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Image
Reports by SOC
Click on image to enlarge.
Title Reports by SOC
Graph_Subgroup General Principles
Code Added Yes
Description For each source of the report the number of subjects experiencing an AE according to the SOC is plotted in which the SOC are sorted according the to most frequent reported AE's within a SOC for those reported by Consumers.
Contributor/Email Mat Soukup (email: Mat.Soukup@fda.hhs.gov)
Background The graphic is based on an early example included in the MedDRA Document: MedDRA Data Retrieval and Presentation: Points to Consider.
Special Considerations

Date Original
Original Date 2007
Modified Date

Use/Suitability Presentation
Software Program R
Software

R-Code - Attachment R-script: Reports by SOC
R-Code ####### ------ Plot of the Number of Reports by SOC ------- #####
name <- c("Blood and the lymphatic system disorders",
"Cardiac disorders",
"Congenital and familial/genetic disorders",
"Ear and labyrinth disorders",
"Endocrine disorders",
"Eye disorders",
"Gastrointestinal disorders",
"General disorders and administration site conditions",
"Hepato-biliary disorders",
"Immune system disorders",
"Infections and infestations",
"Injury, poisoning and procedural complications",
"Investigations",
"Metabolism and nutrition disorders",
"Musculoskeletal and connective tissue disorders",
"Neoplasms benign, malignant, and unspecified",
"Nervous system disorders",
"Pregnancy, puerperium and perinatal conditions",
"Psychiatric disorders",
"Renal and urinary disorders",
"Reproductive system and breast disorders",
"Respiratory, thoracic and mediastinal disorders",
"Skin and subcutaneous tissue disorders",
"Social circumstances",
"Surgical and medical procedures",
"Vascular disorders")
freq <- c(0,100,0,325,0,270,860,875,0,85,60,250,470,60,290,0,1350,0,1475,
105,320,211,1050,5,0,90,100,340,0,450,30,350,815,850,35,330,70,
470,520,75,435,15,2850,3,1325,300,455,320,1825,5,4,335)
grp <- rep(c('Consumers','Health Care Prof'), each=26)

dat <- data.frame(name=rep(name,2), freq, grp)

# Sort the factors based on HC frequencies
library(gdata)
sortmat <- function (Mat, Sort) {
m <- do.call("order", as.data.frame(Mat[, Sort]))
Mat[m, ]
}
dats <- sortmat(subset(dat, grp%in%'Consumers'), 2)

dat1s <- data.frame(name=datsRCode,
freq=datsfreq,
grp=rep(c('Consumers','Health Care Prof'), each=26))
oNames <- datsRCode
datRCode2 <- reorder(datRCode, new.order=oNames)

#png('C:/Research/Graphics/Graphs4Display/webpages/classes/pages/images/ReportsBySOC.png',
# width=900, height=625)
new.back <- trellis.par.get("background")
new.back$col <- "white"
newcol <- trellis.par.get("superpose.symbol")
newcol$col <- c('green4','blue')
newcol$pch <- c(16,17,8)
new.line <- trellis.par.get("superpose.line")
new.line$col <- c('green4','blue')
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)

dotplot(name2~freq, groups=grp, data=dat,
xlab='Number of Reports',
panel=function(x,y,...){
llines(c(0,0), c(-5,105), col='grey90', lty=2)
llines(c(500,500), c(-5,105), col='grey90', lty=2)
llines(c(1000,1000), c(-5,105), col='grey90', lty=2)
llines(c(1500,1500), c(-5,105), col='grey90', lty=2)
llines(c(2000,2000), c(-5,105), col='grey90', lty=2)
llines(c(2500,2500), c(-5,105), col='grey90', lty=2)
llines(c(3000,3000), c(-5,105), col='grey90', lty=2)
panel.dotplot(x,y, col.line='grey70', ...)
},
scales=list(x=list(at=seq(0,3000, 500), labels=seq(0,3000,500))),
key=list(points=list(
pch=trellis.par.get("superpose.symbol")$pch[1:2],
col=trellis.par.get("superpose.symbol")$col[1:2]),
text=list(
lab=c('Consumers','Health Care Prof.'),
col=trellis.par.get("superpose.symbol")$col[1:2]),
columns=2, title='Source of Report'),
sub='Patient Population 1'
)
#dev.off()
SAS-Code - Attachment

SAS-Code

Stata-Code - Attachment

Stata-Code

Other Code - Attachment

Other Code

Keywords safety analysis, adverse event, system organ classification
OPTIONAL FIELDS

References MedDRA Data Retrieval and Presentation: Points to Consider.
Datasets

Data

Attached Data

CATEGORIZATIONS

Classification-Evaluation Safety
Classification-Graph Type

Graph_Type

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

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Reference Image ReportsBySOC_referemce_200.jpg
Topic revision: r12 - 30 Mar 2012 - 13:46:37 - MaryBanach
 

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