TrialDesignPlanSurvival {rpact} | R Documentation |

Trial design plan for survival data.

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

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

`thetaH0`

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

`typeOfComputation`

The type of computation used, either

`"Schoenfeld", "Freedman"`

, or`"HsiehFreedman"`

.`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.`pi1`

The assumed event rate in the treatment group. Is a numeric vector of length

`kMax`

containing values between 0 and 1.`pi2`

The assumed event rate in the control group. Is a numeric vector of length 1 containing a value between 0 and 1.

`median1`

The assumed median survival time in the treatment group. Is a numeric vector.

`median2`

The assumed median survival time in the reference group. Is a numeric vector of length 1.

`lambda1`

The assumed hazard rate in the treatment group. Is a numeric vector of length

`kMax`

.`lambda2`

The assumed hazard rate in the reference group. Is a numeric vector of length 1.

`hazardRatio`

The hazard ratios under consideration. Is a numeric vector of length

`kMax`

.`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.

`maxNumberOfEvents`

The maximum number of events for power calculations. Is a positive numeric vector of length

`kMax`

.`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.

`accountForObservationTimes`

If

`FALSE`

, only the event rates are used for the calculation of the maximum number of subjects. Is a logical vector of length 1.`eventTime`

The assumed time under which the event rates are calculated. Is a numeric vector of length 1.

`accrualTime`

The assumed accrual time intervals for the study. Is a numeric vector.

`totalAccrualTime`

The total accrual time, i.e., the maximum of

`accrualTime`

. Is a positive numeric vector of length 1.`accrualIntensity`

The absolute accrual intensities. Is a numeric vector of length

`kMax`

.`accrualIntensityRelative`

The relative accrual intensities.

`kappa`

The shape of the Weibull distribution if

`kappa!=1`

. Is a numeric vector of length 1.`piecewiseSurvivalTime`

The time intervals for the piecewise definition of the exponential survival time cumulative distribution function. Is a numeric vector.

`followUpTime`

The assumed follow-up time for the study. Is a numeric vector of length 1.

`dropoutRate1`

The assumed drop-out rate in the treatment group. Is a numeric vector of length 1 containing a value between 0 and 1.

`dropoutRate2`

The assumed drop-out rate in the control group. Is a numeric vector of length 1 containing a value between 0 and 1.

`dropoutTime`

The assumed time for drop-out rates in the control and treatment group. Is a numeric vector of length 1.

`chi`

The calculated event probability at end of trial. Is a numeric vector.

`expectedNumberOfEvents`

The expected number of events under specified alternative. Is a numeric vector.

`eventsFixed`

The number of events in a fixed sample size design. Is a numeric vector.

`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.

`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.

`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.`analysisTime`

The estimated time of analysis. Is a numeric matrix.

`studyDurationH1`

The study duration under the alternative hypothesis. Is a positive numeric vector.

`studyDuration`

The study duration for specified effect size. Is a positive numeric vector.

`maxStudyDuration`

The maximum study duration in survival designs. Is a numeric vector.

`eventsPerStage`

Deprecated: use

`singleEventsPerStage`

or`cumulativeEventsPerStage`

instead Is a numeric matrix.`singleEventsPerStage`

The single number of events per stage. Is a numeric matrix.

`cumulativeEventsPerStage`

The cumulative number of events per stage. Is a numeric matrix.

`expectedEventsH0`

The expected number of events under H0. Is a numeric vector.

`expectedEventsH01`

The expected number of events under a value between H0 and H1. Is a numeric vector.

`expectedEventsH1`

The expected number of events under H1. 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.

`expectedNumberOfSubjectsH1`

The expected number of subjects under H1. Is a numeric vector.

`expectedNumberOfSubjects`

The expected number of subjects under specified alternative.

`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]