TrialDesignPlanSurvival: Trial Design Plan Survival
In rpact: Confirmatory Adaptive Clinical Trial Design and Analysis

TrialDesignPlanSurvival

R Documentation

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: 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.