Last updated: 11/03/2018 12:59:43
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
Regulatory TYKERB® tablets PMS
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: 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
Trial 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 informationTYKERB® is a registered trademark of the GlaxoSmithKline group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Occurrence of adverse events after TYKERB® tablets administration
Timeframe: 12 months
Secondary outcomes:
Effectiveness of TYKERB® tablets and Occurrence of unexpected adverse drug reaction and serious adverse event after TYKERB® tablets administration
Timeframe: 12 months
Interventions:
Drug: TYKERB® tablets
Enrollment:
750
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Cancer
Product
lapatinib
Collaborators
Not applicable
Study date(s)
January 2010 to July 2014
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
- All subjects must satisfy the following criteria at PMS entry according to MFDS PMS regulation:
- Subjects with indication in the locally approved prescribing information
Inclusion and exclusion criteria
Inclusion 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
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
No longer a GSK study
Actual primary completion date
Not applicable
Actual study completion date
2014-29-07
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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