Lung Cancer, Small Cell
Conditions
Keywords
PMS (post-marketing surveillance), Topotecan
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.
Interventions
DRUGTopotecan
patients administrated Topotecan according to the prescribing information
Sponsors
GlaxoSmithKline
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of adverse events after Topotecan administration | 9 months |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of unexpected adverse event or adverse drug reaction | 9 months |
| Occurrence of serious adverse event or adverse drug reation | 9 months |
Countries
South Korea
Outcome results
None listed