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ID

28021

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. Visit: All visits. Source: Prof. Dr. med. Georg Heß Universitätsmedizin Mainz

Keywords

Versions (2)
  1. 12/10/17 12/10/17 -
  2. 1/2/18 1/2/18 -
Copyright Holder

Prof. Dr. med. Georg Heß

Uploaded on

December 10, 2017

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Creative Commons BY-NC 3.0
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    Adverse events GOAL Trial B-cell Lymphoma NCT02499003

    English

    Adverse events GOAL Trial B-cell Lymphoma NCT02499003

    1 forms  
    Admininstrative data
    Description

    Admininstrative data

    Subject ID
    Description

    Subject ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Page
    Description

    Page

    Data type

    integer

    Adverse events
    Description

    Adverse events

    No.
    Description

    adverse event number

    Data type

    integer

    AE Term (based on CTCAE 4.0)
    Description

    Adverse event

    Data type

    text

    SAE?
    Description

    Serious adverse event

    Data type

    text

    Study termination
    Description

    Study termination

    Data type

    text

    Start date
    Description

    Start date

    Data type

    date

    Stop date
    Description

    Stop date

    Data type

    date

    Ongoing at End of Treatment?
    Description

    Ongoing adverse event at End of Treatment

    Data type

    boolean

    Max. CTCAE grade
    Description

    Maximum CTCAE grade

    Data type

    integer

    Causality with Obinutuzumab
    Description

    Causality with Obinutuzumab

    Data type

    integer

    Causality with Pixantrone
    Description

    Causality with Pixantrone

    Data type

    integer

    Action taken with Obinutuzumab
    Description

    Action taken with Obinutuzumab

    Data type

    integer

    Action taken with Pixantrone
    Description

    Action taken with Pixantrone

    Data type

    integer

    Treatment given?
    Description

    Treatment

    Data type

    text

    Outcome
    Description

    Treatment Outcome

    Data type

    integer

    I have reviewed the AEs on this page and have assessed them for seriousness, causality, severity and outcome and confirm that, to the best of my knowledge, they accurately reflect the study information obtained for this patient.
    Description

    I have reviewed the AEs on this page and have assessed them for seriousness, causality, severity and outcome and confirm that, to the best of my knowledge, they accurately reflect the study information obtained for this patient.

    Data correct?
    Description

    Data correct

    Data type

    boolean

    Date of signature
    Description

    Date of signature

    Data type

    date

    Name of investigator
    Description

    Name of investigator

    Data type

    text

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    Similar models

    Adverse events GOAL Trial B-cell Lymphoma NCT02499003

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Admininstrative data
    Subject ID
    Item
    Subject ID
    text
    C2348585 (UMLS CUI [1])
    Page
    Item
    Page
    integer
    Item Group
    Adverse events
    Item
    No.
    integer
    adverse event number
    Code List
    No.
    CL Item
    01 (1)
    CL Item
    02 (2)
    CL Item
    03 (3)
    CL Item
    04 (4)
    CL Item
    05 (5)
    CL Item
    06 (6)
    CL Item
    07 (7)
    CL Item
    08 (8)
    CL Item
    09 (9)
    CL Item
    10 (10)
    Adverse event
    Item
    AE Term (based on CTCAE 4.0)
    text
    Serious adverse event
    Code List
    SAE?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Study termination
    text
    Serious adverse event
    Code List
    Study termination
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Start date
    Item
    Start date
    date
    Stop date
    Item
    Stop date
    date
    Ongoing adverse event at End of Treatment
    Item
    Ongoing at End of Treatment?
    boolean
    Maximum CTCAE grade
    Item
    Max. CTCAE grade
    integer
    Item
    Causality with Obinutuzumab
    integer
    Causality with Obinutuzumab
    Code List
    Causality with Obinutuzumab
    CL Item
    Not related (1)
    CL Item
    Related (2)
    Item
    Causality with Pixantrone
    integer
    Causality with Obinutuzumab
    Code List
    Causality with Pixantrone
    CL Item
    Not related (1)
    CL Item
    Related (2)
    Item
    Action taken with Obinutuzumab
    integer
    Action taken with Obinutuzumab
    Code List
    Action taken with Obinutuzumab
    CL Item
    Unchanged (1)
    CL Item
    Reduced (2)
    CL Item
    Interrupted (3)
    CL Item
    Discontinued (4)
    CL Item
    Not applicable (5)
    Item
    Action taken with Pixantrone
    integer
    Action taken with Obinutuzumab
    Code List
    Action taken with Pixantrone
    CL Item
    Unchanged (1)
    CL Item
    Reduced (2)
    CL Item
    Interrupted (3)
    CL Item
    Discontinued (4)
    CL Item
    Not applicable (5)
    Item
    Treatment given?
    text
    Serious adverse event
    Code List
    Treatment given?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Outcome
    integer
    Treatment Outcome
    Code List
    Outcome
    CL Item
    Recovered (1)
    CL Item
    Recovered with sequelae (2)
    CL Item
    Recovering (3)
    CL Item
    Not recovered (4)
    CL Item
    Fatal (5)
    CL Item
    Unknown (6)
    Item Group
    I have reviewed the AEs on this page and have assessed them for seriousness, causality, severity and outcome and confirm that, to the best of my knowledge, they accurately reflect the study information obtained for this patient.
    Data correct
    Item
    Data correct?
    boolean
    Date of signature
    Item
    Date of signature
    date
    Name of investigator
    Item
    Name of investigator
    text
    Back to the top of the page 

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