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临床试验/NCT06148493
NCT06148493已完成不适用

Real-World Usage of Asciminib Among Patients With Chronic Myeloid Leukemia in Chronic Phase in the United States Using a Large Claims Database

Novartis Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 425 人开始时间: 2022年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
425
试验地点
1
主要终点
Age of patients

研究概览

简要总结

This was a retrospective descriptive analysis of health care claims data using the IQVIA open source medical and pharmacy claims databases. Patients were grouped into one of two cohorts depending on the index medication.

All patients with at least 1 pharmacy claim for asciminib occurring between 01 January 2021 and 30 April 2022 in (Phase 1) were grouped into the asciminib cohort. A data refresh was conducted (Phase 1 refresh) and all patients with at least 1 pharmacy claim for asciminib occurring between 01 January 2021 and 29 August 2022 were included in the asciminib cohort. Patients were required to have at least 6 months of continuous data availability prior to the start of treatment and were followed from the start of treatment until the end of available follow-up. The end of available follow up in open source data was defined as 1) last claim date in medical or pharmacy data, OR 2) last day of index pharmacy stability, OR 3) end of study period, whichever came first. While no post-index data availability were required in Phase 1, a subgroup analysis was conducted in patients with at least 3 and 6 months of available follow-up after the index date in Phase 1 refresh.

In Phase 2 of the study, patients with no exposure to asciminib and with at least 1 pharmacy claim for imatinib mesylate, dasatinib, nilotinib, bosutinib or ponatinib were indexed to the first new tyrosine kinase inhibitor (TKI) observed between 01 January 2021 and 29 August 2022 and grouped into the other TKI cohort. The index date was the initiation date of the index medication. Patients were required to have linkage to the open-source medical claims database and at least 3 months of available follow-up after the index date.

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

Age of patients

时间窗: Baseline

Geographic region of patients

时间窗: Baseline

Total duration of available follow-up

时间窗: Up to 6 months

Number of patients with comorbidities

时间窗: Up to 6 months

Number of patients with any prior TKI use

时间窗: Up to 6 months

Sex of patients

时间窗: Baseline

Payer type for prescriptions

时间窗: Baseline

Pre-index medication use

时间窗: Up to 6 months

Starting dose of index medication

时间窗: Up to 6 months

Total day supply of index medication

时间窗: Up to 6 months

Number of patients with chronic myeloid leukemia (CML) diagnosis

时间窗: Up to 6 months

Specialty of prescribing physician

时间窗: Up to 6 months

Number of patients with T315I mutation proxy

时间窗: Up to 6 months

Number of patients with any prior non-TKI CML treatment

时间窗: Up to 6 months

Number of patients still on index therapy at the end of Month 3 post-index

时间窗: Up to 3 months

National Cancer Institute (NCI) comorbidity index for patients

时间窗: Up to 6 months

The NCI comorbidity index score range is 0, 1 to 2, 2 to 3, and 3+, with higher scores indicating more comorbidity.

Number of prescriptions of index medication

时间窗: Up to 6 months

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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