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# Title: Individual QTc display

### ClinECGVitalsGraphicsFormedit

 Image Click on image to enlarge. Title Individual QTc display Graph_Subgroup ECGVitals ECG_Vitals_Clinical_Question 4. How do individuals' values track over time? Contributor/Email A. Paredes, Antonio.Paredes@fda.hhs.govMax Cherny: Max2Cherny@gsk.com Background This figure shows the individual QTc values tracked over time. The individual profile illustrates the individual QTc in time relative to first dose. The red line is a proposed threshold QTc value (define “prolong QTc”). Keywords QTc, Individual, Profile plot References http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129357.pdf Datasets CDISC_Data Other_Data CLASSIFICATIONS Graph_Type Variable_Relationship Continuous versus Continuous Data_Types Continuous Special_Considerations Similar graphics such as QTC, QTCB, etc. may created for any categorization e.g. Gender Code_Available Yes Software Program R Software R-Code - Attachment Cherny R Code v05022013 R-Code # clear objectsrm(list = ls()) # GGPLOTlibrary(ggplot2)# close graphics windowsgraphics.off() #set hours valueshours<- c(6, -4, -2, 0, 2, 4,6,8,10) # Create ECG dataset with some random QTC values# set subject id to be within 20-39 rangeecg= data.frame( subjid= rep(20:39, each = 9), hours = rep(c(hours),20), qtc=sample(330:520, 180, replace=F))# Create DEMO dataset with some random gender valuesdemo= data.frame( subjid= rep(20:39), gender=sample(1:2, 20, replace=T))# Add gender values to ECG dataset ecg<-merge(ecg, demo, by=c("subjid")) # concatanate gender and subject ID together into a new variableecg\$gender_text<-ifelse (ecg\$gender==1, "Male", "Female")ecg\$subjid_gender<- paste(ecg\$subjid," ", ecg\$gender_text)# plot dataggplot(data=ecg, aes(x=hours, y=qtc)) + geom_line() + ylab("QTc (ms)")+ geom_point()+ facet_wrap( ~subjid_gender)+ geom_hline(yintercept = 420, colour="red")+ scale_x_continuous("Time relative to First Dose (Hr)", breaks = c(hours)) SAS-Code - Attachment SAS-Code Stata-Code - Attachment Stata-Code Other Code - Attachment Other Code 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
Topic revision: r4 - 02 May 2013 - 13:57:37 - MaryBanach

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