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Completed

NCT Number: NCT03530215

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

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).

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Key information

Conditions

Cardiac Disease Cancer Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Heart Diseases Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Wounds and Injuries

Age range

0 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Paris, 75013, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antineoplastic and Immunomodulating Agents

Drug

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

Primary outcomes

  1. Cardio-vascular toxicity of antineoplastic and immunomodulating agents

    Time frame: 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 outcomes

  1. Causality assessment of reported cardiovascular events according to the WHO system

    Time frame: Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018

  2. Description of the type of cardiotoxicity depending on the category of antineoplastic and immunomodulating agents

    Time frame: Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018

  3. Description of the duration of treatment when the toxicity happens

    Time frame: Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018

  4. Description of the drug-drug interactions associated with adverse events

    Time frame: Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018

  5. Description of the pathologies (cancer) for which the incriminated drugs have been prescribed

    Time frame: Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018

  6. Description of the population of patients having a cardio-vascular adverse event

    Time frame: Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Other

Registry information

Acronym: EROCA

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
May 21, 2018
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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