This vignette focuses on the visualizations available in the clinDataReview package.

If you have doubts on the data format, please check first the vignette on data preprocessing available at: here.

Please note that the patient profiles and interactive visualizations are only displayed in the vignette if Pandoc is available.

1 Patient profiles

The interactive visualizations of the clinical data package include functionalities to link a plot to patient-specific report, e.g. patient profiles created with the patientProfilesVis package.

Such patient profiles can be created via a config file, with a dedicated template report available in the clinDataReview package.

A simple patient profile report for each subject in the example dataset is created below.

Please note that the patient profiles are created and included in the interactive visualizations only during an interactive session (via interactive()) .

# please change to the working directory
# (a temporary directory is used for the vignette)
dir <- tempdir()

# create a directory to store the patient profiles:
patientProfilesDir <- file.path(dir, "patientProfiles")
dir.create(patientProfilesDir)

# get examples of parameters for the report
configDir <- system.file("skeleton", "config", package = "clinDataReview")
params <- getParamsFromConfig(
    configDir = configDir, 
    configFile = "config-patientProfiles.yml"
)
# create patient profile with only one panel for the demo
params$patientProfilesParams <- params$patientProfilesParams[1]
# use dataset from the clinUtils package
params$pathDataFolder <- system.file("extdata", "cdiscpilot01", "SDTM", package = "clinUtils")
# store patient profile in this folder:
params$patientProfilePath <- patientProfilesDir

# create patient profiles
pathTemplatePkg <- clinDataReview::getPathTemplate(params$template)
pathTemplateUser <- file.path(dir, basename(pathTemplatePkg))
tmp <- file.copy(from = pathTemplatePkg, to = pathTemplateUser)
report <- rmarkdown::render(
  input = pathTemplateUser, 
  envir = new.env()
)

# clean-up
unlink(pathTemplateUser);unlink(report)

Please refer to the vignette about reporting for more details on how to set up a config file and use template reports available in the package.

You can directly skip to reporting vignette, which is available here or run in your console the command below.

vignette("clinDataReview-reporting", "clinDataReview")

2 Data visualization

All the visualizations available in the package are interactive.

2.1 Visualization of individual profiles

Visualization of individual profiles is available via the function scatterplotClinData.

2.1.1 Explore the visualization data

To facilitate the exploration of the data, the underlying data behind each visualization can be included as a table as well below the plot by setting the parameter table to TRUE.

Please note that this functionality is not demonstrated in this document to ensure a lightweight vignette in the package.

2.1.2 Link with patient profiles

Subject-specific report (e.g. patient profiles) can be linked to each profile (pathVar parameter).

If the user clicks on the ‘P’ key while hovering on the plot, or click on the specific subject in the attached table, the specific patient profile is opened in a new window in the browser.

2.1.3 Spaghetti plot of time profile

labParam <- "ALT"
dataPlot <- subset(dataLB, PARAMCD == labParam)

visitLab <- with(dataPlot, tapply(ADY, VISIT, median))
names(visitLab) <- sub("-", "\n", names(visitLab))

# link to patient profiles
if(interactive())
    dataPlot$patientProfilePath <- paste0(
        "patientProfiles/subjectProfile-", 
        sub("/", "-", dataPlot$USUBJID), ".pdf"
    )

scatterplotClinData(
    data = dataPlot, 
    xVar = "ADY",
    yVar = "LBSTRESN",
    aesPointVar = list(color = "TRTP", fill = "TRTP"),
    aesLineVar = list(group = "USUBJID", color = "TRTP"),
    linePars = list(size = 0.5, alpha = 0.7),
    hoverVars = c("USUBJID", "VISIT", "ADY", "LBSTRESN", "TRTP"),
    labelVars = labelVars,
    xPars = list(breaks = visitLab, labels = names(visitLab)),
    title = paste("Actual value of", 
        getLabelParamcd(
            paramcd = labParam, data = dataLB, paramcdVar = "PARAMCD", paramVar = "PARAM"
        )
    ),
    # include link to patient profiles:
    pathVar = if(interactive()) "patientProfilePath",
    subtitle = paste(
        "Profile plot by subject",
        "Points are positioned at relative day",
        "Visits are positioned based on median relative day across subjects.",
        sep = "\n"
    ),
    verbose = TRUE,
    table = FALSE
)

2.1.4 Scatterplot

# format data long -> wide format (one column per lab param)
dataPlot <- subset(dataLB, PARAMCD %in% c("ALT", "ALB"))
dataPlot <- stats::aggregate(
    LBSTRESN ~ USUBJID + VISIT + VISITNUM + PARAMCD, 
    data = dataPlot,
    FUN = mean
)
dataPlotWide <- stats::reshape(
    data = dataPlot,
    timevar = "PARAMCD", idvar = c("USUBJID", "VISIT", "VISITNUM"),
    direction = "wide"
)
colnames(dataPlotWide) <- sub("^LBSTRESN.", "", colnames(dataPlotWide))

# link to patient profiles
if(interactive())
    dataPlotWide$patientProfilePath <- paste0(
        "patientProfiles/subjectProfile-", 
        sub("/", "-", dataPlotWide$USUBJID), ".pdf"
    )

# scatterplot per visit
scatterplotClinData(
    data = dataPlotWide, 
    xVar = "ALT", yVar = "ALB",
    xLab = getLabelParamcd(
        paramcd = "ALT", data = dataLB, paramcdVar = "PARAMCD", paramVar = "PARAM"
    ),
    yLab = getLabelParamcd(
        paramcd = "ALB", data = dataLB, paramcdVar = "PARAMCD", paramVar = "PARAM"
    ),
    aesPointVar = list(color = "USUBJID", fill = "USUBJID"),
    facetPars = list(facets = ~ VISIT),
    labelVars = labelVars,
    pathVar = if(interactive()) "patientProfilePath",
    table = FALSE
)

2.1.5 eDish plot

dataALT <- subset(dataLB, PARAMCD == "ALT")
dataBILI <- subset(dataLB, PARAMCD == "BILI")

byVar <- c("USUBJID", "VISIT")

dataPlot <- merge(
    x = dataALT, y = dataBILI[, c(byVar, "LBSTRESN")], 
    by = c("USUBJID", "VISIT"), 
    suffixes = c(".ALT", ".BILI"),
    all = TRUE
)
labelVars[paste0("LBSTRESN.", c("ALT", "BILI"))] <-
    paste(
        "Actual value of", 
        getLabelParamcd(
            paramcd = c("ALT", "BILI"), data = dataLB, paramcdVar = "PARAMCD", paramVar = "PARAM"
        )
    )

# link to patient profiles
if(interactive())
    dataPlot$patientProfilePath <- paste0(
        "patientProfiles/subjectProfile-", 
        sub("/", "-", dataPlot$USUBJID), ".pdf"
    )

# scatterplot per visit
scatterplotClinData(
    data = dataPlot, 
    xVar = "LBSTRESN.ALT", yVar = "LBSTRESN.BILI",
    xLab = getLabelParamcd(
        paramcd = "ALT", data = dataLB, paramcdVar = "PARAMCD", paramVar = "PARAM"
    ),
    yLab = getLabelParamcd(
        paramcd = "BILI", data = dataLB, paramcdVar = "PARAMCD", paramVar = "PARAM"
    ),
    aesPointVar = list(color = "VISIT", fill = "VISIT"),
    xTrans = "log10", yTrans = "log10",
    hoverVars = "USUBJID",
    labelVars = labelVars,
    table = FALSE, 
    pathVar = if(interactive()) "patientProfilePath"
)

2.1.6 Visualization of time-intervals

Time-intervals are displayed with the timeProfileIntervalPlot function:

# link to patient profiles
if(interactive())
    dataAE$patientProfilePath <- paste0(
        "patientProfiles/subjectProfile-", 
        sub("/", "-", dataAE$USUBJID), ".pdf"
    )
timeProfileIntervalPlot(
    data = dataAE,
    paramVar = "USUBJID",
    # time-variables
    timeStartVar = "ASTDY",
    timeEndVar = "ASTDY",
    colorVar = "AESEV",
    hoverVars = c("USUBJID", "AEDECOD", "ASTDY", "AENDY", "AESEV"),
    labelVars = labelVars,
    table = FALSE, 
    pathVar = if(interactive()) "patientProfilePath",
    tableVars = c("USUBJID", "AEDECOD", "ASTDY", "AENDY", "AESEV")
)

By default, empty intervals are represented if the start/end time variables are missing. Missing start/end time can be imputed, or different symbols can be used to represent such cases:

# create variable to indicate status of start/end date
dataAE$AESTFLG <- ifelse(is.na(dataAE$ASTDY), "Missing start", "Complete")
dataAE$AEENFLG <- ifelse(is.na(dataAE$AENDY), "Missing end", "Complete")
shapePalette <- c(
    `Missing start` = "triangle-left", 
    `Complete` = "square-open", 
    `Missing end` = "triangle-right"
)

# 'simple'-imputation:
# if start is missing, 'Missing' symbol displayed at end interval
dataAE$AESTDYIMP <- with(dataAE, ifelse(is.na(ASTDY), AENDY, ASTDY))
# if end is missing, 'Missing' symbol displayed at start interval
dataAE$AEENDYIMP <- with(dataAE, ifelse(is.na(AENDY), ASTDY, AENDY))

timeProfileIntervalPlot(
    data = dataAE,
    paramVar = "USUBJID", 
    # time-variables
    timeStartVar = "AESTDYIMP", timeStartLab = "Start day",
    timeEndVar = "AEENDYIMP", timeEndLab = "End day",
    # shape variables
    timeStartShapeVar = "AESTFLG",
    timeStartShapeLab = "Status of start date",
    timeEndShapeVar = "AEENFLG",
    timeEndShapeLab = "Status of end date",
    shapePalette = shapePalette,
    hoverVars = c("USUBJID", "AEDECOD", "AESEV", "ASTDY", "AESTFLG", "AENDY", "AEENFLG"),
    labelVars = labelVars,
    table = FALSE, 
    tableVars = c("USUBJID", "AEDECOD", "AESEV", "ASTDY", "AESTFLG", "AENDY", "AEENFLG"),
    pathVar = if(interactive()) "patientProfilePath"
)

2.2 Visualization of summary statistics

Summary statistics can also be visualized with the package, via different types of visualizations: sunburst, treemap and barplot.

These functions take as input a table of summary statistics, especially counts. Such table can e.g. computed with the inTextSummaryTable R package (see corresponding package vignette for more information).

2.2.1 Link with patient profiles

Subject-specific report (e.g. patient profiles) can be linked to each profile (pathVar parameter). If the user clicks on the ‘P’ key while hovering on the plot, a zip file containing the reports for all corresponding patients is downloaded. If the attached table is display, each row can be extended to display the links of the respective patient profile reports.

2.2.2 Categorical variables

2.2.2.1 Compute count statistics

In this example, counts of adverse events are extracted for each Primary System Organ Class and Dictionary-Derived Term.

Besides the counts of the number of subjects, the paths to the patient profile report for each subgroup are extracted and combined.

# total counts: Safety Analysis Set (patients with start date for the first treatment)
dataTotal <- subset(dataDM, RFSTDTC != "")

## patient profiles report

if(interactive()){

    # add path in data
    
    dataAE$patientProfilePath <- paste0(
        "patientProfiles/subjectProfile-", 
        sub("/", "-", dataAE$USUBJID), ".pdf"
    )

    # add link in data (for attached table)
    dataAE$patientProfileLink <- with(dataAE,
        paste0(
            '<a href="', patientProfilePath, 
            '" target="_blank">', USUBJID, '</a>'
        )
    )

    # Specify extra summarizations besides the standard stats
    # When the data is summarized,
    # the patient profile path are summarized
    # as well across patients
    # (the paths should be collapsed with: ', ')
    statsExtraPP <- list(
        statPatientProfilePath = function(data) 
          toString(sort(unique(data$patientProfilePath))),
        statPatientProfileLink = function(data)
          toString(sort(unique(data$patientProfileLink)))
    )
    
}

# get counts (records, subjects, % subjects) + stats with subjects profiles path
statsPP <- c(
    inTextSummaryTable::getStats(type = "count"),
    if(interactive())
        list(
            patientProfilePath = quote(statPatientProfilePath),
            patientProfileLink = quote(statPatientProfileLink)
        )
)

dataAE$AESEV <- factor(
    dataAE$AESEV,
    levels = c("MILD", "MODERATE", "SEVERE")
)
dataAE$AESEVN <- as.numeric(dataAE$AESEV)

# compute adverse event table
tableAE <- inTextSummaryTable::computeSummaryStatisticsTable(
    
    data = dataAE,
    rowVar = c("AESOC", "AEDECOD"),
    dataTotal = dataTotal,
    labelVars = labelVars,
    
    # The total across the variable used for the nodes
    # should be specified
    rowVarTotalInclude = c("AESOC", "AEDECOD"),
    
    rowOrder = "total",
    
    # statistics of interest
    # include columns with patients
    stats = statsPP, 
    # add extra 'statistic': concatenate subject IDs
    statsExtra = if(interactive())  statsExtraPP

)
knitr::kable(head(tableAE),
    caption = paste("Extract of the Adverse Event summary table",
        "used for the sunburst and barplot visualization"
    )
)

Extract of the Adverse Event summary table used for the sunburst and barplot visualization
AESOC	AEDECOD	isTotal	statN	statm	statPercTotalN	statPercN	n	%	m
CARDIAC DISORDERS	MYOCARDIAL INFARCTION	FALSE	1	1	7	14.28571	1	14.3	1
GASTROINTESTINAL DISORDERS	DYSPEPSIA	FALSE	1	1	7	14.28571	1	14.3	1
GASTROINTESTINAL DISORDERS	NAUSEA	FALSE	2	7	7	28.57143	2	28.6	7
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE DERMATITIS	FALSE	1	2	7	14.28571	1	14.3	2
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE ERYTHEMA	FALSE	3	3	7	42.85714	3	42.9	3
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	APPLICATION SITE IRRITATION	FALSE	2	4	7	28.57143	2	28.6	4

2.2.2.2 Sunburst

The sunburstClinData function visualizes the counts of hierarchical data in nested circles.

The different groups are visualized from the biggest class (root node) in the center of the visualization to the smallest sub-groups (leaves) on the outside of the circles.

The size of the different segments is relative the respective counts.

dataSunburst <- tableAE

dataSunburst$m <- as.numeric(dataSunburst$m)

sunburstClinData(
    data = dataSunburst,
    vars = c("AESOC", "AEDECOD"),
    valueVar = "m", 
    valueLab = "Number of adverse events",
    pathVar = if(interactive()) "patientProfileLink",
    pathLab = clinUtils::getLabelVar(var = "USUBJID", labelVars = labelVars),
    table = FALSE,
    labelVars = labelVars
)

2.2.2.3 Treemap

A treemap visualizes the counts of the hierarchical data in nested rectangles. The area of each rectangle is proportional to the counts of the respective group.

Note, that a treemap can also be colored accordingly to a meaningful variable. For instance, if we show adverse events, we might color the plot by severity. This can be achieved with the colorVar parameter.

dataTreemap <- tableAE

dataTreemap$m <- as.numeric(dataTreemap$m)

treemapClinData(
    data = dataTreemap,
    vars = c("AESOC", "AEDECOD"),
    valueVar = "m",
    valueLab = "Number of adverse events",
    pathVar = if(interactive()) "patientProfileLink",
    pathLab = clinUtils::getLabelVar(var = "USUBJID", labelVars = labelVars),
    table = FALSE,
    labelVars = labelVars
)

2.2.2.4 Barplot

A barplot visualizes the counts for one single variable in a specific order.

dataPlot <- subset(tableAE, AEDECOD != "Total")

dataPlot$n <- as.numeric(dataPlot$n)

# create plot
barplotClinData(
    data = dataPlot,
    xVar = "AEDECOD", 
    yVar = "n",
    yLab = "Number of patients with adverse events",
    textVar = "n",
    labelVars = labelVars,
    pathVar = if(interactive()) "patientProfileLink",
    pathLab = clinUtils::getLabelVar(var = "USUBJID", labelVars = labelVars),
    table = FALSE
)

2.2.3 Continuous variable

dataVSDIABP <- subset(dataADaMCDISCP01$ADVS, 
    PARAMCD == "DIABP" & ANL01FL == "Y" &
    AVISIT %in% c("Baseline", "Week 2", "Week 4", "Week 6", "Week 8")
)

# add link to patient profiles report

# add path in data
if(interactive()){
    
    dataVSDIABP$patientProfilePath <- paste0(
        "patientProfiles/subjectProfile-", 
        sub("/", "-", dataVSDIABP$USUBJID), ".pdf"
    )

    # add link in data (for attached table)
    dataVSDIABP$patientProfileLink <- with(dataVSDIABP,
        paste0(
            '<a href="', patientProfilePath, 
            '" target="_blank">', USUBJID, '</a>'
        )
    )

}

2.2.3.1 Compute summary statistics

# Specify extra summarizations besides the standard stats
# When the data is summarized,
# the patient profile path are summarized
# as well across patients
# (the paths should be collapsed with: ', ')
if(interactive())
    statsExtraPP <- list(
        statPatientProfilePath = function(data) 
          toString(sort(unique(data$patientProfilePath))),
        statPatientProfileLink = function(data)
          toString(sort(unique(data$patientProfileLink)))
    )
    
# get default counts + stats with subjects profiles path
statsPP <- c(
    inTextSummaryTable::getStats(x = dataVSDIABP$AVAL, type = "summary"),
    if(interactive())
        list(
            patientProfilePath = quote(statPatientProfilePath),
            patientProfileLink = quote(statPatientProfileLink)
        )
)

# compute summary table of actual value
summaryTableCont <- inTextSummaryTable::computeSummaryStatisticsTable(
    
    data = dataVSDIABP,
    rowVar = c("AVISIT", "ATPT"),
    var = "AVAL",
    
    labelVars = labelVars,
    
    # statistics of interest
    # for DT output, include columns with patients
    stats = statsPP, 
    # add extra 'statistic': concatenate subject IDs
    statsExtra = if(interactive())  statsExtraPP

)
knitr::kable(head(summaryTableCont, 1))

AVISIT	ATPT	isTotal	statN	statm	statMean	statSD	statSE	statMedian	statMin	statMax	statPercTotalN	statPercN	n	Mean	SD	SE	Median	Min	Max	%	m
Baseline	AFTER LYING DOWN FOR 5 MINUTES	FALSE	7	7	70.71429	9.214378	3.482708	70	56	84	7	100	7	70.7	9.2	3.48	70.0	56	84	100	7

2.2.3.2 Plot error bars/confidence intervals

dataPlot <- subset(summaryTableCont, !isTotal)

errorbarClinData(
    data = dataPlot,
    xVar = "AVISIT",
    colorVar = "ATPT",
    
    # use non-rounded statistics for the plot
    yVar = "statMean", 
    yErrorVar = "statSE", 
    
    # display rounded stats in the hover + n: number of subjects
    hoverVars = c("AVISIT", "ATPT", "n", "Mean", "SE"),
    
    yLab = "Mean", yErrorLab = "Standard Error",
    title = "Diastolic Blood Pressure summary profile by actual visit and and analysis timepoint",
    
    # include lines connecting the error bars
    mode = "markers+lines", 
    
    table = FALSE, labelVars = labelVars,
    pathVar = if(interactive()) "patientProfileLink",
    pathLab = clinUtils::getLabelVar(var = "USUBJID", labelVars = labelVars)

)

2.2.3.3 Boxplot

A boxplot visualizes the distribution of a continuous variable of interest versus specific categorical variables.

This visualization doesn’t rely on pre-computed statistics, so the continuous variable of interest is directly passed to the functionality.

dataPlot <- subset(dataADaMCDISCP01$ADVS, 
    PARAMCD == "DIABP" & ANL01FL == "Y" &
    AVISIT %in% c("Baseline", "Week 2", "Week 4", "Week 6", "Week 8")
)

# link to patient profiles
if(interactive())
    dataPlot$patientProfilePath <- paste0(
        "patientProfiles/subjectProfile-", 
        sub("/", "-", dataPlot$USUBJID), ".pdf"
    )

boxplotClinData(
    data = dataPlot,
    xVar = "AVISIT", 
    yVar = "AVAL",
    colorVar = "TRTA",
    facetVar = "ATPT",
    title = "Diastolic Blood Pressure distribution by actual visit and analysis timepoint",
    yLab = "Actual value of the Diastolic Blood Pressure parameter (mmHg)",
    labelVars = labelVars,
    pathVar = if(interactive()) "patientProfilePath",
    pathLab = clinUtils::getLabelVar(var = "USUBJID", labelVars = labelVars),
    table = FALSE
)

2.3 Multiple visualizations in a loop

To include multiple clinical data visualizations (with or without attached table) in a loop (in the same Rmarkdown chunk), the list of visualizations should be passed to the knitPrintListObjects function of the clinUtils package.

# consider only restricted set of lab parameters
dataPlot <- subset(dataLB, PARAMCD %in% c("SODIUM", "K"))

# link to patient profiles
if(interactive())
    dataPlot$patientProfilePath <- paste0(
        "patientProfiles/subjectProfile-", 
        sub("/", "-", dataPlot$USUBJID), ".pdf"
    )

# 1) create plot+table for each laboratory parameter:
library(plyr) # for ddply
plotsLab <- dlply(dataPlot, "PARAMCD", function(dataLBParam){
      
      paramcd <- unique(dataLBParam$PARAMCD)
      
      scatterplotClinData(
          data = dataLBParam, 
          xVar = "ADY",
          yVar = "LBSTRESN",
          aesPointVar = list(color = "TRTP", fill = "TRTP"),
          aesLineVar = list(group = "USUBJID", color = "TRTP"),
          labelVars = labelVars,
          title = paste("Actual value of", 
              getLabelParamcd(
                  paramcd = paramcd, data = dataLBParam, paramcdVar = "PARAMCD", paramVar = "PARAM"
              )
          ),
          # include link to patient profiles:
          pathVar = if(interactive())   "patientProfilePath",
          table = FALSE, 
          # important: each plot should have an unique ID!
          # for unique relationship of interactivity between plot <-> table
          id = paste("labProfileLoop", paramcd, sep = "-")
      )
      
    })

# include this output in the report:
listLabels <- getLabelParamcd(
    paramcd = names(plotsLab), data = dataLB, paramcdVar = "PARAMCD", paramVar = "PARAM"
)
clinUtils::knitPrintListObjects(
    xList = plotsLab, 
    titles = listLabels, titleLevel = 4
)

2.3.0.1 Potassium (mmol/L)

2.3.0.2 Sodium (mmol/L)

2.4 Watermark

A watermark can be included in any of the visualization of the package, from a specified file, via the watermark parameter.

In this example, an exploratory watermark is added to the adverse events barplot.

# create a file with a 'EXPLORATORY' watermark
file <- tempfile(pattern = "watermark", fileext = ".png")
getWatermark(file = file)

# create plot
barplotClinData(
  data = subset(tableAE, AEDECOD != "Total"),
  xVar = "AEDECOD", 
  yVar = "n",
  yLab = "Number of patients with adverse events",
  textVar = "n",
  labelVars = labelVars,
  # include the watermark
  watermark = file,
  table = FALSE
)

Visualization of clinical data

Laure Cougnaud, Michela Pasetto

April 11, 2025