TrialDesignPlanCountData: Trial Design Plan Count Data
In rpact: Confirmatory Adaptive Clinical Trial Design and Analysis

TrialDesignPlanCountData

R Documentation

Trial Design Plan Count Data

Description

Trial design plan for count data.

Details

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

Fields

thetaH0: The difference or assumed effect under H0. Is a numeric vector of length 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.
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.
lambda: A numeric value or vector that represents the assumed rate of a homogeneous Poisson process in the pooled treatment groups Is a numeric vector.
theta: A vector of standardized effect sizes (theta values). 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.
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.
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.
overdispersion: A numeric value that represents the assumed overdispersion of the negative binomial distribution Is a numeric vector.
fixedExposureTime: If specified, the fixed time of exposure per subject for count data Is a numeric vector.
accrualTime: The assumed accrual time intervals for the study. Is a numeric vector.
accrualIntensity: The absolute accrual intensities. Is a numeric vector of length kMax.
followUpTime: The assumed follow-up time for the study. Is a numeric vector of length 1.
calendarTime: The calendar time Is a numeric vector.
expectedStudyDurationH1: The expected study duration under H1 Is a numeric vector.
studyTime: The study time Is a numeric vector.
numberOfSubjects: In simulation results data set: The number of subjects under consideration when the interim analysis takes place.
expectedNumberOfSubjectsH1: The expected number of subjects under H1. Is a numeric vector.
informationOverStages: The information over stages Is a numeric vector.
expectedInformationH0: The expected information under H0 Is a numeric vector.
expectedInformationH01: The expected information under H0/H1 Is a numeric vector.
expectedInformationH1: The expected information under H1 Is a numeric vector.
maxInformation: The maximum information. Is a numeric vector of length 1 containing a whole number.
futilityBoundsPValueScale: The futility bounds for each stage of the trial on the p-value scale. Is a numeric matrix.