Dose Escalation Study Safety Dataset

Simulated dose escalation study adverse event dataset featuring dose-dependent toxicity patterns, escalating severity with increasing dose levels, and dose-limiting toxicity assessment. Designed to test dose-response safety analysis, maximum tolerated dose determination, and phase I trial safety monitoring.

Usage

toxicityprofile_dose_escalation

Format

A data frame with 603 adverse events from 148 patients and 8 variables:

patient_id

Character. Unique patient identifier (DSE_001 to DSE_150)

treatment_group

Factor. Dose level ("Dose Level 1" to "Dose Level 5")

adverse_event

Factor. General adverse events (20 events across all systems)

toxicity_grade

Integer. CTCAE grade with dose-dependent severity escalation

system_organ_class

Factor. Simplified SOC categorization

time_to_event

Integer. Days to AE onset (typically early in dose escalation)

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 a dose escalation study with realistic dose-dependent toxicity patterns, increasing incidence and severity at higher dose levels, and appropriate distributions for dose-limiting toxicity assessment. It reflects typical phase I dose escalation trial safety patterns.

Clinical Context:

• Five-level dose escalation study (3+3 or similar design)

• 150 patients distributed across dose levels

• Dose-dependent incidence and severity patterns

• Early toxicity assessment (first cycle focus)

• DLT evaluation timeframe (typically 28 days)

Dose-Response Characteristics:

• Increasing incidence rates with dose escalation

• Higher grade toxicities at elevated dose levels

• Realistic dose level patient distributions

• Early onset appropriate for DLT assessment

• General toxicity profile applicable across therapeutic areas

Adverse Events Pattern:

• Constitutional: Fatigue, Nausea, Vomiting, Decreased appetite

• Gastrointestinal: Diarrhea, Constipation, Abdominal pain, Dyspepsia

• Neurologic: Headache, Dizziness, Peripheral neuropathy, Muscle weakness

• Psychiatric: Insomnia, Anxiety

• Dermatologic: Rash, Pruritus, Dry mouth

• Musculoskeletal: Arthralgia, Back pain

• Cardiovascular: Hypertension

Key Features:

• Clear dose-response relationship in toxicity

• Escalating severity with increasing dose

• Appropriate for DLT assessment

• Realistic phase I trial patient numbers

• Early onset patterns for cycle 1 evaluation

Recommended Analysis Scenarios:

• Dose-response toxicity analysis

• Maximum tolerated dose determination

• Dose-limiting toxicity identification

• Safety run-in analysis

• Dose modification recommendations

• Phase I safety summary

See also

toxicityprofile, toxicityprofile_datasets

Examples

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

# Dose-response analysis
result <- toxicityprofile(
  data = toxicityprofile_dose_escalation,
  patientID = "patient_id",
  adverseEvent = "adverse_event",
  grade = "toxicity_grade",
  treatment = "treatment_group",
  plotType = "stacked_bar",
  sortBy = "high_grade"
)

# High-grade toxicity by dose level
result_dlts <- toxicityprofile(
  data = toxicityprofile_dose_escalation,
  patientID = "patient_id", 
  adverseEvent = "adverse_event",
  grade = "toxicity_grade",
  treatment = "treatment_group",
  showHighGradeOnly = TRUE,
  groupComparison = FALSE
)

# Dose level comparison
result_comparison <- toxicityprofile(
  data = toxicityprofile_dose_escalation,
  patientID = "patient_id",
  adverseEvent = "adverse_event", 
  grade = "toxicity_grade",
  treatment = "treatment_group",
  plotType = "heatmap"
)
} # }