Last updated: 05/09/2019 15:34:05
A Post-Marketing Observational Study to Evaluate the Safety of Tykerb® in Chinese Patients
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Post-Marketing Observational Study to Evaluate the Safety of Tykerb® in Chinese Patients
Trial description: ObjectiveThe objective of this study is to evaluate the safety profile of TYKERB during post-marketing use via collecting and analysing safety data from patients taking TYKERB (lapatinib).Study designThis study is a single-country, non-interventional, single-arm study among Chinese patients receiving treatment with TYKERB for a medically appropriate use. This program will collect data both prospectively and retrospectively to include 3000 patients who have taken TYKERB. Prospectively registered patients will be followed up according to clinical need. Information collected as part of the routine clinical visits of patients will be collected in the electronic case report form and recorded in the electronic data capture system. No tests or investigations are mandated by this protocol.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
descriptive statistics
Timeframe: After 22 Nov 2018
Secondary outcomes:
None
Timeframe: NA
Interventions:
Enrollment:
Not applicable
Primary completion date:
2018-09-05
Observational study model:
Other
Time perspective:
Other
Clinical publications:
Not applicable
Medical condition
Neoplasms, Breast
Product
lapatinib
Collaborators
Not applicable
Study date(s)
October 2016 to May 2018
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
None
- This study is a single-country, non-interventional, single-arm study among Chinese patients receiving treatment with TYKERB for a medically appropriate use. This program will collect data both prospectively and retrospectively to include 3000 patients who have taken TYKERB. Prospectively registered patients will be followed up according to clinical need. Information collected as part of the routine clinical visits of patients will be collected in the electronic case report form and recorded in the electronic data capture system. No tests or investigations are mandated by this protocol.
Inclusion and exclusion criteria
Inclusion criteria:
- This study is a single-country, non-interventional, single-arm study among Chinese patients receiving treatment with TYKERB for a medically appropriate use. This program will collect data both prospectively and retrospectively to include 3000 patients who have taken TYKERB. Prospectively registered patients will be followed up according to clinical need. Information collected as part of the routine clinical visits of patients will be collected in the electronic case report form and recorded in the electronic data capture system. No tests or investigations are mandated by this protocol.
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
Study complete
Actual primary completion date
2018-09-05
Actual study completion date
2018-23-05
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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