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Image
LocalReactions
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Title Local Reactions over Time
Graph_Subgroup General Principles
Code Added Yes
Description The mean profile of each treatment group is plotted over time for each of the five parameters being collected to assess local reactions to treatment.
Contributor/Email Mat Soukup (email: Mat.Soukup@fda.hhs.gov)
Background Velac Gel is a combination product of which it is well-established that one of it's components, tretinoin, is somewhat of a local irritant. Velac was not approved based on a positive signal in the non-clinical carc study.
Special Considerations

Date Original
Original Date 2007
Modified Date

Use/Suitability Presentation
Software Program R
Software

R-Code - Attachment R-script: Local Reactions - Attached
R-Code library(Hmisc,T)

library(lattice)

dat <- sasxport.get("//Cdsesub1/n50803/N_000/2004-08-23/crt/datasets/vlc.c.304/A_EFF.XPT")
#Make missing be denoted as NA
levels(dat$dry)[levels(dat$dry)%in%""] <- NA
levels(dat$eryth)[levels(dat$eryth)%in%""] <- NA
levels(dat$scal)[levels(dat$scal)%in%""] <- NA
levels(dat$burn)[levels(dat$burn)%in%""] <- NA
levels(dat$itch)[levels(dat$itch)%in%""] <- NA
dat$dryn <- as.numeric(dat$dry)
dat$erythn <- as.numeric(dat$eryth)
dat$scaln <- as.numeric(dat$scal)
dat$burnn <- as.numeric(dat$burn)
dat$itchn <- as.numeric(dat$itch)

skinval <- with(dat, c(dryn, erythn, scaln, burnn, itchn))
skinpar <- rep(c('Dryness','Erythema','Scaling','Burning','Itching'), each=dim(dat)[1])
skinvisit <- rep(dat$visit, 5)
skintrt <- rep(dat$txname, 5)

ss <- summarize(skinval, llist(skinpar, skintrt, skinvisit), function(x)mean(x, na.rm=TRUE))

#png('C:/Research/Graphics/Graphs4Display/webpages/classes/pages/images/local50803.png',
# width=550, height=550)

new.back <- trellis.par.get("background")
new.back$col <- "white"
newcol <- trellis.par.get("superpose.symbol")
newcol$col <- c('blue','green4','black','red' )
newcol$pch <- c(16,17,4,8)
new.line <- trellis.par.get("superpose.line")
new.line$col <- c('blue','green4','black','red' )
new.line$lty <- c(1,1,1,1)
new.pan <- trellis.par.get("strip.background")
new.pan$col <- c('gray90','white')
trellis.par.set("background", new.back)
trellis.par.set("superpose.symbol", newcol)
trellis.par.set("superpose.line", new.line)
trellis.par.set("strip.background",new.pan)

xyplot(skinval ~ skinvisit|skinpar, groups=skintrt, data=ss, type='o',
scales=list(y=list(at=seq(1,2,.25), labels=Cs('none (0)','1.25','1.5','1.75','mild (1)')),
x=list(at=1:5, labels=Cs(0,2,4,8,12))),
xlab="Week", ylab="Mean Value",
xlim=c(.5,5.5),ylim=c(.95,2.05),
key=list(x=.725,y=.8,
lines=list(type='o',
col=trellis.par.get("superpose.symbol")$col[1:4],
lty=trellis.par.get('superpose.line')$lty[1:4],
pch=trellis.par.get('superpose.symbol')$pch[1:4],
size=2),
text=list(
lab=levels(ss$skintrt),
col=trellis.par.get('superpose.line')$col[1:4]),
columns=1, title='Treatment', cex=.8, cex.title=1),
aspect=1)
#dev.off()
SAS-Code - Attachment

SAS-Code

Stata-Code - Attachment

Stata-Code

Other Code - Attachment

Other Code

Keywords safety analysis, treatment group
OPTIONAL FIELDS

References Statistical Review of NDA 50-803 by Mat Soukup, Ph.D.
Datasets

Data

Attached Data

CATEGORIZATIONS

Classification-Evaluation Safety
Classification-Graph Type Scatterplot
Graph_Type Scatterplot
Variable Relationship Continuous versus Categorical
Data Types Categorical and Continuous
Special Cases

Disclaimer The views expressed within CTSpedia are those of the author and must not be taken to represent policy or guidance on the behalf of any organization or institution with which the author is affiliated.
Permission Permission is hereby granted, free of charge, to any person obtaining a copy of this software and associated documentation files (the "Software"), to deal in the Software without restriction, including without limitation the rights to use, copy, modify, merge, publish, distribute, sublicense, and/or sell copies of the Software, and to permit persons to whom the Software is furnished to do so, subject to the following conditions:

The above copyright notice and this permission notice shall be included in all copies or substantial portions of the Software.

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Reference Image local_reference_200.png
Topic revision: r13 - 30 Mar 2012 - 13:47:17 - MaryBanach
 

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