.
futilityBoundsEffectScaleLower: The lower futility bounds for each stage of the trial on the effect size scale. Is a numeric matrix.
futilityBoundsEffectScaleUpper: The upper futility bounds for each stage of the trial on the effect size scale. Is a numeric matrix.
futilityBoundsPValueScale: The futility bounds for each stage of the trial on the p-value scale. Is a numeric matrix.