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