Cervarix Long-term Safety Surveillance (PGRx)
Cervarix Long-term Safety Surveillance Using the PGRx Information System (PGRx Study)
研究概览
详细说明
PGRx is an information system that intends to bridge the resource gap to assess the effect of a drug on the risk of adverse events that are infrequent and/or with a long delay of onset. It uses some characteristics of the ad hoc case-control or case-referent design, transposed on a prospective, on-going, population-based recruitment plan. This particular design is called here systematic case-referent design in contrast to the ad hoc case-control or case-referent methodology. The PGRx information system is based on the routine and targeted recruitment of cases of a series of pathologies, compared to population-based referents for the study of exposure to a wide variety of drugs. Drug exposure ascertainment is obtained from two different sources in the PGRx.
system: A) A structured patient interview (telephone-administered questionnaire) B) The medical data form with the computerized medical prescriptions (interview guide)
研究类型
注册 (实际的)
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Male and female
- Age 14 to 79 years-old (included)
- Patient residing in France
- Patient accepting to participate in the study
- Patient can read and respond to a telephone interview
Exclusion Criteria:
- Prior reported history of the disease
- Patient or Patient's parent cannot read the interview guide or answer a telephone interview questionnaire in French
- Refusal to participate
学习计划
研究是如何设计的？
设计细节
- 观测模型：病例对照
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Case Group
Subjects in this group are incident cases (i.e.
newly diagnosed subjects) reported as having occurred in the previous twelve months before the recruitment consultation.
|
3 doses over a period of 6 months (Month 0 and ideally Month 1 and Month 6, with 1 month minimum between any two doses).
PGRx information system
|
|
Control Group
Subjects selected from the pool of potential referents reported by physicians in general practice, who meet the same general inclusion and exclusion criteria as the cases.
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3 doses over a period of 6 months (Month 0 and ideally Month 1 and Month 6, with 1 month minimum between any two doses).
PGRx information system
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
To assess whether the use of Cervarix® is associated with a modified risk of central demyelination.
大体时间：At Month 36
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At Month 36
|
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To assess whether the use of Cervarix® is associated with a modified risk of type 1 diabetes.
大体时间：At Month 36
|
At Month 36
|
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To assess whether the use of Cervarix® is associated with a modified risk of cutaneous Lupus.
大体时间：At Month 36
|
At Month 36
|
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To assess whether the use of Cervarix® is associated with a modified risk of inflammatory arthritis.
大体时间：At Month 36
|
At Month 36
|
|
To assess whether the use of Cervarix® is associated with a modified risk of idiopathic thrombocytopenic purpura.
大体时间：At Month 36
|
At Month 36
|
|
To assess whether the use of Cervarix® is associated with a modified risk of systemic lupus erythematosus.
大体时间：At Month 36
|
At Month 36
|
|
To assess whether the use of Cervarix® is associated with a modified risk of addendum for cutaneous lupus.
大体时间：At Month 36
|
At Month 36
|
|
To assess whether the use of Cervarix® is associated with a modified risk of myositis.
大体时间：At Month 36
|
At Month 36
|
|
To assess whether the use of Cervarix® is associated with a modified risk of dermatomyositis.
大体时间：At Month 36
|
At Month 36
|
|
To assess whether the use of Cervarix® is associated with a modified risk of Guillain-Barrre syndrome.
大体时间：At Month 36
|
At Month 36
|
|
To assess whether the use of Cervarix® is associated with a modified risk of autoimmune thyroiditis
大体时间：At Month 36
|
At Month 36
|
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To assess whether the use of Cervarix® is associated with a modified risk of Graves disease.
大体时间：At Month 36
|
At Month 36
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 112677
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