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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hepatological toxicity induced by drugs and chemotherapies | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drugs inducing hepatological toxicity | Drug | Drugs susceptible to induce hepatological toxicities |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with a drug that could be reported in the WHO's pharmacovigilance database
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM | Paris | 75013 | France |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D017093 | Liver Failure |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D048550 | Hepatic Insufficiency |
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| 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 |