Evaluation of Reporting of Cardio-vascular Adverse Events With Antineoplastic and Immunomodulating Agents (EROCA)

Study Overview
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Brief Summary
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Antineoplastic and immunomodulating agents may lead to various cardio-vascular adverse reactions. This study investigates reports of cardio-vascular toxicities for treatment including Anatomical Therapeutic Chemical (ATC) classification L (antineoplastic agents, endocrine therapy, immunostimulants, and immunosuppressants drugs) in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).

Detailed Description
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Antineoplastic therapies are responsible of a wide range of cardio-vascular side effects.The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of cardiovascular adverse drug reactions following treatment with antineoplastic and immunomodulating agents

Official Title
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Evaluation of Reporting of Cardio-vascular Adverse Events With Antineoplastic and Immunomodulating Agents (EROCA)

Conditions
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Cancer, Cardiac Disease

Intervention / Treatment
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* Drug: Antineoplastic and Immunomodulating Agents


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Case reported in the World Health Organization (WHO) database of individual safety case reports to 30/04/2018 Adverse events reported were including the MedDRA terms: Cardiac and vascular investigations (excl enzyme tests) (HLGT), Vascular disorders (SOC), Skeletal and cardiac muscle analyses (HLT), Sudden death (PT), Sudden cardiac death (PT), Cardiac disorders (SOC), Cardiac arrhythmias (HLGT), Cardiac disorder signs and symptoms (HLGT), Cardiac neoplasms (HLGT), Cardiac valve disorders (HLGT), Congenital cardiac disorders (HLGT), Coronary artery disorders (HLGT), Endocardial disorders (HLGT), Heart failures (HLGT), Myocardial disorders (HLGT), Pericardial disorders (HLGT) Patients treated with Antineoplastic and immunomodulating agents included in the ATC L. Exclusion Criteria: Chronology not compatible between the drug and the toxicity

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adverse Events with Antineoplastic and immunomodulating agents<br>Cases reported in the World Health Organization (WHO) and the French pharmacovigilance database of patients treated by Antineoplastic and immunomodulating agents, with a chronology compatible with the drug toxicity | Drug: Antineoplastic and Immunomodulating Agents<br>* Antineoplastic agents, endocrine therapy, immunostimulants and immunosuppressants drugs included in the ATC classification L<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardio-vascular toxicity of antineoplastic and immunomodulating agents | Identification and report of cardio-vascular toxicities of antineoplastic and immunomodulating agents. The research includes the report with MedDRA terms: SOC Cardiac Disorders, SOC Vascular Disorders, Sudden death (PT), Cardiac and vascular investigations (excl enzyme tests) (HLGT), Skeletal and cardiac muscle analyses (HLT) | Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Causality assessment of reported cardiovascular events according to the WHO system |  | Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018 | 
| Description of the type of cardiotoxicity depending on the category of antineoplastic and immunomodulating agents |  | Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018 | 
| Description of the duration of treatment when the toxicity happens |  | Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018 | 
| Description of the drug-drug interactions associated with adverse events |  | Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018 | 
| Description of the pathologies (cancer) for which the incriminated drugs have been prescribed |  | Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018 | 
| Description of the population of patients having a cardio-vascular adverse event |  | Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiotoxicity, Antineoplastic and immunomodulating agents