Retrospective Data Collection: Post Study Treatment Anticancer Therapy From All Randomized Patients Involved in IMELDA MO22223
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 32
- 主要终点
- Percentage of Participants Who Prematurely Withdrawn From Maintenance Therapy
研究概览
简要总结
This study aims to understand better the effective results from the IMELDA MO22223 P-trial (NCT00929240) and see if the anti-cancer therapies given during its follow-up time after study treatments were terminated possibly had an effect on efficacy results.
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
- •Having been randomized in the IMELDA MO22223 P-trial
排除标准
- •Not having been randomized in the IMELDA MO22223 P-trial
结局指标
主要结局
Percentage of Participants Who Prematurely Withdrawn From Maintenance Therapy
时间窗: Up to 78 months
Participants who had prematurely withdrawn from maintenance study treatment were reported. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.
Percentage of Participants Who Received Further Anti-Cancer Therapies After Discontinuation of Study Treatment
时间窗: Up to 78 months
Participants who received further anti-cancer therapies after discontinuation of study treatment were reported. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.
Time From Last Maintenance Study Medication Start to Start of Further Anti-Cancer Therapy
时间窗: Up to 78 months
Time from last maintenance study medication to the start of any further anti-cancer therapy was reported. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.
Progression Free Survival (PFS)
时间窗: Up to 78 months
PFS was defined as the time from start of the study to the first documented occurrence of disease progression. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.
Overall Survival
时间窗: Up to 78 months
Overall survival was defined as the interval between start of the study and the date of death from any cause. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.
次要结局
未报告次要终点