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ID

10626

Beschreibung

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

Stichworte

  1. 26.08.12 26.08.12 -
  2. 22.05.15 22.05.15 -
  3. 03.06.15 03.06.15 -
  4. 03.06.15 03.06.15 -
Hochgeladen am

3. Juni 2015

DOI

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Lizenz

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
    Beschreibung

    CALGB clinical trial administrative data

    CALGB Form
    Beschreibung

    CALGBForm

    Datentyp

    text

    CALGB Study No
    Beschreibung

    CALGBProtocolNumber

    Datentyp

    text

    CALGB Patient ID
    Beschreibung

    CALGBPatientID

    Datentyp

    text

    From
    Beschreibung

    From

    Datentyp

    text

    To
    Beschreibung

    To

    Datentyp

    text

    Amended data?
    Beschreibung

    AmendedDataInd

    Datentyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C25474
    UMLS 2011AA ObjectClass
    C1511726
    NCI Thesaurus Property
    C25416
    UMLS 2011AA Property
    C1691222
    Patient clinical trial data
    Beschreibung

    Patient clinical trial data

    Patient's Name
    Beschreibung

    Patient'sName

    Datentyp

    text

    Participating Group
    Beschreibung

    ParticipatingGroup

    Datentyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C17005
    UMLS 2011AA ObjectClass
    C1257890
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    Patient Hospital Number
    Beschreibung

    PatientHospitalNumber

    Datentyp

    text

    Participating Group Protocol No.
    Beschreibung

    ParticipatingGroupProtocolNo.

    Datentyp

    text

    Main Member Institution/Adjunct
    Beschreibung

    MainMemberInstitution/Adjunct

    Datentyp

    text

    Participating Group Patient No.
    Beschreibung

    ParticipatingGroupPatientNo.

    Datentyp

    text

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

    WasanAER/ADRfiledwithCentralOfficebasedonaneventreportedbelow?

    Datentyp

    text

    Expected Adverse Events
    Beschreibung

    Expected Adverse Events

    IMT Code
    Beschreibung

    IMTCode

    Datentyp

    text

    CTC Adverse Event Term
    Beschreibung

    CTCAdverseEventTerm

    Datentyp

    text

    CTC Grade
    Beschreibung

    CTCGrade

    Datentyp

    text

    Attribution
    Beschreibung

    Attribution

    Datentyp

    text

    CTC Adverse Event Term, Specify
    Beschreibung

    CTCAdverseEventTerm,Specify

    Datentyp

    text

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

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

    Datentyp

    text

    Completed By
    Beschreibung

    CompletedBy

    Datentyp

    text

    Date Completed
    Beschreibung

    DateCompleted

    Datentyp

    date

    Ähnliche Modelle

    No Instruction available.

    1. StudyEvent: CALGB: 49808 ADVERSE EVENT FORM DOXORUBICIN + CYCLOPHOSPHAMIDE + ZINECARD (AC+Z)
      1. No Instruction available.
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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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