Monitoring Drug-induced Uveitis

Study Overview
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Brief Summary
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Several drugs and chemotherapies seem to induce uveitis. This study investigates reports of uveitis, 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 eyes and are responsible of uveitis. 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 uveitis 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 Uveitis

Conditions
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Uveitis, Uveitis Drug-Induced, Eye Diseases, Uvea--Diseases

Intervention / Treatment
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* Drug: Drugs inducing uveitis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Case reported in the WHO's pharmacovigilance database till 01/04/2019 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 |
| --- | --- |
| Uveitis induced by drugs and chemotherapies<br>Case reported in the World Health Organization (WHO) of uveitis of patient treated by a drug, with a chronology compatible with the drug toxicity | Drug: Drugs inducing uveitis<br>* Drugs susceptible to induce uveitis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eye toxicities of drugs Identification and report of cases of uevitis associated with drugs | Case reported in the World Health Organization (WHO) database of individual safety case reports | to 01/04/2019 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Causality assessment of reported uveitis according to the WHO system | Case reported in the World Health Organization (WHO) database of individual safety case reports | to 01/04/2019 | 
| All relevants statisticals associations between type of uveitis and the category of drug | Case reported in the World Health Organization (WHO) database of individual safety case reports | to 01/04/2019 | 
| All relevants statisticals associations between other concomittants immune related adverse events and uveitis induced by drugs | Case reported in the World Health Organization (WHO) database of individual safety case reports | to 01/04/2019 | 
| Duration of treatment when uveitis happen (role of cumulative dose) | Case reported in the World Health Organization (WHO) database of individual safety case reports | to 01/04/2019 | 
| All relevants statisticals associations between drug-drug interactions and adverse events | Case reported in the World Health Organization (WHO) database of individual safety case reports | to 01/04/2019 | 
| All relevants statisticals associations between pathologies (cancer) for which the incriminated drugs have been prescribed, and occurence of uveitis | Case reported in the World Health Organization (WHO) database of individual safety case reports | to 01/04/2019 | 
| All relevants statisticals associations between characteristics of the population and occurence of uveitis adverse event | Case reported in the World Health Organization (WHO) database of individual safety case reports | to 01/04/2019 | 

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