Infections, Papillomavirus Clinical Trial
Official title:
Cervarix Long-term Safety Surveillance Using the PGRx Information System (PGRx Study)
This study aims to assess whether the use of Cervarix® is associated with a modified risk of central demyelination, type 1 diabetes (DT1), Cutaneous Lupus, inflammatory arthritis, idiopathic thrombocytopenic purpura (ITP), Lupus erythematosus, myositis and dermatomyositis, Guillain-Barre syndrome and/or Autoimmune thyroiditis and Graves disease by using the PGRx information system.
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)
;
Observational Model: Case Control, Time Perspective: Prospective
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|---|---|---|---|
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