Last updated: 11/03/2018 18:16:37
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study.
Post Marketing Surveillance (PMS) of safety and efficacy of Votrient in Korean patients
Clinicaltrials.gov ID
Not applicable
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: Post Marketing Surveillance (PMS) of safety and efficacy of Votrient in Korean patients
Trial description: Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of Pazopanib administered in Korean patients according to the prescribing information
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Occurrence of adverse events after Pazopanib administration by indication
Timeframe: 12months
Secondary outcomes:
Occurrence of unexpected adverse drug reaction after Pazopanib administration by indication
Timeframe: 12months
Effectiveness after Pazopanib administration by indication
Timeframe: 12months
Occurrence of serious adverse events after Pazopanib administration by indication
Timeframe: 12months
Interventions:
Drug: Pazopanib
Enrollment:
3000
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Carcinoma, Renal Cell, Sarcoma, Soft tissue
Product
pazopanib
Collaborators
Not applicable
Study date(s)
February 2012 to August 2016
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- All subjects must satisfy the following criteria
- Subject who is under the indication to the prescribing information
Inclusion and exclusion criteria
Inclusion criteria:
- All subjects must satisfy the following criteria -Subject who is under the indication to the prescribing information -Subject who don’t have contraindication according to the prescribing information -Subject is willing and able to provide written informed consent
Trial location(s)
No location data available.
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
Not applicable
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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