- design
The trial design. If no trial design is specified, a fixed sample size design is used.
In this case, Type I error rate alpha
, Type II error rate beta
, twoSidedPower
,
and sided
can be directly entered as argument where necessary.
- ...
Ensures that all arguments (starting from the "...") are to be named and
that a warning will be displayed if unknown arguments are passed.
- groups
The number of treatment groups (1 or 2), default is 2
.
- normalApproximation
The type of computation of the p-values. If TRUE
, the variance is
assumed to be known, default is FALSE
, i.e., the calculations are performed
with the t distribution.
- meanRatio
If TRUE
, the sample size for
one-sided testing of H0: mu1 / mu2 = thetaH0
is calculated, default is FALSE
.
- thetaH0
The null hypothesis value,
default is 0
for the normal and the binary case (testing means and rates, respectively),
it is 1
for the survival case (testing the hazard ratio).
For non-inferiority designs, thetaH0
is the non-inferiority bound.
That is, in case of (one-sided) testing of
means: a value != 0
(or a value != 1
for testing the mean ratio) can be specified.
rates: a value != 0
(or a value != 1
for testing the risk ratio pi1 / pi2
) can be specified.
survival data: a bound for testing H0: hazard ratio = thetaH0 != 1
can be specified.
count data: a bound for testing H0: lambda1 / lambda2 = thetaH0 != 1
can be specified.
For testing a rate in one sample, a value thetaH0
in (0, 1) has to be specified for
defining the null hypothesis H0: pi = thetaH0
.
- alternative
The alternative hypothesis value for testing means. This can be a vector of assumed
alternatives, default is seq(0, 1, 0.2)
(power calculations) or seq(0.2, 1, 0.2)
(sample size calculations).
- stDev
The standard deviation under which the sample size or power
calculation is performed, default is 1
.
For two-armed trials, it is allowed to specify the standard deviations separately,
i.e., as vector with two elements.
If meanRatio = TRUE
is specified, stDev
defines
the coefficient of variation sigma / mu2
.
- directionUpper
Logical. 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.
- maxNumberOfSubjects
maxNumberOfSubjects > 0
needs to be specified for power calculations or calculation
of necessary follow-up (count data). For two treatment arms, it is the maximum number of subjects for both treatment arms.
- allocationRatioPlanned
The planned allocation ratio n1 / n2
for a two treatment groups
design, default is 1
. For multi-arm designs, it is the allocation ratio relating the active arm(s) to the control.
For simulating means and rates for a two treatment groups design, it can be a vector of length kMax
, the number of stages.
It can be a vector of length kMax
, too, for multi-arm and enrichment designs.
In these cases, a change of allocating subjects to treatment groups over the stages can be assessed.
Note that internally allocationRatioPlanned
is treated as a vector of length kMax
, not a scalar.