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ID

15544

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 Please document clinically significant findings as Adverse Events. Clinical Significance is defined as any variation in physical findings that has medical relevance and may result in an alteration in medical care. Safety Blood and Urine Examinations: Please document the results for Serum Creatinine, Platelets and TSH on CRF-Pages "Safety Laboratory Assessments". Part: Relapse Evaluation Visit No. 3

Link

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

Keywords

  1. 6/2/16 6/2/16 -
Uploaded on

June 2, 2016

DOI

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License

Creative Commons BY 4.0

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    Relapse Evaluation Visit No. 3 Vital Signs Multiple Sclerosis ALAIN01 NCT02419378

    Relapse Evaluation Visit No. 3 Vital Signs Multiple Sclerosis ALAIN01 NCT02419378

    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Patient ID (derived)
    Description

    Patient ID (derived)

    Data type

    text

    Alias
    UMLS CUI [1]
    C1269815
    Vital Signs and Physical Examination: Date
    Description

    Vital Signs and Physical Examination: Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826644
    Heart rate
    Description

    Heart rate

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Respiratory Rate
    Description

    Respiratory Rate

    Data type

    integer

    Measurement units
    • /min
    Alias
    UMLS CUI [1]
    C0231832
    /min
    Height
    Description

    Height

    Data type

    float

    Measurement units
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Systolic blood pressure
    Description

    Systolic

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Diastolic blood pressure
    Description

    Diastolic

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Temperature
    Description

    Temperature

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1]
    C0039476
    °C
    Body weight
    Description

    Body weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Physical Examination: General Appearance
    Description

    Physical Examination: General Appearance

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1148438
    Physical Examination: General Appearance, Text
    Description

    Physical Examination: General Appearance, Text

    Data type

    text

    Alias
    UMLS CUI [1]
    C1148438
    Physical Examination: Skin
    Description

    Physical Examination: Skin

    Data type

    text

    Alias
    UMLS CUI [1]
    C0437750
    Physical Examination: Skin, Text
    Description

    Physical Examination: Skin, Text

    Data type

    text

    Alias
    UMLS CUI [1]
    C0437750
    Physical Examination: HEENT
    Description

    Physical Examination: HEENT

    Data type

    text

    Alias
    UMLS CUI [1]
    C3494720
    Physical Examination: HEENT, Text
    Description

    Physical Examination: HEENT, Text

    Data type

    text

    Alias
    UMLS CUI [1]
    C3494720
    Physical Examination: Lymph Nodes
    Description

    Lymph Nodes Status

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0024204
    UMLS CUI [1,2]
    C0449438
    Physical Examination: Lymph Nodes, Text
    Description

    Physical Examination: Lymph Nodes, Text

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0024204
    UMLS CUI [1,2]
    C0449438
    Physical Examination: Heart
    Description

    Heart rate, Auscultation of the heart

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0018793
    Physical Examination: Heart, Text
    Description

    Physical Examination: Heart, Text

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0018793
    Physical Examination: Lungs
    Description

    Physical Examination: Lungs

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0024109
    Physical Examination: Lungs, Text
    Description

    Physical Examination: Lungs, Text

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0024109
    Physical Examination: Abdomen
    Description

    Physical Examination: Abdomen

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0000726
    Physical Examination: Abdomen, Text
    Description

    Physical Examination: Abdomen, Text

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0000726
    Physical Examination: Extremeties/Joints
    Description

    Physical Examination: Extremeties/Joints

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0278454
    UMLS CUI [1,3]
    C0022417
    Physical Examination: Extremeties/Joints, Text
    Description

    Physical Examination: Extremeties/Joints, Text

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0022417
    Physical Examination: Mental Status
    Description

    Physical Examination: Mental Status

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0278060
    Physical Examination: Mental Status, Text
    Description

    Physical Examination: Mental Status, Text

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0278060
    Vital Signs and Physical Examination: ND
    Description

    Vital Signs and Physical Examination: ND

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0031809
    UMLS CUI [1,3]
    C1705848

    Similar models

    Relapse Evaluation Visit No. 3 Vital Signs Multiple Sclerosis ALAIN01 NCT02419378

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Patient ID
    Item
    Patient ID (derived)
    text
    C1269815 (UMLS CUI [1])
    Vital Signs date
    Item
    Vital Signs and Physical Examination: Date
    date
    C2826644 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Respiratory Rate
    Item
    Respiratory Rate
    integer
    C0231832 (UMLS CUI [1])
    Height
    Item
    Height
    float
    C0005890 (UMLS CUI [1])
    Systolic blood pressure
    Item
    Systolic blood pressure
    integer
    C0871470 (UMLS CUI [1])
    Diastolic blood pressure
    Item
    Diastolic blood pressure
    integer
    C0428883 (UMLS CUI [1])
    Temperature
    Item
    Temperature
    float
    C0039476 (UMLS CUI [1])
    Weight
    Item
    Body weight
    float
    C0005910 (UMLS CUI [1])
    Item
    Physical Examination: General Appearance
    text
    C1148438 (UMLS CUI [1,1])
    Code List
    Physical Examination: General Appearance
    CL Item
    yes (1)
    CL Item
    no (0)
    General Appearance
    Item
    Physical Examination: General Appearance, Text
    text
    C1148438 (UMLS CUI [1])
    Item
    Physical Examination: Skin
    text
    C0437750 (UMLS CUI [1])
    Code List
    Physical Examination: Skin
    CL Item
    yes (1)
    CL Item
    no (0)
    Skin examination
    Item
    Physical Examination: Skin, Text
    text
    C0437750 (UMLS CUI [1])
    Item
    Physical Examination: HEENT
    text
    C3494720 (UMLS CUI [1])
    Code List
    Physical Examination: HEENT
    CL Item
    yes (1)
    CL Item
    no (0)
    HEENT Examination
    Item
    Physical Examination: HEENT, Text
    text
    C3494720 (UMLS CUI [1])
    Item
    Physical Examination: Lymph Nodes
    text
    C0024204 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    Code List
    Physical Examination: Lymph Nodes
    CL Item
    yes (1)
    CL Item
    no (0)
    Physical Examination: Lymph Nodes, Text
    Item
    Physical Examination: Lymph Nodes, Text
    text
    C0024204 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    Item
    Physical Examination: Heart
    text
    C0018810 (UMLS CUI [1,1])
    C0018793 (UMLS CUI [1,2])
    Code List
    Physical Examination: Heart
    CL Item
    yes (1)
    CL Item
    no (0)
    Physical Examination: Heart, Text
    Item
    Physical Examination: Heart, Text
    text
    C0018810 (UMLS CUI [1,1])
    C0018793 (UMLS CUI [1,2])
    Item
    Physical Examination: Lungs
    text
    C0031809 (UMLS CUI [1,1])
    C0024109 (UMLS CUI [1,2])
    Code List
    Physical Examination: Lungs
    CL Item
    yes (1)
    CL Item
    no (0)
    Physical Examination: Lungs, Text
    Item
    Physical Examination: Lungs, Text
    text
    C0031809 (UMLS CUI [1,1])
    C0024109 (UMLS CUI [1,2])
    Item
    Physical Examination: Abdomen
    text
    C0031809 (UMLS CUI [1,1])
    C0000726 (UMLS CUI [1,2])
    Code List
    Physical Examination: Abdomen
    CL Item
    yes (1)
    CL Item
    no (0)
    Physical Examination: Abdomen, Text
    Item
    Physical Examination: Abdomen, Text
    text
    C0031809 (UMLS CUI [1,1])
    C0000726 (UMLS CUI [1,2])
    Item
    Physical Examination: Extremeties/Joints
    text
    C0031809 (UMLS CUI [1,1])
    C0278454 (UMLS CUI [1,2])
    C0022417 (UMLS CUI [1,3])
    Code List
    Physical Examination: Extremeties/Joints
    CL Item
    yes (1)
    CL Item
    no (0)
    Physical Examination: Extremeties/Joints, Text
    Item
    Physical Examination: Extremeties/Joints, Text
    text
    C0031809 (UMLS CUI [1,1])
    C0022417 (UMLS CUI [1,2])
    Item
    Physical Examination: Mental Status
    text
    C0031809 (UMLS CUI [1,1])
    C0278060 (UMLS CUI [1,2])
    Code List
    Physical Examination: Mental Status
    CL Item
    yes (1)
    CL Item
    no (0)
    Physical Examination: Mental Status, Text
    Item
    Physical Examination: Mental Status, Text
    text
    C0031809 (UMLS CUI [1,1])
    C0278060 (UMLS CUI [1,2])
    Item
    Vital Signs and Physical Examination: ND
    text
    C0518766 (UMLS CUI [1,1])
    C0031809 (UMLS CUI [1,2])
    C1705848 (UMLS CUI [1,3])
    Code List
    Vital Signs and Physical Examination: ND
    CL Item
    Not performed (0)

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