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临床试验/NCT07150793
NCT07150793已完成不适用

Real-world Treatment and Burden of Chronic Myeloid Leukemia Patients in Japan - A Retrospective Claims Database Analysis

Novartis Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 754 人开始时间: 2022年7月5日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
754
试验地点
1
主要终点
Number of Patients by Line of Treatment (LoT) and TKI Received

研究概览

简要总结

The main goal of this study was to describe treatment patterns of patients with chronic myeloid leukemia (CML) who were treated with tyrosine kinase inhibitors (TKIs) in Japan.

This was a retrospective observational study with secondary use of data from the Medical Data Vision (MDV) hospital-based database. The index date was the date of the first prescription of any TKI of interest registered within the selection period (01 January 2011 to 31 December 2019). The follow-up period was from the index date until the end of the study period, end of continuous follow-up in the MDV database, or death, whichever came first.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number of Patients by Line of Treatment (LoT) and TKI Received

时间窗: Up to approximately 9 years

TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.

Number of Patients who Switched TKI Treatment by LoT and TKI

时间窗: Up to approximately 9 years

TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.

Number of Patients who Discontinued TKI Treatment by Type of TKI

时间窗: Up to approximately 9 years

TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.

Number of Patients who Discontinued TKI Treatment for at Least One Year by Type of TKI

时间窗: Up to approximately 9 years

TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.

Number of Patients who Restarted any TKI Treatment After Discontinuing the TKI of Interest by Type of TKI

时间窗: Up to approximately 9 years

TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.

TKI Dose by LoT

时间窗: Baseline, up to approximately 9 years

TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.

TKI Persistence Rate by LoT

时间窗: Months 6, 12, 18, and Year 5

Duration of TKI Treatment by LoT

时间窗: Up to approximately 9 years

次要结局

  • Annual Incidence of Inpatient and Outpatient Visits by LoT(Up to approximately 9 years)
  • Annual Mean Cost of All-cause Healthcare Resource Use by LoT(Up to approximately 9 years)
  • Annual Incidence of CML-related Healthcare Resource Use by LoT(Up to approximately 9 years)
  • Annual Mean Cost of CML-related Healthcare Resource Use by LoT(Up to approximately 9 years)
  • Number of Patients With Adverse Events by TKI(Up to approximately 9 years)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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