Clinical trial NCT06409481: Pharmacovigilance Assessment of Reporting of Cardiovascular Adverse Events With Antineoplastic Agents (PARCA)
Official title: Pharmacovigilance Assessment of Reporting of Cardiovascular Adverse Events With Antineoplastic Agents (PARCA)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiovascular Diseases
Cardiac Diseases
Vascular Diseases
Cancer
Lead sponsor: The First Affiliated Hospital of Xinxiang Medical College
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 800000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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).

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.

Primary outcomes:
measure: Cardio-vascular toxicity of antineoplastic agents
timeFrame: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
Secondary outcomes:
measure: Causality assessment of reported cardiovascular events according to pharmacovigilance databases
timeFrame: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
measure: Assessment of the association between cardiovascular toxicity due to antineoplastic agents and risk factors.
timeFrame: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
measure: Assess cardiovascular toxicity differences among antineoplastic agent classes and within the same class.
timeFrame: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
measure: Assessment of the severity of cardiovascular toxicity associated with antineoplastic agents
timeFrame: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
measure: Description of the duration of treatment when the toxicity happens (role of cumulative dose)
timeFrame: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
measure: Description of the drug-drug interactions associated with adverse events.
timeFrame: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
measure: Description of the population of patients having a cardio-vascular adverse events
timeFrame: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital of Xinjiang Medical University
name: Xiaohong Kang, PhD
role: STUDY_DIRECTOR
References: