Hepatotoxicity, Liver Diseases, Liver Dysfunction, Liver Failure
Conditions
Keywords
hepatological disease, hepatotoxicity, chemotherapies, drugs
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.
Interventions
DRUGDrugs inducing hepatological toxicity
Drugs susceptible to induce hepatological toxicities
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 04/02/2019
Exclusion criteria
* Chronology not compatible between the drug and the toxicity
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 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 |
| 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 |
Countries
France
Outcome results
None listed