qtexplorer QT/ECG Data Explorer

The {qtexplorer} R package contains a set of charts for investigating QT/ECG cardiac safety, extended from {safetyCharts} pkg, developed by the ISG. These charts are optimized for usage with the {safetyGraphics} package and shiny application, but can also easily be used as standalone displays.

Quick start

A demo of the app using sample data is available here or can be initialized as follows:

# Install from github
remotes::install_github("SafetyGraphics/qtexplorer@dev")

library(safetyCharts)
library(safetyGraphics)
library(dplyr)
library(yaml)

qtCharts <- safetyGraphics::makeChartConfig(packages = "qtexplorer") 

# eg_ph2 data
mapping_ph2 <- yaml::read_yaml(
  text = "
ecg:
  id_col: ID
  value_col: VALUE
  measure_col: PARAM
  measure_values:
    QT: ''
    QTcF: QTcF
    QTcB: ''
    RR: HR
    QRS: ''
  normal_col_low: ''
  normal_col_high: ''
  studyday_col: DAY
  visit_col: VISIT
  visitn_col: VISIT
  tpt_col: TIME
  tptn_col: TIME2
  period_col: ''
  unit_col: 'UNIT'
  baseline_flag_col: 'BL_FLAG'
  baseline_flag_values: 'Y'
  treatment_col: TREAT
  analysis_flag_col: ''
  analysis_flag_values: ''
dm:
  id_col: ID
  group_col: TREAT
  sex_col: SEX
  race_col: RACE
  age_col: AGE
"
)

meta <- rbind(qtexplorer::meta_dm, qtexplorer::meta_ecg)

# Launch qt explorer
safetyGraphics::safetyGraphicsApp(
  charts = qtCharts,
  meta=meta,
  domainData = list(ecg = qtexplorer::eg_ph2, dm = qtexplorer::dm_ph2),
  mapping = mapping_ph2
)

Quick introduction to QT/ECG safety

• ICH E14 Guidance for Industry E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
• CTSPEDIA ECG Clinical Questions, contributed by Rich Anziano

Sample ECG data

The qtexplorer package includes 3 sample ECG data sets

• Thorough QT: FDA CiPA ECG Validation Study
• De-identified Phase 2b study (non TQT).
  • Link to data description

qtexplorer Charts

• Central Tendency
• Outlier explorer (ICH E14)
• safetyCharts lab widgets
  • Outlier explorer
  • Boxplot
  • Histogram
  • Shiftplot
  • Paneled outlier plot
  • delta delta