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

Cancer Clinical Trial

— EROCA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03530215
• Other study ID #: CIC1421-18-12
• Status: Completed
• Start date: May 2, 2018
• Est. completion date: April 8, 2023

Study information

• Verified date: April 2023
• Source: Groupe Hospitalier Pitie-Salpetriere
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500000
• Est. completion date: April 8, 2023
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Cardiac Disease
• Heart Diseases

Intervention

Drug:
• Antineoplastic and Immunomodulating Agents
Antineoplastic agents, endocrine therapy, immunostimulants and immunosuppressants drugs included in the ATC classification L

Locations

Country	Name	City	State
France	AP-HP, Pitié-Salpêtrière Hospital,Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Pitie-Salpetriere

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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