Viviant 20mg Special Investigation (Regulatory Post Marketing Commitment Plan) (VIOLINE)
In this survey, to collect the safety and efficacy information of Bazedoxifene in daily medical practice will be examined. In addition, the necessity of special Investigation and post-marketing clinical studies will be examined, while investigating unexpected adverse drug reactions during the survey period and understanding of the status of frequency of adverse drug reactions in daily medical practice.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Viviant Osteoporosis Long Term Treatment In Post Menopausal Women (VIOLINE)|
- The frequency of treatment related adverse events. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Occurrence of all fracture. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Treatment related unlisted adverse events in Japanese Package Insert. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Risk factors likely to affect the frequency of treatment related adverse events. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Subjects taking Bazedoxifene Tablets
For adults, take 1 tablet (20 mg of the active ingredient) at a time, once a day.
All the subjects whom an investigator prescribes the first Bazedoxifene (Viviant) Tablets should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.