0 Bewertungen

ID

11488

Beschreibung

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

Link

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

Stichworte

  1. 26.08.12 26.08.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
  3. 05.07.15 05.07.15 -
Hochgeladen am

5. Juli 2015

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0 Legacy

Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Itemgroup Kommentare für :

Item Kommentare für :


    Keine Kommentare

    Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

    FORM 6 - FINAL REPORT NCT00090974

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

    Patient Information
    Beschreibung

    Patient Information

    Patient Study ID, Coordinating Group
    Beschreibung

    PatientStudyID,CoordinatingGroup

    Datentyp

    text

    Patient Initials (first - middle - last)
    Beschreibung

    Patient Initials

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191 (undefined)
    UMLS CUI-1
    C2986440 (Person Initials)
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    NCI Thesaurus Property
    C25536 (undefined)
    Patient Medical Record Number
    Beschreibung

    PatientMedicalRecordNumber

    Datentyp

    text

    Investigator Name
    Beschreibung

    InvestigatorName

    Datentyp

    text

    Institution Name
    Beschreibung

    InstitutionName

    Datentyp

    text

    Registered Investigator (NCI Investigator #)
    Beschreibung

    RegisteredInvestigator

    Datentyp

    text

    Cause Of Death
    Beschreibung

    Cause Of Death

    Date of death (yyyy mmm dd)
    Beschreibung

    DeathDate/LastContactDate

    Datentyp

    date

    Primary Cause of Death (check one)
    Beschreibung

    PrimaryCauseofDeath

    Datentyp

    text

    Due to other cause, describe primary cause of death
    Beschreibung

    DeathReason,Specify

    Datentyp

    text

    Autopsy
    Beschreibung

    Autopsy

    Autopsy?
    Beschreibung

    AutopsyInd

    Datentyp

    text

    Disease Status
    Beschreibung

    Disease Status

    Status of most recent clinical assessment
    Beschreibung

    CancerFollow-upStatus,Recent

    Datentyp

    text

    Other Malignancies Or Myelodysplastic Syndrome
    Beschreibung

    Other Malignancies Or Myelodysplastic Syndrome

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

    NewPrimaryCancerInd

    Datentyp

    boolean

    Date of diagnosis (yyyy mmm dd)
    Beschreibung

    NewPrimaryCancerDate

    Datentyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164 (undefined)
    UMLS 2011AA ValueDomain
    C0011008 (Date in time)
    SNOMED
    410671006
    Malignancy Type
    Beschreibung

    MalignancyType

    Datentyp

    text

    Site(s) of New Primary
    Beschreibung

    NewPrimarySite

    Datentyp

    text

    Describe (new primary cancer or MDS)
    Beschreibung

    NewPrimaryDiagnosis

    Datentyp

    text

    Toxicity Evaluation
    Beschreibung

    Toxicity Evaluation

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

    Didthepatientexperienceanyneworcontinuingtoxicitiessincethelastreport?

    Datentyp

    boolean

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

    CTCAdverseEventTerm

    Datentyp

    text

    CTC Adverse Event Term, Other (specify)
    Beschreibung

    CTCAdverseEventTerm,Other

    Datentyp

    text

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

    CTCAdverseEventCategory

    Datentyp

    text

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

    CTCAdverseEventGrade

    Datentyp

    text

    CTC Adverse Event Attribution Code
    Beschreibung

    CTCAdverseEventAttributionCode

    Datentyp

    text

    COMMENTS
    Beschreibung

    Comments

    Datentyp

    text

    Adverse Events
    Beschreibung

    Adverse Events

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

    Hasthepatientexperiencedabonefracturesincesubmissionoflastfollow-upform?

    Datentyp

    boolean

    Bone Fracture Site, Spinal (Check)
    Beschreibung

    BoneFractureSite,Spinal

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148 (undefined)
    UMLS 2011AA ValueDomain
    C1512699 (Yes, No, or Unknown Response)
    Bone Fracture Site, Wrist (Check)
    Beschreibung

    BoneFractureSite,Wrist

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148 (undefined)
    UMLS 2011AA ValueDomain
    C1512699 (Yes, No, or Unknown Response)
    Bone Fracture Site, Pelvis (Check)
    Beschreibung

    BoneFractureSite,Pelvis

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148 (undefined)
    UMLS 2011AA ValueDomain
    C1512699 (Yes, No, or Unknown Response)
    Bone Fracture Site, Hip (Check)
    Beschreibung

    BoneFractureSite,Hip

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148 (undefined)
    UMLS 2011AA ValueDomain
    C1512699 (Yes, No, or Unknown Response)
    Bone Fracture Site, Femur (Check)
    Beschreibung

    BoneFractureSite,Femur

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148 (undefined)
    UMLS 2011AA ValueDomain
    C1512699 (Yes, No, or Unknown Response)
    Bone Fracture Site, Tibia (Check)
    Beschreibung

    BoneFractureSite,Tibia

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148 (undefined)
    UMLS 2011AA ValueDomain
    C1512699 (Yes, No, or Unknown Response)
    Bone Fracture Site, Ankle (Check)
    Beschreibung

    BoneFractureSite,Ankle

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148 (undefined)
    UMLS 2011AA ValueDomain
    C1512699 (Yes, No, or Unknown Response)
    Bone Fracture Site, Other (specify) (Check)
    Beschreibung

    BoneFractureSite,Other(specify)

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148 (undefined)
    UMLS 2011AA ValueDomain
    C1512699 (Yes, No, or Unknown Response)
    indicate site (bone fracture site)
    Beschreibung

    indicatesite(bonefracturesite)

    Datentyp

    text

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

    BoneFractureDate

    Datentyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164 (undefined)
    UMLS 2011AA ValueDomain
    C0011008 (Date in time)
    SNOMED
    410671006
    NCI Thesaurus ObjectClass
    C12366 (undefined)
    UMLS 2011AA ObjectClass
    C0262950 (Skeletal bone)
    SNOMED
    272673000
    LOINC
    LP29835-3
    NCI Thesaurus Property
    C3046 (undefined)
    UMLS 2011AA Property
    C0016658 (Fracture)
    SNOMED
    72704001
    LOINC
    LA7437-2
    Has the patient had a new diagnosis of osteoporosis since submission of last follow-up form?
    Beschreibung

    Hasthepatienthadanewdiagnosisofosteoporosissincesubmissionoflastfollow-upform?

    Datentyp

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148 (undefined)
    UMLS 2011AA ValueDomain
    C1512699 (Yes, No, or Unknown Response)
    Date of new diagnosis of osteoporosis (yyyy mmm dd)
    Beschreibung

    DiseaseOsteoporosisDiagnosisDate

    Datentyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164 (undefined)
    UMLS 2011AA ValueDomain
    C0011008 (Date in time)
    SNOMED
    410671006
    NCI Thesaurus Property
    C3298 (undefined)
    UMLS 2011AA Property
    C0029456 (Osteoporosis)
    SNOMED
    64859006
    LOINC
    MTHU020796
    NCI Thesaurus ObjectClass
    C2991 (undefined)
    UMLS 2011AA ObjectClass
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    NCI Thesaurus Property-2
    C15220 (undefined)
    UMLS 2011AA Property-2
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    Has the patient suffered cardiovascular disease since submission of last follow-up form?
    Beschreibung

    Hasthepatientsufferedcardiovasculardiseasesincesubmissionoflastfollow-upform?

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148 (undefined)
    UMLS 2011AA ValueDomain
    C1512699 (Yes, No, or Unknown Response)
    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.)
    Beschreibung

    CardiovascularEvent,Myocardialinfarction

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148 (undefined)
    UMLS 2011AA ValueDomain
    C1512699 (Yes, No, or Unknown Response)
    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.)
    Beschreibung

    CardiovascularEvent,Stroke/transientischemicattack(TIA)

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148 (undefined)
    UMLS 2011AA ValueDomain
    C1512699 (Yes, No, or Unknown Response)
    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.)
    Beschreibung

    CardiovascularEvent,On-goingangina(nosurgicalintervention)

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148 (undefined)
    UMLS 2011AA ValueDomain
    C1512699 (Yes, No, or Unknown Response)
    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.)
    Beschreibung

    HeartPatientAnginaPercutaneousTransluminalCoronaryAngioplastyPersonalMedicalHistoryInd-3

    Datentyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    UMLS 2011AA ObjectClass
    C0030705 (Patients)
    SNOMED
    116154003
    NCI Thesaurus ObjectClass-2
    C12727 (undefined)
    UMLS 2011AA ObjectClass-2
    C0018787 (Heart)
    SNOMED
    80891009
    LOINC
    LP7289-4
    NCI Thesaurus Property
    C51221 (undefined)
    UMLS 2011AA Property
    C0002962 (Angina Pectoris)
    SNOMED
    194828000
    NCI Thesaurus Property-2
    C38078 (undefined)
    UMLS 2011AA Property-2
    C2936173 (Percutaneous Transluminal Coronary Angioplasty)
    SNOMED
    11101003
    NCI Thesaurus Property-3
    C18772 (undefined)
    UMLS 2011AA Property-3
    C0262926 (Medical History)
    SNOMED
    392521001
    LOINC
    LP6817-3
    NCI Thesaurus ValueDomain
    C38148 (undefined)
    UMLS 2011AA ValueDomain
    C1512699 (Yes, No, or Unknown Response)
    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.)
    Beschreibung

    CardiovascularEvent,Thromboembolicevent

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148 (undefined)
    UMLS 2011AA ValueDomain
    C1512699 (Yes, No, or Unknown Response)
    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.)
    Beschreibung

    CardiovascularEvent,Other(specify)

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148 (undefined)
    UMLS 2011AA ValueDomain
    C1512699 (Yes, No, or Unknown Response)
    please describe event (cardiovascular event)
    Beschreibung

    pleasedescribeevent(cardiovascularevent)

    Datentyp

    text

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

    DateofMostRecentEpisode

    Datentyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164 (undefined)
    UMLS 2011AA ValueDomain
    C0011008 (Date in time)
    SNOMED
    410671006
    Treatment Given Since Last Report To Ncic Ctg
    Beschreibung

    Treatment Given Since Last Report To Ncic Ctg

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

    Non-ProtocolTherapyInd

    Datentyp

    boolean

    Non-Protocol Raloxifene Therapy?
    Beschreibung

    Non-ProtocolRaloxifeneTherapy

    Datentyp

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148 (undefined)
    UMLS 2011AA ValueDomain
    C1512699 (Yes, No, or Unknown Response)
    NCI Thesaurus Property
    C1518 (undefined)
    UMLS 2011AA Property
    C0244404 (raloxifene)
    SNOMED
    419530003
    NCI Thesaurus ObjectClass
    C25590 (undefined)
    UMLS 2011AA ObjectClass
    C1518384 (Non-Protocol)
    NCI Thesaurus Property-2
    C25382 (undefined)
    UMLS 2011AA Property-2
    C1521801 (Having administered)
    Non-Protocol Bisphosphonate Therapy?
    Beschreibung

    Non-ProtocolTherapeuticProcedureBiphosphonateAdministeredInd-3

    Datentyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C49236 (undefined)
    UMLS 2011AA ObjectClass
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    NCI Thesaurus ObjectClass-2
    C25590 (undefined)
    UMLS 2011AA ObjectClass-2
    C1518384 (Non-Protocol)
    NCI Thesaurus Property
    C443 (undefined)
    UMLS 2011AA Property
    C0012544 (Diphosphonates)
    SNOMED
    372907000
    NCI Thesaurus Property-2
    C25382 (undefined)
    UMLS 2011AA Property-2
    C1521801 (Having administered)
    NCI Thesaurus ValueDomain
    C38148 (undefined)
    UMLS 2011AA ValueDomain
    C1512699 (Yes, No, or Unknown Response)
    Non-Protocol Lipid Lowering Therapy?
    Beschreibung

    Non-ProtocolLipidLoweringTherapy

    Datentyp

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148 (undefined)
    UMLS 2011AA ValueDomain
    C1512699 (Yes, No, or Unknown Response)
    Other Non-Protocol Therapy?
    Beschreibung

    OtherTherapyInd

    Datentyp

    boolean

    Other Non-Protocol Therapy Name
    Beschreibung

    OtherNon-ProtocolTherapyName

    Datentyp

    text

    Comments
    Beschreibung

    Comments

    Supporting Documentation
    Beschreibung

    Supporting Documentation

    Investigator Signature
    Beschreibung

    Investigator Signature

    Investigator Signature
    Beschreibung

    InvestigatorSignature

    Datentyp

    text

    Alias
    NCI Thesaurus Property
    C25678 (undefined)
    UMLS 2011AA Property
    C1519316 (Signature)
    LOINC
    LP248948-4
    NCI Thesaurus ObjectClass
    C17089 (undefined)
    UMLS 2011AA ObjectClass
    C0035173 (Research Personnel)
    SNOMED
    769038007
    LOINC
    LA23773-7
    Person Completing Form, Last Name
    Beschreibung

    PersonCompletingForm,LastName

    Datentyp

    text

    Person Completing Form, First Name
    Beschreibung

    PersonCompletingForm,FirstName

    Datentyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190 (undefined)
    UMLS 2011AA ObjectClass
    C0027361 (Persons)
    SNOMED
    125676002
    NCI Thesaurus Property
    C25364 (undefined)
    UMLS 2011AA Property
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Form Completion Date, Original (yyyy mmm dd)
    Beschreibung

    FormCompletionDate,Original

    Datentyp

    date

    Ccrr Module For Form 6 - Final Report
    Beschreibung

    Ccrr Module For Form 6 - Final Report

    Ähnliche Modelle

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

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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

    Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

    Zum Video