Data Sheet 1_Exploratory assessment of bleeding risk associated with concurrent use of Anti-VEGF agents and anticoagulants in oncology.xls

208 patients from Hunan Cancer Hospital were analyzed for bleeding risk during concurrent use of anti-VEGF agents and anticoagulants between 2010 and 2025. The dataset includes demographics, safety data, and co-administration durations, supplemented by pharmacovigilance signals from the FDA Adverse Event Reporting System (FAERS) from 2013 to 2024. It was created by Dehua Liao and published in April 2026.

Use Cases

• Assess bleeding event rates (<6% overall) across patient groups defined by anti-VEGF agent (TKI or Bev) and anticoagulant type (DOAC or LMWH).
• Model the relationship between co-administration duration (e.g., median 4 days for TKI prophylaxis) and the occurrence of bleeding events.
• Validate the pharmacovigilance signal (Ω025 = 0.06) for Bev-LMWH co-administration against the hospital's clinical patient records.
• Analyze the distribution of anticoagulant use (Rivaroxaban as primary, followed by LMWH) for VTE treatment versus prophylaxis in the cohort.

Strengths

• Combines detailed clinical data from 208 patients with external validation from the large-scale FAERS database (2013-2024).
• Provides specific, quantified metrics such as bleeding event rates (<6%) and median co-administration durations (e.g., 30 days for TKI treatment).
• Clear temporal coverage for the clinical study (2010-2025) and the FAERS analysis (2013-2024).

Limitations

• Small clinical sample size of 208 patients from a single hospital, limiting statistical power and generalizability.
• Retrospective study design, as noted by the authors, means findings are hypothesis-generating and require prospective validation.
• The dataset is very small (64.5 KB), indicating limited raw data, likely containing only summary statistics and results.

Provenance

Source

Hunan Cancer Hospital patient records and the U.S. FDA Adverse Event Reporting System (FAERS).

Collection Method

Retrospective clinical analysis combined with pharmacovigilance data mining using the Ω shrinkage measure.

Time Range

Clinical data: January 2010 to October 2025. FAERS data: Q1 2013 to Q4 2024.

Freshness

Data is recent, with the study covering periods up to October 2025 and the record last updated in April 2026.

Geography

Primary clinical data is from Hunan Cancer Hospital in China; FAERS data is international with U.S. focus.