Immune checkpoint inhibitors (ICIs) might induce high grade immune-related adverse events (irAEs) involving the cardio-vascular system. This study investigates reports of cardio-vascular toxicity associated with treatment including anti-PD1, Anti-PDL-1, and Anti CTLA4 classes using the World Health Organization (WHO) database VigiBase, Assistance Publique Hopitaux de Paris Entrepot de Données de Santé (APHP.EDS), French Système National Des Données de Santé (SNDS) Databases and a retrospective international multicenter registry of ICI-associated myocarditis
Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2025
Case reported in the APHP Entrepot de Données de Santé (EDS) database of individual safety case reports to 01/01/2025
Case reported in the Système National Des Données de Santé (SNDS) Database of individual safety case reports to 01/01/2025
Case reported in a retrospective international multicenter registry of ICI-associated myocarditis to 01/01/2025
Chronology not compatible between the drug and the toxicity
Patients treated with an ICI for a cancer
Other
Retrospective
ICI
DrugImmune checkpoint inhibitor targeting either PD-1, PD-L1 or CTLA-4, and included in the ATC following list (ATC classification): Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC3)
Identifying risk factors of cardio-vascular toxicity of ICIs.
Identifying risk factors of overreporting of cardiovascular adverse events in ICI treated patients
Causality assessment of reported cardiovascular events
Description of the type of cardiotoxicity depending on the category of ICIs
Description of the duration of treatment when the toxicity happens (role of cumulative dose)
Description of the drug-drug interactions associated with adverse events
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