Regulatory TYKERB® Tablets PMS

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Lapatinib

Criteria

All subjects must satisfy the following criteria at PMS entry according to MFDS PMS regulation:

• Subjects with indication in the locally approved prescribing information

• Subjects with no contraindication according to the prescribing information