0 Beoordelingen
ID

22471

Beschrijving

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.

Trefwoorden

Versies (1)
  1. 05-06-17 05-06-17 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

5 juni 2017

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

  • Nieuwste
  • Oudste
  • Populair
  • Nieuwste
    • Nieuwste
    • Oudste
    • Populair

    Geen commentaren

    U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

    Non-Serious Adverse Events Mepolizumab HES NCT00086658

    Engels

    Non-Serious Adverse Events

    1 Formulieren  
    NON-SERIOUS ADVERSE EVENTS (AE)
    Beschrijving

    NON-SERIOUS ADVERSE EVENTS (AE)

    Alias
    UMLS CUI-1
    C1518404 (Non-serious Adverse Event)
    Subject ID
    Beschrijving

    Subject ID

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Did the subject experience any non-serious adverse events during the study?
    Beschrijving

    Non-Serious Adverse Events

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1518404 (Non-serious Adverse Event)
    Event
    Beschrijving

    Non-Serious Adverse Events

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1518404 (Non-serious Adverse Event)
    Start Date
    Beschrijving

    Start Date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0808070 (Start Date)
    Outcome
    Beschrijving

    Outcome

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1705586 (Adverse Event Outcome)
    End Date
    Beschrijving

    End Date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    Frequency
    Beschrijving

    Frequency

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1561548 (Kind of quantity - Frequency)
    Maximum Intensity
    Beschrijving

    Maximum Intensity

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0518690 (Symptom intensity)
    UMLS CUI [1,2]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
    Beschrijving

    Adverse Event Action Taken with Study Treatment

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2826626 (Adverse Event Action Taken with Study Treatment)
    Did the subject withdraw from study as a result of this AE?
    Beschrijving

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

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    UMLS CUI [1,2]
    C1518404 (Non-serious Adverse Event)
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    Beschrijving

    Causations Adverse event

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0085978 (Causations)
    UMLS CUI [1,2]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Terug naar het begin van de pagina

    Similar models

    Non-Serious Adverse Events

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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])
    Terug naar het begin van de pagina 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial