Association of Adverse Events in the Real World With Treatment Adjustments, and Burden of AEs in Patients With Chronic Myeloid Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,546
- 试验地点
- 1
- 主要终点
- Number of Patients With AEs of Interest During the Study Period Among Those Without the Specific Event During the Baseline Period
研究概览
简要总结
The aim of this study was to assess the frequency of adverse events (AEs) experienced by chronic myeloid leukemia (CML) patients treated with tyrosine kinase inhibitors (TKIs) and evaluate their impact on treatment adjustments as well as the burden of AEs on healthcare resource use (HRU) and costs.
This study used real-world administrative claims data from the PharMetrics Plus database. AEs of interest were selected based on information obtained from the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines, Chronic Myeloid Leukemia Version 1. 2024 and clinical inputs. Given the nature of claims data, only AEs of interest that required medical attention (i.e., resulted in a claim record) were captured in this study.
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
Number of Patients With AEs of Interest During the Study Period Among Those Without the Specific Event During the Baseline Period
时间窗: Up to approximately 7 years and 3 months
The Study Period spanned from treatment initiation until treatment discontinuation, one day before treatment switch to another CML treatment, end of data availability, end of health plan coverage, or death, whichever came first.
Number of Patients With AEs of Interest Among All Patients During the Study Period
时间窗: Up to approximately 7 years and 3 months
The Study Period spanned from treatment initiation until treatment discontinuation, one day before treatment switch to another CML treatment, end of data availability, end of health plan coverage, or death, whichever came first.
次要结局
- Number of Patients With Treatment Adjustments During the Observation Period(Up to approximately 7 years and 3 months)
- Duration of First Treatment Interruption(Up to approximately 7 years and 3 months)
- Time From TKI Initiation to Treatment Adjustment(Up to approximately 7 years and 3 months)
- Number of Patients With AEs of Interest Within 30 Days Before Treatment Adjustment(6 months)
- Number of AEs of Interest Within 30 Days Before Treatment Adjustment(6 months)
- Number of Patients by AE of Interest Experienced Within 30 Days Before Treatment Adjustment(6 months)
- Time Between the Last AE of Interest and Treatment Adjustment(6 months)
- Number of Patients by Last AE of Interest Experienced Before Treatment Adjustment(6 months)
- Number of All-cause Healthcare Visits Per-Patient-Per-Year (PPPY)(6 months)
- Number of Patients With One or More All-cause Healthcare Visits(6 months)
- Number of All-cause Inpatient Days(6 months)
- Number of All-cause Inpatient Days Among Hospitalized Patients(6 months)
- All-cause Healthcare Costs PPPY(6 months)
- Annual Mean Number of Healthcare Visits Associated With AEs of Interest(6 months)
- Annual Mean Costs of Healthcare Visits Associated With AEs of Interest(6 months)