Simulated pediatric clinical trial adverse event dataset featuring age-appropriate adverse events, milder severity profiles, and pediatric-specific safety considerations. Designed to test pediatric safety analysis, age-specific toxicity profiling, and regulatory pediatric safety reporting requirements.
Format
A data frame with 387 adverse events from 114 patients and 8 variables:
- patient_id
Character. Unique patient identifier (PED_001 to PED_120)
- treatment_group
Factor. Treatment assignment ("Active", "Placebo")
- adverse_event
Factor. Pediatric-appropriate adverse events (18 unique events)
- toxicity_grade
Integer. CTCAE grade with pediatric-appropriate severity (1-3 focus)
- system_organ_class
Factor. Simplified SOC for pediatric context
- time_to_event
Integer. Days to AE onset (shorter timeframe, 1-90 days)
- patient_age
Integer. Pediatric age range (6-17 years)
- patient_sex
Factor. Patient sex ("Male", "Female")
Details
This dataset simulates pediatric clinical trial safety data with age-appropriate adverse events, typically milder severity profiles, and pediatric-specific considerations such as growth, development, and behavioral effects. It reflects pediatric safety monitoring requirements and regulatory considerations.
Clinical Context:
Pediatric clinical trial with active treatment vs placebo
120 patients aged 6-17 years
Age-appropriate adverse event profile
Milder severity patterns typical in pediatric populations
Shorter assessment timeframe appropriate for pediatric studies
Pediatric-Specific Adverse Events:
Constitutional: Fatigue, Fever, Decreased appetite, Weight loss
Gastrointestinal: Nausea, Vomiting, Diarrhea, Abdominal pain
Neurologic: Headache
Behavioral: Irritability, Sleep disturbance, Mood changes, Attention difficulties, Hyperactivity
Respiratory: Upper respiratory infection, Cough
Dermatologic: Rash
Local: Injection site reaction
Key Features:
Age-appropriate adverse event selection
Predominantly grade 1-2 events (milder severity)
Behavioral and developmental considerations
Realistic pediatric study size and design
Appropriate timeframe for pediatric assessment
Placebo-controlled design typical in pediatric trials
Recommended Analysis Scenarios:
Pediatric safety profiling
Active vs placebo safety comparison
Age-stratified safety analysis
Behavioral toxicity assessment
Growth and development monitoring
Pediatric regulatory safety reporting
Examples
if (FALSE) { # \dontrun{
# Load the dataset
data(toxicityprofile_pediatric)
# Pediatric safety profile
result <- toxicityprofile(
data = toxicityprofile_pediatric,
patientID = "patient_id",
adverseEvent = "adverse_event",
grade = "toxicity_grade",
treatment = "treatment_group",
plotType = "dot_plot",
showConfidenceIntervals = TRUE
)
# Behavioral toxicity focus
behavioral_events <- c("Irritability", "Sleep disturbance", "Mood changes",
"Attention difficulties", "Hyperactivity")
behavioral_data <- subset(toxicityprofile_pediatric,
adverse_event %in% behavioral_events)
result_behavioral <- toxicityprofile(
data = behavioral_data,
patientID = "patient_id",
adverseEvent = "adverse_event",
grade = "toxicity_grade",
treatment = "treatment_group",
groupComparison = TRUE
)
# Age-stratified analysis
adolescent_data <- subset(toxicityprofile_pediatric, patient_age >= 13)
result_adolescent <- toxicityprofile(
data = adolescent_data,
patientID = "patient_id",
adverseEvent = "adverse_event",
grade = "toxicity_grade",
plotType = "stacked_bar"
)
} # }