NCT01088386Enrolling By Invitation不适用
Zyprexa® Relprevv™ Patient Care Program
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Incidence per injection and per patient of post-injection delirium/sedation syndrome (PDSS) events
研究概览
简要总结
The goal of the Zyprexa Relprevv Patient Care Program is to mitigate the risk of negative outcomes associated with Zyprexa Relprevv post-injection delirium/sedation syndrome (PDSS).
详细描述
The goal of the Zyprexa Relprevv Patient Care Program is to mitigate the risk of negative outcomes associated with Zyprexa Relprevv post-injection delirium/sedation syndrome (PDSS) by:
- Ensuring Zyprexa Relprevv is prescribed only by certified prescribers, dispensed only by certified dispensers, and dispensed for use only in certified healthcare facilities with ready access to emergency response services, and dispensed for use only with documentation of safe use conditions;
- Informing health care providers and patients about the risks and the need for continuous observation of patients for at least 3 hours in certified healthcare facilities; and
- Establishing long-term safety and safe use of Zyprexa Relprevv through periodic monitoring for the risk of PDSS events and by enrolling all patients who receive Zyprexa Relprevv in the Zyprexa Relprevv Patient Care Program registry.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patients receiving Zyprexa Relprevv enrolled in Zyprexa Relprevv Patient Care Program
排除标准
- •Any patient not receiving Zyprexa Relprevv
研究组 & 干预措施
Patients
All patients who will be receiving Zyprexa Relprevv must be enrolled into the Zyprexa Relprevv Patient Care Program
结局指标
主要结局
Incidence per injection and per patient of post-injection delirium/sedation syndrome (PDSS) events
时间窗: Baseline to end of study
次要结局
- Type of post-injection delirium/sedation syndrome (PDSS) by clinical presentation and outcome(Baseline to end of study)
- Potential risk factors of post-injection delirium/sedation syndrome (PDSS).(Baseline to end of study)
研究者
研究点 (1)
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