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Monitoring the Hyperammonaemia:TOXicity of Drugs (AmmoTOX) — AmmoTOX  

Metabolic Disease Clinical Trial

Official title:
Monitoring the Hyperammonaemia:TOXicity of Drugs (AmmoTOX)

Clinical Trial Summary

Several drugs and chemotherapies seem to have an impact on the metabolic system. This study investigates reports of metabolic toxicities such as hyperammonemia, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

Clinical Trial Description

Several drugs and chemotherapies seem to have an impact on the metabolic system and are responsible of a wide range of metabolical side effects such as hyperammonemia. 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 metabolic side effects imputed to drugs in particular hyperammonemia. A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03947034
Study type Observational
Source Groupe Hospitalier Pitie-Salpetriere
Contact
Status Completed
Phase
Start date May 1, 2019
Completion date April 4, 2023
View Details
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