n
|
Sample sizes for each treatment group at stage 1 (interim) and stage 2 (final) analyses |
List of sample sizes; for example, 32 in each group in stage 1 and 64 in stage 2, list(stage1=32, stage2=64)
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An additional list option can be used to increase (enrich) the sample size in stage 2; for example, enrich sample size to 128 in stage 2, list(stage1=32, enrich=128, stage2=64)
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effect
|
Effect sizes for early and final outcomes |
List of effect sizes for the control (first) and each treatment group; for example, for control (0) and two effects of size 0.1 and 0.2 for early and 0.2 and 0.3 for final outcome, list(early=c(0,0.1,0.2), final=c(0,0.2,0.3))
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The first element of each vector is the effect size in the subgroup and the second is the effect size in the full population; for example, for an effect size of 0.4 in subgroup and 0.2 in the full population for both early and final outcomes list(early=c(0.4,0.2), final=c(0.4,0.2)). An optional argument can be included to set the effect size for the control group; for example, default is zero, control=list(early=0, final=NULL)
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outcome
|
Outcome type for early and final outcomes |
List of outcome types, options for normal (N), time‐to‐event (T), and binary (B) are currently available; for example, normal for early and final outcomes list(early="N", final="N"). |
nsim
|
Number of simulations |
An integer
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sprev
|
Subgroup prevalence |
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The prevalence of the subgroup in the main population; . Subgroup prevalence can be either fixed or allowed to vary at each simulation; default is sprev.fixed=TRUE
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corr
|
Correlation between outcomes |
Correlation between early and final outcomes;
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seed
|
Seed number |
Seed number to ensure repeatability of simulations |
select
|
Method for treatment selection |
Seven available options (see Section 4.3.1), with default, select=0, to select all treatments. For select=4, the epsilon rule, can be used to allow more flexibility, with default epsilon=1 and for select=6, all treatments greater than a threshold can be selected, with default thresh=1
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Two options are available. The default threshold selection rule (select="thresh"), for which limits must be set; for example, selim=c(-1,1). A futility selection rule (select="futility"; See Section 5.2) is also available, for which limits must be set; selim=c(0,0). |
ptest
|
Treatments for counts of the number of rejections |
A vector of valid treatment numbers for treatment specific counts of rejections; for example, for four treatments, ptest=c(1), ptest=c(1, 2) or ptest=c(1,2,3,4) are all valid options |
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method
|
Methodology used for simulations; and for subpop.sim either |
Either method="invnorm" or "fisher" to select inverse normal or Fisher combination test |
Select method="CT-SD", "CT-Simes", "CT-Bonferroni" or "CEF" (see Section 4.2.1) |
fu
|
Follow‐up options |
Subjects in the dropped treatment groups can followed‐up (fu=TRUE), with default fu=FALSE (see Section 4.3.1.) |
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weight
|
Stage 1 weight |
Stage 1 weight be defined with this option (0 ⩽ weight ⩽1); default weight=NULL
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level
|
Test level |
Test level must be set (); default level=0.025
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file
|
File name for output |
If unset will default to R console. For example, set file="output.txt", direct output to file in R working directory (getwd()) |