NCT01037023
Completed
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Topotecan
- Conditions
- Lung Cancer, Small Cell
- Sponsor
- GlaxoSmithKline
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- Occurrence of adverse events after Topotecan administration
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Patients administrated Topotecan
There is only one group. This group includes patients administrated Topotecan
Intervention: Topotecan
Outcomes
Primary Outcomes
Occurrence of adverse events after Topotecan administration
Time Frame: 9 months
Secondary Outcomes
- Occurrence of unexpected adverse event or adverse drug reaction(9 months)
- Occurrence of serious adverse event or adverse drug reation(9 months)
Study Sites (1)
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