Image | %LIGHTBOX{ image="EGall.png" thumbnail="tn_EGall.gif" caption="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')<br /> adeg$studyidf <- factor(adeg$studyid, levels=levels(adeg$studyid),<br /> labels=c('ACT 3','ACT 4','ACT 1','Scene 2','CRAFT','ACT 2')) adeg$armex <- factor(adeg$armex, levels=levels(adeg$armex),<br /> 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), <br /> 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")<br />new.back$col <- "white"<br />newcol <- trellis.par.get("superpose.symbol")<br />newcol$col <- c('blue','black', 'green4')<br />newcol$pch <- c(1,16,4,8)<br />new.line <- trellis.par.get("superpose.line")<br />new.line$col <- c('blue','black', 'green4')<br />new.line$lty <- c(1,1,1,1)<br />new.pan <- trellis.par.get("strip.background")<br />new.pan$col <- c('gray90','white')<br />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 | |
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. THE SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF ERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE AUTHORS OR COPYRIGHT OLDERS BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER LIABILITY, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM, OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE SOFTWARE. |
Reference Image |