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ID

36173

Description

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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Versions (1)
  1. 4/22/19 4/22/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 22, 2019

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License

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

    English

    Questionnaire

    1 forms  
    1. StudyEvent: ODM
      1. Questionnaire
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Description

    Clinical Trial Subject Unique Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    General Information
    Description

    General Information

    Alias
    UMLS CUI-1
    C1508263
    Are you currently a smoker?
    Description

    Tobacco use

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0543414
    If Yes, how many cigarettes on average do you smoke?
    Description

    number of cigarettes per day

    Data type

    integer

    Measurement units
    • per day
    Alias
    UMLS CUI [1]
    C3694146
    per day
    If Yes, how many cigarettes on average do you smoke?
    Description

    Smoker -amount smoked

    Data type

    integer

    Measurement units
    • per week
    Alias
    UMLS CUI [1]
    C1608325
    per week
    Did your smoking habits (smoker/non-smoker) have changed since the completion of the last questionnaire?
    Description

    Tobacco use, Changing

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0543414
    UMLS CUI [1,2]
    C0392747
    If Yes, indicate when
    Description

    Tobacco use, Changing, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0543414
    UMLS CUI [1,2]
    C0392747
    UMLS CUI [1,3]
    C0011008
    Sexual History
    Description

    Sexual History

    Alias
    UMLS CUI-1
    C0036864
    Since you completed the previous questionnaire, how often on average did you have sexual intercourse or genital-to-genital sexual contact?
    Description

    Please give your answer in number of times per week or month, whichever is easiest

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0036864
    UMLS CUI [1,2]
    C0449788
    Since you completed the previous questionnaire, with how many partners have you had sexual intercourse or genital-to-genital sexual contact?
    Description

    Sex behavior, Sexual Partners, Count of entities

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0036864
    UMLS CUI [1,2]
    C0036911
    UMLS CUI [1,3]
    C0449788
    How many of these partners were NEW partners?
    Description

    “NEW” means a partner with whom you have never had sexual intercourse or genital-to-genital sexual contact before completion of the previous questionnaire.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0036864
    UMLS CUI [1,2]
    C0036911
    UMLS CUI [1,3]
    C0205314
    UMLS CUI [1,4]
    C0449788
    Contraceptive History
    Description

    Contraceptive History

    Alias
    UMLS CUI-1
    C0700589
    Oral contraceptive (birth control pill)
    Description

    Contraceptives, oral

    Data type

    text

    Alias
    UMLS CUI [1]
    C0009905
    Depo-Provera
    Description

    Depo-provera or injectables (shots)

    Data type

    text

    Alias
    UMLS CUI [1]
    C3842800
    Lunelle
    Description

    Lunelle - a once-a-month injection

    Data type

    text

    Alias
    UMLS CUI [1]
    C3842792
    Hormonal patch
    Description

    Contraceptive patch

    Data type

    text

    Alias
    UMLS CUI [1]
    C2985284
    Vaginal contraceptive ring
    Description

    Vaginal Ring

    Data type

    text

    Alias
    UMLS CUI [1]
    C0042260
    Hormonal coated intrauterine device
    Description

    Intrauterine Devices

    Data type

    text

    Alias
    UMLS CUI [1]
    C0021900
    Male or female condom (rubber)
    Description

    Condom Use

    Data type

    text

    Alias
    UMLS CUI [1]
    C0679782
    Other hormonal contraceptive methods (E. g.: IUD Cu -T380 or multiload; monthly injectable hormonal contraceptives - Mesigyna, Perlutan; etc.), please specify
    Description

    Contraceptive methods, Other

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0700589
    UMLS CUI [1,2]
    C0205394
    Other Gynecological History
    Description

    Other Gynecological History

    Alias
    UMLS CUI-1
    C0474455
    UMLS CUI-2
    C0205394
    Since you completed the previous questionna ire, did your health care provider tell you that you had one of the following conditions? - Venereal/genital warts, condyloma
    Description

    Viral Warts, Genitals; Genital Condyloma

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0343642
    UMLS CUI [1,2]
    C0017420
    UMLS CUI [2]
    C0744357
    Since you completed the previous questionnaire, did your health care provider tell you that you had one of the following conditions? - Genital herpes
    Description

    Genital Herpes

    Data type

    text

    Alias
    UMLS CUI [1]
    C0019342
    Back to the top of the page

    Similar models

    Questionnaire

    1 forms
    1. StudyEvent: ODM
      1. Questionnaire
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Clinical Trial Subject Unique Identifier
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    General Information
    C1508263 (UMLS CUI-1)
    Tobacco use
    Item
    Are you currently a smoker?
    boolean
    C0543414 (UMLS CUI [1])
    number of cigarettes per day
    Item
    If Yes, how many cigarettes on average do you smoke?
    integer
    C3694146 (UMLS CUI [1])
    Smoker -amount smoked
    Item
    If Yes, how many cigarettes on average do you smoke?
    integer
    C1608325 (UMLS CUI [1])
    Tobacco use, Changing
    Item
    Did your smoking habits (smoker/non-smoker) have changed since the completion of the last questionnaire?
    boolean
    C0543414 (UMLS CUI [1,1])
    C0392747 (UMLS CUI [1,2])
    Tobacco use, Changing, Date in time
    Item
    If Yes, indicate when
    date
    C0543414 (UMLS CUI [1,1])
    C0392747 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item Group
    Sexual History
    C0036864 (UMLS CUI-1)
    Sexual Intercourse, Count of entities
    Item
    Since you completed the previous questionnaire, how often on average did you have sexual intercourse or genital-to-genital sexual contact?
    text
    C0036864 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Sex behavior, Sexual Partners, Count of entities
    Item
    Since you completed the previous questionnaire, with how many partners have you had sexual intercourse or genital-to-genital sexual contact?
    integer
    C0036864 (UMLS CUI [1,1])
    C0036911 (UMLS CUI [1,2])
    C0449788 (UMLS CUI [1,3])
    Sex behavior, Sexual Partners, New, Count of entities
    Item
    How many of these partners were NEW partners?
    integer
    C0036864 (UMLS CUI [1,1])
    C0036911 (UMLS CUI [1,2])
    C0205314 (UMLS CUI [1,3])
    C0449788 (UMLS CUI [1,4])
    Item Group
    Contraceptive History
    C0700589 (UMLS CUI-1)
    Item
    Oral contraceptive (birth control pill)
    text
    C0009905 (UMLS CUI [1])
    Lunelle - a once-a-month injection
    Code List
    Oral contraceptive (birth control pill)
    CL Item
    Regularly (1)
    CL Item
    Sometimes (2)
    CL Item
    Never (3)
    Item
    Depo-Provera
    text
    C3842800 (UMLS CUI [1])
    Lunelle - a once-a-month injection
    Code List
    Depo-Provera
    CL Item
    Regularly (1)
    CL Item
    Sometimes (2)
    CL Item
    Never (3)
    Item
    Lunelle
    text
    C3842792 (UMLS CUI [1])
    Lunelle - a once-a-month injection
    Code List
    Lunelle
    CL Item
    Regularly (1)
    CL Item
    Sometimes (2)
    CL Item
    Never (3)
    Item
    Hormonal patch
    text
    C2985284 (UMLS CUI [1])
    Lunelle - a once-a-month injection
    Code List
    Hormonal patch
    CL Item
    Regularly (1)
    CL Item
    Sometimes (2)
    CL Item
    Never (3)
    Item
    Vaginal contraceptive ring
    text
    C0042260 (UMLS CUI [1])
    Lunelle - a once-a-month injection
    Code List
    Vaginal contraceptive ring
    CL Item
    Regularly (1)
    CL Item
    Sometimes (2)
    CL Item
    Never (3)
    Item
    Hormonal coated intrauterine device
    text
    C0021900 (UMLS CUI [1])
    Lunelle - a once-a-month injection
    Code List
    Hormonal coated intrauterine device
    CL Item
    Yes (1)
    CL Item
    Never (2)
    Item
    Male or female condom (rubber)
    text
    C0679782 (UMLS CUI [1])
    Condom Use
    Code List
    Male or female condom (rubber)
    CL Item
    Regularly (1)
    CL Item
    Sometimes (2)
    CL Item
    Never (3)
    Item
    Other hormonal contraceptive methods (E. g.: IUD Cu -T380 or multiload; monthly injectable hormonal contraceptives - Mesigyna, Perlutan; etc.), please specify
    text
    C0700589 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Condom Use
    Code List
    Other hormonal contraceptive methods (E. g.: IUD Cu -T380 or multiload; monthly injectable hormonal contraceptives - Mesigyna, Perlutan; etc.), please specify
    CL Item
    Regularly (1)
    CL Item
    Sometimes (2)
    CL Item
    Never (3)
    Item Group
    Other Gynecological History
    C0474455 (UMLS CUI-1)
    C0205394 (UMLS CUI-2)
    Item
    Since you completed the previous questionna ire, did your health care provider tell you that you had one of the following conditions? - Venereal/genital warts, condyloma
    text
    C0343642 (UMLS CUI [1,1])
    C0017420 (UMLS CUI [1,2])
    C0744357 (UMLS CUI [2])
    Viral Warts, Genitals; Genital Condyloma
    Code List
    Since you completed the previous questionna ire, did your health care provider tell you that you had one of the following conditions? - Venereal/genital warts, condyloma
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    Unknown (3)
    Item
    Since you completed the previous questionnaire, did your health care provider tell you that you had one of the following conditions? - Genital herpes
    text
    C0019342 (UMLS CUI [1])
    Viral Warts, Genitals; Genital Condyloma
    Code List
    Since you completed the previous questionnaire, did your health care provider tell you that you had one of the following conditions? - Genital herpes
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    Unknown (3)
    Back to the top of the page 

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