| nbpowerequiv {lrstat} | R Documentation | 
Power for equivalence in negative binomial rate ratio
Description
Obtains the power for equivalence in negative binomial rate ratio.
Usage
nbpowerequiv(
  kMax = 1L,
  informationRates = NA_real_,
  criticalValues = NA_real_,
  alpha = 0.05,
  typeAlphaSpending = "sfOF",
  parameterAlphaSpending = NA_real_,
  userAlphaSpending = NA_real_,
  rateRatioLower = NA_real_,
  rateRatioUpper = NA_real_,
  allocationRatioPlanned = 1,
  accrualTime = 0L,
  accrualIntensity = NA_real_,
  piecewiseSurvivalTime = 0L,
  stratumFraction = 1L,
  kappa1 = NA_real_,
  kappa2 = NA_real_,
  lambda1 = NA_real_,
  lambda2 = NA_real_,
  gamma1 = 0L,
  gamma2 = 0L,
  accrualDuration = NA_real_,
  followupTime = NA_real_,
  fixedFollowup = 0L,
  spendingTime = NA_real_,
  studyDuration = NA_real_,
  nullVariance = 0L
)
Arguments
kMax | 
 The maximum number of stages.  | 
informationRates | 
 The information rates.
Defaults to   | 
criticalValues | 
 Upper boundaries on the z-test statistic scale for stopping for efficacy.  | 
alpha | 
 The significance level for each of the two one-sided tests. Defaults to 0.05.  | 
typeAlphaSpending | 
 The type of alpha spending. One of the following: "OF" for O'Brien-Fleming boundaries, "P" for Pocock boundaries, "WT" for Wang & Tsiatis boundaries, "sfOF" for O'Brien-Fleming type spending function, "sfP" for Pocock type spending function, "sfKD" for Kim & DeMets spending function, "sfHSD" for Hwang, Shi & DeCani spending function, "user" for user defined spending, and "none" for no early efficacy stopping. Defaults to "sfOF".  | 
parameterAlphaSpending | 
 The parameter value for the alpha spending. Corresponds to Delta for "WT", rho for "sfKD", and gamma for "sfHSD".  | 
userAlphaSpending | 
 The user defined alpha spending. Cumulative alpha spent up to each stage.  | 
rateRatioLower | 
 The lower equivalence limit of rate ratio.  | 
rateRatioUpper | 
 The upper equivalence limit of rate ratio.  | 
allocationRatioPlanned | 
 Allocation ratio for the active treatment versus control. Defaults to 1 for equal randomization.  | 
accrualTime | 
 A vector that specifies the starting time of
piecewise Poisson enrollment time intervals. Must start with 0, e.g.,
  | 
accrualIntensity | 
 A vector of accrual intensities. One for each accrual time interval.  | 
piecewiseSurvivalTime | 
 A vector that specifies the starting time of
piecewise exponential survival time intervals. Must start with 0, e.g.,
  | 
stratumFraction | 
 A vector of stratum fractions that sum to 1. Defaults to 1 for no stratification.  | 
kappa1 | 
 The dispersion parameter (reciprocal of the shape parameter of the gamma mixing distribution) for the active treatment group by stratum.  | 
kappa2 | 
 The dispersion parameter (reciprocal of the shape parameter of the gamma mixing distribution) for the control group by stratum.  | 
lambda1 | 
 The rate parameter of the negative binomial distribution for the active treatment group by stratum.  | 
lambda2 | 
 The rate parameter of the negative binomial distribution for the control group by stratum.  | 
gamma1 | 
 The hazard rate for exponential dropout, a vector of hazard rates for piecewise exponential dropout applicable for all strata, or a vector of hazard rates for dropout in each analysis time interval by stratum for the active treatment group.  | 
gamma2 | 
 The hazard rate for exponential dropout, a vector of hazard rates for piecewise exponential dropout applicable for all strata, or a vector of hazard rates for dropout in each analysis time interval by stratum for the control group.  | 
accrualDuration | 
 Duration of the enrollment period.  | 
followupTime | 
 Follow-up time for the last enrolled subject.  | 
fixedFollowup | 
 Whether a fixed follow-up design is used. Defaults to 0 for variable follow-up.  | 
spendingTime | 
 A vector of length   | 
studyDuration | 
 Study duration for fixed follow-up design.
Defaults to missing, which is to be replaced with the sum of
  | 
nullVariance | 
 Whether to calculate the variance for log rate ratio under the null hypothesis.  | 
Value
An S3 class nbpowerequiv object with 4 components:
-  
overallResults: A data frame containing the following variables:-  
overallReject: The overall rejection probability. -  
alpha: The overall significance level. -  
attainedAlphaH10: The attained significance level under H10. -  
attainedAlphaH20: The attained significance level under H20. -  
numberOfEvents: The total number of events. -  
numberOfDropouts: The total number of dropouts. -  
numbeOfSubjects: The total number of subjects. -  
exposure: The total exposure. -  
studyDuration: The total study duration. -  
information: The maximum information. -  
expectedNumberOfEvents: The expected number of events. -  
expectedNumberOfDropouts: The expected number of dropouts. -  
expectedNumberOfSubjects: The expected number of subjects. -  
expectedExposure: The expected exposure. -  
expectedStudyDuration: The expected study duration. -  
expectedInformation: The expected information. -  
kMax: The number of stages. -  
rateRatioLower: The lower equivalence limit of rate ratio. -  
rateRatioUpper: The upper equivalence limit of rate ratio. -  
rateRatio: The rate ratio. 
 -  
 -  
byStageResults: A data frame containing the following variables:-  
informationRates: The information rates. -  
efficacyBounds: The efficacy boundaries on the Z-scale for each of the two one-sided tests. -  
rejectPerStage: The probability for efficacy stopping. -  
cumulativeRejection: The cumulative probability for efficacy stopping. -  
cumulativeAlphaSpent: The cumulative alpha for each of the two one-sided tests. -  
cumulativeAttainedAlphaH10: The cumulative alpha attained underH10. -  
cumulativeAttainedAlphaH20: The cumulative alpha attained underH20. -  
numberOfEvents: The number of events. -  
numberOfDropouts: The number of dropouts. -  
numberOfSubjects: The number of subjects. -  
exposure: The exposure. -  
analysisTime: The average time since trial start. -  
efficacyRateRatioLower: The efficacy boundaries on the rate ratio scale for the one-sided null hypothesis at the lower equivalence limit. -  
efficacyRateRatioUpper: The efficacy boundaries on the rate ratio scale for the one-sided null hypothesis at the upper equivalence limit. -  
efficacyP: The efficacy bounds on the p-value scale for each of the two one-sided tests. -  
information: The cumulative information. 
 -  
 -  
settings: A list containing the following input parameters:typeAlphaSpending,parameterAlphaSpending,userAlphaSpending,allocationRatioPlanned,accrualTime,accuralIntensity,piecewiseSurvivalTime,stratumFraction,kappa1,kappa2,lambda1,lambda2,gamma1,gamma2,accrualDuration,followupTime,fixedFollowup,spendingTime,nullVariance, andvarianceRatios. ThevarianceRatiosis a data frame with the following variables:-  
varianceRatioH10: The ratio of the variance underH10to the variance underH1. -  
varianceRatioH20: The ratio of the variance underH20to the variance underH1. -  
varianceRatioH12: The ratio of the variance underH10to the variance underH20. -  
varianceRatioH21: The ratio of the variance underH20to the variance underH10. 
 -  
 -  
byTreatmentCounts: A list containing the following counts by treatment group:-  
numberOfEvents1: The number of events by stage for the treatment group. -  
numberOfDropouts1: The number of dropouts by stage for the treatment group. -  
numberOfSubjects1: The number of subjects by stage for the treatment group. -  
exposure1: The exposure by stage for the treatment group. -  
numberOfEvents2: The number of events by stage for the control group. -  
numberOfDropouts2: The number of dropouts by stage for the control group. -  
numberOfSubjects2: The number of subjects by stage for the control group. -  
exposure2: The exposure by stage for the control group. -  
expectedNumberOfEvents1: The expected number of events for the treatment group. -  
expectedNumberOfDropouts1: The expected number of dropouts for the treatment group. -  
expectedNumberOfSubjects1: The expected number of subjects for the treatment group. -  
expectedExposure1: The expected exposure for the treatment group. -  
expectedNumberOfEvents2: The expected number of events for control group. -  
expectedNumberOfDropouts2: The expected number of dropouts for the control group. -  
expectedNumberOfSubjects2: The expected number of subjects for the control group. -  
expectedExposure2: The expected exposure for the control group. 
 -  
 
Author(s)
Kaifeng Lu, kaifenglu@gmail.com
See Also
Examples
# Example 1: Variable follow-up design
nbpowerequiv(kMax = 2, informationRates = c(0.5, 1),
             alpha = 0.05, typeAlphaSpending = "sfOF",
             rateRatioLower = 2/3, rateRatioUpper = 3/2,
             accrualIntensity = 1956/1.25,
             kappa1 = 5, kappa2 = 5,
             lambda1 = 0.125, lambda2 = 0.125,
             gamma1 = 0, gamma2 = 0,
             accrualDuration = 1.25,
             followupTime = 2.75, fixedFollowup = FALSE,
             nullVariance = 1)
# Example 2: Fixed follow-up design
nbpowerequiv(kMax = 2, informationRates = c(0.5, 1),
             alpha = 0.05, typeAlphaSpending = "sfOF",
             rateRatioLower = 0.5, rateRatioUpper = 2,
             accrualIntensity = 220/1.5,
             stratumFraction = c(0.2, 0.8),
             kappa1 = 3, kappa2 = 3,
             lambda1 = c(8.4, 10.2),
             lambda2 = c(8.0, 11.5),
             gamma1 = 0, gamma2 = 0,
             accrualDuration = 1.5,
             followupTime = 0.5, fixedFollowup = TRUE)