Usage
datacheck(design,Survhyp,pe,alfa,beta,duraccrual,durstudy,look,followup,dropout)
Arguments
design
Superiority=c(1,sided)[with sided=1 if 1-sided and 2 if 2-sided]; Non inferiority=c(2); Equivalence=c(3)
Survhyp
For Superiority=c(thyp,t,hype,Sc); for Non inferiority=c(thyp,t,hype,Sc,hypeA); for Equivalence=c(t,delta,Sc): parameters at time t
if thyp=1 then hype is survival rate in experimental arm under the null hypothesis and hypeA is the survival rate in the experimental arm under the alternative hypothesis;
if thyp=2 then hype is the hazard ratio under the null hypothesis and hypeA is the hazard ratio under the alternative hypothesis; Sc is the survival rate in the control arm;
delta is the log hazard ratio equivalence margin. When endpoint is HRQoL, the survival rate is replaced by the rate of patients without the HRQoL deterioration.
pe
Proportion (ratio) of patients assigned to the experimental arm (with 0
alfa
Type I error, for Non inferiority, Equivalence and 1-sided superiority, alfa is a vector of length one.
For 2-sided superiority, alfa is a vector to length two c(alpha.low, alpha.up).
beta
Probability of a type II error.
duraccrual
Accrual duration, expressed in number of days, months or years
durstudy
Study duration, expressed in number of days, months or years
look
The number interim analyses, c(1) for one final analysis; c(nb, bound, timing) for at least one interim analyses with bound=c(bound.eff,bound.fut):1-sided or bound=c(bound.low,bound.up):2-sided.
nb the number of planned looks, bound.eff and bound.fut corresponds to the type of boundaries used for efficacy (i.e. reject H0) and futility (i.e. reject H1).
bound.fut=0: No futility monitoring, 1: Lan deMets O.Brien Fleming, 2: Lan deMets Pocock.
bound.low and bound.up the type of lower and upper boundaries used (1: Lan deMets O.Brien Fleming, 2: Lan deMets Pocock, 3: O.Brien Fleming, 4: Pocock). Default value = 1.
followup
Follow-up information, No fixed:c(0) (follow-up until the end of study);
Fixed:c(1, durfollow) with durfollow is the duration of follow-up
dropout
Drop out information, No drop out:c(0); Drop out:c(1,gammae,gammac) with gammae the hazard drop out rates in experimental arm and control arm respectively.