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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antineoplastic Agents | Drug | small-molecule kinase inhibitors, immune checkpoint inhibitors, monoclonal antibodies, cytotoxic drugs, and other therapeutics |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Causality assessment of reported cardiovascular events according to pharmacovigilance databases | Disproportionality individual case data analysis between cardiovascular events and antineoplastic agents. | Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have been treated with an antineoplastic agent and have been diagnosed with tumors that represent advanced non-small cell lung cancer.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaohong Kang, PhD | Contact | +86-13938756036 | 1fy2014036@xxmu.edu.cn | |
| Zidong Ma, MS | Contact | +86-15207135029 | 1fy2021010@xxmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaohong Kang, PhD | First Affiliated Hospital of Xinjiang Medical University | Study Director |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000970 | Antineoplastic Agents |
| ID | Term |
|---|---|
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Assessment of the association between cardiovascular toxicity due to antineoplastic agents and risk factors. |
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. |
| 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. | 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. | 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 | 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. | 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) | 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. | Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024 |
| Description of the drug-drug interactions associated with adverse events. | Describe cardiovascular adverse events reported when two or more drugs are taken concurrently or consecutively in patients with the same indication. | Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024 |
| Description of the population of patients having a cardio-vascular adverse events | 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. | Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024 |