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

NCT06409481 | Not Yet Recruiting

• 1 other identifier: EC-024-092
• Study Type: observational
• Target: 800,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cardiovascular Diseases; Cardiac Diseases; Vascular Diseases; Cancer

Outcome Measures

Primary Outcomes (1)

• Cardio-vascular toxicity of antineoplastic agents

  Identification and report of the cardio-vascular toxicity of antineoplastic agents. The research includes the report with MedDRA terms: SOC Cardiac Disorders, SOC Vascular Disorders, Cardiac and vascular investigations (excl enzyme tests) (HLGT), Skeletal and cardiac muscle analyses (HLT), Sudden death (PT). Drugs investigated are antineoplastic agents.

  Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024

Secondary Outcomes (7)

• Causality assessment of reported cardiovascular events according to pharmacovigilance databases

  Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024

• Assessment of the association between cardiovascular toxicity due to antineoplastic agents and risk factors.

  Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024

• Assess cardiovascular toxicity differences among antineoplastic agent classes and within the same class.

  Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024

• Assessment of the severity of cardiovascular toxicity associated with antineoplastic agents

  Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024

• Description of the duration of treatment when the toxicity happens (role of cumulative dose)

  Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024

Study Arms (1)

Adverse Events with Antineoplastic agents

Cases reported in VigiBase, FAERS and other pharmacovigilance databases of patients treated by antineoplastic agents, with a chronology compatible with the drug toxicity.

Drug: Antineoplastic Agents

Interventions

Antineoplastic Agents DRUG

small-molecule kinase inhibitors, immune checkpoint inhibitors, monoclonal antibodies, cytotoxic drugs, and other therapeutics

Adverse Events with Antineoplastic agents

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have been treated with an antineoplastic agent and have been diagnosed with tumors that represent advanced non-small cell lung cancer.

You may qualify if:

• Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024.
• 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).
• Patients treated with antineoplastic agents (including small-molecule kinase inhibitors, immune checkpoint inhibitors, monoclonal antibodies, cytotoxic drugs, and other therapeutics).
• The number of reports corresponding to each drug or adverse event is at least three.
• The primary indication is malignant tumors, specifically advanced non-small cell lung cancer.

You may not qualify if:

• Any of the information in the baseline information such as gender, age, region, date of report is empty.
• The severity level of the reported adverse event is empty.
• Adverse events were reported in patients whose drug indications included cardiovascular disease.

Sponsors & Collaborators

• The First Affiliated Hospital of Xinxiang Medical College: lead

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases; Vascular Diseases; Neoplasms

Interventions

Antineoplastic Agents

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Xiaohong Kang, PhD

  First Affiliated Hospital of Xinjiang Medical University

  STUDY DIRECTOR

Central Study Contacts

Xiaohong Kang, PhD

CONTACT

+86-13938756036; 1fy2014036@xxmu.edu.cn

Zidong Ma, MS

CONTACT

+86-15207135029; 1fy2021010@xxmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 10, 2024
• Study Start: June 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: October 30, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share