Skip to contents

Immunotherapy Safety Profile Dataset

Source: R/data_toxicityprofile_docs.R
toxicityprofile_immunotherapy.Rd

Simulated immunotherapy clinical trial adverse event dataset featuring immune-related adverse events (irAEs), monotherapy vs combination therapy comparison, and characteristic delayed-onset toxicity patterns. Designed to test immunotherapy-specific safety analysis, immune-related AE monitoring, and regulatory reporting for checkpoint inhibitors.

Usage

toxicityprofile_immunotherapy

Format

A data frame with 541 adverse events from 171 patients and 8 variables:

patient_id

Character. Unique patient identifier (IMM_001 to IMM_180)

treatment_group

Factor. Treatment regimen ("Monotherapy", "Combination")

adverse_event

Factor. Immune-related adverse events (20 unique irAEs)

toxicity_grade

Integer. CTCAE toxicity grade with irAE-specific distributions

system_organ_class

Factor. MedDRA SOC with emphasis on immune-related systems

time_to_event

Integer. Days to irAE onset (typically delayed, 7-365 days)

patient_age

Integer. Patient age at enrollment

patient_sex

Factor. Patient sex ("Male", "Female")

Source

Simulated data generated using create_toxicityprofile_test_data.R

Details

This dataset simulates immunotherapy safety data with characteristic immune-related adverse events, delayed onset patterns, and combination vs monotherapy toxicity profiles. It reflects real-world immunotherapy safety experience including checkpoint inhibitor toxicities and immune system activation effects.

Clinical Context:

  • Immunotherapy trial comparing monotherapy vs combination treatment

  • 180 patients with immune-related adverse event focus

  • 20 specific immune-related adverse events

  • Delayed onset patterns characteristic of immunotherapy

  • Grade distributions reflecting irAE severity patterns

Immune-Related Adverse Events:

  • Gastrointestinal: Diarrhea, Colitis

  • Pulmonary: Pneumonitis

  • Hepatic: Hepatitis

  • Endocrine: Thyroiditis, Adrenal insufficiency, Diabetes mellitus, Hypophysitis

  • Dermatologic: Rash, Pruritus, Vitiligo, Severe skin reactions

  • Musculoskeletal: Arthralgia, Myalgia

  • Renal: Nephritis

  • Neurologic: Neurological toxicity

  • Cardiac: Myocarditis (rare but serious)

  • Ocular: Uveitis

Key Features:

  • Delayed onset patterns typical of immune activation

  • Higher incidence in combination therapy vs monotherapy

  • Appropriate grade distributions for each irAE type

  • Serious events (myocarditis, severe colitis) at realistic low frequencies

  • System organ class categorization for regulatory reporting

Recommended Analysis Scenarios:

  • Immune-related adverse event profiling

  • Monotherapy vs combination safety comparison

  • Time-to-onset analysis for delayed toxicities

  • Endocrine toxicity monitoring

  • Serious irAE identification and reporting

  • Safety stopping rule evaluation

See also

toxicityprofile, toxicityprofile_datasets

Examples

if (FALSE) { # \dontrun{
# Load the dataset
data(toxicityprofile_immunotherapy)

# Immune-related AE analysis
result <- toxicityprofile(
  data = toxicityprofile_immunotherapy,
  patientID = "patient_id",
  adverseEvent = "adverse_event",
  grade = "toxicity_grade",
  treatment = "treatment_group",
  systemOrganClass = "system_organ_class",
  plotType = "heatmap"
)

# High-grade irAE analysis
result_serious <- toxicityprofile(
  data = toxicityprofile_immunotherapy,
  patientID = "patient_id",
  adverseEvent = "adverse_event",
  grade = "toxicity_grade",
  showHighGradeOnly = TRUE,
  minIncidence = 1
)

# Time-to-onset analysis
result_timing <- toxicityprofile(
  data = toxicityprofile_immunotherapy,
  patientID = "patient_id",
  adverseEvent = "adverse_event",
  grade = "toxicity_grade",
  timeToEvent = "time_to_event",
  plotType = "time_to_event"
)
} # }