Regulatory Hycamtin(Oral) PMS (Hycamtin PMS)

Tracking Information
First Submitted Date	December 10, 2009
First Posted Date	December 21, 2009
Last Update Posted Date	April 15, 2015
Study Start Date	October 2010
Actual Primary Completion Date	November 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: July 24, 2014)	Occurrence of adverse events after Topotecan administration [ Time Frame: 9 months ]
Original Primary Outcome Measures; (submitted: December 18, 2009)	Occurrence of adverse events after Hycamtin administration [ Time Frame: 9months ]
Change History	Complete list of historical versions of study NCT01037023 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: July 24, 2014)	Occurrence of unexpected adverse event or adverse drug reaction [ Time Frame: 9 months ]; Occurrence of serious adverse event or adverse drug reation [ Time Frame: 9 months ]
Original Secondary Outcome Measures; (submitted: December 18, 2009)	Occurrence of unexpected or serious adverse event after Hycamtin administration and effectiveness of HYCAMTIN® [ Time Frame: 9months ]
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Regulatory Hycamtin(Oral) PMS
Official Title	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
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.
Study Type	Observational
Study Design	Not Provided
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	Patients administrated Topotecan at the site
Condition	Lung Cancer, Small Cell
Intervention	Drug: Topotecan; patients administrated Topotecan according to the prescribing information
Study Groups/Cohorts	Patients administrated Topotecan; There is only one group. This group includes patients administrated Topotecan; Intervention: Drug: Topotecan
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: April 14, 2015)	92
Original Estimated Enrollment; (submitted: December 18, 2009)	780
Actual Study Completion Date	November 2014
Actual Primary Completion Date	November 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Senior
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Korea, Republic of
Removed Location Countries
Administrative Information
NCT Number	NCT01037023
Other Study ID Numbers	113946
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	GlaxoSmithKline
Study Sponsor	GlaxoSmithKline
Collaborators	Not Provided
Investigators	Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account	GlaxoSmithKline
Verification Date	April 2015