An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and/or Efficacy of AVANDAMET Between June 2004 and January 2010 (AVANDAMETPMS)
|ClinicalTrials.gov Identifier: NCT01294553|
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : March 15, 2011
Last Update Posted : July 7, 2017
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus, Type 2||Drug: Administration of rosiglitazone/metformin|
|Study Type :||Observational|
|Actual Enrollment :||717 participants|
|Official Title:||An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and/or Efficacy of Avandamet® Administered in Korean Diabetic Patients According to the Prescribing Information|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
Korean subjects who are administered rosiglitazone/metformin according to the prescription information
Drug: Administration of rosiglitazone/metformin
Subjects who are administered rosiglitazone/metformin at least once
Other Name: according to label and physician's decision based on each subject's condition
- Number of Participants With an Adverse Event [ Time Frame: 41.4 weeks ]An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, please see the table entitled "Other (non-serious) adverse events" in the Adverse Event section of the results record.
- Number of Participants With a Serious Adverse Event [ Time Frame: 41.4 weeks ]A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, please see the table entitled "Serious Adverse Events" in the Adverse Event section of the results record.
- Number of Participants With the Indicated Unexpected Adverse Events [ Time Frame: 41.4 weeks ]Unexpected adverse events are defined as those that were not described in the locally approved label by the Korean Food and Drug Administration (KFDA) at the time of surveillance completion.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01294553
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|