Comparative Safety of Liposomal vs. Conventional Irinotecan from Clinical and FAERS Data

Han Shan's dataset compares adverse event profiles for liposomal irinotecan (nal-IRI) and conventional irinotecan (IRI). It integrates a single-center retrospective study of 308 pancreatic cancer patients (treated Dec 2023-Sep 2024) with a disproportionality analysis of the FAERS database (2004-2024). The data is stored in a DOCX file and was last updated on April 21, 2026.

Use Cases

• Compare incidence rates of specific adverse events like leukopenia based on the reported clinical study results.
• Analyze distinct adverse event patterns and outcomes (e.g., fatal outcomes, cholangitis) associated with different drug formulations using the FAERS data.
• Study the timing of toxicity onset based on the reported median time differences between treatment groups.

Strengths

• Integrates two data sources: a clinical study with 308 patients and a large-scale pharmacovigilance database (FAERS).
• Provides specific comparative statistics, such as a 9.16% vs. 3.39% incidence of grade 3-4 leukopenia and median time differences of 20-30 days for toxicity onset.

Limitations

• The dataset is small in file size (676.5 KB), suggesting limited primary data or a summary document.
• Column-level documentation is absent; field semantics must be inferred after download.
• The clinical study is from a single center, which may limit generalizability.

Provenance

Source

Author: Han Shan. Platform: figshare.

Collection Method

Dual-approach combining a single-center retrospective clinical study and disproportionality analysis of the FAERS database.

Time Range

Clinical study: December 2023 to September 2024. FAERS analysis: 2004 to 2024.

Freshness

Last updated 2026-04-21 05:35:39; freshness should be verified.