An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance (PMS) to Monitor the Safety and Effectiveness of TYKERB® Tablets Administered in Korean Patients According to the Prescribing Information
Overview
- Phase
- Not Applicable
- Intervention
- TYKERB® tablets
- Conditions
- Cancer
- Sponsor
- GlaxoSmithKline
- Enrollment
- 750
- Locations
- 1
- Primary Endpoint
- Occurrence of adverse events after TYKERB® tablets administration
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of TYKERB® tablets administered in Korean patients according to the prescribing information TYKERB® is a registered trademark of the GlaxoSmithKline group of companies.
Detailed Description
Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of TYKERB® tablets administered in Korean patients according to the prescribing information TYKERB® tablets will be administered with capecitabine for HER2 overexpressing advanced or metastatic breast cancer treatment or with letrozole for the treatment of postmenopausal women with hormone receptor positive metastatic breast cancer that overexpresses the HER2 as described the prescribing information of TYKERB® tablets
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
TYKERB® tablets
There is only one group. This group includes patients administrated TYKERB® tablets
Intervention: TYKERB® tablets
Outcomes
Primary Outcomes
Occurrence of adverse events after TYKERB® tablets administration
Time Frame: 12 months
Secondary Outcomes
- Effectiveness of TYKERB® tablets and Occurrence of unexpected adverse drug reaction and serious adverse event after TYKERB® tablets administration(12 months)