Monitoring the IMmUological TOXicity of Drugs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 662
- 试验地点
- 2
- 主要终点
- Arthritis, hepatitis, and lupus induced toxicity of Immune Checkpoint inhibitors (ICI) Identification and report of cases of arthritis or lupus associated with ICIs. The research includes the report with MedDRA terms:
研究概览
简要总结
Several drugs and chemotherapies seem to have an impact on the immunological system. This study investigates reports of immunological toxicities, including the International classification of disease ICD-10 codes M05, M32, I78 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 immunological system and are responsible of a wide range of rare immunological side effects. 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 rare immunological side effects (of which systemic lupus, immune arthritis, rheumatoid arthritis, Hepatitis, capillary leak syndrome) imputed to drugs. 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 02/01/2018
- •Adverse event reported were including the MedDRA terms for immune arthritis, systemic lupus erythematosus, hepatitis, rheumatoid arthritis and capillary leak syndrome.
排除标准
- •Chronology not compatible between the drug and the toxicity
研究组 & 干预措施
Arthritis or lupus or CLS induced by a drug
Case reported in the World Health Organization (WHO) of arthritis or lupus, or Hepatitis, or capillary leak syndrome of patient treated by a drug, with a chronology compatible with the drug toxicity
干预措施: drug inducing arthritis, lupus, hepatitis, or capillary leak syndrom (Drug)
结局指标
主要结局
Arthritis, hepatitis, and lupus induced toxicity of Immune Checkpoint inhibitors (ICI) Identification and report of cases of arthritis or lupus associated with ICIs. The research includes the report with MedDRA terms:
时间窗: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018
次要结局
- Description of the population of patients having a arthritis or lupus or hepatitis or CLS adverse event(Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018)
- Causality assessment of reported arthritis, hepatitis, or lupus events according to the WHO system(Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018)
- Description of the type of arthritis or lupus or hepatitis or capillary leak syndrom depending on the category of drug(Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018)
- Description of the other immune related adverse events concomitant to the arthritis or lupus or hepatitis or capillary leak syndrom induced by drugs(Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018)
- 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 to 02/01/2018)
- Description of the drug-drug interactions associated with adverse events(Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018)
- 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 to 02/01/2018)
研究者
Joe Elie Salem
MD,PhD
Groupe Hospitalier Pitie-Salpetriere