0 Ratings
ID

15365

Description

Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential (ALAIN01) https://clinicaltrials.gov/ct2/show/NCT02419378 Principal Investigator Prof. Dr. Dr. Sven Meuth, University Hospital Muenster, Germany

Link

https://clinicaltrials.gov/ct2/show/NCT02419378

Keywords

Versions (2)
  1. 8/13/15 8/13/15 - Martin Dugas
  2. 5/28/16 5/28/16 -
Uploaded on

May 28, 2016

DOI

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License

Creative Commons BY 4.0
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    Adverse Event Multiple Sclerosis ALAIN01 NCT02419378

    English

    Adverse Event Multiple Sclerosis ALAIN01 NCT02419378

    1 forms  
    Adverse Event
    Description

    Adverse Event

    Alias
    UMLS CUI-1
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    AE: Sheet number
    Description

    AE: Sheet number

    Data type

    integer

    AE: Signature date
    Description

    AE: Signature date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1519316 (Signature)
    LOINC
    LP248948-4
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    AERQG
    Description

    AERQG

    AE: Number
    Description

    AE: Number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2826275 (Adverse Event Line Number)
    AE: Term
    Description

    AE: Term

    Data type

    text

    Alias
    UMLS CUI [1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    AE: Start date
    Description

    AE: Start date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2697888 (Adverse Event Start Date)
    AE: Serious event
    Description

    AE: Serious event

    Data type

    text

    Alias
    UMLS CUI [1]
    C1519255 (Serious Adverse Event)
    AE: Toxicity (CTCAE) Grade
    Description

    AE: Toxicity (CTCAE) Grade

    Data type

    text

    Alias
    UMLS CUI [1]
    C2985911 (Adverse Event Grade Code)
    AE: Relationship to study treatment
    Description

    Adverse Event Attribution to Product or Procedure

    Data type

    text

    Alias
    UMLS CUI [1]
    C1510821 (Adverse Event Attribution to Product or Procedure)
    AE: Action taken with study treatment
    Description

    AE: Action taken with study treatment

    Data type

    text

    Alias
    UMLS CUI [1]
    C2981656 (Adverse Event Treatment)
    AE: End date
    Description

    AE: End date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2697886 (Adverse Event End Date)
    AE: Ongoing
    Description

    AE: Ongoing

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826663 (Adverse Event Ongoing)
    AE: Outcome
    Description

    AE: Outcome

    Data type

    text

    Alias
    UMLS CUI [1]
    C1705586 (Adverse Event Outcome)
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    Similar models

    Adverse Event Multiple Sclerosis ALAIN01 NCT02419378

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Adverse Event
    C0877248 (UMLS CUI-1)
    AE: Sheet number
    Item
    integer
    AE: Signature date
    Item
    AE: Signature date
    date
    C1519316 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Adverse Event Number
    Item
    AE: Number
    integer
    C2826275 (UMLS CUI [1])
    Adverse Event
    Item
    AE: Term
    text
    C0877248 (UMLS CUI [1])
    Adverse event start date
    Item
    AE: Start date
    date
    C2697888 (UMLS CUI [1])
    Item
    AE: Serious event
    text
    C1519255 (UMLS CUI [1])
    AE: Serious event
    Code List
    AE: Serious event
    CL Item
    No - AE of Special Interest (AESI) (1)
    CL Item
    No (0)
    CL Item
    Yes (2)
    Item
    AE: Toxicity (CTCAE) Grade
    text
    C2985911 (UMLS CUI [1])
    AE: Toxicity (CTCAE) Grade
    Code List
    AE: Toxicity (CTCAE) Grade
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    0 (0)
    Item
    AE: Relationship to study treatment
    text
    C1510821 (UMLS CUI [1])
    AE: Relationship to study treatment
    Code List
    AE: Relationship to study treatment
    CL Item
    No reasonable possibility (0)
    CL Item
    Reasonable possibility (1)
    Item
    AE: Action taken with study treatment
    text
    C2981656 (UMLS CUI [1])
    AE: Action taken with study treatment
    Code List
    AE: Action taken with study treatment
    CL Item
    Dose not changed (0)
    CL Item
    Dose reduced (1)
    CL Item
    Dose increased (2)
    CL Item
    Drug withdrawn (3)
    CL Item
    Unknown (4)
    CL Item
    Not applicable (5)
    Adverse event end date
    Item
    AE: End date
    date
    C2697886 (UMLS CUI [1])
    Item
    AE: Ongoing
    text
    C2826663 (UMLS CUI [1])
    AE: Ongoing
    Code List
    AE: Ongoing
    CL Item
    yes (1)
    Item
    AE: Outcome
    text
    C1705586 (UMLS CUI [1])
    AE: Outcome
    Code List
    AE: Outcome
    CL Item
    Recovered/Resolved (0)
    CL Item
    Recovering/Resolving (1)
    CL Item
    Not recovered/Not resolved (2)
    CL Item
    Recovered/Resolved with sequelae (3)
    CL Item
    Fatal (4)
    CL Item
    Unknown (5)
    Back to the top of the page 

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