Epidemiology Study to Assess the Safety of a New Slow-release Form of Seroquel (Quetiapine) in the Post-marketing Phase in the UK
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 37,372
- 试验地点
- 1
- 主要终点
- The outcome of interest will be evaluated by means of relative risk based on incidence rates estimates in users of quetiapine XR vs corresponding incidence rates in users of comparison drugs
研究概览
简要总结
The main objective of this observational study is to characterize new users of quetiapine XR as well as new users of other study drugs (i.e. the comparison group) and to quantify the risk of developing newly diagnosed outcomes of interest in new users of quetiapine XR as well as in other study drugs.
详细描述
Epidemiology study to assess the safety of a new slow-release form of Seroquel (quetiapine) in the post-marketing phase in the UK.
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Episodes of new use (>/=1 prescription) of quetiapine XR or other study drugs
排除标准
- •Less than two years of recorded history before the start of the marketing of quetiapine XR (or cohort entry date)
- •If the duration and dose of the antipsychotic drug cannot be determined
结局指标
主要结局
The outcome of interest will be evaluated by means of relative risk based on incidence rates estimates in users of quetiapine XR vs corresponding incidence rates in users of comparison drugs
时间窗: During follow-up of a treatment episode estimated to be on average of 1.5 years
Duration of treatment
时间窗: During follow-up estimated to be on average of 1.5 years.
Duration of treatment episode
时间窗: During follow-up estimated to be on average of 1.5 years
Episode, defined as the treatment time from first to last prescription of quetiapine XR or other study drugs.
Comorbidities defined by clinical diagnosis or prescription
时间窗: Baseline and during follow up of treatment estimated to be on average 1.5 years
Age
时间窗: Baseline
Gender
时间窗: Baseline
Dose
时间窗: During follow-up of treatment estimated to be on average 1.5 years
Adherence
时间窗: During follow-up of treatment estimated to be on average 1.5 years
The number of subjects to whom the drug was prescribed by the general practitioners.
时间窗: During follow-up of treatment estimated to be on average 1.5 years
The number of patients, whom the drug was prescribed by the specified type of prescriber (specialist, general practitioner or another type of physician).
Indication for treatment
时间窗: During follow-up of treatment estimated to be on averaged 1.5 years
次要结局
未报告次要终点