ID

852

Descripción

FORM 1 - ELIGIBILITY CHECK LIST AND INITIAL EVALUATION MA.27 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=ABF84340-BD14-67AC-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=ABF84340-BD14-67AC-E034-0003BA12F5E7

Palabras clave

Versiones (3)
  1. 26/8/12 26/8/12 -
  2. 12/12/14 12/12/14 - Martin Dugas
  3. 13/4/21 13/4/21 - Dr. rer. medic Philipp Neuhaus
Subido en

26 de agosto de 2012

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00090974 On-Study - FORM 1 - ELIGIBILITY CHECK LIST AND INITIAL EVALUATION MA.27 - 2067101v3.0

Inglés

A RANDOMIZED PHASE III TRIAL OF EXEMESTANE VERSUS ANASTROZOLE WITH OR WITHOUT CELECOXIB IN POSTMENOPAUSAL WOMEN WITH RECEPTOR POSITIVE PRIMARY BREAST CANCER-MA.27

1 formularios  
Patient Information
Descripción

Patient Information

Patient Study ID, Coordinating Group
Descripción

PatientStudyID,CoordinatingGroup

Tipo de datos

text

Patient Initials (first - middle - last)
Descripción

PatientInitialsName

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Patient Medical Record Number
Descripción

PatientMedicalRecordNumber

Tipo de datos

text

Investigator Name
Descripción

InvestigatorName

Tipo de datos

text

Institution Name
Descripción

InstitutionName

Tipo de datos

text

Registered Investigator (NCI Investigator #)
Descripción

RegisteredInvestigator

Tipo de datos

text

Patient?s Date of Birth (yyyy mmm dd)
Descripción

PatientBirthDate

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Patient Gender
Descripción

PatientGender

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17357
UMLS 2011AA Property
C0079399
Patient Race (check all that apply Patient is encouraged to self designate: Race Categories and Definitions definitions given with each value)
Descripción

PatientRace

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17049
UMLS 2011AA Property
C0034510
Patient Ethnicity (check one only Ethnicity Categories and Definitions definition given with value value)
Descripción

PatientEthnicity

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17049
UMLS 2011AA Property
C0034510
Payment method (check one USA only)
Descripción

PaymentMethod

Tipo de datos

text

IRB/REB Approval Date ([initial approval or annual renewal] yyyy mmm dd)
Descripción

IRBApprovalDate

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25425
UMLS 2011AA Property
C0205540
Projected Start Date of Treatment ([within 10 working days of randomization] yyyy mmm dd)
Descripción

ProjectedTreatmentBeginDate

Tipo de datos

date

Unnamed Header Module Pg2
Descripción

Unnamed Header Module Pg2

Patient Study ID, Coordinating Group
Descripción

PatientStudyID,CoordinatingGroup

Tipo de datos

text

Patient Initials (first - middle - last)
Descripción

PatientInitialsName

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Eligibility Checklist
Descripción

Eligibility Checklist

Patient has completely resected and histologically confirmed invasive breast carcinoma.
Descripción

Patienthascompletelyresectedandhistologicallyconfirmedinvasivebreastcarcinoma.

Tipo de datos

text

Date Prior Adjuvant Chemotherapy Ended (yyyy-mmm-dd)
Descripción

PriorAdjuvantChemotherapyEndDate

Tipo de datos

date

Pathological TNM classification is (M stage)
Descripción

TNMClassificationScheme

Tipo de datos

text

Pathological TNM classification is (M stage)
Descripción

TNMClassificationScheme

Tipo de datos

text

Pathological TNM classification is (M stage)
Descripción

TNMClassificationScheme

Tipo de datos

text

Primary tumour is receptor positive i.e. ER and/or PgR positive (defined as receptor content of >= 10fmol/mg protein or receptor positive by ERICA or PgRICA).
Descripción

Primarytumourisreceptorpositivei.e.ERand/orPgRpositive

Tipo de datos

text

If patient has bilateral breast cancer, both were diagnosed at the same time and at least one of the bilateral cancers is receptor positive (as defined above)
Descripción

Ifpatienthasbilateralbreastcancer,bothwerediagnosedatthesametimeandatleastoneofthebilateralcancersisreceptorpositive

Tipo de datos

text

Patient is post-menopausal according to one of these three criteria
Descripción

VerificationofPostmenopausalStatus

Tipo de datos

text

Alias
NCI Thesaurus Property
C38008
UMLS 2011AA Property
C0687676
NCI Thesaurus Property
C3231
UMLS 2011AA Property
C0025320
NCI Thesaurus ObjectClass
C25171
UMLS 2011AA ObjectClass
C0013893
FSH value
Descripción

FSHvalue

Tipo de datos

text

Date (FSH value) (yyyy mmm dd)
Descripción

LaboratoryProcedureFollicleStimulatingHormoneResultDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C2286
UMLS 2011AA Property
C0733758
Radiologic investigations have been completed within 4 weeks prior to surgical resection of primary tumour and are negative for metastases
Descripción

Radiologicinvestigationshavebeencompletedwithin4weekspriortosurgicalresectionofprimarytumourandarenegativeformetastases

Tipo de datos

text

Radiologic investigations have been completed (To specify investigations)
Descripción

Radiologicinvestigationshavebeencompleted(Tospecifyinvestigations)

Tipo de datos

text

bone scan (required only if alkaline phosphatase is >= 2 x UNL and/or there are symptoms of metastatic disease a confirmatory x-ray or other imaging study such as CT or MRI is required if the results from the bone scan are questionable)
Descripción

bonescan

Tipo de datos

text

abdominal ultrasound or CT abdomen (required only if the AST/ALT or alkaline phosphatase is > 2 x UNL unless the elevation is in the bone fraction)
Descripción

abdominalultrasoundorCTabdomen

Tipo de datos

text

Date of chest x-ray (yyyy mmm dd)
Descripción

ChestX-RayAssessmentDate

Tipo de datos

date

Patient has had a bilateral mammogram within 10 months prior to randomization.
Descripción

BilateralMammogramAnnualEligibilityInd-2

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C20178
UMLS 2011AA ObjectClass
C0024671
NCI Thesaurus ObjectClass
C13332
UMLS 2011AA ObjectClass
C0238767
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Metathesaurus Property
CL158135
Date of bilateral mammogram (yyyy mmm dd)
Descripción

Dateofbilateralmammogram

Tipo de datos

text

If patient has received prior adjuvant chemotherapy, no less than 3 weeks and no more than 3 months have elapsed since completion of chemotherapy (planned radiotherapy may be given concurrently with protocol therapy).
Descripción

Ifpatienthasreceivedprioradjuvantchemotherapy,nolessthan3weeksandnomorethan3monthshaveelapsedsincecompletionofchemotherapy(plannedradiotherapymaybegivenconcurrentlywithprotocoltherapy).

Tipo de datos

text

Patient has a minimum life expectancy of 5 years.
Descripción

Patienthasaminimumlifeexpectancyof5years.

Tipo de datos

text

Performance Status (ECOG) is (circle one see Appendix II)
Descripción

PerformanceStatus

Tipo de datos

text

Patient is able to swallow the study medication and have adequate unassisted oral intake to maintain a reasonable state of nutrition.
Descripción

Patientisabletoswallowthestudymedicationandhaveadequateunassistedoralintaketomaintainareasonablestateofnutrition.

Tipo de datos

text

Patient is able and willing to comply with scheduled study visits at the participating centre.
Descripción

Patientisableandwillingtocomplywithscheduledstudyvisitsattheparticipatingcentre.

Tipo de datos

text

Informed consent has been signed and dated by patient.
Descripción

Informedconsenthasbeensignedanddatedbypatient.

Tipo de datos

text

Date informed consent signed (yyyy mmm dd)
Descripción

InformedConsentDateSigned

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Stratification
Descripción

Stratification

Axillary Nodes
Descripción

AxillaryNodes

Tipo de datos

text

Prior adjuvant chemotherapy?
Descripción

PriorAdjuvantChemotherapyInd

Tipo de datos

text

Chronic low dose prophylactic aspirin use
Descripción

Chroniclowdoseprophylacticaspirinuse

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Unnamed Header Module Pg3
Descripción

Unnamed Header Module Pg3

Patient Study ID, Coordinating Group
Descripción

PatientStudyID,CoordinatingGroup

Tipo de datos

text

Patient Initials (first - middle - last)
Descripción

PatientInitialsName

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Eligibility Checklist Continued
Descripción

Eligibility Checklist Continued

Required hematologic investigations done within 4 weeks prior to randomization and are within the required parameters for eligibility.
Descripción

Requiredhematologicinvestigationsdonewithin4weekspriortorandomizationandarewithintherequiredparametersforeligibility.

Tipo de datos

text

Required biochemistry investigations done within 4 weeks prior to randomization and are within the required parameters for eligibility unless imaging examinations have ruled out metastatic disease.
Descripción

Requiredbiochemistryinvestigationsdonewithin4weekspriortorandomizationandarewithintherequiredparametersforeligibilityunlessimagingexaminationshaveruledoutmetastaticdisease.

Tipo de datos

text

Initiation of protocol therapy will begin within 10 working days of randomization.
Descripción

TreatmentRequirementBeginIndicator

Tipo de datos

text

Patient has no history of other malignancies except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix or other solid tumours curatively treated with no evidence of disease for >= 5 years from randomization.
Descripción

Patienthasnohistoryofothermalignanciesexceptadequatelytreatednon-melanomaskincancer,curativelytreatedin-situcancerofthecervixorothersolidtumourscurativelytreatedwithnoevidenceofdiseasefor>=5yearsfromrandomization.

Tipo de datos

text

Patient is not receiving concurrent hormonal therapy with estrogens, progesterones, androgens or any selective estrogen receptor modulator (SERM). (previous use of Raloxifene, specifically, is permitted provided this is discontinued at least 3 weeks prior to randomization; intermittent use, i.e. maximum of 2 x per week, of vaginal estrogens is permitted on protocol if other local [trunc. see form])
Descripción

Patientisnotreceivingconcurrenthormonaltherapywithestrogens,progesterones,androgensoranyselectiveestrogenreceptormodulator(SERM).

Tipo de datos

text

No prior treatment with a recognized aromatase inhibitor.
Descripción

Nopriortreatmentwitharecognizedaromataseinhibitor.

Tipo de datos

text

No known or incompletely treated peptic ulcer disease.
Descripción

Noknownorincompletelytreatedpepticulcerdisease.

Tipo de datos

text

Patient is not receiving concurrent NSAID therapy or Cox-2 Inhibitor therapy e.g. Vioxx. (chronic low dose, i.e. <= 81 mg/day, prophylactic aspirin will be allowed)
Descripción

PatientisnotreceivingconcurrentNSAIDtherapyorCox-2Inhibitortherapye.g.Vioxx.

Tipo de datos

text

No known allergy to sulphonamides.
Descripción

Noknownallergytosulphonamides.

Tipo de datos

text

No history of asthma, urticaria or allergic type reactions after taking aspirin or other NSAIDs.
Descripción

Nohistoryofasthma,urticariaorallergictypereactionsaftertakingaspirinorotherNSAIDs.

Tipo de datos

text

No co-existing medical or psychiatric condition that is likely to interfere with study procedures or results.
Descripción

Noco-existingmedicalorpsychiatricconditionthatislikelytointerferewithstudyproceduresorresults.

Tipo de datos

text

If patient has participated in another trial for breast cancer (e.g. adjuvant chemotherapeutic trial), permission has been obtained, from the sponsors of that trial for the patients to participate in MA.27.
Descripción

Ifpatienthasparticipatedinanothertrialforbreastcancer(e.g.adjuvantchemotherapeutictrial),permissionhasbeenobtained,fromthesponsorsofthattrialforthepatientstoparticipateinMA.27.

Tipo de datos

text

Randomization Date (yyyy mmm dd)
Descripción

RandomizationDate

Tipo de datos

date

Certificate Of Eligibility
Descripción

Certificate Of Eligibility

In the opinion of the investigator is the patient eligible?
Descripción

PatientEligibilityInd

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
Investigator Signature
Descripción

InvestigatorSignature

Tipo de datos

text

Alias
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Date of Investigator Signature (yyyy mmm dd)
Descripción

InvestigatorSignatureDate

Tipo de datos

date

Person Completing Form, Last Name
Descripción

PersonCompletingForm,LastName

Tipo de datos

text

Person Completing Form, First Name
Descripción

PersonCompletingForm,FirstName

Tipo de datos

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)
Descripción

FormCompletionDate,Original

Tipo de datos

date

Unnamed Header Module Pg4
Descripción

Unnamed Header Module Pg4

Patient Study ID, Coordinating Group
Descripción

PatientStudyID,CoordinatingGroup

Tipo de datos

text

Patient Initials (first - middle - last)
Descripción

PatientInitialsName

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
History And Physical Exam
Descripción

History And Physical Exam

Date of Evaluation (yyyy-mmm-dd)
Descripción

AssessmentDate

Tipo de datos

date

Performance Status (check one see protocol Appendix II)
Descripción

PerformanceStatus

Tipo de datos

text

Patient Height (cm)
Descripción

PatientHeight

Tipo de datos

double

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25347
UMLS 2011AA Property
C0489786
Patient Weight (kg)
Descripción

PatientWeight

Tipo de datos

double

Patient is post-menopausal according to one of these three criteria
Descripción

VerificationofPostmenopausalStatus

Tipo de datos

text

Alias
NCI Thesaurus Property
C38008
UMLS 2011AA Property
C0687676
NCI Thesaurus Property
C3231
UMLS 2011AA Property
C0025320
NCI Thesaurus ObjectClass
C25171
UMLS 2011AA ObjectClass
C0013893
FSH value
Descripción

FSHvalue

Tipo de datos

text

Date (FSH value) (yyyy mmm dd)
Descripción

LaboratoryProcedureFollicleStimulatingHormoneResultDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C2286
UMLS 2011AA Property
C0733758
Investigations
Descripción

Investigations

Imaging Site
Descripción

DiagnosticImagingAnatomicSite

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus ObjectClass
C16502
UMLS 2011AA ObjectClass
C0011923
NCI Thesaurus Property
C25421
UMLS 2011AA Property
C0002808
Date of Evaluation (yyyy-mmm-dd)
Descripción

AssessmentDate

Tipo de datos

date

Method of Evaluation
Descripción

AssessmentType

Tipo de datos

text

Unnamed Header Module Pg5
Descripción

Unnamed Header Module Pg5

Patient Study ID, Coordinating Group
Descripción

PatientStudyID,CoordinatingGroup

Tipo de datos

text

Patient Initials (first - middle - last)
Descripción

PatientInitialsName

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Investigations Continued Baseline Hematology/biochemistry Values
Descripción

Investigations Continued Baseline Hematology/biochemistry Values

Date Hematology (Blood) Sample Obtained (yyyy mmm dd)
Descripción

Lab,Hematology,SampleCollectionDate

Tipo de datos

date

Hemoglobin (Value)
Descripción

Lab,Hematology,Hemoglobin

Tipo de datos

double

Peripheral Platelet Count (Value)
Descripción

Lab,Hematology,Platelets

Tipo de datos

double

Peripheral WBC Count (Value)
Descripción

Lab,Hematology,WBC

Tipo de datos

double

Lab Unit of Measure (circle unit used)
Descripción

Lab,UnitsofMeasure

Tipo de datos

text

Lab Unit of Measure (circle unit used)
Descripción

Lab,UnitsofMeasure

Tipo de datos

text

Lab Unit of Measure (circle unit used)
Descripción

Lab,UnitsofMeasure

Tipo de datos

text

Lab Unit of Measure (circle unit used)
Descripción

Lab,UnitsofMeasure

Tipo de datos

text

Lab Unit of Measure (circle unit used)
Descripción

Lab,UnitsofMeasure

Tipo de datos

text

Lab Unit of Measure (circle unit used)
Descripción

Lab,UnitsofMeasure

Tipo de datos

text

Lab Unit of Measure (circle unit used)
Descripción

Lab,UnitsofMeasure

Tipo de datos

text

Lab Unit of Measure (circle unit used)
Descripción

Lab,UnitsofMeasure

Tipo de datos

text

Lab Unit of Measure (circle unit used)
Descripción

Lab,UnitsofMeasure

Tipo de datos

text

Lab Unit of Measure (circle unit used)
Descripción

Lab,UnitsofMeasure

Tipo de datos

text

Peripheral Neutrophils (granulocytes) (Value)
Descripción

Lab,Hematology,NeutrophilCount

Tipo de datos

double

Specimen Collection Date (Biochemistry yyyy mmm dd)
Descripción

SpecimenCollectionDate

Tipo de datos

date

SGOT (AST) (Value; Must be < 2 x ULN unless imaging examinations have ruled out metastatic disease.)
Descripción

Lab,Hepatic,SGOT

Tipo de datos

double

SGOT (AST) ULN
Descripción

SGOTLabUpperLimitNormalValue

Tipo de datos

double

Alias
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
SGPT (ALT) (Value; Must be < 2 x ULN unless imaging examinations have ruled out metastatic disease.)
Descripción

Lab,Hepatic,SGPT

Tipo de datos

double

SGPT (ALT) ULN
Descripción

SGPTLabUpperLimitNormalValue

Tipo de datos

double

Alias
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Alkaline Phosphatase (Value; Must be < 2 x ULN unless imaging examinations have ruled out metastatic disease.)
Descripción

Lab,Hepatic,AlkalinePhosphatase

Tipo de datos

double

Alkaline Phosphatase ULN
Descripción

LaboratoryProcedureAlkalinePhosphataseResultUpperLimitNormalValue

Tipo de datos

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C16276
UMLS 2011AA Property
C0002059
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Creatinine (Value)
Descripción

Lab,Renal,Creatinine

Tipo de datos

double

Creatinine ULN
Descripción

LaboratoryProcedureCreatinineResultUpperLimitNormalValue

Tipo de datos

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Calcium (Ca) (Value)
Descripción

Calcium(Ca)

Tipo de datos

double

Calcium LLN
Descripción

LaboratoryProcedureCalciumElectrolytesOutcomeLowerLimitofNormalValue

Tipo de datos

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C331
UMLS 2011AA Property
C0006675
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C464
UMLS 2011AA Property
C0013832
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25555
UMLS 2011AA ValueDomain
C1518030
Calcium ULN
Descripción

LaboratoryProcedureCalciumElectrolytesOutcomeUpperLimitofNormalValue

Tipo de datos

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C331
UMLS 2011AA Property
C0006675
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C464
UMLS 2011AA Property
C0013832
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Follicle Stimulating Hormone (FSH) (Value; ** Required only if necessary to confirm postmenopausal status.)
Descripción

FollicleStimulatingHormone(FSH)

Tipo de datos

double

Postmenopausal LLN
Descripción

PostmenopausalLLN

Tipo de datos

double

Postmenopausal ULN
Descripción

PostmenopausalUpperLimitofNormalValue

Tipo de datos

double

Disease History/prior Treatment/adverse Events
Descripción

Disease History/prior Treatment/adverse Events

First Positive Biopsy Date (date of initial pathologic diagnosis yyyy mmm dd)
Descripción

FirstPositiveBiopsyDate

Tipo de datos

date

Most Extensive Primary Surgery Date (if required, use last re-excision date yyyy mmm dd)
Descripción

PrimarySurgeryDate

Tipo de datos

date

Most extensive primary surgery
Descripción

PrimarySurgeryType

Tipo de datos

text

Was axillary dissection performed?
Descripción

AxillaryDissectionInd

Tipo de datos

text

Axillary Dissection Date (yyyy mmm dd)
Descripción

AxillaryDissectionDate

Tipo de datos

date

Number of lymph nodes examined
Descripción

LymphNode(s)ExaminedNumber

Tipo de datos

double

Alias
NCI Thesaurus Property
C25500
UMLS 2011AA Property
C0332128
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
Number of positive lymph nodes examined
Descripción

LymphNode(s)PositiveNumber

Tipo de datos

double

Alias
NCI Thesaurus Property
C25246
UMLS 2011AA Property
C1446409
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
Unnamed Header Module Pg6
Descripción

Unnamed Header Module Pg6

Patient Study ID, Coordinating Group
Descripción

PatientStudyID,CoordinatingGroup

Tipo de datos

text

Patient Initials (first - middle - last)
Descripción

PatientInitialsName

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Disease History... Continued
Descripción

Disease History... Continued

Tumour Laterality (check one)
Descripción

PrimaryTumorLaterality

Tipo de datos

text

Receptor Status, ER (If measure in fmols/mg, cytosl protein >= 10 is postive. If other measures are used, apply institutional standards; borderline results should be reported as positive)
Descripción

ERStatus

Tipo de datos

text

Receptor Status, PgR (If measure in fmols/mg, cytosl protein >= 10 is postive. If other measures are used, apply institutional standards; borderline results should be reported as positive)
Descripción

PgRStatus

Tipo de datos

text

T Stage, Pathologic (check one)
Descripción

TStage,Pathologic

Tipo de datos

text

N Stage, Pathologic (check one)
Descripción

NStage,Pathologic

Tipo de datos

text

M Stage, Pathologic (check one)
Descripción

MStage,Pathologic

Tipo de datos

text

Prior Treatment For Cancer
Descripción

Prior Treatment For Cancer

Prior adjuvant chemotherapy?
Descripción

PriorAdjuvantChemotherapyInd

Tipo de datos

text

Other (specify) (agent name)
Descripción

AgentName

Tipo de datos

text

Date Prior Adjuvant Chemotherapy Ended (yyyy-mmm-dd)
Descripción

PriorAdjuvantChemotherapyEndDate

Tipo de datos

date

Total Number of Cycles Given
Descripción

TotalCourseNumber

Tipo de datos

double

Prior raloxifene therapy?
Descripción

HormoneTherapyPriorRaloxifeneReceivedInd-3

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C1518
UMLS 2011AA Property
C0244404
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Date Prior Raloxifene Therapy Ended (yyyy mmm dd)
Descripción

AgentEndDate

Tipo de datos

date

Prior adjuvant RT?
Descripción

PriorAdjuvantRTInd

Tipo de datos

text

Date Adjuvant Radiation Therapy Started (yyyy mmm dd)
Descripción

AdjuvantRTBeginDate

Tipo de datos

date

Total dose of Radiation Therapy (cGy)
Descripción

RTTotalDose

Tipo de datos

double

Date Adjuvant Radiation Therapy Ended (yyyy mmm dd)
Descripción

AdjuvantRTEndDate

Tipo de datos

date

Is concurrent RT planned for this patient?
Descripción

IsconcurrentRTplannedforthispatient?

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Planned Concurrent RT Start Date (yyyy mmm dd)
Descripción

PlannedConcurrentRTStartDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Unnamed Header Module Pg7
Descripción

Unnamed Header Module Pg7

Patient Study ID, Coordinating Group
Descripción

PatientStudyID,CoordinatingGroup

Tipo de datos

text

Patient Initials (first - middle - last)
Descripción

PatientInitialsName

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Disease History... Continued; Bone Fractures
Descripción

Disease History... Continued; Bone Fractures

Has the patient experienced a bone fracture in the last 10 years?
Descripción

Hasthepatientexperiencedabonefractureinthelast10years?

Tipo de datos

text

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

BoneFractureSite,Spinal

Tipo de datos

text

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

BoneFractureSite,Wrist

Tipo de datos

text

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

BoneFractureSite,Pelvis

Tipo de datos

text

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

BoneFractureSite,Hip

Tipo de datos

text

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

BoneFractureSite,Femur

Tipo de datos

text

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

BoneFractureSite,Tibia

Tipo de datos

text

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

BoneFractureSite,Ankle

Tipo de datos

text

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

BoneFractureSite,Other(specify)

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
If sites other than specified, indicated site (bone fracture site)
Descripción

indicatesite(bonefracturesite)

Tipo de datos

text

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

BoneFractureDate

Tipo de datos

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
Osteoporosis
Descripción

Osteoporosis

Has the patient had a diagnosis of osteoporosis?
Descripción

Hasthepatienthadadiagnosisofosteoporosis?

Tipo de datos

text

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

DiseaseOsteoporosisDiagnosisDate

Tipo de datos

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
C15220
UMLS 2011AA Property
C0011900
Cardiovascular Morbidity
Descripción

Cardiovascular Morbidity

Has the patient suffered cardiovascular disease?
Descripción

CardiovascularDiseasePresentInd-2

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C25292
UMLS 2011AA ObjectClass
C0007226
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
Cardiovascular Event
Descripción

Cardiovascular Event

Myocardial infarction
Descripción

CardiovascularEvent,Myocardialinfarction

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Stroke/transient ischemic attack (TIA)
Descripción

CardiovascularEvent,Stroke/transientischemicattack(TIA)

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
On-going angina (no surgical intervention)
Descripción

CardiovascularEvent,On-goingangina(nosurgicalintervention)

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Angina requiring percutaneous transluminal coronary angioplasty (PTCA)
Descripción

HeartPatientAnginaPercutaneousTransluminalCoronaryAngioplastyPersonalMedicalHistoryInd-3

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus Property
C51221
UMLS 2011AA Property
C0002962
NCI Thesaurus Property
C38078
UMLS 2011AA Property
C2936173
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Thromboembolic event
Descripción

CardiovascularEvent,Thromboembolicevent

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Other (specify), Cardiovascular Event
Descripción

CardiovascularEvent,Other(specify)

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
please describe event (cardiovascular event) (If other specified,)
Descripción

pleasedescribeevent(cardiovascularevent)

Tipo de datos

text

Unnamed Header Module Pg8
Descripción

Unnamed Header Module Pg8

Patient Study ID, Coordinating Group
Descripción

PatientStudyID,CoordinatingGroup

Tipo de datos

text

Patient Initials (first - middle - last)
Descripción

PatientInitialsName

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Baseline Symptoms/"toxicity" Status
Descripción

Baseline Symptoms/"toxicity" Status

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

CTCAdverseEventTerm

Tipo de datos

text

CTC Adverse Event Term, Other (specify; other CTC adverse event term)
Descripción

CTCAdverseEventTerm,Other

Tipo de datos

text

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

CTCAdverseEventCategory

Tipo de datos

text

CTC Adverse Event Grade (Code/grade according to NCI Common Toxicity Criteria, Version 2.0 0=None NA=Not Assessed)
Descripción

CTCAdverseEventGrade

Tipo de datos

text

COMMENTS
Descripción

Comments

Tipo de datos

text

Unnamed Header Module Pg9
Descripción

Unnamed Header Module Pg9

Patient Study ID, Coordinating Group
Descripción

PatientStudyID,CoordinatingGroup

Tipo de datos

text

Patient Initials (first - middle - last)
Descripción

PatientInitialsName

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Concomitant Medications
Descripción

Concomitant Medications

Is the patient taking any medication?
Descripción

Isthepatienttakinganymedication?

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Agent Name (generic or trade name)
Descripción

AgentName

Tipo de datos

text

Alias
NCI Metathesaurus ValueDomain
C0027365
Other (specify) (agent name)
Descripción

AgentName

Tipo de datos

text

Indication (chronic low dose, prophylactic)
Descripción

AgentAdministeredReason

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Continuing
Descripción

Continuing

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Other Major Medical Problems
Descripción

Other Major Medical Problems

Have there been any major medical problems?
Descripción

Havetherebeenanymajorongoingmedicalproblems?

Tipo de datos

text

Major Medical Problem (e.g. hypertension, diabetes, previous cancers)
Descripción

PatientMedicalConditionText

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25261
UMLS 2011AA Property
C0205476
NCI Thesaurus Property
C25457
UMLS 2011AA Property
C0348080
Comments
Descripción

Comments

COMMENTS
Descripción

Comments

Tipo de datos

text

Supporting Documentation
Descripción

Supporting Documentation

Investigator Signature
Descripción

Investigator Signature

Investigator Signature
Descripción

InvestigatorSignature

Tipo de datos

text

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

PersonCompletingForm,LastName

Tipo de datos

text

Person Completing Form, First Name
Descripción

PersonCompletingForm,FirstName

Tipo de datos

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)
Descripción

FormCompletionDate,Original

Tipo de datos

date

Ccrr Module For Form 1 - Eligibility Check List And Initial Evaluation Ma.27
Descripción

Ccrr Module For Form 1 - Eligibility Check List And Initial Evaluation Ma.27

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A RANDOMIZED PHASE III TRIAL OF EXEMESTANE VERSUS ANASTROZOLE WITH OR WITHOUT CELECOXIB IN POSTMENOPAUSAL WOMEN WITH RECEPTOR POSITIVE PRIMARY BREAST CANCER-MA.27

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Patient Information
PatientStudyID,CoordinatingGroup
Item
Patient Study ID, Coordinating Group
text
PatientInitialsName
Item
Patient Initials (first - middle - last)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA 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
PatientBirthDate
Item
Patient?s Date of Birth (yyyy mmm dd)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Item
Patient Gender
text
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17357 (NCI Thesaurus Property)
C0079399 (UMLS 2011AA Property)
CL.1
Code List
Patient Gender
CL Item
Male (Male)
CL Item
Female (Female)
Item
Patient Race (check all that apply Patient is encouraged to self designate: Race Categories and Definitions definitions given with each value)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17049 (NCI Thesaurus Property)
C0034510 (UMLS 2011AA Property)
CL.2
Code List
Patient Race (check all that apply Patient is encouraged to self designate: Race Categories and Definitions definitions given with each value)
CL Item
White_cdus (White)
CL Item
Black_cdus (Black or African American)
CL Item
Pacific_islander_cdus (Native Hawaiian or other Pacific Islander)
CL Item
Asian_cdus (Asian)
CL Item
Native_american_cdus (American Indian or Alaska Native)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Patient Ethnicity (check one only Ethnicity Categories and Definitions definition given with value value)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17049 (NCI Thesaurus Property)
C0034510 (UMLS 2011AA Property)
CL.3
Code List
Patient Ethnicity (check one only Ethnicity Categories and Definitions definition given with value value)
CL Item
Hispanic_or_latino (Hispanic or Latino)
CL Item
Non_hispanic (Non-Hispanic)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Payment method (check one USA only)
text
CL.4
Code List
Payment method (check one USA only)
CL Item
Private Insurance (Private Insurance)
CL Item
Medicare (Medicare)
C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)
CL Item
Medicare And Private Insurance (Medicare and Private Insurance)
CL Item
Medicaid (Medicaid)
C0025071 (NCI Metathesaurus)
CL Item
Medicaid And Medicare (Medicaid and Medicare)
CL Item
Military Or Veterans Sponsored Nos (Military or Veterans Sponsored NOS)
CL Item
Military Sponsored (including Champus & Tricare) (Military sponsored (including CHAMPUS and TRICARE))
CL Item
Veterans Sponsored (Veterans Sponsored)
CL Item
Self Pay (no Insurance) (Self pay (no insurance))
CL Item
No Means Of Payment (no Insurance) (No means of payment (no insurance))
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
IRBApprovalDate
Item
IRB/REB Approval Date ([initial approval or annual renewal] yyyy mmm dd)
date
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25425 (NCI Thesaurus Property)
C0205540 (UMLS 2011AA Property)
ProjectedTreatmentBeginDate
Item
Projected Start Date of Treatment ([within 10 working days of randomization] yyyy mmm dd)
date
Item Group
Unnamed Header Module Pg2
PatientStudyID,CoordinatingGroup
Item
Patient Study ID, Coordinating Group
text
PatientInitialsName
Item
Patient Initials (first - middle - last)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
Item Group
Eligibility Checklist
Patienthascompletelyresectedandhistologicallyconfirmedinvasivebreastcarcinoma.
Item
Patient has completely resected and histologically confirmed invasive breast carcinoma.
text
PriorAdjuvantChemotherapyEndDate
Item
Date Prior Adjuvant Chemotherapy Ended (yyyy-mmm-dd)
date
Item
Pathological TNM classification is (M stage)
text
CL.7
Code List
Pathological TNM classification is (M stage)
CL Item
M0 (M0)
Item
Pathological TNM classification is (M stage)
text
CL.7
Code List
Pathological TNM classification is (M stage)
CL Item
M0 (M0)
Item
Pathological TNM classification is (M stage)
text
CL.7
Code List
Pathological TNM classification is (M stage)
CL Item
M0 (M0)
Primarytumourisreceptorpositivei.e.ERand/orPgRpositive
Item
Primary tumour is receptor positive i.e. ER and/or PgR positive (defined as receptor content of >= 10fmol/mg protein or receptor positive by ERICA or PgRICA).
text
Item
If patient has bilateral breast cancer, both were diagnosed at the same time and at least one of the bilateral cancers is receptor positive (as defined above)
text
CL.8
Code List
If patient has bilateral breast cancer, both were diagnosed at the same time and at least one of the bilateral cancers is receptor positive (as defined above)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
Item
Patient is post-menopausal according to one of these three criteria
text
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
C3231 (NCI Thesaurus Property)
C0025320 (UMLS 2011AA Property)
C25171 (NCI Thesaurus ObjectClass)
C0013893 (UMLS 2011AA ObjectClass)
CL.20
Code List
Patient is post-menopausal according to one of these three criteria
CL Item
greater than (>) 55 years of age with no spontaneous menses for at least 12 months; (greater than (>) 55 years of age with no spontaneous menses for at least 12 months;)
CL Item
less or equal to (<=) 55 years of age with no spontaneous menses within the past 12 months (i.e. spontaneous cessation or secondary to hysterectomy) AND with and FSH level in the postmenopausal range according to institutional/laboratory standards (less or equal to (<=) 55 years of age with no spontaneous menses within the past 12 months (i.e. spontaneous cessation or secondary to hysterectomy) AND with and FSH level in the postmenopausal range according to institutional/laboratory standards)
CL Item
Bilateral Oophorectomy (bilateral oophorectomy)
FSHvalue
Item
FSH value
text
LaboratoryProcedureFollicleStimulatingHormoneResultDate
Item
Date (FSH value) (yyyy mmm dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C2286 (NCI Thesaurus Property)
C0733758 (UMLS 2011AA Property)
Radiologicinvestigationshavebeencompletedwithin4weekspriortosurgicalresectionofprimarytumourandarenegativeformetastases
Item
Radiologic investigations have been completed within 4 weeks prior to surgical resection of primary tumour and are negative for metastases
text
Item
Radiologic investigations have been completed (To specify investigations)
text
CL.10
Code List
Radiologic investigations have been completed (To specify investigations)
CL Item
Bone Scan (bone scan)
C17646 (NCI Thesaurus)
C0203668 (UMLS 2011AA)
CL Item
Abdominal Ultrasound Or Ct Abdomen (abdominal ultrasound or CT abdomen)
CL Item
Chest X-ray (chest x-ray)
Item
bone scan (required only if alkaline phosphatase is >= 2 x UNL and/or there are symptoms of metastatic disease a confirmatory x-ray or other imaging study such as CT or MRI is required if the results from the bone scan are questionable)
text
CL.11
Code List
bone scan (required only if alkaline phosphatase is >= 2 x UNL and/or there are symptoms of metastatic disease a confirmatory x-ray or other imaging study such as CT or MRI is required if the results from the bone scan are questionable)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
Item
abdominal ultrasound or CT abdomen (required only if the AST/ALT or alkaline phosphatase is > 2 x UNL unless the elevation is in the bone fraction)
text
CL.12
Code List
abdominal ultrasound or CT abdomen (required only if the AST/ALT or alkaline phosphatase is > 2 x UNL unless the elevation is in the bone fraction)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
ChestX-RayAssessmentDate
Item
Date of chest x-ray (yyyy mmm dd)
date
BilateralMammogramAnnualEligibilityInd-2
Item
Patient has had a bilateral mammogram within 10 months prior to randomization.
text
C20178 (NCI Thesaurus ObjectClass)
C0024671 (UMLS 2011AA ObjectClass)
C13332 (NCI Thesaurus ObjectClass)
C0238767 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
CL158135 (NCI Metathesaurus Property)
Dateofbilateralmammogram
Item
Date of bilateral mammogram (yyyy mmm dd)
text
Item
If patient has received prior adjuvant chemotherapy, no less than 3 weeks and no more than 3 months have elapsed since completion of chemotherapy (planned radiotherapy may be given concurrently with protocol therapy).
text
CL.13
Code List
If patient has received prior adjuvant chemotherapy, no less than 3 weeks and no more than 3 months have elapsed since completion of chemotherapy (planned radiotherapy may be given concurrently with protocol therapy).
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
Patienthasaminimumlifeexpectancyof5years.
Item
Patient has a minimum life expectancy of 5 years.
text
Item
Performance Status (ECOG) is (circle one see Appendix II)
text
CL.14
Code List
Performance Status (ECOG) is (circle one see Appendix II)
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
CL Item
1 (1)
CL Item
2 (2)
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
Patientisabletoswallowthestudymedicationandhaveadequateunassistedoralintaketomaintainareasonablestateofnutrition.
Item
Patient is able to swallow the study medication and have adequate unassisted oral intake to maintain a reasonable state of nutrition.
text
Patientisableandwillingtocomplywithscheduledstudyvisitsattheparticipatingcentre.
Item
Patient is able and willing to comply with scheduled study visits at the participating centre.
text
Informedconsenthasbeensignedanddatedbypatient.
Item
Informed consent has been signed and dated by patient.
text
InformedConsentDateSigned
Item
Date informed consent signed (yyyy mmm dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Stratification
Item
Axillary Nodes
text
CL.15
Code List
Axillary Nodes
CL Item
Regional Lymph Nodes Cannot Be Assessed (e.g., Previously Removed) (NX)
CL Item
No Regional Lymph Node Metastasis (N0)
CL Item
Metastasis To Movable Ipsilateral Axillary Lymph Node(s) (N1)
Item
Prior adjuvant chemotherapy?
text
CL.41
Code List
Prior adjuvant chemotherapy?
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
Chronic low dose prophylactic aspirin use
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.17
Code List
Chronic low dose prophylactic aspirin use
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item Group
Unnamed Header Module Pg3
PatientStudyID,CoordinatingGroup
Item
Patient Study ID, Coordinating Group
text
PatientInitialsName
Item
Patient Initials (first - middle - last)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
Item Group
Eligibility Checklist Continued
Requiredhematologicinvestigationsdonewithin4weekspriortorandomizationandarewithintherequiredparametersforeligibility.
Item
Required hematologic investigations done within 4 weeks prior to randomization and are within the required parameters for eligibility.
text
Requiredbiochemistryinvestigationsdonewithin4weekspriortorandomizationandarewithintherequiredparametersforeligibilityunlessimagingexaminationshaveruledoutmetastaticdisease.
Item
Required biochemistry investigations done within 4 weeks prior to randomization and are within the required parameters for eligibility unless imaging examinations have ruled out metastatic disease.
text
TreatmentRequirementBeginIndicator
Item
Initiation of protocol therapy will begin within 10 working days of randomization.
text
Patienthasnohistoryofothermalignanciesexceptadequatelytreatednon-melanomaskincancer,curativelytreatedin-situcancerofthecervixorothersolidtumourscurativelytreatedwithnoevidenceofdiseasefor>=5yearsfromrandomization.
Item
Patient has no history of other malignancies except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix or other solid tumours curatively treated with no evidence of disease for >= 5 years from randomization.
text
Patientisnotreceivingconcurrenthormonaltherapywithestrogens,progesterones,androgensoranyselectiveestrogenreceptormodulator(SERM).
Item
Patient is not receiving concurrent hormonal therapy with estrogens, progesterones, androgens or any selective estrogen receptor modulator (SERM). (previous use of Raloxifene, specifically, is permitted provided this is discontinued at least 3 weeks prior to randomization; intermittent use, i.e. maximum of 2 x per week, of vaginal estrogens is permitted on protocol if other local [trunc. see form])
text
Nopriortreatmentwitharecognizedaromataseinhibitor.
Item
No prior treatment with a recognized aromatase inhibitor.
text
Noknownorincompletelytreatedpepticulcerdisease.
Item
No known or incompletely treated peptic ulcer disease.
text
PatientisnotreceivingconcurrentNSAIDtherapyorCox-2Inhibitortherapye.g.Vioxx.
Item
Patient is not receiving concurrent NSAID therapy or Cox-2 Inhibitor therapy e.g. Vioxx. (chronic low dose, i.e. <= 81 mg/day, prophylactic aspirin will be allowed)
text
Noknownallergytosulphonamides.
Item
No known allergy to sulphonamides.
text
Nohistoryofasthma,urticariaorallergictypereactionsaftertakingaspirinorotherNSAIDs.
Item
No history of asthma, urticaria or allergic type reactions after taking aspirin or other NSAIDs.
text
Noco-existingmedicalorpsychiatricconditionthatislikelytointerferewithstudyproceduresorresults.
Item
No co-existing medical or psychiatric condition that is likely to interfere with study procedures or results.
text
Ifpatienthasparticipatedinanothertrialforbreastcancer(e.g.adjuvantchemotherapeutictrial),permissionhasbeenobtained,fromthesponsorsofthattrialforthepatientstoparticipateinMA.27.
Item
If patient has participated in another trial for breast cancer (e.g. adjuvant chemotherapeutic trial), permission has been obtained, from the sponsors of that trial for the patients to participate in MA.27.
text
RandomizationDate
Item
Randomization Date (yyyy mmm dd)
date
Item Group
Certificate Of Eligibility
Item
In the opinion of the investigator is the patient eligible?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
CL.18
Code List
In the opinion of the investigator is the patient eligible?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
InvestigatorSignature
Item
Investigator Signature
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignatureDate
Item
Date of Investigator Signature (yyyy mmm dd)
date
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
Unnamed Header Module Pg4
PatientStudyID,CoordinatingGroup
Item
Patient Study ID, Coordinating Group
text
PatientInitialsName
Item
Patient Initials (first - middle - last)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
Item Group
History And Physical Exam
AssessmentDate
Item
Date of Evaluation (yyyy-mmm-dd)
date
Item
Performance Status (check one see protocol Appendix II)
text
CL.19
Code List
Performance Status (check one see protocol Appendix II)
CL Item
0 (Fully active, able to carry on all pre-disease performance without restriction (Karnofsky 90 - 100))
C0919414 (NCI Metathesaurus)
CL Item
1 (Restricted in physically strenuous activity but ambulatory (K 70 - 80))
CL Item
2 (Ambulatory and capable of all self-care but unable to carry out any work activities (K 50 - 60))
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
3 (Capable of only limited self-care, confined to bed or chair more than 50% of waking hours (K 30-40))
CL Item
4 (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair (K 10-20))
PatientHeight
Item
Patient Height (cm)
double
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS 2011AA Property)
PatientWeight
Item
Patient Weight (kg)
double
Item
Patient is post-menopausal according to one of these three criteria
text
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
C3231 (NCI Thesaurus Property)
C0025320 (UMLS 2011AA Property)
C25171 (NCI Thesaurus ObjectClass)
C0013893 (UMLS 2011AA ObjectClass)
CL.20
Code List
Patient is post-menopausal according to one of these three criteria
CL Item
greater than (>) 55 years of age with no spontaneous menses for at least 12 months; (greater than (>) 55 years of age with no spontaneous menses for at least 12 months;)
CL Item
less or equal to (<=) 55 years of age with no spontaneous menses within the past 12 months (i.e. spontaneous cessation or secondary to hysterectomy) AND with and FSH level in the postmenopausal range according to institutional/laboratory standards (less or equal to (<=) 55 years of age with no spontaneous menses within the past 12 months (i.e. spontaneous cessation or secondary to hysterectomy) AND with and FSH level in the postmenopausal range according to institutional/laboratory standards)
CL Item
Bilateral Oophorectomy (bilateral oophorectomy)
FSHvalue
Item
FSH value
text
LaboratoryProcedureFollicleStimulatingHormoneResultDate
Item
Date (FSH value) (yyyy mmm dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C2286 (NCI Thesaurus Property)
C0733758 (UMLS 2011AA Property)
Item Group
Investigations
Item
Imaging Site
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C25421 (NCI Thesaurus Property)
C0002808 (UMLS 2011AA Property)
CL.21
Code List
Imaging Site
CL Item
Chest (Chest)
C25389 (NCI Thesaurus)
C0817096 (UMLS 2011AA)
CL Item
Abdomen (Abdomen)
C12664 (NCI Thesaurus)
C0230168 (UMLS 2011AA)
CL Item
Bone (Bone)
C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)
AssessmentDate
Item
Date of Evaluation (yyyy-mmm-dd)
date
Item
Method of Evaluation
text
CL.22
Code List
Method of Evaluation
CL Item
Chest X-ray (Chest X-ray)
CL Item
Ct Scan (CT Scan)
CL Item
Mri (MRI (NMR))
CL Item
Bilateral Mammogram (Bilateral Mammogram)
CL Item
Ultrasound (Ultrasound)
C64384 (NCI Thesaurus)
C1456803 (UMLS 2011AA)
CL Item
Bone Scan (Bone Scan)
C17646 (NCI Thesaurus)
C0203668 (UMLS 2011AA)
CL Item
Not Evaluated (Not Evaluated)
Item Group
Unnamed Header Module Pg5
PatientStudyID,CoordinatingGroup
Item
Patient Study ID, Coordinating Group
text
PatientInitialsName
Item
Patient Initials (first - middle - last)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
Item Group
Investigations Continued Baseline Hematology/biochemistry Values
Lab,Hematology,SampleCollectionDate
Item
Date Hematology (Blood) Sample Obtained (yyyy mmm dd)
date
Lab,Hematology,Hemoglobin
Item
Hemoglobin (Value)
double
Lab,Hematology,Platelets
Item
Peripheral Platelet Count (Value)
double
Lab,Hematology,WBC
Item
Peripheral WBC Count (Value)
double
Item
Lab Unit of Measure (circle unit used)
text
CL.32
Code List
Lab Unit of Measure (circle unit used)
CL Item
Iu/l (IU/L)
Item
Lab Unit of Measure (circle unit used)
text
CL.32
Code List
Lab Unit of Measure (circle unit used)
CL Item
Iu/l (IU/L)
Item
Lab Unit of Measure (circle unit used)
text
CL.32
Code List
Lab Unit of Measure (circle unit used)
CL Item
Iu/l (IU/L)
Item
Lab Unit of Measure (circle unit used)
text
CL.32
Code List
Lab Unit of Measure (circle unit used)
CL Item
Iu/l (IU/L)
Item
Lab Unit of Measure (circle unit used)
text
CL.32
Code List
Lab Unit of Measure (circle unit used)
CL Item
Iu/l (IU/L)
Item
Lab Unit of Measure (circle unit used)
text
CL.32
Code List
Lab Unit of Measure (circle unit used)
CL Item
Iu/l (IU/L)
Item
Lab Unit of Measure (circle unit used)
text
CL.32
Code List
Lab Unit of Measure (circle unit used)
CL Item
Iu/l (IU/L)
Item
Lab Unit of Measure (circle unit used)
text
CL.32
Code List
Lab Unit of Measure (circle unit used)
CL Item
Iu/l (IU/L)
Item
Lab Unit of Measure (circle unit used)
text
CL.32
Code List
Lab Unit of Measure (circle unit used)
CL Item
Iu/l (IU/L)
Item
Lab Unit of Measure (circle unit used)
text
CL.32
Code List
Lab Unit of Measure (circle unit used)
CL Item
Iu/l (IU/L)
Lab,Hematology,NeutrophilCount
Item
Peripheral Neutrophils (granulocytes) (Value)
double
SpecimenCollectionDate
Item
Specimen Collection Date (Biochemistry yyyy mmm dd)
date
Lab,Hepatic,SGOT
Item
SGOT (AST) (Value; Must be < 2 x ULN unless imaging examinations have ruled out metastatic disease.)
double
SGOTLabUpperLimitNormalValue
Item
SGOT (AST) ULN
double
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Lab,Hepatic,SGPT
Item
SGPT (ALT) (Value; Must be < 2 x ULN unless imaging examinations have ruled out metastatic disease.)
double
SGPTLabUpperLimitNormalValue
Item
SGPT (ALT) ULN
double
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Lab,Hepatic,AlkalinePhosphatase
Item
Alkaline Phosphatase (Value; Must be < 2 x ULN unless imaging examinations have ruled out metastatic disease.)
double
LaboratoryProcedureAlkalinePhosphataseResultUpperLimitNormalValue
Item
Alkaline Phosphatase ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C16276 (NCI Thesaurus Property)
C0002059 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Lab,Renal,Creatinine
Item
Creatinine (Value)
double
LaboratoryProcedureCreatinineResultUpperLimitNormalValue
Item
Creatinine ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Calcium(Ca)
Item
Calcium (Ca) (Value)
double
LaboratoryProcedureCalciumElectrolytesOutcomeLowerLimitofNormalValue
Item
Calcium LLN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C331 (NCI Thesaurus Property)
C0006675 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C464 (NCI Thesaurus Property)
C0013832 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)
LaboratoryProcedureCalciumElectrolytesOutcomeUpperLimitofNormalValue
Item
Calcium ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C331 (NCI Thesaurus Property)
C0006675 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C464 (NCI Thesaurus Property)
C0013832 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
FollicleStimulatingHormone(FSH)
Item
Follicle Stimulating Hormone (FSH) (Value; ** Required only if necessary to confirm postmenopausal status.)
double
PostmenopausalLLN
Item
Postmenopausal LLN
double
PostmenopausalUpperLimitofNormalValue
Item
Postmenopausal ULN
double
Item Group
Disease History/prior Treatment/adverse Events
FirstPositiveBiopsyDate
Item
First Positive Biopsy Date (date of initial pathologic diagnosis yyyy mmm dd)
date
PrimarySurgeryDate
Item
Most Extensive Primary Surgery Date (if required, use last re-excision date yyyy mmm dd)
date
Item
Most extensive primary surgery
text
CL.33
Code List
Most extensive primary surgery
CL Item
Partial Mastectomy/lumpectomy/excisional Biopsy (partial mastectomy/lumpectomy/excisional biopsy)
CL Item
Mastectomy, Nos (mastectomy, NOS)
Item
Was axillary dissection performed?
text
CL.34
Code List
Was axillary dissection performed?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
AxillaryDissectionDate
Item
Axillary Dissection Date (yyyy mmm dd)
date
LymphNode(s)ExaminedNumber
Item
Number of lymph nodes examined
double
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
LymphNode(s)PositiveNumber
Item
Number of positive lymph nodes examined
double
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
Item Group
Unnamed Header Module Pg6
PatientStudyID,CoordinatingGroup
Item
Patient Study ID, Coordinating Group
text
PatientInitialsName
Item
Patient Initials (first - middle - last)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
Item Group
Disease History... Continued
Item
Tumour Laterality (check one)
text
CL.35
Code List
Tumour Laterality (check one)
CL Item
Left (Left)
C25229 (NCI Thesaurus)
C0205091 (UMLS 2011AA)
CL Item
Right (Right)
C25228 (NCI Thesaurus)
C0205090 (UMLS 2011AA)
CL Item
Bilateral (Bilateral)
Item
Receptor Status, ER (If measure in fmols/mg, cytosl protein >= 10 is postive. If other measures are used, apply institutional standards; borderline results should be reported as positive)
text
CL.36
Code List
Receptor Status, ER (If measure in fmols/mg, cytosl protein >= 10 is postive. If other measures are used, apply institutional standards; borderline results should be reported as positive)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
Item
Receptor Status, PgR (If measure in fmols/mg, cytosl protein >= 10 is postive. If other measures are used, apply institutional standards; borderline results should be reported as positive)
text
CL.37
Code List
Receptor Status, PgR (If measure in fmols/mg, cytosl protein >= 10 is postive. If other measures are used, apply institutional standards; borderline results should be reported as positive)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
Item
T Stage, Pathologic (check one)
text
CL.38
Code List
T Stage, Pathologic (check one)
CL Item
Refer To Figo And/or Ajcc Staging Guidelines Per Protocol (TX)
CL Item
Refer To Figo And/or Ajcc Staging Guidelines Per Protocol (T1)
CL Item
Refer To Figo And/or Ajcc Staging Guidelines Per Protocol (T2)
CL Item
Refer To Figo And/or Ajcc Staging Guidelines Per Protocol (T3)
Item
N Stage, Pathologic (check one)
text
CL.39
Code List
N Stage, Pathologic (check one)
CL Item
Nx, According To Ajcc Criteria (NX)
CL Item
N0, According To Ajcc Criteria (N0)
CL Item
N1, According To Ajcc Criteria (N1)
Item
M Stage, Pathologic (check one)
text
CL.40
Code List
M Stage, Pathologic (check one)
CL Item
No Distant Metastasis (M0)
Item Group
Prior Treatment For Cancer
Item
Prior adjuvant chemotherapy?
text
CL.41
Code List
Prior adjuvant chemotherapy?
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)
AgentName
Item
Other (specify) (agent name)
text
PriorAdjuvantChemotherapyEndDate
Item
Date Prior Adjuvant Chemotherapy Ended (yyyy-mmm-dd)
date
TotalCourseNumber
Item
Total Number of Cycles Given
double
Item
Prior raloxifene therapy?
text
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C1518 (NCI Thesaurus Property)
C0244404 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.42
Code List
Prior raloxifene therapy?
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)
AgentEndDate
Item
Date Prior Raloxifene Therapy Ended (yyyy mmm dd)
date
Item
Prior adjuvant RT?
text
CL.43
Code List
Prior adjuvant RT?
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)
AdjuvantRTBeginDate
Item
Date Adjuvant Radiation Therapy Started (yyyy mmm dd)
date
RTTotalDose
Item
Total dose of Radiation Therapy (cGy)
double
AdjuvantRTEndDate
Item
Date Adjuvant Radiation Therapy Ended (yyyy mmm dd)
date
Item
Is concurrent RT planned for this patient?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.44
Code List
Is concurrent RT planned for this patient?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
PlannedConcurrentRTStartDate
Item
Planned Concurrent RT Start Date (yyyy mmm dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Unnamed Header Module Pg7
PatientStudyID,CoordinatingGroup
Item
Patient Study ID, Coordinating Group
text
PatientInitialsName
Item
Patient Initials (first - middle - last)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
Item Group
Disease History... Continued; Bone Fractures
Item
Has the patient experienced a bone fracture in the last 10 years?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.45
Code List
Has the patient experienced a bone fracture in the last 10 years?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Bone Fracture Site, Spinal (Check)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.46
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)
CL.47
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)
CL.48
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)
CL.49
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)
CL.50
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)
CL.51
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)
CL.52
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)
CL.53
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
If sites other than specified, indicated 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)
Item Group
Osteoporosis
Item
Has the patient had a diagnosis of osteoporosis?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.54
Code List
Has the patient had a diagnosis of osteoporosis?
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)
DiseaseOsteoporosisDiagnosisDate
Item
Date of 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)
C0011900 (UMLS 2011AA Property)
Item Group
Cardiovascular Morbidity
Item
Has the patient suffered cardiovascular disease?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25292 (NCI Thesaurus ObjectClass)
C0007226 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
CL.55
Code List
Has the patient suffered cardiovascular disease?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Cardiovascular Event
Item
Myocardial infarction
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.56
Code List
Myocardial infarction
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
Stroke/transient ischemic attack (TIA)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.57
Code List
Stroke/transient ischemic attack (TIA)
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
On-going angina (no surgical intervention)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.58
Code List
On-going angina (no surgical intervention)
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
Angina requiring percutaneous transluminal coronary angioplasty (PTCA)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C51221 (NCI Thesaurus Property)
C0002962 (UMLS 2011AA Property)
C38078 (NCI Thesaurus Property)
C2936173 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.59
Code List
Angina requiring percutaneous transluminal coronary angioplasty (PTCA)
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
Thromboembolic event
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.60
Code List
Thromboembolic event
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
Other (specify), Cardiovascular Event
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.61
Code List
Other (specify), Cardiovascular Event
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) (If other specified,)
text
Item Group
Unnamed Header Module Pg8
PatientStudyID,CoordinatingGroup
Item
Patient Study ID, Coordinating Group
text
PatientInitialsName
Item
Patient Initials (first - middle - last)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
Item Group
Baseline Symptoms/"toxicity" Status
Item
CTC Adverse Event Term (Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
text
CL.62
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; other CTC adverse event term)
text
Item
CTC Adverse Event Category (Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
text
CL.63
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 0=None NA=Not Assessed)
text
Comments
Item
COMMENTS
text
Item Group
Unnamed Header Module Pg9
PatientStudyID,CoordinatingGroup
Item
Patient Study ID, Coordinating Group
text
PatientInitialsName
Item
Patient Initials (first - middle - last)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
Item Group
Concomitant Medications
Item
Is the patient taking any medication?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.64
Code List
Is the patient taking any medication?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Agent Name (generic or trade name)
text
C0027365 (NCI Metathesaurus ValueDomain)
CL.65
Code List
Agent Name (generic or trade name)
CL Item
Aspirin (Aspirin)
CL Item
Bisphosphonate (Bisphosphonate)
CL Item
Calcium (Calcium)
C331 (NCI Thesaurus)
C0006675 (UMLS 2011AA)
CL Item
Lipid Lowering Drug (Lipid Lowering Drug)
CL Item
Cardiovascular Medication (Cardiovascular Medication)
CL Item
Other Specify (Other (specify))
AgentName
Item
Other (specify) (agent name)
text
AgentAdministeredReason
Item
Indication (chronic low dose, prophylactic)
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Continuing
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.66
Code List
Continuing
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
Other Major Medical Problems
Item
Have there been any major medical problems?
text
CL.67
Code List
Have there been any major medical problems?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
PatientMedicalConditionText
Item
Major Medical Problem (e.g. hypertension, diabetes, previous cancers)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25457 (NCI Thesaurus Property)
C0348080 (UMLS 2011AA Property)
Item Group
Comments
Comments
Item
COMMENTS
text
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 1 - Eligibility Check List And Initial Evaluation Ma.27
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