Regulatory Hycamtin(Oral) PMS

GlaxoSmithKline92 enrolled

Overview

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

Enrollment

Conditions

Lung Cancer, Small Cell

Interventions

TopotecanDRUG

patients administrated Topotecan according to the prescribing information

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (2)

GSK Investigational Site

Seongnam-si, Gyeonggi-do, South Korea

GSK Investigational Site

Seoul, South Korea

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

Time frame: 9 months

Occurrence of serious adverse event or adverse drug reation

Time frame: 9 months

Data from ClinicalTrials.gov

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