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11488

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FORM 6 - FINAL REPORT NCT00090974 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=ABE51386-B5AC-5668-E034-0003BA12F5E7

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=ABE51386-B5AC-5668-E034-0003BA12F5E7

Nyckelord

  1. 2012-08-26 2012-08-26 -
  2. 2015-01-09 2015-01-09 - Martin Dugas
  3. 2015-07-05 2015-07-05 -
Uppladdad den

5 juli 2015

DOI

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Creative Commons BY-NC 3.0 Legacy

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    FORM 6 - FINAL REPORT NCT00090974

    To be submitted within 6 weeks of the patient's death.

    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

    Cause Of Death
    Beskrivning

    Cause Of Death

    Date of death (yyyy mmm dd)
    Beskrivning

    DeathDate/LastContactDate

    Datatyp

    date

    Primary Cause of Death (check one)
    Beskrivning

    PrimaryCauseofDeath

    Datatyp

    text

    Due to other cause, describe primary cause of death
    Beskrivning

    DeathReason,Specify

    Datatyp

    text

    Autopsy
    Beskrivning

    Autopsy

    Autopsy?
    Beskrivning

    AutopsyInd

    Datatyp

    text

    Disease Status
    Beskrivning

    Disease Status

    Status of most recent clinical assessment
    Beskrivning

    CancerFollow-upStatus,Recent

    Datatyp

    text

    Other Malignancies Or Myelodysplastic Syndrome
    Beskrivning

    Other Malignancies Or Myelodysplastic Syndrome

    Has a new primary cancer or MDS been diagnosed that has not been previously reported?
    Beskrivning

    NewPrimaryCancerInd

    Datatyp

    boolean

    Date of diagnosis (yyyy mmm dd)
    Beskrivning

    NewPrimaryCancerDate

    Datatyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    Malignancy Type
    Beskrivning

    MalignancyType

    Datatyp

    text

    Site(s) of New Primary
    Beskrivning

    NewPrimarySite

    Datatyp

    text

    Describe (new primary cancer or MDS)
    Beskrivning

    NewPrimaryDiagnosis

    Datatyp

    text

    Toxicity Evaluation
    Beskrivning

    Toxicity Evaluation

    Did the patient experience any new or continuing toxicities since the last report?
    Beskrivning

    Didthepatientexperienceanyneworcontinuingtoxicitiessincethelastreport?

    Datatyp

    boolean

    CTC Adverse Event Term (Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
    Beskrivning

    CTCAdverseEventTerm

    Datatyp

    text

    CTC Adverse Event Term, Other (specify)
    Beskrivning

    CTCAdverseEventTerm,Other

    Datatyp

    text

    CTC Adverse Event Category (Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
    Beskrivning

    CTCAdverseEventCategory

    Datatyp

    text

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

    CTCAdverseEventGrade

    Datatyp

    text

    CTC Adverse Event Attribution Code
    Beskrivning

    CTCAdverseEventAttributionCode

    Datatyp

    text

    COMMENTS
    Beskrivning

    Comments

    Datatyp

    text

    Adverse Events
    Beskrivning

    Adverse Events

    Has the patient experienced a bone fracture since submission of last follow-up form?
    Beskrivning

    Hasthepatientexperiencedabonefracturesincesubmissionoflastfollow-upform?

    Datatyp

    boolean

    Bone Fracture Site, Spinal (Check)
    Beskrivning

    BoneFractureSite,Spinal

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Bone Fracture Site, Wrist (Check)
    Beskrivning

    BoneFractureSite,Wrist

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Bone Fracture Site, Pelvis (Check)
    Beskrivning

    BoneFractureSite,Pelvis

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Bone Fracture Site, Hip (Check)
    Beskrivning

    BoneFractureSite,Hip

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Bone Fracture Site, Femur (Check)
    Beskrivning

    BoneFractureSite,Femur

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Bone Fracture Site, Tibia (Check)
    Beskrivning

    BoneFractureSite,Tibia

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Bone Fracture Site, Ankle (Check)
    Beskrivning

    BoneFractureSite,Ankle

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Bone Fracture Site, Other (specify) (Check)
    Beskrivning

    BoneFractureSite,Other(specify)

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    indicate site (bone fracture site)
    Beskrivning

    indicatesite(bonefracturesite)

    Datatyp

    text

    Date of Bone Fracture (yyyy-mmm-dd)
    Beskrivning

    BoneFractureDate

    Datatyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C12366
    UMLS 2011AA ObjectClass
    C0262950
    NCI Thesaurus Property
    C3046
    UMLS 2011AA Property
    C0016658
    Has the patient had a new diagnosis of osteoporosis since submission of last follow-up form?
    Beskrivning

    Hasthepatienthadanewdiagnosisofosteoporosissincesubmissionoflastfollow-upform?

    Datatyp

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Date of new diagnosis of osteoporosis (yyyy mmm dd)
    Beskrivning

    DiseaseOsteoporosisDiagnosisDate

    Datatyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C3298
    UMLS 2011AA Property
    C0029456
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    NCI Thesaurus Property-2
    C15220
    UMLS 2011AA Property-2
    C0011900
    Has the patient suffered cardiovascular disease since submission of last follow-up form?
    Beskrivning

    Hasthepatientsufferedcardiovasculardiseasesincesubmissionoflastfollow-upform?

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Cardiovascular Event, Myocardial infarction (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
    Beskrivning

    CardiovascularEvent,Myocardialinfarction

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Cardiovascular Event, Stroke/transient ischemic attack (TIA) (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
    Beskrivning

    CardiovascularEvent,Stroke/transientischemicattack(TIA)

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Cardiovascular Event, On-going angina (no surgical intervention) (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
    Beskrivning

    CardiovascularEvent,On-goingangina(nosurgicalintervention)

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Cardiovascular Event, Angina requiring percutaneous transluminal coronary angioplasty (PTCA) (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
    Beskrivning

    HeartPatientAnginaPercutaneousTransluminalCoronaryAngioplastyPersonalMedicalHistoryInd-3

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ObjectClass-2
    C12727
    UMLS 2011AA ObjectClass-2
    C0018787
    NCI Thesaurus Property
    C51221
    UMLS 2011AA Property
    C0002962
    NCI Thesaurus Property-2
    C38078
    UMLS 2011AA Property-2
    C2936173
    NCI Thesaurus Property-3
    C18772
    UMLS 2011AA Property-3
    C0262926
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Cardiovascular Event, Thromboembolic event (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
    Beskrivning

    CardiovascularEvent,Thromboembolicevent

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Cardiovascular Event, Other (specify) (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
    Beskrivning

    CardiovascularEvent,Other(specify)

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    please describe event (cardiovascular event)
    Beskrivning

    pleasedescribeevent(cardiovascularevent)

    Datatyp

    text

    Date of Most Recent Episode (yyyy-mmm-dd)
    Beskrivning

    DateofMostRecentEpisode

    Datatyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    Treatment Given Since Last Report To Ncic Ctg
    Beskrivning

    Treatment Given Since Last Report To Ncic Ctg

    Is the patient receiving any non-protocol cancer therapy not previously reported?
    Beskrivning

    Non-ProtocolTherapyInd

    Datatyp

    boolean

    Non-Protocol Raloxifene Therapy?
    Beskrivning

    Non-ProtocolRaloxifeneTherapy

    Datatyp

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus Property
    C1518
    UMLS 2011AA Property
    C0244404
    NCI Thesaurus ObjectClass
    C25590
    UMLS 2011AA ObjectClass
    C1518384
    NCI Thesaurus Property-2
    C25382
    UMLS 2011AA Property-2
    C1521801
    Non-Protocol Bisphosphonate Therapy?
    Beskrivning

    Non-ProtocolTherapeuticProcedureBiphosphonateAdministeredInd-3

    Datatyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C49236
    UMLS 2011AA ObjectClass
    C0087111
    NCI Thesaurus ObjectClass-2
    C25590
    UMLS 2011AA ObjectClass-2
    C1518384
    NCI Thesaurus Property
    C443
    UMLS 2011AA Property
    C0012544
    NCI Thesaurus Property-2
    C25382
    UMLS 2011AA Property-2
    C1521801
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Non-Protocol Lipid Lowering Therapy?
    Beskrivning

    Non-ProtocolLipidLoweringTherapy

    Datatyp

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Other Non-Protocol Therapy?
    Beskrivning

    OtherTherapyInd

    Datatyp

    boolean

    Other Non-Protocol Therapy Name
    Beskrivning

    OtherNon-ProtocolTherapyName

    Datatyp

    text

    Comments
    Beskrivning

    Comments

    Supporting Documentation
    Beskrivning

    Supporting Documentation

    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 Form 6 - Final Report
    Beskrivning

    Ccrr Module For Form 6 - Final Report

    Similar models

    To be submitted within 6 weeks of the patient's death.

    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
    Cause Of Death
    DeathDate/LastContactDate
    Item
    Date of death (yyyy mmm dd)
    date
    Item
    Primary Cause of Death (check one)
    text
    Code List
    Primary Cause of Death (check one)
    CL Item
    Due To This Disease (Due to this disease)
    CL Item
    Due To Protocol Treatment (Due to protocol treatment)
    CL Item
    Cardiovascular death (specify) (Cardiovascular death (specify))
    CL Item
    Due To Other Cause, Specify (Due to other cause, describe primary cause of death)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    DeathReason,Specify
    Item
    Due to other cause, describe primary cause of death
    text
    Item Group
    Autopsy
    Item
    Autopsy?
    text
    Code List
    Autopsy?
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    Unknown (UNKNOWN)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item Group
    Disease Status
    Item
    Status of most recent clinical assessment
    text
    Code List
    Status of most recent clinical assessment
    CL Item
    No Evidence Of Disease (No evidence of disease)
    CL Item
    Cancer Present (Cancer Present)
    Item Group
    Other Malignancies Or Myelodysplastic Syndrome
    NewPrimaryCancerInd
    Item
    Has a new primary cancer or MDS been diagnosed that has not been previously reported?
    boolean
    NewPrimaryCancerDate
    Item
    Date of diagnosis (yyyy mmm dd)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    MalignancyType
    Item
    Malignancy Type
    text
    NewPrimarySite
    Item
    Site(s) of New Primary
    text
    NewPrimaryDiagnosis
    Item
    Describe (new primary cancer or MDS)
    text
    Item Group
    Toxicity Evaluation
    Didthepatientexperienceanyneworcontinuingtoxicitiessincethelastreport?
    Item
    Did the patient experience any new or continuing toxicities since the last report?
    boolean
    Item
    CTC Adverse Event Term (Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
    text
    Code List
    CTC Adverse Event Term (Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
    CL Item
    edema (edema)
    CL Item
    fatigue (lethary/malaise/asthenia) (fatigue (lethary/malaise/asthenia))
    CL Item
    sweating (diaphoresis) (sweating (diaphoresis))
    CL Item
    rash/desquamation (rash/desquamation)
    CL Item
    hot flashes/flushes (hot flashes/flushes)
    CL Item
    anorexia (anorexia)
    CL Item
    constipation (constipation)
    CL Item
    diarrhea (patients without colostomy) (diarrhea (patients without colostomy))
    CL Item
    dyspepsia/heartburn (dyspepsia/heartburn)
    CL Item
    flatulence (flatulence)
    CL Item
    nausea (nausea)
    CL Item
    vomiting (vomiting)
    CL Item
    vaginal bleeding (vaginal bleeding)
    CL Item
    infection (without neutropenia) (infection (without neutropenia))
    CL Item
    hypercholesterolemia (hypercholesterolemia)
    CL Item
    dizziness/lightheadedness (dizziness/lightheadedness)
    CL Item
    abdominal pain or cramping (abdominal pain or cramping)
    CL Item
    arthralgia (joint pain) (arthralgia (joint pain))
    CL Item
    headache (headache)
    CL Item
    cough (cough)
    CL Item
    dyspnea (shortness of breath) (dyspnea (shortness of breath))
    CL Item
    other (other)
    CTCAdverseEventTerm,Other
    Item
    CTC Adverse Event Term, Other (specify)
    text
    Item
    CTC Adverse Event Category (Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
    text
    Code List
    CTC Adverse Event Category (Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
    CL Item
    cardiovascular (cardiovascular)
    CL Item
    constitutional symptoms (constitutional symptoms)
    CL Item
    dermatology/skin (dermatology/skin)
    CL Item
    endocrine (endocrine)
    CL Item
    gastrointestinal (gastrointestinal)
    CL Item
    hemorrhage (hemorrhage)
    CL Item
    infection (infection)
    CL Item
    metabolic (metabolic)
    CL Item
    neurology (neurology)
    CL Item
    pain (pain)
    CL Item
    pulmonary (pulmonary)
    CTCAdverseEventGrade
    Item
    CTC Adverse Event Grade (Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
    text
    Item
    CTC Adverse Event Attribution Code
    text
    Code List
    CTC Adverse Event Attribution Code
    CL Item
    Unrelated (unrelated)
    C25328 (NCI Thesaurus)
    C0445356 (UMLS 2011AA)
    CL Item
    Unlikely (unlikely)
    CL Item
    possible (possible)
    CL Item
    Probably (probable)
    CL Item
    Definitely (definite)
    Comments
    Item
    COMMENTS
    text
    Item Group
    Adverse Events
    Hasthepatientexperiencedabonefracturesincesubmissionoflastfollow-upform?
    Item
    Has the patient experienced a bone fracture since submission of last follow-up form?
    boolean
    Item
    Bone Fracture Site, Spinal (Check)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    Code List
    Bone Fracture Site, Spinal (Check)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Bone Fracture Site, Wrist (Check)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    Code List
    Bone Fracture Site, Wrist (Check)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Bone Fracture Site, Pelvis (Check)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    Code List
    Bone Fracture Site, Pelvis (Check)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Bone Fracture Site, Hip (Check)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    Code List
    Bone Fracture Site, Hip (Check)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Bone Fracture Site, Femur (Check)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    Code List
    Bone Fracture Site, Femur (Check)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Bone Fracture Site, Tibia (Check)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    Code List
    Bone Fracture Site, Tibia (Check)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Bone Fracture Site, Ankle (Check)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    Code List
    Bone Fracture Site, Ankle (Check)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Bone Fracture Site, Other (specify) (Check)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    Code List
    Bone Fracture Site, Other (specify) (Check)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    indicatesite(bonefracturesite)
    Item
    indicate site (bone fracture site)
    text
    BoneFractureDate
    Item
    Date of Bone Fracture (yyyy-mmm-dd)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C12366 (NCI Thesaurus ObjectClass)
    C0262950 (UMLS 2011AA ObjectClass)
    C3046 (NCI Thesaurus Property)
    C0016658 (UMLS 2011AA Property)
    Hasthepatienthadanewdiagnosisofosteoporosissincesubmissionoflastfollow-upform?
    Item
    Has the patient had a new diagnosis of osteoporosis since submission of last follow-up form?
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    DiseaseOsteoporosisDiagnosisDate
    Item
    Date of new diagnosis of osteoporosis (yyyy mmm dd)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C3298 (NCI Thesaurus Property)
    C0029456 (UMLS 2011AA Property)
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    C15220 (NCI Thesaurus Property-2)
    C0011900 (UMLS 2011AA Property-2)
    Hasthepatientsufferedcardiovasculardiseasesincesubmissionoflastfollow-upform?
    Item
    Has the patient suffered cardiovascular disease since submission of last follow-up form?
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    Item
    Cardiovascular Event, Myocardial infarction (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    Code List
    Cardiovascular Event, Myocardial infarction (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Cardiovascular Event, Stroke/transient ischemic attack (TIA) (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    Code List
    Cardiovascular Event, Stroke/transient ischemic attack (TIA) (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Cardiovascular Event, On-going angina (no surgical intervention) (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    Code List
    Cardiovascular Event, On-going angina (no surgical intervention) (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Cardiovascular Event, Angina requiring percutaneous transluminal coronary angioplasty (PTCA) (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C12727 (NCI Thesaurus ObjectClass-2)
    C0018787 (UMLS 2011AA ObjectClass-2)
    C51221 (NCI Thesaurus Property)
    C0002962 (UMLS 2011AA Property)
    C38078 (NCI Thesaurus Property-2)
    C2936173 (UMLS 2011AA Property-2)
    C18772 (NCI Thesaurus Property-3)
    C0262926 (UMLS 2011AA Property-3)
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    Code List
    Cardiovascular Event, Angina requiring percutaneous transluminal coronary angioplasty (PTCA) (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Cardiovascular Event, Thromboembolic event (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    Code List
    Cardiovascular Event, Thromboembolic event (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Cardiovascular Event, Other (specify) (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    Code List
    Cardiovascular Event, Other (specify) (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    pleasedescribeevent(cardiovascularevent)
    Item
    please describe event (cardiovascular event)
    text
    DateofMostRecentEpisode
    Item
    Date of Most Recent Episode (yyyy-mmm-dd)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    Item Group
    Treatment Given Since Last Report To Ncic Ctg
    Non-ProtocolTherapyInd
    Item
    Is the patient receiving any non-protocol cancer therapy not previously reported?
    boolean
    Non-ProtocolRaloxifeneTherapy
    Item
    Non-Protocol Raloxifene Therapy?
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C1518 (NCI Thesaurus Property)
    C0244404 (UMLS 2011AA Property)
    C25590 (NCI Thesaurus ObjectClass)
    C1518384 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property-2)
    C1521801 (UMLS 2011AA Property-2)
    Non-ProtocolTherapeuticProcedureBiphosphonateAdministeredInd-3
    Item
    Non-Protocol Bisphosphonate Therapy?
    boolean
    C49236 (NCI Thesaurus ObjectClass)
    C0087111 (UMLS 2011AA ObjectClass)
    C25590 (NCI Thesaurus ObjectClass-2)
    C1518384 (UMLS 2011AA ObjectClass-2)
    C443 (NCI Thesaurus Property)
    C0012544 (UMLS 2011AA Property)
    C25382 (NCI Thesaurus Property-2)
    C1521801 (UMLS 2011AA Property-2)
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    Non-ProtocolLipidLoweringTherapy
    Item
    Non-Protocol Lipid Lowering Therapy?
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    OtherTherapyInd
    Item
    Other Non-Protocol Therapy?
    boolean
    OtherNon-ProtocolTherapyName
    Item
    Other Non-Protocol Therapy Name
    text
    Item Group
    Comments
    Item Group
    Supporting Documentation
    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 Form 6 - Final Report

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