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ID

28276

Beschrijving

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

Trefwoorden

Versies (2)
  1. 10-12-17 10-12-17 -
  2. 02-01-18 02-01-18 -
Houder van rechten

Prof. Dr. med. Georg Heß

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2 januari 2018

DOI

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

    Engels

    Adverse events GOAL Trial B-cell Lymphoma NCT02499003

    1 Formulieren  
    Admininstrative data
    Beschrijving

    Admininstrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject ID
    Beschrijving

    Subject ID

    Datatype

    text

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

    Page

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1704732 (Page (document))
    Adverse events
    Beschrijving

    Adverse events

    Alias
    UMLS CUI-1
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    No.
    Beschrijving

    adverse event number

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [1,2]
    C0449788 (Count of entities)
    SNOMED
    410681005
    AE Term (based on CTCAE 4.0)
    Beschrijving

    CTCAE Adverse event

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1516728 (National Cancer Institute common terminology criteria for adverse events)
    SNOMED
    446391000124101
    UMLS CUI [1,2]
    C2826934 (Adverse Event Dictionary Derived Term)
    SAE?
    Beschrijving

    Serious adverse event

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1519255 (Serious Adverse Event)
    Study termination
    Beschrijving

    Study termination

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2718058 (Early Termination of Clinical Trials)
    Start date
    Beschrijving

    Start date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0808070 (Start Date)
    Stop date
    Beschrijving

    Stop date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    Ongoing at End of Treatment?
    Beschrijving

    Ongoing adverse event

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2826663 (Adverse Event Ongoing)
    Max. CTCAE grade
    Beschrijving

    CTCAE grade

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C1516728 (National Cancer Institute common terminology criteria for adverse events)
    SNOMED
    446391000124101
    UMLS CUI [1,2]
    C0441800 (Grade)
    SNOMED
    103421006
    LOINC
    MTHU003112
    Causality with Obinutuzumab
    Beschrijving

    Causality Obinutuzumab

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0015127 (Etiology aspects)
    UMLS CUI [1,2]
    C2742503 (obinutuzumab)
    SNOMED
    710287009
    Causality with Pixantrone
    Beschrijving

    Causality Pixantrone

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0015127 (Etiology aspects)
    UMLS CUI [1,2]
    C0253355 (pixantrone)
    SNOMED
    710295008
    Action taken with Obinutuzumab
    Beschrijving

    Action taken Obinutuzumab

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C2826626 (Adverse Event Action Taken with Study Treatment)
    UMLS CUI [1,2]
    C2742503 (obinutuzumab)
    SNOMED
    710287009
    Action taken with Pixantrone
    Beschrijving

    Action taken Pixantrone

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C2826626 (Adverse Event Action Taken with Study Treatment)
    UMLS CUI [1,2]
    C0253355 (pixantrone)
    SNOMED
    710295008
    Treatment given?
    Beschrijving

    Treatment

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    Outcome
    Beschrijving

    Treatment Outcome

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0085415 (Treatment outcome)
    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.
    Beschrijving

    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 (Investigator Signature)
    Data correct?
    Beschrijving

    correct

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2349182 (Correct (qualifier))
    LOINC
    LA9960-1
    Date of signature
    Beschrijving

    Date of signature

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0807937 (Signature date)
    LOINC
    MTHU008294
    Name of investigator
    Beschrijving

    Name of investigator

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2826892 (Investigator Name)
    Terug naar het begin van de pagina

    Similar models

    Adverse events GOAL Trial B-cell Lymphoma NCT02499003

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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])
    Terug naar het begin van de pagina 

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