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44256

Beskrivning

Study ID: 109616 (Y7), 109624 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

Nyckelord

Versioner (2)
  1. 2019-04-22 2019-04-22 -
  2. 2021-09-20 2021-09-20 -
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GlaxoSmithKline

Uppladdad den

20 september 2021

DOI

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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

    Engelsk

    Visit 5

    1 Formulär  
    1. StudyEvent: ODM
      1. Visit 5
    Administrative Data
    Beskrivning

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Beskrivning

    Clinical Trial Subject Unique Identifier

    Datatyp

    integer

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

    Check for Study Continuation

    Alias
    UMLS CUI-1
    C0805733
    UMLS CUI-2
    C0008976
    Did the subject return for visit 5?
    Beskrivning

    Continuation status, Clinical Trials

    Datatyp

    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
    Beskrivning

    Continuation status, Clinical Trials, Reason

    Datatyp

    text

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

    Continuation status, Clinical Trials, Decision

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0805733
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [1,3]
    C0679006
    Demographics
    Beskrivning

    Demographics

    Alias
    UMLS CUI-1
    C1704791
    Center number
    Beskrivning

    Institution name, Identifier

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1301943
    UMLS CUI [1,2]
    C0600091
    Date of Birth
    Beskrivning

    Patient date of birth

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0421451
    Gender
    Beskrivning

    Gender

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0079399
    Occurrence of Adverse Event
    Beskrivning

    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 fourth visit of HPV-023 and the fifth visit of HPV-023?
    Beskrivning

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

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    UMLS CUI [2]
    C0012634
    Colposcopy Information
    Beskrivning

    Colposcopy Information

    Alias
    UMLS CUI-1
    C0009417
    Has a colposcopy been performed between the fourth visit of HPV-023 and the fifth visit of HPV-023 or directly related to cytology results from Visit 5?
    Beskrivning

    Yes, please complete the Colposcopy section

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0009417
    Laboratory Tests - Blood Sample
    Beskrivning

    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?
    Beskrivning

    Collection of blood specimen for laboratory procedure

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0005834
    Date
    Beskrivning

    Please complete only if different from visit date

    Datatyp

    date

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

    Woman's Health (Pelvic) Examination

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

    Physical Examination, Pelvis

    Datatyp

    boolean

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

    Please complete only if different from visit date

    Datatyp

    date

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

    Collection of Cervical Swab

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

    Gonococcal cervical swab, cervical swab test, Chlamydia swab

    Datatyp

    boolean

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

    Please complete only if different from visit date

    Datatyp

    date

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

    Cervical Specimen

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

    Specimen, Cervical

    Datatyp

    boolean

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

    Please complete only if different from visit date

    Datatyp

    date

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

    Repeated Cervical Cytology Specimen

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

    Specimen, CervicalCytology, Repeat

    Datatyp

    boolean

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

    Pleasevcomplete only if different from visit date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0370003
    UMLS CUI [1,2]
    C0856201
    UMLS CUI [1,3]
    C0205341
    UMLS CUI [1,4]
    C0011008
    Second Repeated Cervical Specimen
    Beskrivning

    Second Repeated Cervical Specimen

    Alias
    UMLS CUI-1
    C0370003
    UMLS CUI-2
    C0205064
    UMLS CUI-3
    C0205341
    Has a repeated cervical specimen been collected?
    Beskrivning

    Specimen, CervicalCytology, Repeat

    Datatyp

    boolean

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

    Pleasevcomplete only if different from visit date

    Datatyp

    date

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

    Questionnaire

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

    Questionnaires

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0034394
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    Similar models

    Visit 5

    1 Formulär
    1. StudyEvent: ODM
      1. Visit 5
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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 5?
    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
    Demographics
    C1704791 (UMLS CUI-1)
    Institution name, Identifier
    Item
    Center number
    integer
    C1301943 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Patient date of birth
    Item
    Date of Birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Gender
    text
    C0079399 (UMLS CUI [1])
    Gender
    Code List
    Gender
    CL Item
    Male (1)
    CL Item
    Female (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 fourth visit of HPV-023 and the fifth visit of HPV-023?
    boolean
    C1519255 (UMLS CUI [1])
    C0012634 (UMLS CUI [2])
    Item Group
    Colposcopy Information
    C0009417 (UMLS CUI-1)
    Colposcopy
    Item
    Has a colposcopy been performed between the fourth visit of HPV-023 and the fifth visit of HPV-023 or directly related to cytology results from Visit 5?
    boolean
    C0009417 (UMLS CUI [1])
    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
    Second Repeated Cervical Specimen
    C0370003 (UMLS CUI-1)
    C0205064 (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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