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ID

7238

Description

Prostate Cancer - Adverse Event Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DC4FB6C8-2D4F-5BF6-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DC4FB6C8-2D4F-5BF6-E034-0003BA12F5E7

Keywords

  1. 9/20/12 9/20/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 1/9/15 1/9/15 - Martin Dugas
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January 9, 2015

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Creative Commons BY-NC 3.0 Legacy

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    Toxicity - Prostate Cancer - Adverse Event Form - 2283646v3.0

    Note to Editor: Adverse events on this form are to be expected for the drugs/regimens of the protocol and conform to CTCAE v. 3.0 terminology. The CTCAE v. 3.0 can be found at http://ctep.cancer.gov. This list of expected events should be limited to what can fit on one page and should be alphabetized. Some groups may insert a column of internal codes.

    Crf Header
    Description

    Crf Header

    Coordinating Group Protocol No.
    Description

    Protocol ID Coordinating Group

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1711341
    NCI Thesaurus Property
    C25462
    NCI Thesaurus Property-2
    C25364
    Coordinating Group Code
    Description

    Coordinating Group Code

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS CUI-1
    C1711341
    NCI Thesaurus ObjectClass
    C17005
    UMLS CUI-2
    C0805701
    NCI Thesaurus ObjectClass-2
    C25462
    NCI Thesaurus Property
    C25364
    Protocol Title
    Description

    Protocol Title

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986303
    NCI Thesaurus ObjectClass
    C25320
    NCI Thesaurus Property
    C42774
    Patient Study ID
    Description

    Patient Study ID

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25462
    NCI Thesaurus Property-2
    C25364
    Institution/Affiliate
    Description

    Institution Name

    Data type

    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
    Other Patient ID
    Description

    Trial subject ID Participating Group

    Data type

    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
    Participating Group Code
    Description

    ParticipatingGroupIdentifierCode

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus ObjectClass
    C25608
    UMLS 2011AA ObjectClass
    C0679823
    NCI Thesaurus ObjectClass-2
    C17005
    UMLS 2011AA ObjectClass-2
    C1257890
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    Patient Name (initials acceptable)
    Description

    PatientName

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    Prostate: Adverse Events
    Description

    Prostate: Adverse Events

    Adverse Event Reporting From Date
    Description

    CTCAdverseEventReportBeginDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C25375
    UMLS 2011AA Property
    C0684224
    NCI Thesaurus ValueDomain-2
    C25431
    UMLS 2011AA ValueDomain-2
    C0439659
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    Adverse Event Reporting To Date
    Description

    CTCAdverseEventReportEndDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C25375
    UMLS 2011AA Property
    C0684224
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    CTC Adverse Event Term (Non-Hematologic examples only)
    Description

    CommonToxicityCriteriaAdverseEventTermType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus Property
    C45559
    UMLS 2011AA Property
    C1705313
    CTC Adverse Event Term (Non-Hematologic examples only)
    Description

    CommonToxicityCriteriaAdverseEventTermType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus Property
    C45559
    UMLS 2011AA Property
    C1705313
    Other CTC Adverse Event Term not listed (s)
    Description

    CTCAdverseEventTermSpecify

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus Property
    C45559
    UMLS 2011AA Property
    C1705313
    Other CTC Adverse Event Term not listed (s)
    Description

    CTCAdverseEventTermSpecify

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus Property
    C45559
    UMLS 2011AA Property
    C1705313
    CTC Adverse Event Grade (Only report Grade 3-5 for non-hematologic)
    Description

    CommonToxicityCriteriaAdverseEventGrade

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus ValueDomain
    C18000
    UMLS 2011AA ValueDomain
    C0919553
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    CTC Adverse Event Grade (Only report Grade 3-5 for non-hematologic)
    Description

    CommonToxicityCriteriaAdverseEventGrade

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus ValueDomain
    C18000
    UMLS 2011AA ValueDomain
    C0919553
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    Comments
    Description

    Comments

    Comments
    Description

    Research Comments

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0947611
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393

    Similar models

    Note to Editor: Adverse events on this form are to be expected for the drugs/regimens of the protocol and conform to CTCAE v. 3.0 terminology. The CTCAE v. 3.0 can be found at http://ctep.cancer.gov. This list of expected events should be limited to what can fit on one page and should be alphabetized. Some groups may insert a column of internal codes.

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Crf Header
    Protocol ID Coordinating Group
    Item
    Coordinating Group Protocol No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1711341 (UMLS CUI-2)
    C25462 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Coordinating Group Code
    Item
    Coordinating Group Code
    text
    C25162 (NCI Thesaurus ValueDomain)
    C1711341 (UMLS CUI-1)
    C17005 (NCI Thesaurus ObjectClass)
    C0805701 (UMLS CUI-2)
    C25462 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    Protocol Title
    Item
    Protocol Title
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986303 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C42774 (NCI Thesaurus Property)
    Patient Study ID
    Item
    Patient Study ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25462 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Institution Name
    Item
    Institution/Affiliate
    text
    C25454 (NCI Thesaurus ObjectClass)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    C25191 (NCI Thesaurus ValueDomain)
    C21541 (NCI Thesaurus ValueDomain-2)
    Trial subject ID Participating Group
    Item
    Other Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C2347449 (UMLS CUI-2)
    C25608 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    ParticipatingGroupIdentifierCode
    Item
    Participating Group Code
    text
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C25608 (NCI Thesaurus ObjectClass)
    C0679823 (UMLS 2011AA ObjectClass)
    C17005 (NCI Thesaurus ObjectClass-2)
    C1257890 (UMLS 2011AA ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    PatientName
    Item
    Patient Name (initials acceptable)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    Item Group
    Prostate: Adverse Events
    CTCAdverseEventReportBeginDate
    Item
    Adverse Event Reporting From Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25375 (NCI Thesaurus Property)
    C0684224 (UMLS 2011AA Property)
    C25431 (NCI Thesaurus ValueDomain-2)
    C0439659 (UMLS 2011AA ValueDomain-2)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    CTCAdverseEventReportEndDate
    Item
    Adverse Event Reporting To Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25375 (NCI Thesaurus Property)
    C0684224 (UMLS 2011AA Property)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    Item
    CTC Adverse Event Term (Non-Hematologic examples only)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C45559 (NCI Thesaurus Property)
    C1705313 (UMLS 2011AA Property)
    Code List
    CTC Adverse Event Term (Non-Hematologic examples only)
    CL Item
    Anorexia (Anorexia)
    C2875 (NCI Thesaurus)
    C0003123 (UMLS 2011AA)
    CL Item
    Nausea (Nausea)
    C3258 (NCI Thesaurus)
    C0027497 (UMLS 2011AA)
    CL Item
    Diarrhoea Nos (Diarrhea)
    CL Item
    Dermatitis Exfoliative Nos (Rash/desquamation)
    CL Item
    Vomiting Nos (Vomiting)
    Item
    CTC Adverse Event Term (Non-Hematologic examples only)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C45559 (NCI Thesaurus Property)
    C1705313 (UMLS 2011AA Property)
    Code List
    CTC Adverse Event Term (Non-Hematologic examples only)
    CL Item
    Anorexia (Anorexia)
    C2875 (NCI Thesaurus)
    C0003123 (UMLS 2011AA)
    CL Item
    Nausea (Nausea)
    C3258 (NCI Thesaurus)
    C0027497 (UMLS 2011AA)
    CL Item
    Diarrhoea Nos (Diarrhea)
    CL Item
    Dermatitis Exfoliative Nos (Rash/desquamation)
    CL Item
    Vomiting Nos (Vomiting)
    CTCAdverseEventTermSpecify
    Item
    Other CTC Adverse Event Term not listed (s)
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C45559 (NCI Thesaurus Property)
    C1705313 (UMLS 2011AA Property)
    CTCAdverseEventTermSpecify
    Item
    Other CTC Adverse Event Term not listed (s)
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C45559 (NCI Thesaurus Property)
    C1705313 (UMLS 2011AA Property)
    CommonToxicityCriteriaAdverseEventGrade
    Item
    CTC Adverse Event Grade (Only report Grade 3-5 for non-hematologic)
    float
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C18000 (NCI Thesaurus ValueDomain)
    C0919553 (UMLS 2011AA ValueDomain)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    CommonToxicityCriteriaAdverseEventGrade
    Item
    CTC Adverse Event Grade (Only report Grade 3-5 for non-hematologic)
    float
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C18000 (NCI Thesaurus ValueDomain)
    C0919553 (UMLS 2011AA ValueDomain)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    Item Group
    Comments
    Research Comments
    Item
    Comments
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0947611 (UMLS CUI-1)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)

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