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Evaluation of Reporting of Immune Checkpoint Inhibitor Associated Cardio-vascular Adverse Reactions — RAFALE  

Myocarditis Clinical Trial

Official title:
Evaluation of Reporting of Immune Checkpoint Inhibitor Associated Cardio-vascular Adverse Reactions Using International Pharmacovigilance Database

Clinical Trial Summary

Immune checkpoint inhibitors (ICIs) might have high grade immune-related adverse events (irAEs) on the cardio-vascular system. This study investigates reports of cardio-vascular toxicity with treatment including anti-PD1, Anti-PDL-1, and Anti CTLA4 classes using the World Health Organization (WHO) database VigiBase.

Clinical Trial Description

ICIs have dramatically improved clinical outcomes in multiple cancer types and are increasingly being tested in earlier disease settings and used in combination. However, irAEs can occur. Here the investigators use VigiBase (http://www.vigiaccess.org/), the World Health Organization (WHO) database of individual safety case reports, to identify cases of cardiovascular adverse drug reaction following treatment with ICIs. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03387540
Study type Observational [Patient Registry]
Source Groupe Hospitalier Pitie-Salpetriere
Contact
Status Completed
Phase
Start date December 2, 2017
Completion date December 31, 2017
View Details
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