NCT02066805已完成不适用
Estimation of Off-Label Use of XGEVA® (Denosumab) Using Population-Based Databases in Denmark
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 142
- 主要终点
- on or off label individual prescription type
研究概览
简要总结
This study aims to evaluate off-label XGEVA use in Denmark using data linked from registries and other sources in Northern Jutland Region and Copenhagen. This will allow for accurate assessment of prescriptions and diagnoses, especially those related to cancer patients during the first year post the initial market availability of XGEVA.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 接受健康志愿者
- 否
入选标准
- •The study will include patients with a prescription for XGEVA® given in secondary care with a minimum of 108 XGEVA users, in the Northern Jutland Region and Copenhagen during the first 1-year post XGEVA market availability, defined as 12 months after RADS opinion on 24th January 2013 or after the minimum sample has been achieved.
排除标准
- 未提供
研究组 & 干预措施
Cohort 1
干预措施: Database assessment of off-label XGEVA use (Drug)
结局指标
主要结局
on or off label individual prescription type
时间窗: 12 months
Yes/no regarding whether an individual prescription was on (or off) label
on or off label patient treatment
时间窗: 12 months
Yes/no regarding whether the patient was treated on (or off) label
次要结局
- type of off-label use(12 months)
- off-label use stratified by administering department(12 months)
研究者
相似试验
已完成
不适用
A Drug Utilization Study of Radium-223 in SwedenNeoplasmsNCT02331303Bayer37
已完成
不适用
Evaluation of Potential Off-label Use of Dabigatran Etexilate in EuropeAtrial FibrillationNCT02240654Boehringer Ingelheim36,573
终止
不适用
Xydalba Utilization Registry in GermanyBacterial InfectionsNCT03696901Correvio International Sarl16
已完成
3 期
Study to Evaluate the Safety and Efficacy of Denosumab and Actonel® in Post Menopausal Women Transitioned From Alendronate TherapyOsteoporosisNCT00919711Amgen870
终止
不适用
A Nationwide Observational Study Looking at Effectiveness and Bleeding Complications of NOACs vs. VKA in Non-valvular Atrial Fibrillation Patients.Non-valvular Atrial FibrillationNCT03715725Bayer70,000