Cancer, Cardiac Disease
Conditions
Keywords
Cardiotoxicity, Antineoplastic and immunomodulating agents
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
Interventions
Antineoplastic agents, endocrine therapy, immunostimulants and immunosuppressants drugs included in the ATC classification L
Sponsors
Groupe Hospitalier Pitie-Salpetriere
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
0 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 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 |
| 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 |
Countries
France
Outcome results
None listed