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ID

28276

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

Mots-clés

Versions (2)
  1. 10/12/2017 10/12/2017 -
  2. 02/01/2018 02/01/2018 -
Détendeur de droits

Prof. Dr. med. Georg Heß

Téléchargé le

2 janvier 2018

DOI

Pour une demande vous connecter.

Licence

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

    Anglais

    Adverse events GOAL Trial B-cell Lymphoma NCT02499003

    1 Formulaires  
    Admininstrative data
    Description

    Admininstrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject ID
    Description

    Subject ID

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2348585
    Page
    Description

    Page

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C1704732
    Adverse events
    Description

    Adverse events

    Alias
    UMLS CUI-1
    C0877248
    No.
    Description

    adverse event number

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0449788
    AE Term (based on CTCAE 4.0)
    Description

    CTCAE Adverse event

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1516728
    UMLS CUI [1,2]
    C2826934
    SAE?
    Description

    Serious adverse event

    Type de données

    text

    Alias
    UMLS CUI [1]
    C1519255
    Study termination
    Description

    Study termination

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2718058
    Start date
    Description

    Start date

    Type de données

    date

    Alias
    UMLS CUI [1]
    C0808070
    Stop date
    Description

    Stop date

    Type de données

    date

    Alias
    UMLS CUI [1]
    C0806020
    Ongoing at End of Treatment?
    Description

    Ongoing adverse event

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2826663
    Max. CTCAE grade
    Description

    CTCAE grade

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C1516728
    UMLS CUI [1,2]
    C0441800
    Causality with Obinutuzumab
    Description

    Causality Obinutuzumab

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0015127
    UMLS CUI [1,2]
    C2742503
    Causality with Pixantrone
    Description

    Causality Pixantrone

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0015127
    UMLS CUI [1,2]
    C0253355
    Action taken with Obinutuzumab
    Description

    Action taken Obinutuzumab

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C2826626
    UMLS CUI [1,2]
    C2742503
    Action taken with Pixantrone
    Description

    Action taken Pixantrone

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C2826626
    UMLS CUI [1,2]
    C0253355
    Treatment given?
    Description

    Treatment

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0087111
    Outcome
    Description

    Treatment Outcome

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0085415
    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.

    Alias
    UMLS CUI-1
    C2346576
    Data correct?
    Description

    correct

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2349182
    Date of signature
    Description

    Date of signature

    Type de données

    date

    Alias
    UMLS CUI [1]
    C0807937
    Name of investigator
    Description

    Name of investigator

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2826892
    Retour au début de la page

    Similar models

    Adverse events GOAL Trial B-cell Lymphoma NCT02499003

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Admininstrative data
    C1320722 (UMLS CUI-1)
    Subject ID
    Item
    Subject ID
    text
    C2348585 (UMLS CUI [1])
    Page
    Item
    Page
    integer
    C1704732 (UMLS CUI [1])
    Item Group
    Adverse events
    C0877248 (UMLS CUI-1)
    Item
    No.
    integer
    C0877248 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    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)
    CTCAE Adverse event
    Item
    AE Term (based on CTCAE 4.0)
    text
    C1516728 (UMLS CUI [1,1])
    C2826934 (UMLS CUI [1,2])
    Item
    SAE?
    text
    C1519255 (UMLS CUI [1])
    Serious adverse event
    Code List
    SAE?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Study termination
    text
    C2718058 (UMLS CUI [1])
    Serious adverse event
    Code List
    Study termination
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Start date
    Item
    Start date
    date
    C0808070 (UMLS CUI [1])
    Stop date
    Item
    Stop date
    date
    C0806020 (UMLS CUI [1])
    Ongoing adverse event
    Item
    Ongoing at End of Treatment?
    boolean
    C2826663 (UMLS CUI [1])
    CTCAE grade
    Item
    Max. CTCAE grade
    integer
    C1516728 (UMLS CUI [1,1])
    C0441800 (UMLS CUI [1,2])
    Item
    Causality with Obinutuzumab
    integer
    C0015127 (UMLS CUI [1,1])
    C2742503 (UMLS CUI [1,2])
    Causality with Obinutuzumab
    Code List
    Causality with Obinutuzumab
    CL Item
    Not related (1)
    C1546988 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Related (2)
    C1704787 (UMLS CUI-1)
    (Comment:en)
    Item
    Causality with Pixantrone
    integer
    C0015127 (UMLS CUI [1,1])
    C0253355 (UMLS CUI [1,2])
    Causality with Obinutuzumab
    Code List
    Causality with Pixantrone
    CL Item
    Not related (1)
    C1546988 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Related (2)
    C1704787 (UMLS CUI-1)
    (Comment:en)
    Item
    Action taken with Obinutuzumab
    integer
    C2826626 (UMLS CUI [1,1])
    C2742503 (UMLS CUI [1,2])
    Action taken with Obinutuzumab
    Code List
    Action taken with Obinutuzumab
    CL Item
    Unchanged (1)
    C0442739 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Reduced (2)
    C1707814 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Interrupted (3)
    C1512900 (UMLS CUI-1)
    C0178602 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Discontinued (4)
    C0558681 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Not applicable (5)
    C1272460 (UMLS CUI-1)
    (Comment:en)
    Item
    Action taken with Pixantrone
    integer
    C2826626 (UMLS CUI [1,1])
    C0253355 (UMLS CUI [1,2])
    Action taken with Obinutuzumab
    Code List
    Action taken with Pixantrone
    CL Item
    Unchanged (1)
    C0442739 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Reduced (2)
    C1707814 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Interrupted (3)
    C0178602 (UMLS CUI-1)
    C0443239 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Discontinued (4)
    C0558681 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Not applicable (5)
    C1272460 (UMLS CUI-1)
    (Comment:en)
    Item
    Treatment given?
    text
    C0087111 (UMLS CUI [1])
    Serious adverse event
    Code List
    Treatment given?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Outcome
    integer
    C0085415 (UMLS CUI [1])
    Treatment Outcome
    Code List
    Outcome
    CL Item
    Recovered (1)
    C2004454 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Recovered with sequelae (2)
    C1709862 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Recovering (3)
    C1709864 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Not recovered (4)
    C1709277 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Fatal (5)
    C1302234 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Unknown (6)
    C0439673 (UMLS CUI-1)
    (Comment:en)
    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.
    C2346576 (UMLS CUI-1)
    correct
    Item
    Data correct?
    boolean
    C2349182 (UMLS CUI [1])
    Date of signature
    Item
    Date of signature
    date
    C0807937 (UMLS CUI [1])
    Name of investigator
    Item
    Name of investigator
    text
    C2826892 (UMLS CUI [1])
    Retour au début de la page 

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