NCT06409481

Pharmacovigilance Assessment of Reporting of Cardiovascular Adverse Events With Antineoplastic Agents (PARCA)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 800,000 (estimated)
• Sponsor: The First Affiliated Hospital of Xinxiang Medical College · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The aim of this observational study is to explore and analyze reports of cardiac or vascular adverse events linked to the administration of antineoplastic agents among patients diagnosed with tumors represented by advanced non-small cell lung cancer. The study leverages pharmacovigilance databases such as the World Health Organization (WHO) database (VigiBase), FDA Adverse Event Reporting System (FAERS), and others to gather individual safety case reports for analysis.

Detailed description

Concomitant antineoplastic drug therapy may produce serious adverse cardiac or vascular system events. In this study, reports of cardiovascular adverse drug events following treatment with antineoplastic drugs were investigated using the World Health Organization (WHO) personal safety case report database (VigiBase) and FDA Adverse Event Reporting System (FAERS).

Conditions

• Cardiovascular Diseases
• Cardiac Diseases
• Vascular Diseases
• Cancer

Interventions

Type	Name	Description
DRUG	Antineoplastic Agents	small-molecule kinase inhibitors, immune checkpoint inhibitors, monoclonal antibodies, cytotoxic drugs, and other therapeutics

Timeline

• Start date: 2024-06-01
• Primary completion: 2024-06-30
• Completion: 2024-10-30
• First posted: 2024-05-10
• Last updated: 2024-05-10