Clozapine and Haematologic Malignancies: an Observational and Retrospective Study Using the WHO Pharmacovigilance Database
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000,000
- 试验地点
- 1
- 主要终点
- Correlation between clozapine and haematologic malignancies using a disproportionality analysis in Individual Case Reports involving at least one liable antipsychotic drug in Vigibase®.
研究概览
简要总结
Clozapine may lead to various adverse reactions, including neutropenia and agranulocytosis. This study investigates reports of lymphoma and leukaemias for clozapine in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).
详细描述
Clozapine is responsible of a wide range of adverse side effects.The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of haematologic malignancies following treatment with clozapine.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Case reported in the World Health Organization (WHO) database of individual safety case reports to 03/05/2019
- •Adverse events reported were including the MedDRA terms: Malignant Lymphoma (SMQ), Leukaemia (HLGT)
- •Patients treated with at least one liable antipsychotic drug (ATC class N05A)
排除标准
- •Chronology not compatible between the drug and the toxicity
研究组 & 干预措施
Haematologic malignancies with clozapine
Cases reported in the World Health Organization (WHO) database of patients treated by Clozapine, with a chronology compatible with the drug toxicity
干预措施: Clozapine (Drug)
结局指标
主要结局
Correlation between clozapine and haematologic malignancies using a disproportionality analysis in Individual Case Reports involving at least one liable antipsychotic drug in Vigibase®.
时间窗: Case reported in the World Health Organization (WHO) of individual safety case reports to March 2019 ]
Study the correlation between clozapine and haematologic malignancies by comparing the proportion of Individual Case Reports (ICSRs) of hematologic malignancies with liable clozapine with the proportion of ICSRs of hematologic malignancies with at least one liable antipsychotic.
次要结局
- investigate a potential dose-dependent effect(Case reported in the World Health Organization (WHO) of individual safety case reports to March 2019 ])
- Description of the clinical features of clozapine-related haematologic malignancies(Case reported in the World Health Organization (WHO) of individual safety case reports to March 2019 ])