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ID

9402

Beskrivning

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

Länk

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

Nyckelord

Versioner (2)
  1. 2012-08-26 2012-08-26 -
  2. 2015-01-09 2015-01-09 - Martin Dugas
Uppladdad den

9 januari 2015

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy
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    Breast Cancer NCT00090974 Off Treatment - OFF TREATMENT FORM (OPT) - 2058934v3.0

    Engelsk

    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 Formulär  
    Patient Information
    Beskrivning

    Patient Information

    Patient Study ID, Coordinating Group
    Beskrivning

    PatientStudyID,CoordinatingGroup

    Datatyp

    text

    Patient Initials (first - middle - last)
    Beskrivning

    Patient Initials

    Datatyp

    text

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

    PatientMedicalRecordNumber

    Datatyp

    text

    Investigator Name
    Beskrivning

    InvestigatorName

    Datatyp

    text

    Institution Name
    Beskrivning

    InstitutionName

    Datatyp

    text

    Registered Investigator (NCI Investigator #)
    Beskrivning

    RegisteredInvestigator

    Datatyp

    text

    Off Protocol Therapy
    Beskrivning

    Off Protocol Therapy

    Treatment End Date (yyyy mmm dd)
    Beskrivning

    TreatmentEndDate

    Datatyp

    date

    Reason treatment ended (both components of study)
    Beskrivning

    OffTreatmentReason

    Datatyp

    text

    Other specify (Reason treatment ended)
    Beskrivning

    OffTreatmentReason,Other

    Datatyp

    text

    CTC Adverse Event Term
    Beskrivning

    CTCAdverseEventTerm

    Datatyp

    text

    CTC Adverse Event Category
    Beskrivning

    CTCAdverseEventCategory

    Datatyp

    text

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

    CTCAdverseEventGrade

    Datatyp

    text

    CTC Adverse Event Attribution Code
    Beskrivning

    CTCAdverseEventAttributionCode

    Datatyp

    text

    Unblinding
    Beskrivning

    Unblinding

    Was study treatment unblinded?
    Beskrivning

    TreatmentUnblindingIndicator

    Datatyp

    boolean

    Date study treatment unblinded (yyyy mmm dd)
    Beskrivning

    TreatmentUnblindedDate

    Datatyp

    text

    Header
    Beskrivning

    Header

    Patient Study ID, Coordinating Group
    Beskrivning

    PatientStudyID,CoordinatingGroup

    Datatyp

    text

    Patient Initials (first - middle - last)
    Beskrivning

    Patient Initials

    Datatyp

    text

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

    Comments

    COMMENTS
    Beskrivning

    Comments

    Datatyp

    text

    Investigator Signature
    Beskrivning

    Investigator Signature

    Investigator Signature
    Beskrivning

    InvestigatorSignature

    Datatyp

    text

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

    PersonCompletingForm,LastName

    Datatyp

    text

    Person Completing Form, First Name
    Beskrivning

    PersonCompletingForm,FirstName

    Datatyp

    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)
    Beskrivning

    FormCompletionDate,Original

    Datatyp

    date

    Ccrr Module For Off Treatment Form (opt)
    Beskrivning

    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 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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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