## Create data set modeled after the Isavuconazole study # See Study 0104 and the ITT analysis in: # www.fda.gov/downloads/AdvisoryCommittees/ # CommitteesMeetingMaterials/Drugs/ # Anti-InfectiveDrugsAdvisoryCommittee/UCM430748.pdf # # Figure 20 shows that data has about 20% failures by day 42 and 30% # failures by day 84, so we use a exponential cure model with 60% cured # and exponential mean=60.5932 that matches those two failure rates. # We censor only those that make it until day 100 without an event R.Version()$version.string set.seed(1) n<- 258 y<- rexp(2*n,rate=1/60.5932) cured<- rbinom(2*n,1,0.60) y[cured==1]<- 100 status<-rep(1,2*n) status[cured==1]<-0 z<-rep(c(1,2),each=n) IsaSimData<-data.frame(y=y,z=z,status=status) #nicq.test(y,g=nimDiffOR,delta0=0.10,q=0.20, z=z, status=status)
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