0 Ratings
ID

27902

Description

NCT02499003 The GOAL Trial: Rescue Treatment With the Monoclonal Anti CD20-antibody Obinutuzumab (GA101) in Combination With Pixantrone for the Treatment of Patients With Relapsed Aggressive B-cell Lymphoma Source: Prof. Dr. med. Georg Heß Universitätsmedizin Mainz

Keywords

Versions (3)
  1. 11/30/17 11/30/17 -
  2. 12/4/17 12/4/17 -
  3. 12/31/17 12/31/17 -
Copyright Holder

Prof. Dr. med. Georg Heß

Uploaded on

December 4, 2017

DOI

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License

Creative Commons BY-NC 3.0
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    Vital signs GOAL Trial B-cell Lymphoma NCT02499003

    English

    Vital signs GOAL Trial B-cell Lymphoma NCT02499003

    1 forms  
    Administrative data
    Description

    Administrative data

    Subject ID
    Description

    Subject ID

    Data type

    text

    Visit
    Description

    Visit

    Data type

    text

    Vital signs
    Description

    Vital signs

    Date
    Description

    Date

    Data type

    date

    Blood Pressure Systolic
    Description

    Blood Pressure Systolic

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    Blood Pressure Diastolic
    Description

    Blood Pressure Diastolic

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    Pulse
    Description

    Pulse

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0232117 (Pulse Rate)
    SNOMED
    78564009
    Body Temperature
    Description

    Body Temperature

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1]
    C0005903 (Body Temperature)
    SNOMED
    722490005
    LOINC
    LP36617-6
    °C
    ECOG
    Description

    Item only applies to the following visits: Screening, Day 1 of Cycles 2 - 6, Interim Staging, End of Treatment, and Follow Up 1 - 8.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    Weight
    Description

    Item only applies to the following visits: Screening, Day 1 of Cycles 2 - 6, Interim Staging, End of Treatment, and Follow Up 1 - 8.

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910 (Body Weight)
    SNOMED
    27113001
    kg
    Height
    Description

    Item only applies to Screening.

    Data type

    float

    Measurement units
    • cm
    Alias
    UMLS CUI [1]
    C0005890 (Body Height)
    SNOMED
    50373000
    cm
    Cycle day not done
    Description

    Item only applies to visits during Cycles 1 - 6 (Day 1, 8, 15, or 22; except Cycle 1 Day 1).

    Data type

    boolean

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    Similar models

    Vital signs GOAL Trial B-cell Lymphoma NCT02499003

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    Subject ID
    Item
    Subject ID
    text
    Item
    Visit
    text
    Visit
    Code List
    Visit
    CL Item
    Screening (Screening)
    CL Item
    Cycle 1 Day 1 (Cycle 1 Day 1)
    CL Item
    Cycle 1 Day 8 (Cycle 1 Day 8)
    CL Item
    Cycle 1 Day 15 (Cycle 1 Day 15)
    CL Item
    Cycle 1 Day 22 (Cycle 1 Day 22)
    CL Item
    Cycle 2 Day 1 (Cycle 2 Day 1)
    CL Item
    Cycle 2 Day 8 (Cycle 2 Day 8)
    CL Item
    Cycle 2 Day 15 (Cycle 2 Day 15)
    CL Item
    Cycle 2 Day 22 (Cycle 2 Day 22)
    CL Item
    Cycle 3 Day 1 (Cycle 3 Day 1)
    CL Item
    Cycle 3 Day 8 (Cycle 3 Day 8)
    CL Item
    Cycle 3 Day 15 (Cycle 3 Day 15)
    CL Item
    Cycle 3 Day 22 (Cycle 3 Day 22)
    CL Item
    Interim Staging (Interim Staging)
    CL Item
    Cycle 4 Day 1 (Cycle 4 Day 1)
    CL Item
    Cycle 4 Day 8 (Cycle 4 Day 8)
    CL Item
    Cycle 4 Day 15 (Cycle 4 Day 15)
    CL Item
    Cycle 4 Day 22 (Cycle 4 Day 22)
    CL Item
    Cycle 5 Day 1 (Cycle 5 Day 1)
    CL Item
    Cycle 5 Day 8 (Cycle 5 Day 8)
    CL Item
    Cycle 5 Day 15 (Cycle 5 Day 15)
    CL Item
    Cycle 5 Day 22 (Cycle 5 Day 22)
    CL Item
    Cycle 6 Day 1 (Cycle 6 Day 1)
    CL Item
    Cycle 6 Day 8 (Cycle 6 Day 8)
    CL Item
    Cycle 6 Day 15 (Cycle 6 Day 15)
    CL Item
    Cycle 6 Day 22 (Cycle 6 Day 22)
    CL Item
    End of Treatment (End of Treatment)
    CL Item
    Follow Up 1: 3 months after EoT (Follow Up 1: 3 months after EoT)
    CL Item
    Follow Up 2: 6 months after EoT (Follow Up 2: 6 months after EoT)
    CL Item
    Follow Up 3: 9 months after EoT (Follow Up 3: 9 months after EoT)
    CL Item
    Follow Up 4: 12 months after EoT (Follow Up 4: 12 months after EoT)
    CL Item
    Follow Up 5: 15 months after EoT (Follow Up 5: 15 months after EoT)
    CL Item
    Follow Up 6: 18 months after EoT (Follow Up 6: 18 months after EoT)
    CL Item
    Follow Up 7: 21 months after EoT (Follow Up 7: 21 months after EoT)
    CL Item
    Follow Up 8: 24 months after EoT (Follow Up 8: 24 months after EoT)
    Item Group
    Vital signs
    Date
    Item
    Date
    date
    Blood Pressure Systolic
    Item
    Blood Pressure Systolic
    integer
    C0871470 (UMLS CUI [1])
    Blood Pressure Diastolic
    Item
    Blood Pressure Diastolic
    integer
    C0428883 (UMLS CUI [1])
    Pulse
    Item
    Pulse
    integer
    C0232117 (UMLS CUI [1])
    Body Temperature
    Item
    Body Temperature
    float
    C0005903 (UMLS CUI [1])
    ECOG
    Item
    ECOG
    integer
    C1520224 (UMLS CUI [1])
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Height
    Item
    Height
    float
    C0005890 (UMLS CUI [1])
    Cycle day not done
    Item
    Cycle day not done
    boolean
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