Monitoring the Hyperammonaemia:TOXicity of Drugs (AmmoTOX)

Groupe Hospitalier Pitie-Salpetriere

Status: Completed

Conditions: Adverse Drug Event; Hyperammonemia; Metabolic Disease; Drug Toxicity

Treatments: Drug: Drugs inducing hyperammonemia

Study type: Observational

Funder types: Other

Identifiers

NCT03947034

CIC1421-19-09

Details and patient eligibility

About

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).

Full 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.

Enrollment: 2,700 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Case reported in the WHO's pharmacovigilance database till 01/05/2019

Exclusion criteria

• Chronology not compatible between the drug and the toxicity

Trial design

2,700 participants in 1 patient group

Metabolic toxicity induced by drugs and chemotherapies

Description:

Case reported in the World Health Organization (WHO) of metabolic toxicities(such as hyperammonemia) of patient treated by a drug, with a chronology compatible with the drug toxicity

Treatment:

Drug: Drugs inducing hyperammonemia