Heart and Blood Diseases

All Conditions

Vascular Diseases

Heart Diseases

All Drugs and Chemicals

Antineoplastic Agents

Dermatologic Agents

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Antibodies, Monoclonal

Immune Checkpoint Inhibitors

Immunoglobulins

Coal Tar

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

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

Xiaohong Kang, PhD

Zidong Ma, MS

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.

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).

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

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.

Disproportionality individual case data analysis between cardiovascular events and antineoplastic agents.

Cardiovascular events are identified using MedDRA terms. Each cardiovascular event and risk factor will be assessed for potential over-reporting by calculating odds ratios. Factors evaluated will include, but are not limited to, cancer type and patient baseline characteristics (gender, age, country of reporting, etc.). Additionally, the year of reporting and other relevant variables will be considered.

The data were classified into different drug classes based on the Anatomical Therapeutic Chemical (ATC) classification system. This included small molecule kinase inhibitors, immune checkpoint inhibitors, and monoclonal antibodies. The occurrence of major adverse events was identified using the Medical Dictionary for Regulatory Activities (MedDRA) terminology. The differences in cardiovascular toxicity between drug classes were evaluated using disproportionality analysis (single drug vs. full database). To assess toxicity differences between drugs in the same class, for example, a comparison could be made between the cardiovascular toxicity of drugs such as erlotinib, afatinib, and osimertinib, which all belong to the category of EGFR tyrosine kinase inhibitors. Disproportionality analyses (single drug vs. other drugs in the same class) were employed in this regard.

Reports with fatal outcomes will be compared with reports without fatal outcomes. Odds ratio will be calculated to compare covariates that may be associated with an increased risk of death, including type of adverse cardiovascular event, type of cancer reported, age of the patient, gender, comorbidities, and antitumor monotherapy or combination therapy.

The analysis includes analyzing the relationship between the duration of treatment and the occurrence of toxicity, taking into account the cumulative dose of the administered medication.

Describe cardiovascular adverse events reported when two or more drugs are taken concurrently or consecutively in patients with the same indication.

The patient population with cardiovascular adverse events was described in terms of baseline information, including patient indication, age, sex, country of reporting origin, and clinical outcomes, among other factors.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pharmacovigilance Assessment of Reporting of Cardiovascular Adverse Events With Antineoplastic Agents (PARCA)	NCT06409481	Cardiovascular ... Cardiac Disease... Vascular Diseas... Cancer	Antineoplastic ...	18 Years - 100 Years	The First Affiliated Hospital of Xinxiang Medical College
Pharmacovigilance Assessment of Reporting of Cardiovascular Adverse Events With Antineoplastic Agents (PARCA)	NCT06409481	Cardiovascular ... Cardiac Disease... Vascular Diseas... Cancer	Antineoplastic ...	18 Years - 100 Years	The First Affiliated Hospital of Xinxiang Medical College
Pharmacovigilance Assessment of Reporting of Cardiovascular Adverse Events With Antineoplastic Agents (PARCA)	NCT06409481	Cardiovascular ... Cardiac Disease... Vascular Diseas... Cancer	Antineoplastic ...	18 Years - 100 Years	The First Affiliated Hospital of Xinxiang Medical College
Pharmacovigilance Assessment of Reporting of Cardiovascular Adverse Events With Antineoplastic Agents (PARCA)	NCT06409481	Cardiovascular ... Cardiac Disease... Vascular Diseas... Cancer	Antineoplastic ...	18 Years - 100 Years	The First Affiliated Hospital of Xinxiang Medical College

Spots Global Cancer Trial Database for cardiac diseases