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Summary EG Parameters
Click on image to enlarge.
Title Summary of All EG Parameters
Graph_Subgroup General Principles
Code Added Yes
Description For the CDISC EG domain, the mean for each treatment group is calculated at each time point for each of the parameters included in the EG domain.
Contributor/Email Mat Soukup (email: Mat.Soukup@fda.hhs.gov)
Background The graphic is based on the EG analysis data set submitted by the sponsor. In this trial subjects could receive a second injection (denoted as RSD1235-2) at 20 minutes if there was no response to the first injection at baseline.
Special Considerations

Date Modified
Original Date 2007
Modified Date

Use/Suitability Publication
Software Program SAS
Software

R-Code - Attachment R-script: Summary of All EG Parameters - Attached
R-Code library(Hmisc)
library(lattice)


# analysis data set
adeg <- sasxport.get('//Cdsesub1/evsprod/NDA022034/0011/m5/datasets/iss/analysis/adeg.xpt')
adeg$studyidf <- factor(adeg$studyid, levels=levels(adeg$studyid),
labels=c('ACT 3','ACT 4','ACT 1','Scene 2','CRAFT','ACT 2'))
adeg$armex <- factor(adeg$armex, levels=levels(adeg$armex),
labels=c('Placebo','RSD1235-1','RSD1235-2'))
# RSD1235-1 and RSD1235-2 correspond to 1 and 2 injections, respectively.

# Graph of all ECG parameters
ss <- with(subset(adeg, egtptnum%nin%1),
summarize(egstresn, llist(egtestcd, egtptnum, armex), mean))

#png('C:/Research/Graphics/Graphs4Display/webpages/classes/pages/images/EGall.png',
# width=936, height=625)

new.back <- trellis.par.get("background")
new.back$col <- "white"
newcol <- trellis.par.get("superpose.symbol")
newcol$col <- c('blue','black', 'green4')
newcol$pch <- c(1,16,4,8)
new.line <- trellis.par.get("superpose.line")
new.line$col <- c('blue','black', 'green4')
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(egstresn~egtptnum|egtestcd, groups=armex, data=ss, type='l',
ylab='',
xlab='Time of measurement',
lwd=2, cex=1,
pch=trellis.par.get('superpose.symbol')$pch[1:3],
scales=list(x=list(at=c(2,6,9,12,15,16,17,18),
labels=c('Base','15m','30','45','2h','4','','24')),
y='free'),
aspect=1,
key=list(x=.7, y=.9,
lines=list(type='l',
col=trellis.par.get("superpose.symbol")$col[1:3],
lty=trellis.par.get('superpose.line')$lty[1:3],
lwd=2),
text=list(
lab=levels(adeg$armex),
col=trellis.par.get('superpose.line')$col[1:3]),
columns=1, title='Treatment', cex=1.5))
#dev.off()
SAS-Code - Attachment

SAS-Code

Stata-Code - Attachment

Stata-Code

Other Code - Attachment

Other Code

Keywords safety analysis, CDISC, EG parameters
OPTIONAL FIELDS

References

Datasets CDISC Datasets
Data

Attached Data

CATEGORIZATIONS

Classification-Evaluation Safety
Classification-Graph Type

Graph_Type

Variable Relationship Continuous versus Categorical Conditioned
Data Types Categorical and Continuous
Special Cases

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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:

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Reference Image EGall_Reference_200.png
Topic revision: r13 - 03 Apr 2012 - 14:07:10 - MaryBanach
 

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