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

Completed

• Conditions: Cardiac Disease; Cancer
• Interventions: Drug: Antineoplastic and Immunomodulating Agents

• Registration Number: NCT03530215
• Lead Sponsor: Groupe Hospitalier Pitie-Salpetriere

Brief Summary

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

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 Timeline

• Study Start: 2018-05-02
• Study First Submitted: 2018-05-08
• Study First Submitted QC: 2018-05-08
• Study First Posted: 2018-05-21
• Primary Completion: 2022-05-01
• Status Verified: 2023-04
• Study Completion: 2023-04-08
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adverse Events with Antineoplastic and immunomodulating agents	Antineoplastic and Immunomodulating Agents	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

Primary Outcome Measures

Name	Time	Method
Cardio-vascular toxicity of antineoplastic and immunomodulating agents	Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018	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)

Secondary Outcome Measures

Name	Time	Method
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 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 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
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

Trial Locations

Locations (1)

AP-HP, Pitié-Salpêtrière Hospital,Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.; 🇫🇷 Paris, France