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ID

25399

Beschrijving

IDMC Consensus Report - 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. 03-09-17 03-09-17 -
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glaxoSmithKline

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3 september 2017

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    IDMC Consensus Report - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

    Engels

    IDMC Consensus Report - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

    1 Formulieren  
    Rash
    Beschrijving

    Rash

    Alias
    UMLS CUI-1
    C0015230
    Rash Start Date
    Beschrijving

    Rash Start Date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C0808070
    Episode number
    Beschrijving

    Episode number rash

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C4086638
    Number of lesions
    Beschrijving

    Number of lesions

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0008049
    UMLS CUI [1,2]
    C0221198
    UMLS CUI [1,3]
    C0449788
    Character of most lesions:
    Beschrijving

    Maximum intensity: Macular < Papular < Mostly vesicular < Hemorrhagic

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0008049
    UMLS CUI [1,2]
    C0221198
    UMLS CUI [1,3]
    C0332307
    Fever
    Beschrijving

    Fever

    Alias
    UMLS CUI-1
    C0015967
    Fever
    Beschrijving

    Fever

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0015967
    Systemic signs
    Beschrijving

    Systemic signs

    Alias
    UMLS CUI-1
    C0037088
    UMLS CUI-2
    C0205373
    Systemic signs
    Beschrijving

    Systemic signs

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C0205373
    Pain in back or abdomen
    Beschrijving

    Back pain or Pain in abdomen

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0004604
    UMLS CUI [2]
    C0000737
    Interstitial pneumonia
    Beschrijving

    Interstitial pneumonia

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0206061
    Encephalitis
    Beschrijving

    Encephalitis

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0596773
    Subjective assessment of the illness by investigator
    Beschrijving

    Subjective assessment of the illness by investigator

    Alias
    UMLS CUI-1
    C0221423
    UMLS CUI-2
    C0220825
    UMLS CUI-3
    C0035173
    Subjective assessment of the illness by investigator
    Beschrijving

    Subjective assessment of the illness by investigator

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0221423
    UMLS CUI [1,2]
    C0220825
    UMLS CUI [1,3]
    C0035173
    Varicella Clinical Case?
    Beschrijving

    Varicella Clinical Case?

    Alias
    UMLS CUI-1
    C0042338
    UMLS CUI-2
    C0205210
    Varicella Clinical Case?
    Beschrijving

    Please provide the IDMC's rationale for rejecting the case

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0008049
    UMLS CUI [1,2]
    C0205210
    Herpes Zoster case?
    Beschrijving

    Please provide the IDMC's rationale for rejecting the case

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0740380
    UMLS CUI [1,2]
    C0205210
    Rash distribution is inconsistent with varicella
    Beschrijving

    Rash distribution is inconsistent with varicella

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0008049
    UMLS CUI [1,2]
    C0015230
    UMLS CUI [1,3]
    C0442809
    Character of lesions is inconsistent with varicella
    Beschrijving

    Character of lesions is inconsistent with varicella

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0008049
    UMLS CUI [1,2]
    C0221198
    UMLS CUI [1,3]
    C0442809
    Evolution of the rash is inconsistent with varicella
    Beschrijving

    Evolution of the rash is inconsistent with varicella

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C0242656
    UMLS CUI [1,3]
    C0442809
    Duration of illness is inconsistent with varicella
    Beschrijving

    Duration of illness is inconsistent with varicella

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0008049
    UMLS CUI [1,2]
    C3176590
    UMLS CUI [1,3]
    C0442809
    Other features of illness inconsistent with varicella
    Beschrijving

    Other features of illness inconsistent with varicella

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0221423
    UMLS CUI [1,2]
    C0008049
    UMLS CUI [1,3]
    C0442809
    Other, please specify
    Beschrijving

    specify other reason

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C3840932
    UMLS CUI [1,2]
    C1521902
    PCR result
    Beschrijving

    PCR result

    Alias
    UMLS CUI-1
    C0042338
    UMLS CUI-2
    C0032520
    UMLS CUI-3
    C2825142
    PCR result
    Beschrijving

    PCR result

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0042338
    UMLS CUI [1,2]
    C0032520
    UMLS CUI [1,3]
    C2825142
    If Varicella Clinical Case = Yes, please encode the epidemiological link
    Beschrijving

    Only answer, if PCR result wasn't positive.

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0042338
    UMLS CUI [1,2]
    C0014507
    Classification
    Beschrijving

    Classification

    Alias
    UMLS CUI-1
    C0042338
    UMLS CUI-2
    C0008902
    Classification
    Beschrijving

    According to the Varicella clinical case definition in the study protocol, please enter below the IDMC's classification of this case.

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0008902
    UMLS CUI [1,2]
    C0042338
    Expert signature
    Beschrijving

    Expert signature

    Alias
    UMLS CUI-1
    C1519316
    UMLS CUI-2
    C0600219
    Expert number
    Beschrijving

    Expert 1 -5

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0600219
    UMLS CUI [1,2]
    C0449788
    Expert's signature
    Beschrijving

    I confirm that I have reviewed the consensus report and I am in agreement with it.

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1519316
    UMLS CUI [1,2]
    C0600219
    Printed expert's name
    Beschrijving

    Printed expert's name

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1519316
    UMLS CUI [1,2]
    C0600219
    Date
    Beschrijving

    Date of expert's signature

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C1519316
    UMLS CUI [1,3]
    C0600219
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    Similar models

    IDMC Consensus Report - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Rash
    C0015230 (UMLS CUI-1)
    Rash Start Date
    Item
    Rash Start Date
    date
    C0015230 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Episode number rash
    Item
    Episode number
    integer
    C0015230 (UMLS CUI [1,1])
    C4086638 (UMLS CUI [1,2])
    Item
    Number of lesions
    integer
    C0008049 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    C0449788 (UMLS CUI [1,3])
    Number of lesions
    Code List
    Number of lesions
    CL Item
    1-50 (1)
    CL Item
    51-100 (2)
    CL Item
    101 - 500 (3)
    CL Item
    >500 (4)
    CL Item
    Information not available (5)
    Item
    Character of most lesions:
    integer
    C0008049 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    C0332307 (UMLS CUI [1,3])
    Character of lesions
    Code List
    Character of most lesions:
    CL Item
    Macular (1)
    CL Item
    Papular (2)
    CL Item
    Mostly vesicular (3)
    CL Item
    Hemorrhagic (4)
    CL Item
    Information not available (5)
    Item Group
    Fever
    C0015967 (UMLS CUI-1)
    Item
    Fever
    integer
    C0015967 (UMLS CUI [1])
    Fever
    Code List
    Fever
    CL Item
    Temperature < 38.8°C (Rectally) or < 38.3°C (Axillary) (1)
    CL Item
    Temperature 38.8°C - 39.9°C (Rectally) or 38.3°C - 39.4°C (Axillary) (2)
    CL Item
    Temperature > 40.0°C (Rectally) or > 39.5°C (Axillary) (3)
    CL Item
    Temperature not taken (4)
    Item Group
    Systemic signs
    C0037088 (UMLS CUI-1)
    C0205373 (UMLS CUI-2)
    Systemic signs
    Item
    Systemic signs
    boolean
    C0037088 (UMLS CUI [1,1])
    C0205373 (UMLS CUI [1,2])
    Back pain or Pain in abdomen
    Item
    Pain in back or abdomen
    boolean
    C0004604 (UMLS CUI [1])
    C0000737 (UMLS CUI [2])
    Interstitial pneumonia
    Item
    Interstitial pneumonia
    boolean
    C0206061 (UMLS CUI [1])
    Encephalitis
    Item
    Encephalitis
    boolean
    C0596773 (UMLS CUI [1])
    Item Group
    Subjective assessment of the illness by investigator
    C0221423 (UMLS CUI-1)
    C0220825 (UMLS CUI-2)
    C0035173 (UMLS CUI-3)
    Item
    Subjective assessment of the illness by investigator
    integer
    C0221423 (UMLS CUI [1,1])
    C0220825 (UMLS CUI [1,2])
    C0035173 (UMLS CUI [1,3])
    Subjective assessment of the illness by investigator
    Code List
    Subjective assessment of the illness by investigator
    CL Item
    Subject does not appear ill (1)
    CL Item
    Subject appears moderately ill (2)
    CL Item
    Subject appears severely ill (3)
    CL Item
    Information not available (4)
    Item Group
    Varicella Clinical Case?
    C0042338 (UMLS CUI-1)
    C0205210 (UMLS CUI-2)
    Varicella Clinical Case
    Item
    Varicella Clinical Case?
    boolean
    C0008049 (UMLS CUI [1,1])
    C0205210 (UMLS CUI [1,2])
    Herpes Zoster case
    Item
    Herpes Zoster case?
    boolean
    C0740380 (UMLS CUI [1,1])
    C0205210 (UMLS CUI [1,2])
    Rash distribution is inconsistent with varicella
    Item
    Rash distribution is inconsistent with varicella
    boolean
    C0008049 (UMLS CUI [1,1])
    C0015230 (UMLS CUI [1,2])
    C0442809 (UMLS CUI [1,3])
    Character of lesions is inconsistent with varicella
    Item
    Character of lesions is inconsistent with varicella
    boolean
    C0008049 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    C0442809 (UMLS CUI [1,3])
    Evolution of the rash is inconsistent with varicella
    Item
    Evolution of the rash is inconsistent with varicella
    boolean
    C0015230 (UMLS CUI [1,1])
    C0242656 (UMLS CUI [1,2])
    C0442809 (UMLS CUI [1,3])
    Duration of illness is inconsistent with varicella
    Item
    Duration of illness is inconsistent with varicella
    boolean
    C0008049 (UMLS CUI [1,1])
    C3176590 (UMLS CUI [1,2])
    C0442809 (UMLS CUI [1,3])
    Other features of illness inconsistent with varicella
    Item
    Other features of illness inconsistent with varicella
    boolean
    C0221423 (UMLS CUI [1,1])
    C0008049 (UMLS CUI [1,2])
    C0442809 (UMLS CUI [1,3])
    specify other reason
    Item
    Other, please specify
    text
    C3840932 (UMLS CUI [1,1])
    C1521902 (UMLS CUI [1,2])
    Item Group
    PCR result
    C0042338 (UMLS CUI-1)
    C0032520 (UMLS CUI-2)
    C2825142 (UMLS CUI-3)
    Item
    PCR result
    integer
    C0042338 (UMLS CUI [1,1])
    C0032520 (UMLS CUI [1,2])
    C2825142 (UMLS CUI [1,3])
    PCR result
    Code List
    PCR result
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    CL Item
    Invalid result (3)
    CL Item
    Result not available (4)
    Item
    If Varicella Clinical Case = Yes, please encode the epidemiological link
    integer
    C0042338 (UMLS CUI [1,1])
    C0014507 (UMLS CUI [1,2])
    Varicella epidemiological link
    Code List
    If Varicella Clinical Case = Yes, please encode the epidemiological link
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    CL Item
    Information not available (3)
    Item Group
    Classification
    C0042338 (UMLS CUI-1)
    C0008902 (UMLS CUI-2)
    Item
    Classification
    integer
    C0008902 (UMLS CUI [1,1])
    C0042338 (UMLS CUI [1,2])
    Classification varicella
    Code List
    Classification
    CL Item
    No Varicella case (1)
    CL Item
    Probable Varicella case (2)
    CL Item
    PCR confirmed Varicella case (3)
    CL Item
    Epidemiologically confirmed Varicella case (4)
    Item Group
    Expert signature
    C1519316 (UMLS CUI-1)
    C0600219 (UMLS CUI-2)
    Expert number
    Item
    Expert number
    integer
    C0600219 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Expert's signature
    Item
    Expert's signature
    text
    C1519316 (UMLS CUI [1,1])
    C0600219 (UMLS CUI [1,2])
    Printed expert's name
    Item
    Printed expert's name
    text
    C1519316 (UMLS CUI [1,1])
    C0600219 (UMLS CUI [1,2])
    Date of expert's signature
    Item
    Date
    date
    C0011008 (UMLS CUI [1,1])
    C1519316 (UMLS CUI [1,2])
    C0600219 (UMLS CUI [1,3])
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