An observational study in Hyperammonemia, Metabolic Disease and Adverse Drug Event, sponsored by Groupe Hospitalier Pitie-Salpetriere. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-05.
Sponsored by Groupe Hospitalier Pitie-Salpetriere · Observational
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).
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.
997 studies on the registry are indexed under Metabolic Diseases; 234 are open to participants now.
This study's enrollment of 2,700 is above the median of 176 across 300 observational studies indexed under Metabolic Diseases.
Browse Metabolic Diseases studies →Groupe Hospitalier Pitie-Salpetriere is the lead sponsor of 65 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients treated with a drug that could be reported in the WHO's pharmacovigilance database
Exclusion Criteria:
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
Drug: Drugs inducing hyperammonemia
Drugs susceptible to induce metabolic toxicities such as hyperammonemia
Metabolic toxicities (such as hyperammnemia) of drugs Identification and report of cases of metabolic toxicities associated with drugs.
Case reported in the World Health Organization (WHO) database of individual safety case reports
Time frame: to 01/05/2019
Causality assessment of reported metabolic toxicities events according to the WHO system
Case reported in the World Health Organization (WHO) database of individual safety case reports
Time frame: to 01/05/2019
Description of the type of metabolic toxicity depending on the category of drug
Case reported in the World Health Organization (WHO) database of individual safety case reports
Time frame: to 01/05/2019
Description of the other immune related adverse events concomitant to the metabolic toxicity induced by drugs
Case reported in the World Health Organization (WHO) database of individual safety case reports
Time frame: to 01/05/2019
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
Time frame: to 01/05/2019
Description of the drug-drug interactions associated with adverse events
Case reported in the World Health Organization (WHO) database of individual safety case reports
Time frame: to 01/05/2019
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
Time frame: to 01/05/2019
Description of the population of patients having hematological toxicity adverse event
Case reported in the World Health Organization (WHO) database of individual safety case reports
Time frame: to 01/05/2019
Plan to share: Undecided
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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Groupe Hospitalier Pitie-Salpetriere