Viviant®20mg Special Investigation (Regulatory Post Marketing Commitment Plan)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 3,187
- 主要终点
- Number of Participants With Any Fracture
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post menopausal women subjects with Osteoporosis who has no experience of use of Bazedoxifene.
排除标准
- •Subject with present or past venous thromboembolism such as deep venous thrombosis, pulmonary embolism, or retinal venous thrombosis
- •Subject in long-term immovability (postoperative recovery, long-term bed rest)
- •Subject with antiphospholipid antibody syndrome
研究组 & 干预措施
Bazedoxifene Tablets
Subjects taking Bazedoxifene Tablets
干预措施: Bazedoxifene (Drug)
结局指标
主要结局
Number of Participants With Any Fracture
时间窗: 3 years
Occurrence of any fracture after Viviant administration was examined to evaluate effectiveness of Viviant. The event of fracture was defined as an event which included "fracture" in Preferred Term (PT) or Lowest Level Term (LLT) of the MedDRA/J version 18.1.
Number of Participants With Treatment-Related Adverse Events
时间窗: 3 years
A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to Viviant was assessed by the physician.
次要结局
- Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert(3 years)
- Number of Participants With Treatment-Related Adverse Events by Smoking Status(3 years)
- Number of Participants With Treatment-Related Adverse Events by Use of Previous Medication(3 years)
- Number of Participants With Treatment-Related Adverse Events by Age(3 years)
- Number of Participants With Treatment-Related Adverse Events by Use of Steroid(3 years)
- Number of Participants With Treatment-Related Adverse Events by Use of Concomitant Medication(3 years)