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
18 Years
N/A
Both
Lung Cancer, Small Cell
Trial Information
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
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.
Inclusion Criteria
Eligibility Criteria:
- Subjects administered with Topotecan following the locally approved prescribing
information
- Subjects who the investigator believes that they can and will comply with the
requirements of the protocol and follow the administration regimen
- Subjects with no contraindication according to the prescribing information
Type of Study:
Observational
Study Design:
Time Perspective: Prospective
Outcome Measure:
Occurrence of adverse events after Topotecan administration
Outcome Time Frame:
9months
Safety Issue:
No
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
Korea: Korea Food & Drug Administration
Study ID:
113946
NCT ID:
NCT01037023
Start Date:
November 2010
Completion Date:
February 2015
Related Keywords:
- Lung Cancer, Small Cell
- PMS (post-marketing surveillance)
- Topotecan
- Lung Neoplasms
- Small Cell Lung Carcinoma
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