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Oncology Clinical Trial Safety Dataset

Source: R/data_toxicityprofile_docs.R
toxicityprofile_oncology_trial.Rd

Simulated comprehensive oncology clinical trial adverse event dataset with three treatment arms, realistic CTCAE grading, and time-to-event information. Designed to test standard oncology safety analysis, treatment comparisons, regulatory reporting, and comprehensive toxicity profiling typical in phase II/III oncology trials.

Usage

toxicityprofile_oncology_trial

Format

A data frame with 2,061 adverse events from 250 patients and 9 variables:

patient_id

Character. Unique patient identifier (PT_001 to PT_250)

treatment_group

Factor. Treatment assignment ("Control", "Treatment A", "Treatment B")

adverse_event

Factor. CTCAE adverse event term (22 unique oncology-specific events)

toxicity_grade

Integer. CTCAE toxicity grade (1-5 scale)

system_organ_class

Factor. MedDRA System Organ Class categorization

time_to_event

Integer. Days from treatment initiation to AE onset (1-365 days)

event_date

Date. Calculated date of adverse event occurrence

patient_age

Integer. Patient age at enrollment (range varies by realistic distribution)

patient_sex

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

Source

Simulated data generated using create_toxicityprofile_test_data.R

Details

This dataset simulates a comprehensive oncology clinical trial with realistic adverse event patterns, CTCAE grading distributions, and treatment-specific toxicity profiles. It includes common oncology adverse events such as hematologic toxicities, gastrointestinal effects, constitutional symptoms, and treatment-specific events.

Clinical Context:

  • Multi-arm oncology trial with control and two experimental treatments

  • 250 patients with realistic demographic distribution

  • 22 common oncology adverse events with expected frequency patterns

  • CTCAE v5.0 compatible grading system

  • Realistic time-to-event distributions for safety monitoring

Adverse Events Included:

  • Hematologic: Anemia, Neutropenia, Thrombocytopenia

  • Gastrointestinal: Nausea, Vomiting, Diarrhea, Constipation, Mucositis

  • Constitutional: Fatigue, Fever, Decreased appetite

  • Neurologic: Peripheral neuropathy

  • Dermatologic: Alopecia, Rash

  • Laboratory: Elevated ALT/AST, Hyponatremia

  • Serious Events: Pneumonitis, Infection, Dehydration

  • Cardiovascular: Hypertension, Proteinuria

Statistical Features:

  • Treatment-specific incidence patterns with realistic effect sizes

  • Grade distributions appropriate for each adverse event type

  • Time-to-event patterns reflecting clinical experience

  • Balanced patient demographics across treatment arms

Recommended Analysis Scenarios:

  • Standard safety tabulations and listings

  • Treatment group comparisons with statistical testing

  • Time-to-event analysis and cumulative incidence

  • System organ class summaries for regulatory reporting

  • High-grade (≥3) adverse event analysis

  • Dose-limiting toxicity assessment

See also

toxicityprofile, toxicityprofile_datasets

Examples

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

# Basic toxicity profile analysis
result <- toxicityprofile(
  data = toxicityprofile_oncology_trial,
  patientID = "patient_id",
  adverseEvent = "adverse_event",
  grade = "toxicity_grade",
  treatment = "treatment_group",
  plotType = "stacked_bar",
  showHighGradeOnly = FALSE
)

# Treatment comparison analysis
result_comparison <- toxicityprofile(
  data = toxicityprofile_oncology_trial,
  patientID = "patient_id",
  adverseEvent = "adverse_event", 
  grade = "toxicity_grade",
  treatment = "treatment_group",
  systemOrganClass = "system_organ_class",
  groupComparison = TRUE,
  showConfidenceIntervals = TRUE
)

# Time-to-event analysis
result_time <- toxicityprofile(
  data = toxicityprofile_oncology_trial,
  patientID = "patient_id",
  adverseEvent = "adverse_event",
  grade = "toxicity_grade", 
  timeToEvent = "time_to_event",
  plotType = "time_to_event",
  cumulativeIncidence = TRUE
)
} # }