0 Evaluaciones
ID

25356

Descripción

Phase A - Year 2 Demographics and Parents contact for rash - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

Palabras clave

Versiones (1)
  1. 2/9/17 2/9/17 -
Titular de derechos de autor

glaxoSmithKline

Subido en

2 de septiembre de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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    Phase A - Year 2 Demographics and Parents contact for rash - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

    Inglés

    Phase A - Year 2 Demographics and Parents contact for rash - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

    1 formularios  
    Demographics
    Descripción

    Demographics

    Alias
    UMLS CUI-1
    C1704791 (Demographics Domain)
    Center number
    Descripción

    Center number

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1301943 (Institution name)
    SNOMED
    398321007
    UMLS CUI [1,2]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Date of birth
    Descripción

    Date of birth

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0421451 (Patient date of birth)
    SNOMED
    184099003
    LOINC
    LP57552-9
    Gender
    Descripción

    Gender

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    Parents/Guardians contact for rash
    Descripción

    Parents/Guardians contact for rash

    Alias
    UMLS CUI-1
    C0015230 (Exanthema)
    SNOMED
    271807003
    LOINC
    LP30547-1
    UMLS CUI-2
    C0030551 (parent)
    SNOMED
    40683002
    LOINC
    LA30680-5
    UMLS CUI-3
    C0582446 (Informing doctor)
    SNOMED
    304562007
    UMLS CUI-5
    C0015230 (Exanthema)
    SNOMED
    271807003
    LOINC
    LP30547-1
    UMLS CUI-6
    C0023226 (Legal Guardians)
    SNOMED
    58626002
    UMLS CUI-7
    C0582446 (Informing doctor)
    SNOMED
    304562007
    Have the subject's parents/guardians contacted the investigator about the occurrence of any skin rash / eruption which was not reported in the Varicella / Zoster Case section?
    Descripción

    If yes, please complete below.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0015230 (Exanthema)
    SNOMED
    271807003
    LOINC
    LP30547-1
    UMLS CUI [1,2]
    C0030551 (parent)
    SNOMED
    40683002
    LOINC
    LA30680-5
    UMLS CUI [1,3]
    C0582446 (Informing doctor)
    SNOMED
    304562007
    UMLS CUI [2,1]
    C0015230 (Exanthema)
    SNOMED
    271807003
    LOINC
    LP30547-1
    UMLS CUI [2,2]
    C0023226 (Legal Guardians)
    SNOMED
    58626002
    UMLS CUI [2,3]
    C0582446 (Informing doctor)
    SNOMED
    304562007
    Parents/Guardians contact for rash
    Descripción

    Parents/Guardians contact for rash

    Alias
    UMLS CUI-1
    C0015230 (Exanthema)
    SNOMED
    271807003
    LOINC
    LP30547-1
    UMLS CUI-2
    C0030551 (parent)
    SNOMED
    40683002
    LOINC
    LA30680-5
    UMLS CUI-3
    C0582446 (Informing doctor)
    SNOMED
    304562007
    UMLS CUI-5
    C0015230 (Exanthema)
    SNOMED
    271807003
    LOINC
    LP30547-1
    UMLS CUI-6
    C0023226 (Legal Guardians)
    SNOMED
    58626002
    UMLS CUI-7
    C0582446 (Informing doctor)
    SNOMED
    304562007
    Contact number
    Descripción

    1-6

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C3812666 (Personal Contact)
    UMLS CUI [1,2]
    C0449788 (Count of entities)
    SNOMED
    410681005
    Date of contact
    Descripción

    Date of contact

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C1705415 (Communication Contact)
    Has a visit to the investigator been arranged?
    Descripción

    arranged visit

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082 (Visit)
    UMLS CUI [1,2]
    C0420317 (Recall arranged)
    SNOMED
    183641008
    Why has no visit been arranged?
    Descripción

    Only answer, if no visit has been arranged.

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0545082 (Visit)
    UMLS CUI [1,2]
    C0420317 (Recall arranged)
    SNOMED
    183641008
    Other, specify:
    Descripción

    Only answer, if no visit has been arranged.

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C3840932 (Other Reason)
    LOINC
    LA6535-4
    UMLS CUI [1,2]
    C0545082 (Visit)
    UMLS CUI [1,3]
    C0420317 (Recall arranged)
    SNOMED
    183641008
    Why has a visit been arranged?
    Descripción

    Only answer, if visit to the investigator has been arranged.

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0545082 (Visit)
    UMLS CUI [1,2]
    C0420317 (Recall arranged)
    SNOMED
    183641008
    Diagnosis, specify
    Descripción

    Only answer, if visit to the investigator has been arranged.

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    UMLS CUI [1,2]
    C1521902 (To specify)
    UMLS CUI [1,3]
    C0420317 (Recall arranged)
    SNOMED
    183641008
    Comments
    Descripción

    Only answer, if visit to the investigator has been arranged.

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    UMLS CUI [1,2]
    C0545082 (Visit)
    UMLS CUI [1,3]
    C0420317 (Recall arranged)
    SNOMED
    183641008
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    Similar models

    Phase A - Year 2 Demographics and Parents contact for rash - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Demographics
    C1704791 (UMLS CUI-1)
    Center number
    Item
    Center number
    text
    C1301943 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    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 (M)
    CL Item
    Female (F)
    Item Group
    Parents/Guardians contact for rash
    C0015230 (UMLS CUI-1)
    C0030551 (UMLS CUI-2)
    C0582446 (UMLS CUI-3)
    C0015230 (UMLS CUI-5)
    C0023226 (UMLS CUI-6)
    C0582446 (UMLS CUI-7)
    Parents/Guardians contact for rash
    Item
    Have the subject's parents/guardians contacted the investigator about the occurrence of any skin rash / eruption which was not reported in the Varicella / Zoster Case section?
    boolean
    C0015230 (UMLS CUI [1,1])
    C0030551 (UMLS CUI [1,2])
    C0582446 (UMLS CUI [1,3])
    C0015230 (UMLS CUI [2,1])
    C0023226 (UMLS CUI [2,2])
    C0582446 (UMLS CUI [2,3])
    Item Group
    Parents/Guardians contact for rash
    C0015230 (UMLS CUI-1)
    C0030551 (UMLS CUI-2)
    C0582446 (UMLS CUI-3)
    C0015230 (UMLS CUI-5)
    C0023226 (UMLS CUI-6)
    C0582446 (UMLS CUI-7)
    Contact number
    Item
    Contact number
    integer
    C3812666 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Date of contact
    Item
    Date of contact
    date
    C0011008 (UMLS CUI [1,1])
    C1705415 (UMLS CUI [1,2])
    arranged visit
    Item
    Has a visit to the investigator been arranged?
    boolean
    C0545082 (UMLS CUI [1,1])
    C0420317 (UMLS CUI [1,2])
    Item
    Why has no visit been arranged?
    integer
    C0545082 (UMLS CUI [1,1])
    C0420317 (UMLS CUI [1,2])
    no arranged visit
    Code List
    Why has no visit been arranged?
    CL Item
    No need; diagnosis obviously not varicella/zoster (1)
    CL Item
    Other, specify (2)
    Specify other reason for non arranged visit to investigator
    Item
    Other, specify:
    text
    C3840932 (UMLS CUI [1,1])
    C0545082 (UMLS CUI [1,2])
    C0420317 (UMLS CUI [1,3])
    Item
    Why has a visit been arranged?
    text
    C0545082 (UMLS CUI [1,1])
    C0420317 (UMLS CUI [1,2])
    arranged visit
    Code List
    Why has a visit been arranged?
    CL Item
    Diagnosis, specify (1)
    CL Item
    Comments (2)
    Specify diagnosis for arranged visit
    Item
    Diagnosis, specify
    text
    C0011900 (UMLS CUI [1,1])
    C1521902 (UMLS CUI [1,2])
    C0420317 (UMLS CUI [1,3])
    Comment arranged visit
    Item
    Comments
    text
    C0947611 (UMLS CUI [1,1])
    C0545082 (UMLS CUI [1,2])
    C0420317 (UMLS CUI [1,3])
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