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25187

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Phase A - Year 1 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

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  1. 28-08-17 28-08-17 -
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glaxoSmithKline

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28 augustus 2017

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    Phase A - Year 1 Demographics and Parents contact for rash - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

    Englisch

    Phase A - Year 1 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 Formulare  
    Demographics
    Beschreibung

    Demographics

    Alias
    UMLS CUI-1
    C1704791
    Center number
    Beschreibung

    Center number

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1301943
    UMLS CUI [1,2]
    C0600091
    Date of birth
    Beschreibung

    Date of birth

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C0421451
    Gender
    Beschreibung

    Gender

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0079399
    Parents/Guardians contact for rash
    Beschreibung

    Parents/Guardians contact for rash

    Alias
    UMLS CUI-1
    C0015230
    UMLS CUI-2
    C0030551
    UMLS CUI-3
    C0582446
    UMLS CUI-5
    C0015230
    UMLS CUI-6
    C0023226
    UMLS CUI-7
    C0582446
    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?
    Beschreibung

    If yes, please complete below.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C0030551
    UMLS CUI [1,3]
    C0582446
    UMLS CUI [2,1]
    C0015230
    UMLS CUI [2,2]
    C0023226
    UMLS CUI [2,3]
    C0582446
    Parents/Guardians contact for rash
    Beschreibung

    Parents/Guardians contact for rash

    Alias
    UMLS CUI-1
    C0015230
    UMLS CUI-2
    C0030551
    UMLS CUI-3
    C0582446
    UMLS CUI-5
    C0015230
    UMLS CUI-6
    C0023226
    UMLS CUI-7
    C0582446
    Contact number
    Beschreibung

    1-6

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C3812666
    UMLS CUI [1,2]
    C0449788
    Date of contact
    Beschreibung

    Date of contact

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C1705415
    Has a visit to the investigator been arranged?
    Beschreibung

    arranged visit

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0420317
    Why has no visit been arranged?
    Beschreibung

    Only answer, if no visit has been arranged.

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0420317
    Other, specify:
    Beschreibung

    Only answer, if no visit has been arranged.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C3840932
    UMLS CUI [1,2]
    C0545082
    UMLS CUI [1,3]
    C0420317
    Why has a visit been arranged?
    Beschreibung

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

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0420317
    Diagnosis, specify
    Beschreibung

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

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0011900
    UMLS CUI [1,2]
    C1521902
    UMLS CUI [1,3]
    C0420317
    Comments
    Beschreibung

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

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C0545082
    UMLS CUI [1,3]
    C0420317
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Phase A - Year 1 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 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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])
    Zum Seitenanfang zurückkehren 

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