Pralatrexate Adverse Event Reports from the FDA FAERS Database

FAERS data from 2004 to 2025 provides 2,241 adverse event reports for 563 patients treated with the anticancer drug pralatrexate. The dataset was created by Wei Yang in 2026 for a pharmacovigilance study analyzing the drug's postmarketing safety profile. It includes patient demographics, reported adverse events, signal detection results, and time-to-onset data.

Use Cases

• Identify novel adverse event signals like hypochloremia or intestinal ischemia using disproportionality analysis algorithms (ROR, PRR, BCPNN, MGPS).
• Analyze demographic risk factors by correlating adverse events like toxic epidermal necrolysis with patient sex or mucosal injury with age groups (≥65 vs. <65 years).
• Model time-to-onset distributions for adverse events using the reported median of 16 days and interquartile range (6–59 days).
• Investigate severe outcome predictors by linking specific adverse events (mucositis, hematologic toxicity) to reported outcomes like death or hospitalization.

Strengths

• Contains 2,241 adverse event reports extracted from the authoritative FDA FAERS database.
• Reports span a 21-year period from the first quarter of 2004 through the first quarter of 2025.
• Analysis includes 84 statistically detected positive signals and detailed subgroup analyses by sex and age.

Limitations

• Limited to 563 unique patients, a small sample size for robust subgroup comparisons.
• Data reflects spontaneous reporting biases inherent to FAERS, not a controlled clinical trial population.
• Dataset is small (656.5 KB), indicating limited raw data or aggregated summary tables rather than full case reports.

Provenance

Source

FDA Adverse Event Reporting System (FAERS) database.

Collection Method

Standardized data cleaning and signal detection analysis applied to primary suspected drug-related AE reports.

Time Range

First quarter of 2004 through the first quarter of 2025.

Freshness

Data current through Q1 2025, with the dataset last updated in April 2026.

Geography

United States (FDA database).