Monitoring the HePAtological TOXicity of Drugs (HePATOX)

Study Overview
=================
Brief Summary
-----------------
Several drugs and chemotherapies seem to have an impact on the hepatological system. This study investigates reports of hepatological toxicities, 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 hepatological system and are responsible of a wide range of hepatological diseases and side effects. 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 rare hepatological side effects imputed to drugs. A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.

Official Title
-----------------
Monitoring the HePAtological TOXicity of Drugs

Conditions
-----------------
Liver Diseases, Liver Dysfunction, Liver Failure, Hepatotoxicity

Intervention / Treatment
-----------------
* Drug: Drugs inducing hepatological toxicity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Case reported in the WHO's pharmacovigilance database till 04/02/2019 Exclusion Criteria: Chronology not compatible between the drug and the toxicity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatological toxicities of drugs Identification and report of cases of hepatological toxicities associated with drugs. |  | Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Causality assessment of reported hepatological toxicities events according to the WHO system |  | Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019 | 
| Description of the type of hepatoilogical toxicity depending on the category of drug |  | Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019 | 
| Description of the other immune related adverse events concomitant to the hepatological toxicity induced by drugs |  | Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019 | 
| 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 04/02/2019 | 
| 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 04/02/2019 | 
| 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 04/02/2019 | 
| Description of the population of patients having hepatological toxicity adverse event |  | Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatological disease, hepatotoxicity, chemotherapies, drugs