Status:

COMPLETED

Regulatory TYKERB® Tablets PMS

Lead Sponsor:

GlaxoSmithKline

Conditions:

Cancer

Eligibility:

All Genders

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 presc...

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 presc...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    January 1 2010

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    July 1 2014

    Estimated Enrollment :

    750 Patients enrolled

    Trial Details

    Trial ID

    NCT00975988

    Start Date

    January 1 2010

    End Date

    July 1 2014

    Last Update

    October 27 2014

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    GSK Investigational Site

    Seoul, South Korea, 110-744

    2

    GSK Investigational Site

    Seoul, South Korea, 134-701