TrialDesignPlanRates {rpact} | R Documentation |

Trial design plan for rates.

This object cannot be created directly; use `getSampleSizeRates()`

with suitable arguments to create a design plan for a dataset of rates.

`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.

[Package *rpact* version 4.0.0 Index]