Regulatory Hycamtin(Oral) PMS (Hycamtin PMS)
An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance (PMS) to Monitor the Safety and Effectiveness of HYCAMTIN Administered in Korean Patients According to the Prescribing Information
研究概览
详细说明
Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of Topotecan administered in Korean patients according to the prescribing information
Topotecan will be administered as described the prescribing information or by physician's decision.
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
-
Seongnam-si, Gyeonggi-do、大韩民国、463-707
- GSK Investigational Site
-
Seoul、大韩民国、137-701
- GSK Investigational Site
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
All subjects must satisfy the following criteria.
- Subject who is under the indication to the prescribing information of oral Hycamtin.
- Subject who is treated with oral Hycamtin according to the judgement of her or his investigator.
All subjects must not satisfy the following criteria.
• Subject who is under the contraindication to the prescribing information of oral Hycamtin.
As considering the characteristic of observational post marketing surveillance, the exclusion criteria is not strict. All investigators should prescribe oral Hycamtin according to prescribing information which approved in Korea.
学习计划
研究是如何设计的？
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Patients administrated Topotecan
There is only one group.
This group includes patients administrated Topotecan
|
patients administrated Topotecan according to the prescribing information
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Occurrence of adverse events after Topotecan administration
大体时间：9 months
|
9 months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Occurrence of unexpected adverse event or adverse drug reaction
大体时间：9 months
|
9 months
|
|
Occurrence of serious adverse event or adverse drug reation
大体时间：9 months
|
9 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.