Cervarix Long-term Safety Surveillance (PGRx)
Cervarix Long-term Safety Surveillance Using the PGRx Information System (PGRx Study)
연구 개요
상세 설명
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)
연구 유형
등록 (실제)
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 컨트롤
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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.
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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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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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To assess whether the use of Cervarix® is associated with a modified risk of central demyelination.
기간: 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.
기간: 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 cutaneous Lupus.
기간: 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 inflammatory arthritis.
기간: 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 idiopathic thrombocytopenic purpura.
기간: 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 systemic lupus erythematosus.
기간: 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 addendum for cutaneous lupus.
기간: 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 myositis.
기간: 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 dermatomyositis.
기간: 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 Guillain-Barrre syndrome.
기간: 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 autoimmune thyroiditis
기간: 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 Graves disease.
기간: At Month 36
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At Month 36
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 112677
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