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ID

9402

Description

OFF TREATMENT FORM (OPT) Quality Of Life Companion Study For JMA27 (NCIC-MA.27): A Randomized Phase III Trial Of Exemestane Versus Anastrozole With Or Without Celecoxib In Postmenopausal Women With Receptor Positive Primary Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=ABE19FE8-ADA4-53BD-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=ABE19FE8-ADA4-53BD-E034-0003BA12F5E7

Keywords

Versions (2)
  1. 8/26/12 8/26/12 -
  2. 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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    Breast Cancer NCT00090974 Off Treatment - OFF TREATMENT FORM (OPT) - 2058934v3.0

    English

    Canadian Centres: When completed please mail to: National Cancer Institute of Canada, Clinical Trials Group, Queen's University, 82-84 Barrie Street, Kingston, Ontario, K7L 3N6

    1 forms  
    Patient Information
    Description

    Patient Information

    Patient Study ID, Coordinating Group
    Description

    PatientStudyID,CoordinatingGroup

    Data type

    text

    Patient Initials (first - middle - last)
    Description

    Patient Initials

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    Patient Medical Record Number
    Description

    PatientMedicalRecordNumber

    Data type

    text

    Investigator Name
    Description

    InvestigatorName

    Data type

    text

    Institution Name
    Description

    InstitutionName

    Data type

    text

    Registered Investigator (NCI Investigator #)
    Description

    RegisteredInvestigator

    Data type

    text

    Off Protocol Therapy
    Description

    Off Protocol Therapy

    Treatment End Date (yyyy mmm dd)
    Description

    TreatmentEndDate

    Data type

    date

    Reason treatment ended (both components of study)
    Description

    OffTreatmentReason

    Data type

    text

    Other specify (Reason treatment ended)
    Description

    OffTreatmentReason,Other

    Data type

    text

    CTC Adverse Event Term
    Description

    CTCAdverseEventTerm

    Data type

    text

    CTC Adverse Event Category
    Description

    CTCAdverseEventCategory

    Data type

    text

    CTC Adverse Event Grade (Grade according to NCI Common Toxicity Criteria, Version 2.0)
    Description

    CTCAdverseEventGrade

    Data type

    text

    CTC Adverse Event Attribution Code
    Description

    CTCAdverseEventAttributionCode

    Data type

    text

    Unblinding
    Description

    Unblinding

    Was study treatment unblinded?
    Description

    TreatmentUnblindingIndicator

    Data type

    boolean

    Date study treatment unblinded (yyyy mmm dd)
    Description

    TreatmentUnblindedDate

    Data type

    text

    Header
    Description

    Header

    Patient Study ID, Coordinating Group
    Description

    PatientStudyID,CoordinatingGroup

    Data type

    text

    Patient Initials (first - middle - last)
    Description

    Patient Initials

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    Comments
    Description

    Comments

    COMMENTS
    Description

    Comments

    Data type

    text

    Investigator Signature
    Description

    Investigator Signature

    Investigator Signature
    Description

    InvestigatorSignature

    Data type

    text

    Alias
    NCI Thesaurus Property
    C25678
    UMLS 2011AA Property
    C1519316
    NCI Thesaurus ObjectClass
    C17089
    UMLS 2011AA ObjectClass
    C0035173
    Person Completing Form, Last Name
    Description

    PersonCompletingForm,LastName

    Data type

    text

    Person Completing Form, First Name
    Description

    PersonCompletingForm,FirstName

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    Form Completion Date, Original (yyyy mmm dd)
    Description

    FormCompletionDate,Original

    Data type

    date

    Ccrr Module For Off Treatment Form (opt)
    Description

    Ccrr Module For Off Treatment Form (opt)

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    Similar models

    Canadian Centres: When completed please mail to: National Cancer Institute of Canada, Clinical Trials Group, Queen's University, 82-84 Barrie Street, Kingston, Ontario, K7L 3N6

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Patient Information
    PatientStudyID,CoordinatingGroup
    Item
    Patient Study ID, Coordinating Group
    text
    Patient Initials
    Item
    Patient Initials (first - middle - last)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    PatientMedicalRecordNumber
    Item
    Patient Medical Record Number
    text
    InvestigatorName
    Item
    Investigator Name
    text
    InstitutionName
    Item
    Institution Name
    text
    RegisteredInvestigator
    Item
    Registered Investigator (NCI Investigator #)
    text
    Item Group
    Off Protocol Therapy
    TreatmentEndDate
    Item
    Treatment End Date (yyyy mmm dd)
    date
    Item
    Reason treatment ended (both components of study)
    text
    CL.1
    Code List
    Reason treatment ended (both components of study)
    CL Item
    Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
    CL Item
    Patient Off-treatment For Other Complicating Disease (Patient off treatment for other complicating disease)
    CL Item
    Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
    CL Item
    Toxicity/side Effects/complications (Toxicity/side effects/complications)
    CL Item
    Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal or refusal after beginning protocol therapy)
    CL Item
    Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal or refusal prior to beginning protocol therapy)
    CL Item
    Death On Study (Death on-study)
    CL Item
    Other, Specify (Other specify)
    OffTreatmentReason,Other
    Item
    Other specify (Reason treatment ended)
    text
    CTCAdverseEventTerm
    Item
    CTC Adverse Event Term
    text
    CTCAdverseEventCategory
    Item
    CTC Adverse Event Category
    text
    CTCAdverseEventGrade
    Item
    CTC Adverse Event Grade (Grade according to NCI Common Toxicity Criteria, Version 2.0)
    text
    Item
    CTC Adverse Event Attribution Code
    text
    CL.2
    Code List
    CTC Adverse Event Attribution Code
    CL Item
    Unrelated (unrelated)
    C25328 (NCI Thesaurus)
    C0445356 (UMLS 2011AA)
    CL Item
    Unlikely (unlikely)
    CL Item
    Possibly (possible)
    CL Item
    Probably (probable)
    CL Item
    Definitely (definite)
    Item Group
    Unblinding
    TreatmentUnblindingIndicator
    Item
    Was study treatment unblinded?
    boolean
    TreatmentUnblindedDate
    Item
    Date study treatment unblinded (yyyy mmm dd)
    text
    Item Group
    Header
    PatientStudyID,CoordinatingGroup
    Item
    Patient Study ID, Coordinating Group
    text
    Patient Initials
    Item
    Patient Initials (first - middle - last)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Item Group
    Comments
    Comments
    Item
    COMMENTS
    text
    Item Group
    Investigator Signature
    InvestigatorSignature
    Item
    Investigator Signature
    text
    C25678 (NCI Thesaurus Property)
    C1519316 (UMLS 2011AA Property)
    C17089 (NCI Thesaurus ObjectClass)
    C0035173 (UMLS 2011AA ObjectClass)
    PersonCompletingForm,LastName
    Item
    Person Completing Form, Last Name
    text
    PersonCompletingForm,FirstName
    Item
    Person Completing Form, First Name
    text
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    FormCompletionDate,Original
    Item
    Form Completion Date, Original (yyyy mmm dd)
    date
    Item Group
    Ccrr Module For Off Treatment Form (opt)
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