Myocardial Dysfunction, Myocardial Failure, Myocarditis
Conditions
Keywords
myocardial toxicity, chemotherapies, drugs
Brief summary
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
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.
Interventions
DRUGDrug inducing myocarditis
Drugs susceptible to induce myocarditis
Sponsors
Groupe Hospitalier Pitie-Salpetriere
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 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 |
| 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 |
Countries
France
Outcome results
None listed