Description Usage Arguments Details
this function check the parameters required to calcul the sample size for nsurvival and ncoprimary functions. datacheck is a simple utility for carrying out parameter checks and reporting on problems or errors.
1 |
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<pe<1) |
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. |
the datacheck function performs consistency checks on the arguments
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