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

Groupe Hospitalier Pitie-Salpetriere500,000 enrolled

Overview

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).

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

Study Type

OBSERVATIONAL

Enrollment

500,000

Conditions

Cardiac Disease Cancer

Interventions

Antineoplastic and Immunomodulating AgentsDRUG

Antineoplastic agents, endocrine therapy, immunostimulants and immunosuppressants drugs included in the ATC classification L

Eligibility

Sex: ALLMin age: 0 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

AP-HP, Pitié-Salpêtrière Hospital,Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.

Paris, France

Outcomes

Primary Outcomes

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)