ID

852

Beschrijving

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

Trefwoorden

D004608

C50-C50

26-08-12 26-08-12 -
12-12-14 12-12-14 - Martin Dugas
13-04-21 13-04-21 - Dr. rer. medic Philipp Neuhaus

Geüploaded op

26 augustus 2012

DOI

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Licentie

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

model
Details

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 Formulieren

StudyEvent: FORM 1 - ELIGIBILITY CHECK LIST AND INITIAL EVALUATION MA.27
1. A RANDOMIZED PHASE III TRIAL OF EXEMESTANE VERSUS ANASTROZOLE WITH OR WITHOUT CELECOXIB IN POSTMENOPAUSAL WOMEN WITH RECEPTOR POSITIVE PRIMARY BREAST CANCER-MA.27

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

PATIENT INFORMATION

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)

PatientGender

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)

PatientRace

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)

PatientEthnicity

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)

PaymentMethod

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

Unnamed Header Module pg2

Item Group

Unnamed Header Module Pg2

PatientStudyID,CoordinatingGroup

Item

Patient Study ID, Coordinating Group

text

PatientInitialsName

Item

Patient Initials (first - middle - last)

text

ELIGIBILITY CHECKLIST

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

TNMClassificationScheme

Item

Pathological TNM classification is (M stage)

text

CL.7

Code List

Pathological TNM classification is (M stage)

CL Item

M0 (M0)

TNMClassificationScheme

Item

Pathological TNM classification is (M stage)

text

CL.7

Code List

Pathological TNM classification is (M stage)

CL Item

M0 (M0)

TNMClassificationScheme

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

Ifpatienthasbilateralbreastcancer,bothwerediagnosedatthesametimeandatleastoneofthebilateralcancersisreceptorpositive

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)

VerificationofPostmenopausalStatus

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

Radiologicinvestigationshavebeencompleted(Tospecifyinvestigations)

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)

bonescan

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

CL Item

Not Applicable (Not Applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

abdominalultrasoundorCTabdomen

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

Ifpatienthasreceivedprioradjuvantchemotherapy,nolessthan3weeksandnomorethan3monthshaveelapsedsincecompletionofchemotherapy(plannedradiotherapymaybegivenconcurrentlywithprotocoltherapy).

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

CL Item

Not Applicable (Not Applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

Patienthasaminimumlifeexpectancyof5years.

Item

Patient has a minimum life expectancy of 5 years.

text

PerformanceStatus

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)

Stratification

Item Group

Stratification

AxillaryNodes

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)

PriorAdjuvantChemotherapyInd

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)

Chroniclowdoseprophylacticaspirinuse

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)

Unnamed Header Module pg3

Item Group

Unnamed Header Module Pg3

PatientStudyID,CoordinatingGroup

Item

Patient Study ID, Coordinating Group

text

PatientInitialsName

Item

Patient Initials (first - middle - last)

text

ELIGIBILITY CHECKLIST continued

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

Certificate of Eligibility

Item Group

Certificate Of Eligibility

PatientEligibilityInd

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

Unnamed Header Module pg4

Item Group

Unnamed Header Module Pg4

PatientStudyID,CoordinatingGroup

Item

Patient Study ID, Coordinating Group

text

PatientInitialsName

Item

Patient Initials (first - middle - last)

text

HISTORY AND PHYSICAL EXAM

Item Group

History And Physical Exam

AssessmentDate

Item

Date of Evaluation (yyyy-mmm-dd)

date

PerformanceStatus

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

VerificationofPostmenopausalStatus

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

Bilateral Oophorectomy (bilateral oophorectomy)

FSHvalue

Item

FSH value

text

LaboratoryProcedureFollicleStimulatingHormoneResultDate

Item

Date (FSH value) (yyyy mmm dd)

date

INVESTIGATIONS

Item Group

Investigations

DiagnosticImagingAnatomicSite

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

AssessmentType

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)

Unnamed Header Module pg5

Item Group

Unnamed Header Module Pg5

PatientStudyID,CoordinatingGroup

Item

Patient Study ID, Coordinating Group

text

PatientInitialsName

Item

Patient Initials (first - middle - last)

text

INVESTIGATIONS continued BASELINE HEMATOLOGY/BIOCHEMISTRY VALUES

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

Lab,UnitsofMeasure

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,UnitsofMeasure

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,UnitsofMeasure

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,UnitsofMeasure

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,UnitsofMeasure

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,UnitsofMeasure

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,UnitsofMeasure

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,UnitsofMeasure

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,UnitsofMeasure

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,UnitsofMeasure

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

DISEASE HISTORY/PRIOR TREATMENT/ADVERSE EVENTS

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

PrimarySurgeryType

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)

AxillaryDissectionInd

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)

Unnamed Header Module pg6

Item Group

Unnamed Header Module Pg6

PatientStudyID,CoordinatingGroup

Item

Patient Study ID, Coordinating Group

text

PatientInitialsName

Item

Patient Initials (first - middle - last)

text

DISEASE HISTORY... continued

Item Group

Disease History... Continued

PrimaryTumorLaterality

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)

ERStatus

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)

PgRStatus

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)

TStage,Pathologic

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)

NStage,Pathologic

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)

MStage,Pathologic

Item

M Stage, Pathologic (check one)

text

CL.40

Code List

M Stage, Pathologic (check one)

CL Item

No Distant Metastasis (M0)

PRIOR TREATMENT FOR CANCER

Item Group

Prior Treatment For Cancer

PriorAdjuvantChemotherapyInd

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

HormoneTherapyPriorRaloxifeneReceivedInd-3

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

PriorAdjuvantRTInd

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

IsconcurrentRTplannedforthispatient?

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)

Unnamed Header Module pg7

Item Group

Unnamed Header Module Pg7

PatientStudyID,CoordinatingGroup

Item

Patient Study ID, Coordinating Group

text

PatientInitialsName

Item

Patient Initials (first - middle - last)

text

DISEASE HISTORY... continued; Bone Fractures

Item Group

Disease History... Continued; Bone Fractures

Hasthepatientexperiencedabonefractureinthelast10years?

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)

BoneFractureSite,Spinal

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)

BoneFractureSite,Wrist

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)

BoneFractureSite,Pelvis

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)

BoneFractureSite,Hip

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)

BoneFractureSite,Femur

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)

BoneFractureSite,Tibia

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)

BoneFractureSite,Ankle

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)

BoneFractureSite,Other(specify)

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)

Osteoporosis

Item Group

Osteoporosis

Hasthepatienthadadiagnosisofosteoporosis?

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)

Cardiovascular Morbidity

Item Group

Cardiovascular Morbidity

CardiovascularDiseasePresentInd-2

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)

Cardiovascular Event

Item Group

Cardiovascular Event

CardiovascularEvent,Myocardialinfarction

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)

CardiovascularEvent,Stroke/transientischemicattack(TIA)

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)

CardiovascularEvent,On-goingangina(nosurgicalintervention)

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)

HeartPatientAnginaPercutaneousTransluminalCoronaryAngioplastyPersonalMedicalHistoryInd-3

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)

CardiovascularEvent,Thromboembolicevent

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)

CardiovascularEvent,Other(specify)

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

Unnamed Header Module pg8

Item Group

Unnamed Header Module Pg8

PatientStudyID,CoordinatingGroup

Item

Patient Study ID, Coordinating Group

text

PatientInitialsName

Item

Patient Initials (first - middle - last)

text

BASELINE SYMPTOMS/"TOXICITY" STATUS

Item Group

Baseline Symptoms/"toxicity" Status

CTCAdverseEventTerm

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

CTCAdverseEventCategory

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

Unnamed Header Module pg9

Item Group

Unnamed Header Module Pg9

PatientStudyID,CoordinatingGroup

Item

Patient Study ID, Coordinating Group

text

PatientInitialsName

Item

Patient Initials (first - middle - last)

text

CONCOMITANT MEDICATIONS

Item Group

Concomitant Medications

Isthepatienttakinganymedication?

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)

AgentName

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)

Continuing

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)

ID

Beschrijving

Link

Trefwoorden

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Licentie

Model Commentaren :

Itemgroep Commentaren voor :

Item Commentaren voor :

Breast Cancer NCT00090974 On-Study - FORM 1 - ELIGIBILITY CHECK LIST AND INITIAL EVALUATION MA.27 - 2067101v3.0

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

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