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ID

9634

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
Uploaded on

January 9, 2015

DOI

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License

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 (undefined)
    UMLS CUI-1
    C3274381 (Clinical Trial Registry Identifier)
    NCI Thesaurus ObjectClass
    C25320 (undefined)
    UMLS CUI-2
    C1711341 (Group Coordinator)
    NCI Thesaurus Property
    C25462 (undefined)
    NCI Thesaurus Property-2
    C25364 (undefined)
    Coordinating Group Code
    Description

    Coordinating Group Code

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162 (undefined)
    UMLS CUI-1
    C1711341 (Group Coordinator)
    NCI Thesaurus ObjectClass
    C17005 (undefined)
    UMLS CUI-2
    C0805701 (Code)
    NCI Thesaurus ObjectClass-2
    C25462 (undefined)
    NCI Thesaurus Property
    C25364 (undefined)
    Protocol Title
    Description

    Protocol Title

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191 (undefined)
    UMLS CUI-1
    C2986303 (Study Protocol Document Version Public Title)
    NCI Thesaurus ObjectClass
    C25320 (undefined)
    NCI Thesaurus Property
    C42774 (undefined)
    Patient Study ID
    Description

    Patient Study ID

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337 (undefined)
    UMLS CUI-1
    C2348585 (Clinical Trial Subject Unique Identifier)
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    NCI Thesaurus Property
    C25462 (undefined)
    NCI Thesaurus Property-2
    C25364 (undefined)
    Institution/Affiliate
    Description

    Institution Name

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25454 (undefined)
    UMLS CUI-1
    C1301943 (Institution name)
    SNOMED
    398321007
    NCI Thesaurus ObjectClass-2
    C21541 (undefined)
    NCI Thesaurus Property
    C25364 (undefined)
    NCI Thesaurus ValueDomain
    C25191 (undefined)
    NCI Thesaurus ValueDomain-2
    C21541 (undefined)
    Other Patient ID
    Description

    Trial subject ID Participating Group

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337 (undefined)
    UMLS CUI-1
    C2348585 (Clinical Trial Subject Unique Identifier)
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    UMLS CUI-2
    C2347449 (Participating Clinical Study Organization)
    NCI Thesaurus Property
    C25608 (undefined)
    NCI Thesaurus Property-2
    C25364 (undefined)
    Participating Group Code
    Description

    ParticipatingGroupIdentifierCode

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162 (undefined)
    UMLS 2011AA ValueDomain
    C0805701 (Code)
    NCI Thesaurus ObjectClass
    C25608 (undefined)
    UMLS 2011AA ObjectClass
    C0679823 (Participation)
    NCI Thesaurus ObjectClass-2
    C17005 (undefined)
    UMLS 2011AA ObjectClass-2
    C1257890 (Population Group)
    SNOMED
    389109008
    LOINC
    LA12078-4
    NCI Thesaurus Property
    C25364 (undefined)
    UMLS 2011AA Property
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Patient Name (initials acceptable)
    Description

    Patient Name

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191 (undefined)
    UMLS CUI-1
    C1299487 (Patient name)
    SNOMED
    371484003
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    NCI Thesaurus Property
    C25364 (undefined)
    Prostate: Adverse Events
    Description

    Prostate: Adverse Events

    Adverse Event Reporting From Date
    Description

    Adverse Event Start Date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164 (undefined)
    UMLS CUI-1
    C2697888 (Adverse Event Start Date)
    NCI Thesaurus Property
    C25375 (undefined)
    NCI Thesaurus ValueDomain-2
    C25431 (undefined)
    NCI Thesaurus ObjectClass
    C49704 (undefined)
    Adverse Event Reporting To Date
    Description

    Adverse Event End Date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164 (undefined)
    UMLS CUI-1
    C2697886 (Adverse Event End Date)
    NCI Thesaurus Property
    C25375 (undefined)
    NCI Thesaurus ObjectClass
    C49704 (undefined)
    CTC Adverse Event Term (Non-Hematologic examples only)
    Description

    CTC Adverse Event Term

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284 (undefined)
    UMLS CUI-1
    C1516728 (National Cancer Institute common terminology criteria for adverse events)
    SNOMED
    446391000124101
    NCI Thesaurus ObjectClass
    C49704 (undefined)
    UMLS CUI-2
    C2826934 (Adverse Event Dictionary Derived Term)
    NCI Thesaurus Property
    C45559 (undefined)
    CTC Adverse Event Term (Non-Hematologic examples only)
    Description

    CTC Adverse Event Term

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284 (undefined)
    UMLS CUI-1
    C1516728 (National Cancer Institute common terminology criteria for adverse events)
    SNOMED
    446391000124101
    NCI Thesaurus ObjectClass
    C49704 (undefined)
    UMLS CUI-2
    C2826934 (Adverse Event Dictionary Derived Term)
    NCI Thesaurus Property
    C45559 (undefined)
    Other CTC Adverse Event Term not listed (s)
    Description

    CTC Adverse Event Term

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685 (undefined)
    UMLS CUI-1
    C1516728 (National Cancer Institute common terminology criteria for adverse events)
    SNOMED
    446391000124101
    NCI Thesaurus ObjectClass
    C49704 (undefined)
    UMLS CUI-2
    C2826934 (Adverse Event Dictionary Derived Term)
    NCI Thesaurus Property
    C45559 (undefined)
    Other CTC Adverse Event Term not listed (s)
    Description

    CTC Adverse Event Term

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685 (undefined)
    UMLS CUI-1
    C1516728 (National Cancer Institute common terminology criteria for adverse events)
    SNOMED
    446391000124101
    NCI Thesaurus ObjectClass
    C49704 (undefined)
    UMLS CUI-2
    C2826934 (Adverse Event Dictionary Derived Term)
    NCI Thesaurus Property
    C45559 (undefined)
    CTC Adverse Event Grade (Only report Grade 3-5 for non-hematologic)
    Description

    CTC Adverse Event Grade

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704 (undefined)
    UMLS CUI-1
    C2985911 (Adverse Event Grade Code)
    NCI Thesaurus ValueDomain
    C18000 (undefined)
    NCI Thesaurus Property
    C25365 (undefined)
    CTC Adverse Event Grade (Only report Grade 3-5 for non-hematologic)
    Description

    CTC Adverse Event Grade

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704 (undefined)
    UMLS CUI-1
    C2985911 (Adverse Event Grade Code)
    NCI Thesaurus ValueDomain
    C18000 (undefined)
    NCI Thesaurus Property
    C25365 (undefined)
    Comments
    Description

    Comments

    Comments
    Description

    Research Comments

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704 (undefined)
    UMLS CUI-1
    C0947611 (Comment)
    LOINC
    LP72293-1
    NCI Thesaurus ObjectClass
    C15319 (undefined)
    NCI Thesaurus Property
    C25393 (undefined)

    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)
    Patient Name
    Item
    Patient Name (initials acceptable)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1299487 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25364 (NCI Thesaurus Property)
    Item Group
    Prostate: Adverse Events
    Adverse Event Start Date
    Item
    Adverse Event Reporting From Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2697888 (UMLS CUI-1)
    C25375 (NCI Thesaurus Property)
    C25431 (NCI Thesaurus ValueDomain-2)
    C49704 (NCI Thesaurus ObjectClass)
    Adverse Event End Date
    Item
    Adverse Event Reporting To Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2697886 (UMLS CUI-1)
    C25375 (NCI Thesaurus Property)
    C49704 (NCI Thesaurus ObjectClass)
    Item
    CTC Adverse Event Term (Non-Hematologic examples only)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C1516728 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C2826934 (UMLS CUI-2)
    C45559 (NCI Thesaurus 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)
    C1516728 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C2826934 (UMLS CUI-2)
    C45559 (NCI Thesaurus 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)
    CTC Adverse Event Term
    Item
    Other CTC Adverse Event Term not listed (s)
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1516728 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C2826934 (UMLS CUI-2)
    C45559 (NCI Thesaurus Property)
    CTC Adverse Event Term
    Item
    Other CTC Adverse Event Term not listed (s)
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1516728 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C2826934 (UMLS CUI-2)
    C45559 (NCI Thesaurus Property)
    CTC Adverse Event Grade
    Item
    CTC Adverse Event Grade (Only report Grade 3-5 for non-hematologic)
    float
    C49704 (NCI Thesaurus ObjectClass)
    C2985911 (UMLS CUI-1)
    C18000 (NCI Thesaurus ValueDomain)
    C25365 (NCI Thesaurus Property)
    CTC Adverse Event Grade
    Item
    CTC Adverse Event Grade (Only report Grade 3-5 for non-hematologic)
    float
    C49704 (NCI Thesaurus ObjectClass)
    C2985911 (UMLS CUI-1)
    C18000 (NCI Thesaurus ValueDomain)
    C25365 (NCI Thesaurus 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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