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 GSK Clinical Study Register is no longer maintained for this study.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

GSK study ID
115578
See study documents
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
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    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)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    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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