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

Launched by THE FIRST AFFILIATED HOSPITAL OF XINXIANG MEDICAL COLLEGE · May 9, 2024

Keywords

ClinConnect Summary

The PARCA trial is an observational study that aims to investigate heart-related problems that may occur in patients with advanced non-small cell lung cancer who are receiving cancer treatments called antineoplastic agents. These treatments can include various types of medications, such as small-molecule inhibitors and monoclonal antibodies. The study will use large safety databases to collect and analyze reports of any heart or blood vessel issues linked to these treatments, helping to understand the risks better.

To be eligible for this study, participants must have reports of heart or vascular problems documented in specific safety databases and must have received antineoplastic agents for their cancer. The trial is not yet recruiting participants, but it focuses on individuals aged 65 and older who have been treated for malignant tumors, specifically advanced non-small cell lung cancer. Participants can expect that their safety data will contribute to a better understanding of how these cancer treatments may affect heart health, ultimately aiming to improve patient care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024.
• • 2. Adverse events reported were including the MedDRA terms: Cardiac disorders (SOC), Vascular disorders (SOC), Cardiac and vascular investigations (excl enzyme tests) (HLGT), Sudden death (PT), Sudden cardiac death (PT), Cardiac arrhythmias (HLGT), Cardiac disorder signs and symptoms (HLGT), Cardiac neoplasms (HLGT), Cardiac valve disorders (HLGT), Coronary artery disorders (HLGT), Endocardial disorders (HLGT), Heart failures (HLGT), Myocardial disorders (HLGT), Pericardial disorders (HLGT), Vascular disorders NEC(HLGT), Vascular inflammations(HLGT), Embolism and thrombosis(HLGT), Vascular hypertensive disorders(HLGT), Blood pressure disorders NEC(HLGT), Venous varices(HLGT), Arteriosclerosis, stenosis, vascular insufficiency and necrosis(HLGT), Aneurysms and artery dissections(HLGT).
• • 3. Patients treated with antineoplastic agents (including small-molecule kinase inhibitors, immune checkpoint inhibitors, monoclonal antibodies, cytotoxic drugs, and other therapeutics).
• • 4. The number of reports corresponding to each drug or adverse event is at least three.
• • 5. The primary indication is malignant tumors, specifically advanced non-small cell lung cancer.
• Exclusion Criteria:
• • 1. Any of the information in the baseline information such as gender, age, region, date of report is empty.
• • 2. The severity level of the reported adverse event is empty.
• • 3. Adverse events were reported in patients whose drug indications included cardiovascular disease.