Monitoring the Hyperammonaemia:TOXicity of Drugs (AmmoTOX)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,700
- 试验地点
- 1
- 主要终点
- Metabolic toxicities (such as hyperammnemia) of drugs Identification and report of cases of metabolic toxicities associated with drugs.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Case reported in the WHO's pharmacovigilance database till 01/05/2019
排除标准
- •Chronology not compatible between the drug and the toxicity
研究组 & 干预措施
Metabolic toxicity induced by drugs and chemotherapies
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
干预措施: Drugs inducing hyperammonemia (Drug)
结局指标
主要结局
Metabolic toxicities (such as hyperammnemia) of drugs Identification and report of cases of metabolic toxicities associated with drugs.
时间窗: to 01/05/2019
Case reported in the World Health Organization (WHO) database of individual safety case reports
次要结局
- Description of the population of patients having hematological toxicity adverse event(to 01/05/2019)
- Causality assessment of reported metabolic toxicities events according to the WHO system(to 01/05/2019)
- Description of the duration of treatment when the toxicity happens (role of cumulative dose)(to 01/05/2019)
- Description of the drug-drug interactions associated with adverse events(to 01/05/2019)
- Description of the type of metabolic toxicity depending on the category of drug(to 01/05/2019)
- Description of the other immune related adverse events concomitant to the metabolic toxicity induced by drugs(to 01/05/2019)
- Description of the pathologies (cancer) for which the incriminated drugs have been prescribed(to 01/05/2019)
研究者
Joe Elie Salem
Assistant director, clinical investigation center Paris Est
Groupe Hospitalier Pitie-Salpetriere