Monitoring Drug-induced Myocarditis (CardiTOX)

Study Overview
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Brief Summary
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Several drugs and chemotherapies seem to induce myocarditis. This study investigates reports of myocarditis, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

Detailed Description
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Several drugs and chemotherapies seem to have an impact on the myocardium and are responsible of myocarditis. Those are poorly described, due to the modification of the pharmacopeia, and the recent recognition of several of these adverse events. This study investigates the main characteristics of patients affected by myocarditis side effect imputed to drugs. A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.

Official Title
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Monitoring Drug-induced Myocarditis

Conditions
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Myocarditis, Myocardial Failure, Myocardial Dysfunction

Intervention / Treatment
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* Drug: Drug inducing myocarditis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Case reported in the WHO's pharmacovigilance database till 25/02/2019 Exclusion Criteria: Chronology not compatible between the drug and the toxicity

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| myocarditis induced by drugs and chemotherapies<br>Case reported in the World Health Organization (WHO) of myocarditis of patient treated by a drug, with a chronology compatible with the drug toxicity | Drug: Drug inducing myocarditis<br>* Drugs susceptible to induce myocarditis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of myocarditis induced by drugs and report of cases of myocarditis associated with drugs. |  | Case reported in the World Health Organization (WHO) database of individual safety case reports to 25/02/2019 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Causality assessment of reported myocarditis events according to the WHO system |  | Case reported in the World Health Organization (WHO) database of individual safety case reports to 25/02/2019 | 
| Description of the myocarditis depending on the category of drug |  | Case reported in the World Health Organization (WHO) database of individual safety case reports to 25/02/2019 | 
| Description of the other related adverse events concomitant to the myocarditis induced by drugs |  | Case reported in the World Health Organization (WHO) database of individual safety case reports to 25/02/2019 | 
| Description of the duration of treatment when the toxicity happens (role of cumulative dose) |  | Case reported in the World Health Organization (WHO) database of individual safety case reports to 25/02/2019 | 
| Description of the drug-drug interactions associated with adverse events |  | Case reported in the World Health Organization (WHO) database of individual safety case reports to 25/02/2019 | 
| Description of the population of patients having myocarditis adverse event |  | Case reported in the World Health Organization (WHO) database of individual safety case reports to 25/02/2019 | 
| Description of the pathologies (cancer) for which the incriminated drugs have been prescribed |  | Case reported in the World Health Organization (WHO) database of individual safety case reports to 25/02/2019 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myocardial toxicity, chemotherapies, drugs