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25109

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GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Concomitant Vaccination, Medication and Non SAE 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. 26/08/2017 26/08/2017 -
Titular dos direitos

glaxoSmithKline

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26 de agosto de 2017

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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 - Concomitant Vaccination,Medication and Non SAE

    Inglês

    GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Concomitant Vaccination,Medication and Non SAE

    1 Formulários  
    Concomitant Vaccination
    Descrição

    Concomitant Vaccination

    Alias
    UMLS CUI-1
    C0042196
    UMLS CUI-2
    C2347852
    Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
    Descrição

    If yes, please record concomitant vaccination with trade name and/or generic name, route and vaccine administration date.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0042196
    UMLS CUI [1,2]
    C2347852
    Concomitant vaccination
    Descrição

    Concomitant vaccination

    Alias
    UMLS CUI-1
    C0042196
    UMLS CUI-2
    C2347852
    Trade / (Generic) Name
    Descrição

    Trade name of vaccine

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0592503
    UMLS CUI [1,2]
    C0042196
    Route
    Descrição

    Administration route of vaccine

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0013153
    UMLS CUI [1,2]
    C0042210
    Administration date
    Descrição

    Vaccine administration date

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C1533734
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0042210
    Medication
    Descrição

    Medication

    Alias
    UMLS CUI-1
    C0013227
    Have any medications/treatments been administered during study period according to protocol?
    Descrição

    Medication

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0013227
    Medication
    Descrição

    Medication

    Alias
    UMLS CUI-1
    C0013227
    Trade / Generic name
    Descrição

    Trade name of medication

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0592503
    UMLS CUI [1,2]
    C0013227
    Medical indication
    Descrição

    Medical indication for medication

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C3146298
    Prophylactic
    Descrição

    Prophylactic medication

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0420172
    Total daily dose
    Descrição

    Total daily dose

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C2348070
    UMLS CUI [1,2]
    C0013227
    Route
    Descrição

    Route of administration

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0013153
    Start Date
    Descrição

    Start Date of medication

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0808070
    End date
    Descrição

    End Date of Medication

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0806020
    Continuous medication
    Descrição

    Medication continuing

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0549178
    Non-serious adverse event
    Descrição

    Non-serious adverse event

    Alias
    UMLS CUI-1
    C1518404
    Has any non-serious adverse events occurred within 42 days after the vaccinations, excluding those recorded on the Solicited Adverse Events pages?
    Descrição

    Please report all serious adverse events only on the Serious Adverse Event (SAE) form

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1518404
    Non-serious adverse event
    Descrição

    Non-serious adverse event

    Alias
    UMLS CUI-1
    C1518404
    Non-serious adverse event No.
    Descrição

    Non-serious adverse event number

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0449788
    Description
    Descrição

    Description of non-serious adverse event

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0678257
    Anatomic site of non-serious adverse event
    Descrição

    Anatomic site of non-serious adverse event

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0678257
    UMLS CUI [1,3]
    C1515974
    Date started
    Descrição

    Start date of non-serious adverse event

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0808070
    Did the non-serious adverse event start during immediate post-vaccination period (30 minutes)?
    Descrição

    Non-serious adverse event start time vaccination

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0808070
    UMLS CUI [1,3]
    C0042196
    UMLS CUI [1,4]
    C0205253
    Date stopped
    Descrição

    End Date of non-serious adverse event

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C1518404
    Intensity
    Descrição

    Intensity of non-serious adverse event

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0518690
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    Descrição

    Relationship to investigational products

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0009952
    UMLS CUI [1,2]
    C0085978
    UMLS CUI [1,3]
    C0042210
    Outcome
    Descrição

    Outcome

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C1547647
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    GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Concomitant Vaccination,Medication and Non SAE

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Concomitant Vaccination
    C0042196 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    Concomitant vaccination
    Item
    Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
    boolean
    C0042196 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Item Group
    Concomitant vaccination
    C0042196 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    Trade name of vaccine
    Item
    Trade / (Generic) Name
    text
    C0592503 (UMLS CUI [1,1])
    C0042196 (UMLS CUI [1,2])
    Item
    Route
    text
    C0013153 (UMLS CUI [1,1])
    C0042210 (UMLS CUI [1,2])
    Administration route of vaccine
    Code List
    Route
    CL Item
    Intradermal  (ID)
    CL Item
    Inhalation (IH)
    CL Item
    Intramuscular  (IM)
    CL Item
    Intravenous  (IV)
    CL Item
    Intranasal  (NA)
    CL Item
    Other (OTH)
    CL Item
    Parenteral (PE)
    CL Item
    Oral (PO)
    CL Item
    Subcutaneous  (SC)
    CL Item
    Sublingual (SL)
    CL Item
    Transdermal  (TD)
    CL Item
    Unknown (UNK)
    Vaccine administration date
    Item
    Administration date
    date
    C1533734 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0042210 (UMLS CUI [1,3])
    Item Group
    Medication
    C0013227 (UMLS CUI-1)
    Medication
    Item
    Have any medications/treatments been administered during study period according to protocol?
    boolean
    C0013227 (UMLS CUI [1])
    Item Group
    Medication
    C0013227 (UMLS CUI-1)
    Trade name of medication
    Item
    Trade / Generic name
    text
    C0592503 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Medical indication for medication
    Item
    Medical indication
    text
    C0013227 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    Prophylactic medication
    Item
    Prophylactic
    boolean
    C0420172 (UMLS CUI [1])
    Total daily dose
    Item
    Total daily dose
    text
    C2348070 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Item
    Route
    text
    C0013153 (UMLS CUI [1])
    Route of administration
    Code List
    Route
    CL Item
    External (EXT)
    CL Item
    Intradermal (ID)
    CL Item
    Inhalation (IH)
    CL Item
    Intramuscular (IM)
    CL Item
    Intraarticular (IR)
    CL Item
    Intrathecal (IT)
    CL Item
    Intravenous (IV)
    CL Item
    Intranasal (NA)
    CL Item
    Other (OTH)
    CL Item
    Parenteral (PE)
    CL Item
    Oral (PO)
    CL Item
    Rectal  (PR)
    CL Item
    Subcutaneous (SC)
    CL Item
    Sublingual (SL)
    CL Item
    Transdermal (TD)
    CL Item
    Topical (TO)
    CL Item
    Unknown (UNK)
    CL Item
    Vaginal (VA)
    Start Date of medication
    Item
    Start Date
    date
    C0013227 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    End Date of Medication
    Item
    End date
    date
    C0013227 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Medication continuing
    Item
    Continuous medication
    boolean
    C0013227 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Item Group
    Non-serious adverse event
    C1518404 (UMLS CUI-1)
    Non-serious adverse event
    Item
    Has any non-serious adverse events occurred within 42 days after the vaccinations, excluding those recorded on the Solicited Adverse Events pages?
    boolean
    C1518404 (UMLS CUI [1])
    Item Group
    Non-serious adverse event
    C1518404 (UMLS CUI-1)
    Non-serious adverse event number
    Item
    Non-serious adverse event No.
    integer
    C1518404 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Description of non-serious adverse event
    Item
    Description
    text
    C1518404 (UMLS CUI [1,1])
    C0678257 (UMLS CUI [1,2])
    Item
    Anatomic site of non-serious adverse event
    text
    C1518404 (UMLS CUI [1,1])
    C0678257 (UMLS CUI [1,2])
    C1515974 (UMLS CUI [1,3])
    Anatomic site of non-serious adverse event
    Code List
    Anatomic site of non-serious adverse event
    CL Item
    Administration site (L)
    CL Item
    Non-administration site (G)
    Start date of non-serious adverse event
    Item
    Date started
    date
    C1518404 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Non-serious adverse event start time vaccination
    Item
    Did the non-serious adverse event start during immediate post-vaccination period (30 minutes)?
    boolean
    C1518404 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    C0042196 (UMLS CUI [1,3])
    C0205253 (UMLS CUI [1,4])
    End Date of non-serious adverse event
    Item
    Date stopped
    date
    C0806020 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Item
    Intensity
    integer
    C1518404 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Intensity of non-serious adverse event
    Code List
    Intensity
    CL Item
    mild (1)
    CL Item
    moderate (2)
    CL Item
    severe (3)
    Relationship to investigational products
    Item
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    boolean
    C0009952 (UMLS CUI [1,1])
    C0085978 (UMLS CUI [1,2])
    C0042210 (UMLS CUI [1,3])
    Item
    Outcome
    integer
    C1547647 (UMLS CUI [1])
    Outcome
    Code List
    Outcome
    CL Item
    Recovered / resolved  (1)
    CL Item
    Recovering / resolving  (2)
    CL Item
    Not recovered / not resolved  (3)
    CL Item
    Recovered with sequelae / resolved with sequelae (4)
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