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ID

22471

Description

Study part: Non-Serious Adverse Events.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

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Versions (1)
  1. 6/5/17 6/5/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 5, 2017

DOI

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License

Creative Commons BY-NC 3.0
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    Non-Serious Adverse Events Mepolizumab HES NCT00086658

    English

    Non-Serious Adverse Events

    1 forms  
    NON-SERIOUS ADVERSE EVENTS (AE)
    Description

    NON-SERIOUS ADVERSE EVENTS (AE)

    Alias
    UMLS CUI-1
    C1518404
    Subject ID
    Description

    Subject ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Did the subject experience any non-serious adverse events during the study?
    Description

    Non-Serious Adverse Events

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1518404
    Event
    Description

    Non-Serious Adverse Events

    Data type

    text

    Alias
    UMLS CUI [1]
    C1518404
    Start Date
    Description

    Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0808070
    Outcome
    Description

    Outcome

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1705586
    End Date
    Description

    End Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0806020
    Frequency
    Description

    Frequency

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1561548
    Maximum Intensity
    Description

    Maximum Intensity

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0518690
    UMLS CUI [1,2]
    C0877248
    Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
    Description

    Adverse Event Action Taken with Study Treatment

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826626
    Did the subject withdraw from study as a result of this AE?
    Description

    Complete Study Conclusion page and Adverse event as reason for withdrawal.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C1518404
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    Description

    Causations Adverse event

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0085978
    UMLS CUI [1,2]
    C0877248
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    Similar models

    Non-Serious Adverse Events

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    NON-SERIOUS ADVERSE EVENTS (AE)
    C1518404 (UMLS CUI-1)
    Subject ID
    Item
    Subject ID
    text
    C2348585 (UMLS CUI [1])
    Non-Serious Adverse Events
    Item
    Did the subject experience any non-serious adverse events during the study?
    boolean
    C1518404 (UMLS CUI [1])
    Non-Serious Adverse Events
    Item
    Event
    text
    C1518404 (UMLS CUI [1])
    Start Date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1])
    Item
    Outcome
    integer
    C1705586 (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/Resolved with sequelae (4)
    End Date
    Item
    End Date
    date
    C0806020 (UMLS CUI [1])
    Item
    Frequency
    integer
    C1561548 (UMLS CUI [1])
    Frequency
    Code List
    Frequency
    CL Item
    Single episode (1)
    CL Item
    Intermittent (2)
    Item
    Maximum Intensity
    text
    C0518690 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Maximum Intensity
    Code List
    Maximum Intensity
    CL Item
    Mild (Mild)
    CL Item
    Moderate (Moderate)
    CL Item
    Severe (Severe)
    CL Item
    Not applicable (Not applicable)
    Item
    Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
    text
    C2826626 (UMLS CUI [1])
    Action Taken
    Code List
    Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
    CL Item
    Investigational product(s) withdrawn (Investigational product(s) withdrawn)
    CL Item
    Dose reduced (Dose reduced)
    CL Item
    Dose increased (Dose increased)
    CL Item
    Dose not changed (Dose not changed)
    CL Item
    Dose interrupted (Dose interrupted)
    CL Item
    Not applicable (Not applicable)
    subject withdraw from study as a result of AE
    Item
    Did the subject withdraw from study as a result of this AE?
    boolean
    C0422727 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Causations Adverse event
    Item
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    boolean
    C0085978 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
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