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ID

44254

Beschrijving

Study ID: 109616 (Y7) Clinical Study ID: 109616 (Y7) Study Title: A blinded long-term follow-up study of the efficacy of candidate HPV-16/18 L1 VLP AS04 vaccine in young adult women in Brazil vaccinated in the phase IIb, double-blind, multi- center primary study HPV-001 and having participated in the follow-up study HPV-007 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00518336 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: HPV Vaccine Trade Name: Cervarix Study Indication: Infections, Papillomavirus

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Versies (2)
  1. 22-04-19 22-04-19 -
  2. 20-09-21 20-09-21 -
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GlaxoSmithKline

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20 september 2021

DOI

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Licentie

Creative Commons BY-NC 3.0
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    Candidate HPV-16/18 L1 VLP A04 Vaccine in Young Adult Women Vaccinated in Phase IIb, NCT00518336

    Engels

    Visit 3

    1 Formulieren  
    1. StudyEvent: ODM
      1. Visit 3
    Administrative Data
    Beschrijving

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Beschrijving

    Clinical Trial Subject Unique Identifier

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Check for Study Continuation
    Beschrijving

    Check for Study Continuation

    Alias
    UMLS CUI-1
    C0805733
    UMLS CUI-2
    C0008976
    Did the subject return for visit 3?
    Beschrijving

    Continuation status, Clinical Trials

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0805733
    UMLS CUI [1,2]
    C0008976
    If No, Please tick (!) the ONE most a ppropria te reason and skip the following pages of this visit
    Beschrijving

    Continuation status, Clinical Trials, Reason

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0805733
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [1,3]
    C0566251
    Please tick who made the decision
    Beschrijving

    Continuation status, Clinical Trials, Decision

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0805733
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [1,3]
    C0679006
    Occurrence of Adverse Event
    Beschrijving

    Occurrence of Adverse Event

    Alias
    UMLS CUI-1
    C0877248
    Did the subject experience any serious adverse events or NOCDs or other medically significant conditions between the second visit of HPV-023 and third visit of HPV-023?
    Beschrijving

    Yes, please fill in Non-Serious Adverse Event section or the Serious Adverse Event report as necessary.

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    UMLS CUI [2]
    C0012634
    Laboratory Tests - Blood Sample
    Beschrijving

    Laboratory Tests - Blood Sample

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0005834
    Has a blood sample been taken for HPV-16 and HPV-18 serology?
    Beschrijving

    Collection of blood specimen for laboratory procedure

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0005834
    Date
    Beschrijving

    Please complete only if different from visit date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    Woman's Health (Pelvic) Examination
    Beschrijving

    Woman's Health (Pelvic) Examination

    Alias
    UMLS CUI-1
    C0031809
    UMLS CUI-2
    C0030797
    Has a woman's health (pelvic) examination been performed?
    Beschrijving

    Physical Examination, Pelvis

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0030797
    Date
    Beschrijving

    Please complete only if different from visit date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0030797
    UMLS CUI [1,3]
    C0011008
    Collection of Cervical Swab
    Beschrijving

    Collection of Cervical Swab

    Alias
    UMLS CUI-1
    C2266656
    Has a sample been taken for Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) screening?
    Beschrijving

    Gonococcal cervical swab, cervical swab test, Chlamydia swab

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1303035
    UMLS CUI [1,2]
    C2266656
    UMLS CUI [1,3]
    C0563467
    Date
    Beschrijving

    Please complete only if different from visit date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C1303035
    UMLS CUI [1,2]
    C2266656
    UMLS CUI [1,3]
    C0563467
    UMLS CUI [1,4]
    C0011008
    Cervical Specimen
    Beschrijving

    Cervical Specimen

    Alias
    UMLS CUI-1
    C0370003
    UMLS CUI-2
    C0205064
    Has a cervical specimen been collected?
    Beschrijving

    Specimen, Cervical

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0370003
    UMLS CUI [1,2]
    C0205064
    Date
    Beschrijving

    Please complete only if different from visit date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0370003
    UMLS CUI [1,2]
    C0205064
    UMLS CUI [1,3]
    C0011008
    Repeated Cervical Cytology Specimen
    Beschrijving

    Repeated Cervical Cytology Specimen

    Alias
    UMLS CUI-1
    C0370003
    UMLS CUI-2
    C0856201
    UMLS CUI-3
    C0205341
    Has a repeated cervical specimen been collected?
    Beschrijving

    Specimen, CervicalCytology, Repeat

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0370003
    UMLS CUI [1,2]
    C0856201
    UMLS CUI [1,3]
    C0205341
    Date
    Beschrijving

    Pleasevcomplete only if different from visit date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0370003
    UMLS CUI [1,2]
    C0856201
    UMLS CUI [1,3]
    C0205341
    UMLS CUI [1,4]
    C0011008
    Questionnaire
    Beschrijving

    Questionnaire

    Alias
    UMLS CUI-1
    C0034394
    Has the questionnaire been filled in?
    Beschrijving

    Questionnaires

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0034394
    Terug naar het begin van de pagina

    Similar models

    Visit 3

    1 Formulieren
    1. StudyEvent: ODM
      1. Visit 3
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Clinical Trial Subject Unique Identifier
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Check for Study Continuation
    C0805733 (UMLS CUI-1)
    C0008976 (UMLS CUI-2)
    Continuation status, Clinical Trials
    Item
    Did the subject return for visit 3?
    boolean
    C0805733 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    Item
    If No, Please tick (!) the ONE most a ppropria te reason and skip the following pages of this visit
    text
    C0805733 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Continuation status, Clinical Trials, Reason
    Code List
    If No, Please tick (!) the ONE most a ppropria te reason and skip the following pages of this visit
    CL Item
    Same reason and decision as previous visit. (1)
    CL Item
    Serious adverse event (Please complete and submit SAE report, Please specify SAE No.) (2)
    CL Item
    Non-Serious adverse event (Please complete Non-serious Adverse Event section, Please specify AE No.) (3)
    CL Item
    Other, please specify (e.g.: consent withdrawal, Protocol violation, ...) (4)
    Item
    Please tick who made the decision
    text
    C0805733 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    C0679006 (UMLS CUI [1,3])
    Continuation status, Clinical Trials, Reason
    Code List
    Please tick who made the decision
    CL Item
    Investigator  (1)
    CL Item
    Subject (2)
    Item Group
    Occurrence of Adverse Event
    C0877248 (UMLS CUI-1)
    Serious Averse Event; Disease
    Item
    Did the subject experience any serious adverse events or NOCDs or other medically significant conditions between the second visit of HPV-023 and third visit of HPV-023?
    boolean
    C1519255 (UMLS CUI [1])
    C0012634 (UMLS CUI [2])
    Item Group
    Laboratory Tests - Blood Sample
    C0022885 (UMLS CUI-1)
    C0005834 (UMLS CUI-2)
    Collection of blood specimen for laboratory procedure
    Item
    Has a blood sample been taken for HPV-16 and HPV-18 serology?
    boolean
    C0005834 (UMLS CUI [1])
    Collection of blood specimen for laboratory procedure, Date in time
    Item
    Date
    date
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Woman's Health (Pelvic) Examination
    C0031809 (UMLS CUI-1)
    C0030797 (UMLS CUI-2)
    Physical Examination, Pelvis
    Item
    Has a woman's health (pelvic) examination been performed?
    boolean
    C0031809 (UMLS CUI [1,1])
    C0030797 (UMLS CUI [1,2])
    Physical Examination, Pelvis, Date in time
    Item
    Date
    date
    C0031809 (UMLS CUI [1,1])
    C0030797 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item Group
    Collection of Cervical Swab
    C2266656 (UMLS CUI-1)
    Gonococcal cervical swab, cervical swab test, Chlamydia swab
    Item
    Has a sample been taken for Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) screening?
    boolean
    C1303035 (UMLS CUI [1,1])
    C2266656 (UMLS CUI [1,2])
    C0563467 (UMLS CUI [1,3])
    Gonococcal cervical swab, cervical swab test, Chlamydia swab, Date in time
    Item
    Date
    date
    C1303035 (UMLS CUI [1,1])
    C2266656 (UMLS CUI [1,2])
    C0563467 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Item Group
    Cervical Specimen
    C0370003 (UMLS CUI-1)
    C0205064 (UMLS CUI-2)
    Specimen, Cervical
    Item
    Has a cervical specimen been collected?
    boolean
    C0370003 (UMLS CUI [1,1])
    C0205064 (UMLS CUI [1,2])
    Specimen, Cervical, Date in time
    Item
    Date
    date
    C0370003 (UMLS CUI [1,1])
    C0205064 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item Group
    Repeated Cervical Cytology Specimen
    C0370003 (UMLS CUI-1)
    C0856201 (UMLS CUI-2)
    C0205341 (UMLS CUI-3)
    Specimen, CervicalCytology, Repeat
    Item
    Has a repeated cervical specimen been collected?
    boolean
    C0370003 (UMLS CUI [1,1])
    C0856201 (UMLS CUI [1,2])
    C0205341 (UMLS CUI [1,3])
    Specimen, Cervical, Repeat, Date in time
    Item
    Date
    date
    C0370003 (UMLS CUI [1,1])
    C0856201 (UMLS CUI [1,2])
    C0205341 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Item Group
    Questionnaire
    C0034394 (UMLS CUI-1)
    Questionnaires
    Item
    Has the questionnaire been filled in?
    boolean
    C0034394 (UMLS CUI [1])
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