Trial Design Plan Survival

Description

Trial design plan for survival data.

Details

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

Fields

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

The 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.