Adverse Drug Event, Drug Toxicity, Hyperammonemia, Metabolic Disease
Conditions
Brief 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).
Detailed 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.
Interventions
DRUGDrugs inducing hyperammonemia
Drugs susceptible to induce metabolic toxicities such as hyperammonemia
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 01/05/2019
Exclusion criteria
* Chronology not compatible between the drug and the toxicity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic toxicities (such as hyperammnemia) of drugs Identification and report of cases of metabolic toxicities associated with drugs. | to 01/05/2019 | Case reported in the World Health Organization (WHO) database of individual safety case reports |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Description of the type of metabolic toxicity depending on the category of drug | to 01/05/2019 | Case reported in the World Health Organization (WHO) database of individual safety case reports |
| Description of the other immune related adverse events concomitant to the metabolic toxicity induced by drugs | to 01/05/2019 | Case reported in the World Health Organization (WHO) database of individual safety case reports |
| Description of the duration of treatment when the toxicity happens (role of cumulative dose) | to 01/05/2019 | Case reported in the World Health Organization (WHO) database of individual safety case reports |
| Causality assessment of reported metabolic toxicities events according to the WHO system | to 01/05/2019 | Case reported in the World Health Organization (WHO) database of individual safety case reports |
| Description of the pathologies (cancer) for which the incriminated drugs have been prescribed | to 01/05/2019 | Case reported in the World Health Organization (WHO) database of individual safety case reports |
| Description of the population of patients having hematological toxicity adverse event | to 01/05/2019 | Case reported in the World Health Organization (WHO) database of individual safety case reports |
| Description of the drug-drug interactions associated with adverse events | to 01/05/2019 | Case reported in the World Health Organization (WHO) database of individual safety case reports |
Countries
France
Outcome results
None listed