TrinetX Study of Hypereosinophilic Syndrome (HES) Without an Identifiable Non-haematological Secondary Cause
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Comorbidities prior to first HES record
研究概览
简要总结
The purpose of this study is to build the knowledge base on clinical characteristics, clinical management, and treatment outcomes of HES.
详细描述
Retrospective database analysis using TriNetX database to describe HES patient characteristics, journey, and disease burden.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis record of HES (ICD-10-CM D72.11) anytime during 01 October 2020 to 30 June 2023
- •At least 12 months of patient insurance record prior to first HES record.
排除标准
- •Any mutation in PDGFRA, PDGFRB or FGFR1 genes (to exclude clonal HES).
- •History of BCR-ABL tyrosine kinase inhibitor use: imatinib, dasatinib, nolitinib, bosutinib, ponatinib, asciminib (to exclude clonal HES)
- •History of myeloid leukemia, myeloproliferative disorder, myelodysplastic disorder, myelomonocytic leukemia, acute erythroid leukemia, acute megakaryoblastic leukaemia, acute panmyelosis with myelofibrosis, and other specified leukaemias (to exclude reactive HES)
- •History of helminthiasis or use of anthelmintic medication (to exclude reactive HES)
- •History of autoimmune disease (to exclude reactive HES)
- •History of use of specific drugs: antiepileptics, sulfonamides, allopurinol, and immune checkpoint inhibitors (to exclude reactive HES)
结局指标
主要结局
Comorbidities prior to first HES record
时间窗: 01 October 2020- the most recent data available in 2023
To describe clinical characteristics of patients with HES.
Other eosinophilic conditions
时间窗: 01 October 2020- the most recent data available in 2023
To describe the clinical characteristics of HES patients.
Organ system with HES signs and/or symptoms
时间窗: 01 October 2020- the most recent data available in 2023
To describe the disease burden of HES.
Number of organ systems with HES signs and/or symptoms
时间窗: 01 October 2020 - the most recent data available in 2023
To describe the disease burden of HES.
次要结局
- HES and non-HES therapies & treatment pattern(01 October 2020 - the most recent data available in 2023)
- Demographic characteristics(01 October 2020- the most recent data available in 2023)
- Patient journey in diagnostic phase(01 October 2020 - the most recent data available in 2023)
- Clinical outcomes(01 October 2020 - the most recent data available in 2023)