0 Bedömningar
ID

36165

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2019-04-22 2019-04-22 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

22 april 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

  • Senaste
  • Äldsta
  • Önskad
  • Senaste
    • Senaste
    • Äldsta
    • Önskad

    Inga kommentarer

    Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

    Candidate HPV-16/18 L1 VLP A04 Vaccine in Young Adult Women Vaccinated in Phase IIb, NCT00518336

    Engelsk

    Questionnaire

    1 Formulär  
    1. StudyEvent: ODM
      1. Questionnaire
    Administrative Data
    Beskrivning

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Number
    Beskrivning

    Clinical Trial Subject Unique Identifier

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    General Information
    Beskrivning

    General Information

    Alias
    UMLS CUI-1
    C1508263 (General information section)
    LOINC
    MTHU015719
    Are you currently a smoker?
    Beskrivning

    Tobacco use

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0543414 (Tobacco use)
    If Yes, how many cigarettes on average do you smoke?
    Beskrivning

    number of cigarettes per day

    Datatyp

    integer

    Måttenheter
    • per day
    Alias
    UMLS CUI [1]
    C3694146 (number of cigarettes per day)
    per day
    If Yes, how many cigarettes on average do you smoke?
    Beskrivning

    Smoker -amount smoked

    Datatyp

    integer

    Måttenheter
    • per week
    Alias
    UMLS CUI [1]
    C1608325 (Smoker - amount smoked)
    per week
    Did your smoking habits (smoker/non-smoker) have changed since the completion of the last questionnaire?
    Beskrivning

    Tobacco use, Changing

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0543414 (Tobacco use)
    UMLS CUI [1,2]
    C0392747 (Changing)
    SNOMED
    18307000
    If Yes, indicate when
    Beskrivning

    Tobacco use, Changing, Date in time

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0543414 (Tobacco use)
    UMLS CUI [1,2]
    C0392747 (Changing)
    SNOMED
    18307000
    UMLS CUI [1,3]
    C0011008 (Date in time)
    SNOMED
    410671006
    Sexual History
    Beskrivning

    Sexual History

    Alias
    UMLS CUI-1
    C0036864 (Sex Behavior)
    SNOMED
    473013003
    Since you completed the previous questionnaire, how often on average did you have sexual intercourse or genital-to-genital sexual contact?
    Beskrivning

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

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0036864 (Sex Behavior)
    SNOMED
    473013003
    UMLS CUI [1,2]
    C0449788 (Count of entities)
    SNOMED
    410681005
    Since you completed the previous questionnaire, with how many partners have you had sexual intercourse or genital-to-genital sexual contact?
    Beskrivning

    Sex behavior, Sexual Partners, Count of entities

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0036864 (Sex Behavior)
    SNOMED
    473013003
    UMLS CUI [1,2]
    C0036911 (Sexual Partners)
    SNOMED
    225517006
    UMLS CUI [1,3]
    C0449788 (Count of entities)
    SNOMED
    410681005
    How many of these partners were NEW partners?
    Beskrivning

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

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0036864 (Sex Behavior)
    SNOMED
    473013003
    UMLS CUI [1,2]
    C0036911 (Sexual Partners)
    SNOMED
    225517006
    UMLS CUI [1,3]
    C0205314 (New)
    SNOMED
    7147002
    LOINC
    LA9039-4
    UMLS CUI [1,4]
    C0449788 (Count of entities)
    SNOMED
    410681005
    Contraceptive History
    Beskrivning

    Contraceptive History

    Alias
    UMLS CUI-1
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    Oral contraceptive (birth control pill)
    Beskrivning

    Contraceptives, oral

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0009905 (Contraceptives, Oral)
    LOINC
    LA16247-1
    Depo-Provera
    Beskrivning

    Depo-provera or injectables (shots)

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C3842800 (Depo-provera or injectables (shots))
    LOINC
    LA16569-8
    Lunelle
    Beskrivning

    Lunelle - a once-a-month injection

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C3842792 (Lunelle - a once-a-month injection)
    LOINC
    LA16580-5
    Hormonal patch
    Beskrivning

    Contraceptive patch

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2985284 (Contraceptive patch)
    SNOMED
    450881000124106
    LOINC
    LA16581-3
    Vaginal contraceptive ring
    Beskrivning

    Vaginal Ring

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0042260 (Vaginal System)
    Hormonal coated intrauterine device
    Beskrivning

    Intrauterine Devices

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0021900 (Intrauterine Devices)
    SNOMED
    268460000
    Male or female condom (rubber)
    Beskrivning

    Condom Use

    Datatyp

    text

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

    Contraceptive methods, Other

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    UMLS CUI [1,2]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    Other Gynecological History
    Beskrivning

    Other Gynecological History

    Alias
    UMLS CUI-1
    C0474455 (Gynecological history)
    SNOMED
    267011001
    UMLS CUI-2
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    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
    Beskrivning

    Viral Warts, Genitals; Genital Condyloma

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0343642 (Viral warts, unspecified)
    UMLS CUI [1,2]
    C0017420 (Genitalia)
    LOINC
    LP7264-7
    UMLS CUI [2]
    C0744357 (GENITAL CONDYLOMA)
    Since you completed the previous questionnaire, did your health care provider tell you that you had one of the following conditions? - Genital herpes
    Beskrivning

    Genital Herpes

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0019342 (Genital Herpes)
    SNOMED
    33839006
    Tillbaka till toppen

    Similar models

    Questionnaire

    1 Formulär
    1. StudyEvent: ODM
      1. Questionnaire
    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
    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)
    Tillbaka till toppen 

    Hjälp

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial