Regulatory Hycamtin(Oral) PMS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

92 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2014-11-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Lung Cancer, Small Cell

Study Groups

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Patients administrated Topotecan

There is only one group. This group includes patients administrated Topotecan

Topotecan

Intervention Type DRUG

patients administrated Topotecan according to the prescribing information

Interventions

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Topotecan

patients administrated Topotecan according to the prescribing information

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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.

Exclusion Criteria

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No