Class for Simulation Results Multi-Arm Survival

Description

A class for simulation results survival in multi-arm designs.

Details

Use getSimulationMultiArmSurvival() to create an object of this type.

Fields

maxNumberOfIterations

The number of simulation iterations. Is a numeric vector of length 1 containing a whole number.

seed

The seed used for random number generation. Is a numeric vector of length 1.

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.

conditionalPower

The conditional power at each stage of the trial. Is a numeric vector of length 1 containing a value between 0 and 1.

iterations

The number of iterations used for simulations. Is a numeric vector of length 1 containing a whole number.

futilityPerStage

The per-stage probabilities of stopping the trial for futility. Is a numeric matrix.

futilityStop

In simulation results data set: indicates whether trial is stopped for futility or not.

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.

plannedEvents

Determines the number of cumulated (overall) events in survival designs when the interim stages are planned. For two treatment arms, is the number of events for both treatment arms. For multi-arm designs, refers to the overall number of events for the selected arms plus control. Is a numeric vector of length kMax containing whole numbers.

minNumberOfEventsPerStage

Determines the minimum number of events per stage for data-driven sample size recalculation. Is a numeric vector of length kMax containing whole numbers.

maxNumberOfEventsPerStage

Determines the maximum number of events per stage for data-driven sample size recalculation. Is a numeric vector of length kMax containing whole numbers.

expectedNumberOfEvents

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

activeArms

The number of active treatment arms to be compared with control. Is a numeric vector of length 1 containing a whole number.

effectMatrix

The matrix of effect sizes with activeArms columns and number of rows reflecting the different situations to consider.

typeOfShape

The shape of the dose-response relationship over the treatment groups. Is a character vector of length 1.

omegaMaxVector

The range of hazard ratios with highest response for "linear" and "sigmoidEmax" model. Is a numeric vector.

gED50

The ED50 of the sigmoid Emax model. Only necessary if typeOfShape = "sigmoidEmax" has been specified. Is a numeric vector of length 1.

slope

The slope of the sigmoid Emax model, if typeOfShape = "sigmoidEmax" Is a numeric vector of length 1.

intersectionTest

The multiple test used for intersection hypotheses in closed systems of hypotheses. Is a character vector of length 1.

adaptations

Indicates whether or not an adaptation takes place at interim k. Is a logical vector of length kMax minus 1.

epsilonValue

Needs to be specified if typeOfSelection = "epsilon". Is a numeric vector of length 1.

rValue

Needs to be specified if typeOfSelection = "rBest". Is a numeric vector of length 1.

threshold

The selection criterion: treatment arm/population is only selected if effectMeasure exceeds threshold. Either a single numeric value or a numeric vector of length activeArms referring to a separate threshold condition for each treatment arm.

selectArmsFunction

An optional function that can be entered to define how treatment arms are selected.

correlationComputation

If "alternative", a correlation matrix according to Deng et al. (Biometrics, 2019) accounting for the respective alternative is used for simulating log-rank statistics in the many-to-one design. If "null", a constant correlation matrix valid under the null hypothesis is used.

earlyStop

The probability to stopping the trial either for efficacy or futility. Is a numeric vector.

selectedArms

The selected arms in multi-armed designs.

numberOfActiveArms

The number of active arms in a multi-armed design. Is a numeric matrix.

rejectAtLeastOne

The probability to reject at least one of the (multiple) hypotheses. Is a numeric vector.

rejectedArmsPerStage

The simulated number of rejected arms per stage.

successPerStage

The simulated success probabilities per stage where success is defined by user. Is a numeric matrix.

eventsPerStage

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

singleNumberOfEventsPerStage

In simulation results data set: the number of events per stage that is used for the analysis.

conditionalPowerAchieved

The calculated conditional power, under the assumption of observed or assumed effect sizes. Is a numeric matrix.