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24857

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GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Visit 3 - Day 84 and Parents/ Guardians contact for rash 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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Versões (1)
  1. 20/08/2017 20/08/2017 -
Titular dos direitos

glaxoSmithKline

Transferido a

20 de agosto de 2017

DOI

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Licença

Creative Commons BY-NC 3.0
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    GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Visit 3 and Guardians contact for rash

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    GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Visit 3 and Guardians contact for rash

    1 Formulários  
    Check for study continuation
    Descrição

    Check for study continuation

    Alias
    UMLS CUI-1
    C0805733
    UMLS CUI-2
    C0008976
    UMLS CUI-3
    C0042210
    Did the subject return for visit 3?
    Descrição

    study continuation

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0008972
    UMLS CUI [1,2]
    C0805733
    Why didn't the subject return to visit 3?
    Descrição

    Please tick the ONE most appropriate reason and skip the following pages of this visit

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2348568
    Same reason and decision as previous visit.
    Descrição

    Same reason and decision as previous visit.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C2127115
    SAE No
    Descrição

    Please specify number of SAE if that is the reason, why subject didn't return to visit 2.

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0449788
    Please specify unsolicited AE No
    Descrição

    number of unsolicited adverse event

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0449788
    solicited AE code
    Descrição

    solicited AE code

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0449788
    Please specify 'other' most appropriate category for not returning to visit 2.
    Descrição

    e.g.: consent withdrawal, protocol violation, non-serious AE for non-subset...

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C3840932
    UMLS CUI [1,2]
    C1521902
    UMLS CUI [1,3]
    C2348568
    Please tick who took the decision
    Descrição

    decision for study withdrawal

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0679006
    Laboratory tests
    Descrição

    Laboratory tests

    Alias
    UMLS CUI-1
    C0022885
    Has a blood sample been taken?
    Descrição

    Blood sample

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0005834
    Date blood sample taken
    Descrição

    Please complete only if different from visit date

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1277698
    UMLS CUI [1,2]
    C0011008
    Household exposure
    Descrição

    Household exposure

    Alias
    UMLS CUI-1
    C0332157
    UMLS CUI-2
    C0020052
    Irrespective of whether the subject developed/develops varicella/zoster, was the subject exposed for more than one day to any varicella or zoster case presented by a household member or another person living temporarily within the household between Visit 1 and Visit 2?
    Descrição

    Exposure in household to varicella/zoster

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0008049
    UMLS CUI [1,2]
    C0332157
    UMLS CUI [1,3]
    C0020052
    UMLS CUI [2,1]
    C0740380
    UMLS CUI [2,2]
    C0332157
    UMLS CUI [2,3]
    C0020052
    Household exposure number
    Descrição

    Household exposure number

    Alias
    UMLS CUI-1
    C0332157
    UMLS CUI-2
    C0020052
    UMLS CUI-3
    C0449788
    Household Exposure No
    Descrição

    Household Exposure No

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0332157
    UMLS CUI [1,2]
    C0020052
    UMLS CUI [1,3]
    C0449788
    Date of onset exposure
    Descrição

    Date of onset exposure

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0574845
    UMLS CUI [1,2]
    C0332157
    Type of exposure
    Descrição

    Type of exposure

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0332157
    Varicella or zoster
    Descrição

    Varicella or zoster

    Alias
    UMLS CUI-1
    C0008049
    UMLS CUI-3
    C0740380
    Did the subject present any signs of varicella or zoster symptoms between Visit 1 and Visit 2?
    Descrição

    if 'yes', please complete the Varicella or Zoster Case section.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C0740380
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0008049
    How many episodes?
    Descrição

    Number of episodes of varicella/zoster signs and symptoms

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C0740380
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0008049
    Parents/Guardians contact for rash
    Descrição

    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?
    Descrição

    If yes, please complete below.

    Tipo de dados

    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
    Descrição

    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
    Descrição

    1-3

    Tipo de dados

    integer

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

    Date of contact

    Tipo de dados

    date

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

    arranged visit

    Tipo de dados

    boolean

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

    Only answer, if no visit has been arranged.

    Tipo de dados

    integer

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

    Only answer, if no visit has been arranged.

    Tipo de dados

    text

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

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

    Tipo de dados

    text

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

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

    Tipo de dados

    text

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

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

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C0545082
    UMLS CUI [1,3]
    C0420317
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    GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Visit 3 and Guardians contact for rash

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Check for study continuation
    C0805733 (UMLS CUI-1)
    C0008976 (UMLS CUI-2)
    C0042210 (UMLS CUI-3)
    Item
    Did the subject return for visit 3?
    integer
    C0008972 (UMLS CUI [1,1])
    C0805733 (UMLS CUI [1,2])
    study continuation
    Code List
    Did the subject return for visit 3?
    CL Item
    Yes, please complete the next pages. (1)
    CL Item
    No, please complete below. (2)
    Item
    Why didn't the subject return to visit 3?
    text
    C2348568 (UMLS CUI [1])
    Why didn't the subject return to visit 2?
    Code List
    Why didn't the subject return to visit 3?
    CL Item
    Serious adverse event (complete the Serious Adverse Event form) (SAE)
    CL Item
    Non-Serious adverse event (complete the Non-serious Adverse Event section) (AEX)
    CL Item
    Other, please specify (e.g.: consent withdrawal, protocol violation, non-serious AE for non-subset...) (OTH)
    Same reason and decision as previous visit.
    Item
    Same reason and decision as previous visit.
    boolean
    C2348568 (UMLS CUI [1,1])
    C2127115 (UMLS CUI [1,2])
    Number of serious adverse event
    Item
    SAE No
    integer
    C1519255 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    number of unsolicited adverse event
    Item
    Please specify unsolicited AE No
    integer
    C0877248 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    solicited AE code
    Item
    solicited AE code
    text
    C0877248 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    specify other reason
    Item
    Please specify 'other' most appropriate category for not returning to visit 2.
    text
    C3840932 (UMLS CUI [1,1])
    C1521902 (UMLS CUI [1,2])
    C2348568 (UMLS CUI [1,3])
    Item
    Please tick who took the decision
    text
    C2348568 (UMLS CUI [1,1])
    C0679006 (UMLS CUI [1,2])
    decision for study withdrawal
    Code List
    Please tick who took the decision
    CL Item
    Investigator (I)
    CL Item
    Parents / Guardians (P)
    Item Group
    Laboratory tests
    C0022885 (UMLS CUI-1)
    Blood sample
    Item
    Has a blood sample been taken?
    boolean
    C0005834 (UMLS CUI [1])
    Date blood sample taken
    Item
    Date blood sample taken
    boolean
    C1277698 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Household exposure
    C0332157 (UMLS CUI-1)
    C0020052 (UMLS CUI-2)
    Exposure in household to varicella/zoster
    Item
    Irrespective of whether the subject developed/develops varicella/zoster, was the subject exposed for more than one day to any varicella or zoster case presented by a household member or another person living temporarily within the household between Visit 1 and Visit 2?
    boolean
    C0008049 (UMLS CUI [1,1])
    C0332157 (UMLS CUI [1,2])
    C0020052 (UMLS CUI [1,3])
    C0740380 (UMLS CUI [2,1])
    C0332157 (UMLS CUI [2,2])
    C0020052 (UMLS CUI [2,3])
    Item Group
    Household exposure number
    C0332157 (UMLS CUI-1)
    C0020052 (UMLS CUI-2)
    C0449788 (UMLS CUI-3)
    Household Exposure No
    Item
    Household Exposure No
    integer
    C0332157 (UMLS CUI [1,1])
    C0020052 (UMLS CUI [1,2])
    C0449788 (UMLS CUI [1,3])
    Date of onset exposure
    Item
    Date of onset exposure
    date
    C0574845 (UMLS CUI [1,1])
    C0332157 (UMLS CUI [1,2])
    Item
    Type of exposure
    integer
    C0332157 (UMLS CUI [1])
    Type of exposure
    Code List
    Type of exposure
    CL Item
    Varicella (1)
    CL Item
    Zoster (2)
    Item Group
    Varicella or zoster
    C0008049 (UMLS CUI-1)
    C0740380 (UMLS CUI-3)
    signs or symptoms of varicella or zoster
    Item
    Did the subject present any signs of varicella or zoster symptoms between Visit 1 and Visit 2?
    boolean
    C0037088 (UMLS CUI [1,1])
    C0740380 (UMLS CUI [1,2])
    C0037088 (UMLS CUI [2,1])
    C0008049 (UMLS CUI [2,2])
    Number of episodes of varicella/zoster signs and symptoms
    Item
    How many episodes?
    integer
    C0037088 (UMLS CUI [1,1])
    C0740380 (UMLS CUI [1,2])
    C0037088 (UMLS CUI [2,1])
    C0008049 (UMLS CUI [2,2])
    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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