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临床试验/NCT07188428
NCT07188428已完成不适用

Treatment Patterns and Outcomes Among Patients With Chronic Myeloid Leukemia (CML) in All Lines of Therapy: An Analysis of Medicare Fee-for-Service (FFS) Data

Novartis Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 2,298 人开始时间: 2024年2月27日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
2,298
试验地点
1
主要终点
Number of Patients Who Switched to Another CML-related Treatment by TKI Generation and Treatment Profile

研究概览

简要总结

The aim of this study was to evaluate the real-world treatment patterns, healthcare resource use and costs among patients newly diagnosed with CML who were treated with tyrosine kinase inhibitors (TKIs) in first- and second-line therapy.

详细描述

The study used claims from Medicare FFS data from 1 January 2016 to 31 December 2022 (observation period). The patient identification period spanned from 1 January 2017 to 30 June 2022. The index date was the date of treatment line initiation. Patients were followed from index date until death, end of enrollment, or study end (31 December 2022), whichever came first. Each patient's follow-up was variable in length.

Variables were assessed during the follow-up period in first-line (1L) and second-line (2L) treatment cohorts and were stratified by generations of TKIs and treatment profiles. Patients were categorized into non-optimal treatment (NOPT) profiles and reference groups, and treatment patterns, healthcare resource utilization (HCRU), and payer healthcare costs were summarized descriptively for each group.

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
18 Years 至 —(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 Who Switched to Another CML-related Treatment by TKI Generation and Treatment Profile

时间窗: Up to approximately 6 years

Number of Patients Who Switched to Another CML-related Treatment Within 6 Months of Starting Treatment by TKI Generation and Treatment Profile

时间窗: 6 months

Time to Treatment Switch by TKI Generation and Treatment Profile

时间窗: Up to approximately 6 years

次要结局

  • Proportion of Days Covered (PDC) by TKI Generation and Treatment Profile(Up to approximately 6 years)
  • Number of Patients With PDC >80% by TKI Generation and Treatment Profile(Up to approximately 6 years)
  • Number of Patients who Discontinued Treatment by TKI Generation and Treatment Profile(Up to approximately 6 years)
  • Time to Treatment Discontinuation by TKI Generation and Treatment Profile(Up to approximately 6 years)
  • Number of Patients With Treatment Interruption by TKI Generation and Treatment Profile(Up to approximately 6 years)
  • Time to First Treatment Interruption by TKI Generation and Treatment Profile(Up to approximately 6 years)
  • Number of Patients With a Dose Reduction by TKI Generation and Treatment Profile(Up to approximately 6 years)
  • Time to Dose Reduction by TKI Generation and Treatment Profile(Up to approximately 6 years)
  • Mean Number of All-cause Healthcare Visits per Person per Year (PPPY) by Treatment Profile(Up to approximately 6 years)
  • Mean Number of CML-related Healthcare Visits per Person per Year (PPPY) by Treatment Profile(Up to approximately 6 years)
  • Mean Length of Stay (LoS) of Inpatient Visits PPPY by Treatment Profile(Up to approximately 6 years)
  • Mean All-cause Healthcare Cost PPPY by Treatment Profile(Up to approximately 6 years)
  • Mean CML-related Healthcare Cost PPPY by Treatment Profile(Up to approximately 6 years)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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