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ID

10626

Description

CALGB: 49808 ADVERSE EVENT FORM DOXORUBICIN + CYCLOPHOSPHAMIDE + ZINECARD (AC+Z) NCT00016276 Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9E35395C-8D28-227A-E034-080020C9C0E0

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9E35395C-8D28-227A-E034-080020C9C0E0

Keywords

  1. 8/26/12 8/26/12 -
  2. 5/22/15 5/22/15 -
  3. 6/3/15 6/3/15 -
  4. 6/3/15 6/3/15 -
Uploaded on

June 3, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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    CALGB: 49808 ADVERSE EVENT FORM DOXORUBICIN + CYCLOPHOSPHAMIDE + ZINECARD (AC+Z) NCT00016276

    No Instruction available.

    1. StudyEvent: CALGB: 49808 ADVERSE EVENT FORM DOXORUBICIN + CYCLOPHOSPHAMIDE + ZINECARD (AC+Z)
      1. No Instruction available.
    CALGB clinical trial administrative data
    Description

    CALGB clinical trial administrative data

    CALGB Form
    Description

    CALGBForm

    Data type

    text

    CALGB Study No
    Description

    CALGBProtocolNumber

    Data type

    text

    CALGB Patient ID
    Description

    CALGBPatientID

    Data type

    text

    From
    Description

    From

    Data type

    text

    To
    Description

    To

    Data type

    text

    Amended data?
    Description

    AmendedDataInd

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25474 (undefined)
    UMLS 2011AA ObjectClass
    C1511726 (Data)
    NCI Thesaurus Property
    C25416 (undefined)
    UMLS 2011AA Property
    C1691222 (Amended)
    Patient clinical trial data
    Description

    Patient clinical trial data

    Patient's Name
    Description

    Patient'sName

    Data type

    text

    Participating Group
    Description

    ParticipatingGroup

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C17005 (undefined)
    UMLS 2011AA ObjectClass
    C1257890 (Population Group)
    SNOMED
    389109008
    LOINC
    LA12078-4
    NCI Thesaurus Property
    C25364 (undefined)
    UMLS 2011AA Property
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Patient Hospital Number
    Description

    PatientHospitalNumber

    Data type

    text

    Participating Group Protocol No.
    Description

    ParticipatingGroupProtocolNo.

    Data type

    text

    Main Member Institution/Adjunct
    Description

    MainMemberInstitution/Adjunct

    Data type

    text

    Participating Group Patient No.
    Description

    ParticipatingGroupPatientNo.

    Data type

    text

    Was an AER/ADR filed with Central Office based on an event reported below? (see section 16.0 of the protocol)
    Description

    WasanAER/ADRfiledwithCentralOfficebasedonaneventreportedbelow?

    Data type

    text

    Expected Adverse Events
    Description

    Expected Adverse Events

    IMT Code
    Description

    IMTCode

    Data type

    text

    CTC Adverse Event Term
    Description

    CTCAdverseEventTerm

    Data type

    text

    CTC Grade
    Description

    CTCGrade

    Data type

    text

    Attribution
    Description

    Attribution

    Data type

    text

    CTC Adverse Event Term, Specify
    Description

    CTCAdverseEventTerm,Specify

    Data type

    text

    Were any other events (Hematologic grade 4-5 only or Non-Hematologic grade 3-5 only) noted during this time period?
    Description

    Wereanyotherevents(Hematologicgrade4-5onlyorNon-Hematologicgrade3-5only)notedduringthistimeperiod?

    Data type

    text

    Completed By
    Description

    CompletedBy

    Data type

    text

    Date Completed
    Description

    DateCompleted

    Data type

    date

    Similar models

    No Instruction available.

    1. StudyEvent: CALGB: 49808 ADVERSE EVENT FORM DOXORUBICIN + CYCLOPHOSPHAMIDE + ZINECARD (AC+Z)
      1. No Instruction available.
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    CALGB clinical trial administrative data
    CALGBForm
    Item
    CALGB Form
    text
    CALGBProtocolNumber
    Item
    CALGB Study No
    text
    CALGBPatientID
    Item
    CALGB Patient ID
    text
    From
    Item
    From
    text
    To
    Item
    To
    text
    Item
    Amended data?
    text
    C25474 (NCI Thesaurus ObjectClass)
    C1511726 (UMLS 2011AA ObjectClass)
    C25416 (NCI Thesaurus Property)
    C1691222 (UMLS 2011AA Property)
    Code List
    Amended data?
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item Group
    Patient clinical trial data
    Patient'sName
    Item
    Patient's Name
    text
    ParticipatingGroup
    Item
    Participating Group
    text
    C17005 (NCI Thesaurus ObjectClass)
    C1257890 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    PatientHospitalNumber
    Item
    Patient Hospital Number
    text
    ParticipatingGroupProtocolNo.
    Item
    Participating Group Protocol No.
    text
    MainMemberInstitution/Adjunct
    Item
    Main Member Institution/Adjunct
    text
    ParticipatingGroupPatientNo.
    Item
    Participating Group Patient No.
    text
    Item
    Was an AER/ADR filed with Central Office based on an event reported below? (see section 16.0 of the protocol)
    text
    Code List
    Was an AER/ADR filed with Central Office based on an event reported below? (see section 16.0 of the protocol)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item Group
    Expected Adverse Events
    IMTCode
    Item
    IMT Code
    text
    CTCAdverseEventTerm
    Item
    CTC Adverse Event Term
    text
    CTCGrade
    Item
    CTC Grade
    text
    Item
    Attribution
    text
    Code List
    Attribution
    CL Item
    Unrelated To Treatment (unrelated to treatment)
    CL Item
    Unlikely To Be Related To Treatment (unlikely to be related to treatment)
    CL Item
    Possibly Related To Treatment (possibly related to treatment)
    CL Item
    Probably Related To Treatment (probably related to treatment)
    CL Item
    Definitely Related To Treatment (definitely related to treatment)
    CTCAdverseEventTerm,Specify
    Item
    CTC Adverse Event Term, Specify
    text
    Item
    Were any other events (Hematologic grade 4-5 only or Non-Hematologic grade 3-5 only) noted during this time period?
    text
    Code List
    Were any other events (Hematologic grade 4-5 only or Non-Hematologic grade 3-5 only) noted during this time period?
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes, Document Below (Yes, document below)
    CompletedBy
    Item
    Completed By
    text
    DateCompleted
    Item
    Date Completed
    date

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