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.

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.