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8008

Descrizione

CALGB-10501 Summary Response / Progression Form for Leukemia Early or Delayed Fludarabine and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=33F80721-319D-3F50-E044-0003BA3F9857

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=33F80721-319D-3F50-E044-0003BA3F9857

Keywords

versioni (3)
  1. 19/09/12 19/09/12 -
  2. 09/01/15 09/01/15 - Martin Dugas
  3. 18/06/15 18/06/15 -
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9 gennaio 2015

DOI

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Licenza

Creative Commons BY-NC 3.0 Legacy
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    NCT00513747 Response - CALGB-10501 Summary Response / Progression Form for Leukemia - 2661184v1.0

    Inglese

    [Optional Form - may be selected for specific protocols where appropriate.]

    1 moduli  
    1. StudyEvent: CALGB-10501 Summary Response / Progression Form for Leukemia
      1. [Optional Form - may be selected for specific protocols where appropriate.]
    Header
    Descrizione

    Header

    CALGB Form
    Descrizione

    Form ID CALGB

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3262252
    NCI Thesaurus ObjectClass
    C19464
    UMLS CUI-2
    C1516238
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ObjectClass-2
    C25442
    CALGB Study No
    Descrizione

    Protocol ID CALGB

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1516238
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25442
    CALGB Patient ID
    Descrizione

    Trial subject ID CALGB

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1516238
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25442
    Date of Assessment
    Descrizione

    Assessment Date

    Tipo di dati

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2985720
    NCI Thesaurus ObjectClass
    C25367
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus Property
    C38000
    Are data amended
    Descrizione

    Data amended

    Tipo di dati

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus Property
    C25416
    Unnamed2
    Descrizione

    Unnamed2

    Patient Initials (Last, First Middle)
    Descrizione

    Patient Initials

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    Patient Hospital No.
    Descrizione

    Medical Record Number

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1301894
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25261
    NCI Thesaurus Property-2
    C25198
    Institution/Affiliate
    Descrizione

    Institution Name

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C25454
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass-2
    C21541
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ValueDomain
    C25191
    NCI Thesaurus ValueDomain-2
    C21541
    Participating Group
    Descrizione

    Participating Group

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2347449
    NCI Thesaurus ObjectClass
    C25608
    NCI Thesaurus ObjectClass-2
    C17005
    NCI Thesaurus Property
    C25364
    Participating Group Study No.
    Descrizione

    Study Number Participating Group

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C2347449
    NCI Thesaurus Property
    C25608
    NCI Thesaurus Property-2
    C25364
    Participating Group Patient ID
    Descrizione

    Trial subject ID Participating Group

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C2347449
    NCI Thesaurus Property
    C25608
    NCI Thesaurus Property-2
    C25364
    Lymphoma: Response Assessment
    Descrizione

    Lymphoma: Response Assessment

    Has the patient achieved a response? (during this time period)
    Descrizione

    TumorResponseInd-3

    Tipo di dati

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C3262
    UMLS 2011AA ObjectClass
    C0027651
    NCI Thesaurus Property
    C25755
    UMLS 2011AA Property
    C0871261
    NCI Thesaurus ValueDomain-2
    C25755
    UMLS 2011AA ValueDomain-2
    C0871261
    Complete Response (CR) First Observed Date (MM DD YYYY)
    Descrizione

    Complete Response First Observed Date

    Tipo di dati

    date

    Alias
    NCI Thesaurus ObjectClass
    C25755
    UMLS CUI-1
    C0677874
    NCI Thesaurus ObjectClass-2
    C25250
    UMLS CUI-2
    C1115465
    NCI Thesaurus Property
    C25509
    NCI Thesaurus Property-2
    C25599
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25367
    Nodular partial response (NPR) first observed date (MM DD YYYY)
    Descrizione

    NodalPartialResponseFirstObservedDate

    Tipo di dati

    date

    Alias
    NCI Thesaurus ObjectClass
    C25755
    UMLS 2011AA ObjectClass
    C0871261
    NCI Thesaurus ObjectClass-2
    C25378
    UMLS 2011AA ObjectClass-2
    C0728938
    NCI Thesaurus ObjectClass-3
    C25323
    UMLS 2011AA ObjectClass-3
    C0443268
    NCI Thesaurus Property
    C25509
    UMLS 2011AA Property
    C1279901
    NCI Thesaurus Property-2
    C25599
    UMLS 2011AA Property-2
    C1441672
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    Partial Response (PR) First Observed Date (MM DD YYYY)
    Descrizione

    Partial Response First Observed Date

    Tipo di dati

    date

    Alias
    NCI Thesaurus ObjectClass
    C25755
    UMLS CUI-1
    C1521726
    NCI Thesaurus ObjectClass-2
    C25378
    UMLS CUI-2
    C1115465
    NCI Thesaurus Property
    C25509
    NCI Thesaurus Property-2
    C25599
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25367
    Stable Disease First Observed Date (SD)
    Descrizione

    StableResponseFirstObservedDate

    Tipo di dati

    date

    Alias
    NCI Thesaurus ObjectClass
    C25755
    UMLS 2011AA ObjectClass
    C0871261
    NCI Thesaurus ObjectClass-2
    C18213
    UMLS 2011AA ObjectClass-2
    C0677946
    NCI Thesaurus Property
    C25509
    UMLS 2011AA Property
    C1279901
    NCI Thesaurus Property-2
    C25599
    UMLS 2011AA Property-2
    C1441672
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    Has the patient been diagnosed with a new progression (during this reporting period not previously reported)
    Descrizione

    DiseaseNewProgressionInd-2

    Tipo di dati

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus Property
    C25586
    UMLS 2011AA Property
    C0205314
    NCI Thesaurus Property-2
    C25331
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    Progressive Disease (PD) Observed Date (Second MM DD YYYY)
    Descrizione

    Progressive Disease Observed Date

    Tipo di dati

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1335499
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C25331
    NCI Thesaurus Property
    C25599
    UMLS CUI-2
    C0011008
    Progressive Disease (PD) Observed Date (Second MM DD YYYY)
    Descrizione

    Progressive Disease Observed Date

    Tipo di dati

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1335499
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C25331
    NCI Thesaurus Property
    C25599
    UMLS CUI-2
    C0011008
    Liver Assessment
    Descrizione

    LiverProgressionCriteriaInd-3

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C25331
    NCI Thesaurus ObjectClass-2
    C12392
    UMLS 2011AA ObjectClass
    C0023884
    NCI Thesaurus Property
    C25466
    UMLS 2011AA Property
    C0243161
    Spleen Assessment
    Descrizione

    SpleenProgressionCriteriaInd-3

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C25331
    NCI Thesaurus ObjectClass-2
    C12432
    UMLS 2011AA ObjectClass
    C0037993
    NCI Thesaurus Property
    C25466
    UMLS 2011AA Property
    C0243161
    Lymph Node Assessment
    Descrizione

    LymphNodeProgressionCriteriaInd-3

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C25331
    NCI Thesaurus ObjectClass-2
    C12745
    UMLS 2011AA ObjectClass
    C0024204
    NCI Thesaurus Property
    C25466
    UMLS 2011AA Property
    C0243161
    Lymphocytes (> 50% increase in absolute number of circulating lymphocyctes to at least 5000/uL)
    Descrizione

    LymphocyteProgressionCriteriaInd-3

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C25331
    NCI Thesaurus ObjectClass-2
    C12535
    UMLS 2011AA ObjectClass
    C0024264
    NCI Thesaurus Property
    C25466
    UMLS 2011AA Property
    C0243161
    Comments
    Descrizione

    Comments

    Completed by (Last name, First name)
    Descrizione

    Person Completing Form

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1550483
    NCI Thesaurus ObjectClass
    C25657
    NCI Thesaurus Property
    C25364
    Date Form Completed (MM DD YYYY)
    Descrizione

    Date Form Completed

    Tipo di dati

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1115437
    NCI Thesaurus ObjectClass
    C40988
    NCI Thesaurus Property
    C25250
    NCI Thesaurus ValueDomain-2
    C25367
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    [Optional Form - may be selected for specific protocols where appropriate.]

    1 moduli
    1. StudyEvent: CALGB-10501 Summary Response / Progression Form for Leukemia
      1. [Optional Form - may be selected for specific protocols where appropriate.]
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Header
    Form ID CALGB
    Item
    CALGB Form
    text
    C25337 (NCI Thesaurus ValueDomain)
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    C19464 (NCI Thesaurus ObjectClass)
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    C25442 (NCI Thesaurus ObjectClass-2)
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    Item
    Date of Assessment
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2985720 (UMLS CUI-1)
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    C38148 (NCI Thesaurus ValueDomain)
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    Patient Hospital No.
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    C16960 (NCI Thesaurus ObjectClass)
    C25261 (NCI Thesaurus Property)
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    Institution Name
    Item
    Institution/Affiliate
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    Trial subject ID Participating Group
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    C3262 (NCI Thesaurus ObjectClass)
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    C0871261 (UMLS 2011AA ValueDomain-2)
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    Complete Response (CR) First Observed Date (MM DD YYYY)
    date
    C25755 (NCI Thesaurus ObjectClass)
    C0677874 (UMLS CUI-1)
    C25250 (NCI Thesaurus ObjectClass-2)
    C1115465 (UMLS CUI-2)
    C25509 (NCI Thesaurus Property)
    C25599 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
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    NodalPartialResponseFirstObservedDate
    Item
    Nodular partial response (NPR) first observed date (MM DD YYYY)
    date
    C25755 (NCI Thesaurus ObjectClass)
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    Item
    Stable Disease First Observed Date (SD)
    date
    C25755 (NCI Thesaurus ObjectClass)
    C0871261 (UMLS 2011AA ObjectClass)
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    C0677946 (UMLS 2011AA ObjectClass-2)
    C25509 (NCI Thesaurus Property)
    C1279901 (UMLS 2011AA Property)
    C25599 (NCI Thesaurus Property-2)
    C1441672 (UMLS 2011AA Property-2)
    C25164 (NCI Thesaurus ValueDomain)
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    DiseaseNewProgressionInd-2
    Item
    Has the patient been diagnosed with a new progression (during this reporting period not previously reported)
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    text
    C38148 (NCI Thesaurus ValueDomain)
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    CL.4
    Code List
    Liver Assessment
    CL Item
    No (NO)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    C49487 (NCI Thesaurus-3)
    C1298908 (UMLS 2011AA-4)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    CL Item
    Yes (YES)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    C49488 (NCI Thesaurus-3)
    C1705108 (UMLS 2011AA-4)
    Item
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    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C25331 (NCI Thesaurus ObjectClass)
    C12432 (NCI Thesaurus ObjectClass-2)
    C0037993 (UMLS 2011AA ObjectClass)
    C25466 (NCI Thesaurus Property)
    C0243161 (UMLS 2011AA Property)
    CL.5
    Code List
    Spleen Assessment
    CL Item
    No (NO)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    C49487 (NCI Thesaurus-3)
    C1298908 (UMLS 2011AA-4)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    CL Item
    Yes (YES)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    C49488 (NCI Thesaurus-3)
    C1705108 (UMLS 2011AA-4)
    Item
    Lymph Node Assessment
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C25331 (NCI Thesaurus ObjectClass)
    C12745 (NCI Thesaurus ObjectClass-2)
    C0024204 (UMLS 2011AA ObjectClass)
    C25466 (NCI Thesaurus Property)
    C0243161 (UMLS 2011AA Property)
    CL.6
    Code List
    Lymph Node Assessment
    CL Item
    No (NO)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    C49487 (NCI Thesaurus-3)
    C1298908 (UMLS 2011AA-4)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    CL Item
    Yes (YES)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    C49488 (NCI Thesaurus-3)
    C1705108 (UMLS 2011AA-4)
    Item
    Lymphocytes (> 50% increase in absolute number of circulating lymphocyctes to at least 5000/uL)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C25331 (NCI Thesaurus ObjectClass)
    C12535 (NCI Thesaurus ObjectClass-2)
    C0024264 (UMLS 2011AA ObjectClass)
    C25466 (NCI Thesaurus Property)
    C0243161 (UMLS 2011AA Property)
    CL.7
    Code List
    Lymphocytes (> 50% increase in absolute number of circulating lymphocyctes to at least 5000/uL)
    CL Item
    No (NO)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    C49487 (NCI Thesaurus-3)
    C1298908 (UMLS 2011AA-4)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    CL Item
    Yes (YES)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    C49488 (NCI Thesaurus-3)
    C1705108 (UMLS 2011AA-4)
    Item Group
    Comments
    Person Completing Form
    Item
    Completed by (Last name, First name)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1550483 (UMLS CUI-1)
    C25657 (NCI Thesaurus ObjectClass)
    C25364 (NCI Thesaurus Property)
    Date Form Completed
    Item
    Date Form Completed (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1115437 (UMLS CUI-1)
    C40988 (NCI Thesaurus ObjectClass)
    C25250 (NCI Thesaurus Property)
    C25367 (NCI Thesaurus ValueDomain-2)
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