Evaluation of Safety and Efficacy of Xeloda in Metastatic Colorectal Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 258
- 主要终点
- Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
This prospective observational study will evaluate the safety and efficacy of Xeloda (capecitabine) administered in monotherapy in patients with metastatic colorectal cancer. Patients will be followed until disease progression or unacceptable toxicity occurs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients, >/= 18 years of age
- •Metastatic colorectal cancer
- •Receiving Xeloda according to registered indication
排除标准
- •Patients who are not eligible for Xeloda treatment according to the Summary of Product Characteristics
结局指标
主要结局
Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Baseline up to end of study (up to 42 months)
An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs was exclusive of serious AEs.
次要结局
- Percentage of Participants With Disease Progression(Baseline to progressive disease or death (up to 42 months))
- Number of Participants With Hand-Foot Syndrome (HFS)(Baseline up to end of study (up to 42 months))
- Progression-Free Survival (PFS)(Baseline to progressive disease or death (up to 42 months))