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25376

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Phase A - Year 1 - Visit 4 - 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. 9/2/17 9/2/17 -
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glaxoSmithKline

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September 2, 2017

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    Phase A - Year 1 - Visit 4 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

    English

    Phase A - Year 1 - Visit 4 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

    1 forms  
    Check for study continuation
    Description

    Check for study continuation

    Alias
    UMLS CUI-1
    C0805733 (Continuation status)
    LOINC
    MTHU008303
    UMLS CUI-2
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI-3
    C0042210 (Vaccines)
    SNOMED
    787859002
    LOINC
    LA20283-0
    Did the subject return for visit 4?
    Description

    study continuation

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0008972 (Clinical Research)
    UMLS CUI [1,2]
    C0805733 (Continuation status)
    LOINC
    MTHU008303
    Why didn't the subject return to visit 4?
    Description

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

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
    SAE No
    Description

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

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1519255 (Serious Adverse Event)
    UMLS CUI [1,2]
    C0449788 (Count of entities)
    SNOMED
    410681005
    Please specify unsolicited AE No
    Description

    number of unsolicited adverse event

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [1,2]
    C0449788 (Count of entities)
    SNOMED
    410681005
    solicited AE code
    Description

    solicited AE code

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [1,2]
    C0449788 (Count of entities)
    SNOMED
    410681005
    Please specify 'other' most appropriate category for not returning to visit 4.
    Description

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

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3840932 (Other Reason)
    LOINC
    LA6535-4
    UMLS CUI [1,2]
    C1521902 (To specify)
    UMLS CUI [1,3]
    C2348568 (Study Subject Participation Status)
    Please tick who took the decision
    Description

    decision for study withdrawal

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [1,2]
    C0679006 (Decision)
    Laboratory tests
    Description

    Laboratory tests

    Alias
    UMLS CUI-1
    C0022885 (Laboratory Procedures)
    SNOMED
    269814003
    Has a blood sample been taken?
    Description

    Blood sample

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    Date blood sample taken
    Description

    Please complete only if different from visit date

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1277698 (Blood sample taken)
    SNOMED
    313334002
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Household exposure
    Description

    Household exposure

    Alias
    UMLS CUI-1
    C0332157 (Exposure to)
    SNOMED
    24932003
    UMLS CUI-2
    C0020052 (Households)
    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 since last contact?
    Description

    Exposure in household to varicella/zoster

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0008049 (Chickenpox)
    SNOMED
    38907003
    LOINC
    LA10517-3
    UMLS CUI [1,2]
    C0332157 (Exposure to)
    SNOMED
    24932003
    UMLS CUI [1,3]
    C0020052 (Households)
    UMLS CUI [2,1]
    C0740380 (Varicella zoster)
    UMLS CUI [2,2]
    C0332157 (Exposure to)
    SNOMED
    24932003
    UMLS CUI [2,3]
    C0020052 (Households)
    Household exposure number
    Description

    Household exposure number

    Alias
    UMLS CUI-1
    C0332157 (Exposure to)
    SNOMED
    24932003
    UMLS CUI-2
    C0020052 (Households)
    UMLS CUI-3
    C0449788 (Count of entities)
    SNOMED
    410681005
    Household Exposure No
    Description

    Household Exposure No

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0332157 (Exposure to)
    SNOMED
    24932003
    UMLS CUI [1,2]
    C0020052 (Households)
    UMLS CUI [1,3]
    C0449788 (Count of entities)
    SNOMED
    410681005
    Date of onset exposure
    Description

    Date of onset exposure

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0574845 (Date of onset)
    SNOMED
    298059007
    LOINC
    MTHU048807
    UMLS CUI [1,2]
    C0332157 (Exposure to)
    SNOMED
    24932003
    Type of exposure
    Description

    Type of exposure

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0332157 (Exposure to)
    SNOMED
    24932003
    Varicella or zoster
    Description

    Varicella or zoster

    Alias
    UMLS CUI-1
    C0008049 (Chickenpox)
    SNOMED
    38907003
    LOINC
    LA10517-3
    UMLS CUI-3
    C0740380 (Varicella zoster)
    Did the subject present any signs of varicella or zoster symptoms between last contact and Visit 4?
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0037088 (Signs and Symptoms)
    SNOMED
    404684003
    LOINC
    LP185402-7
    UMLS CUI [1,2]
    C0740380 (Varicella zoster)
    UMLS CUI [2,1]
    C0037088 (Signs and Symptoms)
    SNOMED
    404684003
    LOINC
    LP185402-7
    UMLS CUI [2,2]
    C0008049 (Chickenpox)
    SNOMED
    38907003
    LOINC
    LA10517-3
    How many episodes?
    Description

    Number of episodes of varicella/zoster signs and symptoms

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0037088 (Signs and Symptoms)
    SNOMED
    404684003
    LOINC
    LP185402-7
    UMLS CUI [1,2]
    C0740380 (Varicella zoster)
    UMLS CUI [2,1]
    C0037088 (Signs and Symptoms)
    SNOMED
    404684003
    LOINC
    LP185402-7
    UMLS CUI [2,2]
    C0008049 (Chickenpox)
    SNOMED
    38907003
    LOINC
    LA10517-3
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    Similar models

    Phase A - Year 1 - Visit 4 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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 4?
    integer
    C0008972 (UMLS CUI [1,1])
    C0805733 (UMLS CUI [1,2])
    study continuation
    Code List
    Did the subject return for visit 4?
    CL Item
    Yes, please complete the next pages. (1)
    CL Item
    No (2)
    Item
    Why didn't the subject return to visit 4?
    text
    C2348568 (UMLS CUI [1])
    Why didn't the subject return to visit 2?
    Code List
    Why didn't the subject return to visit 4?
    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)
    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 4.
    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)
    Item
    Has a blood sample been taken?
    integer
    C0005834 (UMLS CUI [1])
    Blood sample
    Code List
    Has a blood sample been taken?
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    NA (3)
    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 since last contact?
    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 last contact and Visit 4?
    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])
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