Retrospective, Non-interventional Study to Evaluate Chronic Myeloid Leukemia Treatment Landscape and Real-life Treatment Outcomes in Hungary: Analysis of National Health Insurance Fund Database
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,484
- 试验地点
- 1
- 主要终点
- Overall Survival Rate: Type of Second Line TKI
研究概览
简要总结
The objectives of this study are to describe patient demographics, clinical and disease characteristics and treatment patterns of Chronic Lymphoid Leukaemia (CML) in Hungary.
The primary endpoint of this study is the overall survival of CML patients treated with tyrosine kinase inhibitors in Hungary. The Overall Survival (OS) of all enrolled patients, OS by sequence pattern and by the number of treatment lines will be analyzed.
Secondary objectives are description of the treatment length in 1st and later lines, incidence and prevalence of CML, the patient demographics (as age, gender, comorbidities), average number of patients' comorbidities, most frequent comorbidities and patient number with comorbidities at baseline and at different treatment lines by investigated Thyrosine Kinase Inhibitor (TKI), distribution of the investigated TKI therapies by treatment lines
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male patients diagnosed with chronic myeloid leukemia
- •Patients receiving tyrosine kinase inhibitor therapy under the terms of the current marketing authorization
排除标准
- •Patients receiving TKI for non-CML diagnoses
结局指标
主要结局
Overall Survival Rate: Type of Second Line TKI
时间窗: 5 years, during analysis period from 01-January-2011 till 30-June-2020 (retrieved data assessed in this observational study for approximately 1.2 years)
Overall survival rate in this study was defined as percentage of participants alive during analysis period of 01-January-2011 till 30-June-2020. 5 years overall survival rate was demonstrated with Kaplan-Meier curve.
Overall Survival Rate: All Participants
时间窗: 5 years, during analysis period from 01-January-2011 till 30-June-2020 (retrieved data assessed in this observational study for approximately 1.2 years)
Overall survival rate in this study was defined as percentage of participants alive during analysis period of 01-January-2011 till 30-June-2020. 5 years overall survival rate was demonstrated with Kaplan-Meier curve.
Overall Survival Rate: Per Sequence of Treatment
时间窗: 5 years, during analysis period from 01-January-2011 till 30-June-2020 (retrieved data assessed in this observational study for approximately 1.2 years)
Overall survival rate in this study was defined as percentage of participants alive during analysis period of 01-January-2011 till 30-June-2020. 5 years overall survival rate was demonstrated with Kaplan-Meier curve.
Overall Survival Rate: Type of First Line TKI
时间窗: 5 years, during analysis period from 01-January-2011 till 30-June-2020 (retrieved data assessed in this observational study for approximately 1.2 years)
Overall survival rate in this study was defined as percentage of participants alive during analysis period of 01-January-2011 till 30-June-2020. 5 years overall survival rate was demonstrated with Kaplan-Meier curve.
次要结局
未报告次要终点