NCT03530215

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 500,000 (actual)
• Sponsor: Groupe Hospitalier Pitie-Salpetriere · Academic / Other
• Sex: All
• Age: 0 Years – 100 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cardiac Disease
• Cancer

Interventions

Type	Name	Description
DRUG	Antineoplastic and Immunomodulating Agents	Antineoplastic agents, endocrine therapy, immunostimulants and immunosuppressants drugs included in the ATC classification L

Timeline

• Start date: 2018-05-02
• Primary completion: 2022-05-01
• Completion: 2023-04-08
• First posted: 2018-05-21
• Last updated: 2023-04-13

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated drug study