Assessment of Real-world Outcomes Among Patients Treated With Kisqali (Ribociclib)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 373
- 试验地点
- 1
- 主要终点
- Number of Patients by Type of Real-world Adverse Event (AE) of Interest During 1L Treatment
研究概览
简要总结
The main aim of the study was to evaluate the real-world tolerability and safety of ribociclib as a first-line (1L) treatment among adults with hormone receptor-positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) metastatic breast cancer (mBC).
This study used data from the Flatiron Health Research Database (FHRD). The FHRD is a longitudinal database derived from electronic health records (EHRs) and other real-world data (RWD) sources from cancer care providers across the United States. The dataset generated for this study included de-identified patient-level data for eligible individuals between 1 January 2015 up to the data cutoff date, 30 November 2022.
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 by Type of Real-world Adverse Event (AE) of Interest During 1L Treatment
时间窗: Up to approximately 5 years and 5 months
Number of Patients by Real-world AE of Interest at Baseline
时间窗: Baseline
Number of Patients by Type of Real-world AE of Interest During 1L Treatment Among Those Without the Specific Real-world AE at Baseline
时间窗: Up to approximately 5 years and 5 months
次要结局
- Clinical Characteristic: Time Between Initial Diagnosis and Metastatic Diagnosis(Baseline)
- Clinical Characteristic: Duration of Follow-up(Up to approximately 5 years and 5 months)
- Number of Patients by Demographic Category(Baseline)
- Number of Patients by Clinical Characteristic Category(Baseline)
- Clinical Characteristic: Body Mass Index (BMI)(Baseline)
- Clinical Characteristic: Time Between Metastatic Diagnosis and Initiation of 1L Treatment(Baseline)
- Clinical Characteristic: Number of Patients by Patient Disposition at Data Cutoff(Up to approximately 5 years and 5 months)
- Number of Patients by Year of Treatment Initiation for Each Line of Treatment(Up to approximately 5 years and 5 months)
- Duration of Each Line of Treatment(Up to approximately 5 years and 5 months)
- Number of Patients Still on 1L Treatment at Last EHR Activity(Up to approximately 5 years and 5 months)
- Number of Patients Still on 2L Treatment at Last EHR Activity(Up to approximately 5 years and 5 months)
- Number of Patients Still on 3L Treatment at Last EHR Activity(Up to approximately 5 years and 5 months)
- Number of Patients by Type of ET Partner During 1L Treatment(Up to approximately 5 years and 5 months)
- Number of Patients by Treatment Category During Each Line of Treatment(Up to approximately 5 years and 5 months)
- Number of Patients by Type of CDK4/6 Inhibitor Based Treatment During Each Line of Treatment(Up to approximately 5 years and 5 months)
- Number of Patients by Total Number of Ribocicilib Dose Reduction Episodes During 1L Treatment(Up to approximately 5 years and 5 months)
- Number of Patients by Ribociclib Dose at Each Dose Reduction Episode During 1L Treatment(Up to approximately 5 years and 5 months)
- Number of Patients by Ribociclib Dosing Schedule at Each Dose Reduction Episode During 1L Treatment(Up to approximately 5 years and 5 months)
- Number of Patients by Status of Oral Therapy at the End of Each Dose Reduction Episode During 1L Treatment(Up to approximately 5 years and 5 months)
- Number of Patients by Reason for Change in Ribociclib Dose During 1L Treatment(Up to approximately 5 years and 5 months)
- Number of Patients by Reason for Stopping Ribociclib 1L Treatment(Up to approximately 5 years and 5 months)
- Number of Patients by Type of Real-world Adverse Event (AE) During 1L Treatment(Up to approximately 5 years and 5 months)
- Number of Patients by Action Following or in Response to Real-world AE During 1L Treatment(Up to approximately 5 years and 5 months)