ID

8873

Description

NSABP Protocol B-42 - Protocol Entry Form Worksheet Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=17AF2627-D64B-3BA6-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=17AF2627-D64B-3BA6-E044-0003BA3F9857

Keywords

  1. 12/18/14 12/18/14 - Martin Dugas
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

January 9, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT00382070 Registration - NSABP Protocol B-42 - Protocol Entry Form Worksheet - 2494107v1.0

Submit every 6 months from date of randomization for the first 5 years; yearly thereafter, and when a protocol event occurs. Fax Form F to 412-622-2111

Header
Description

Header

Last
Description

Patient Initials Last

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1517741
NCI Thesaurus Property
C25536
NCI Thesaurus Property-2
C25551
First
Description

Patient Initials First

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C0205435
NCI Thesaurus Property
C25536
NCI Thesaurus Property-2
C25509
Middle
Description

PatientMiddleInitialsName

Data type

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
NCI Thesaurus Property-2
C25569
UMLS 2011AA Property-2
C0444598
Site Name
Description

ClinicalTrialSiteNameText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15207
NCI Thesaurus Property
C37901
UMLS 2011AA Property
C0205145
NCI Thesaurus ValueDomain-2
C42614
UMLS 2011AA ValueDomain-2
C0027365
Patient Birth Date
Description

Patient Birth Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0421451
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C25155
Treating physician
Description

TreatingPhysicianName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C25741
UMLS 2011AA ObjectClass
C0031831
NCI Thesaurus ObjectClass-2
C25705
UMLS 2011AA ObjectClass-2
C1522326
Patient Social Security Number (USA Only)
Description

Social Security Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301821
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25686
Unnamed2
Description

Unnamed2

Eligibility Criteria
Description

NSABPPatientClinicalTrialEligibilityCriteriaB-42Type

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C15818
UMLS 2011AA ObjectClass-2
C1513905
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
Race
Description

Race

Race
Description

Racial Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS CUI-1
C0034510
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C17049
Person Completing Form, Last Name
Description

Person Completing Form, Last Name

Method of Payment (mark primary method only)
Description

PatientPaymentType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25371
UMLS 2011AA Property
C0680264
Ethnicity
Description

Ethnic Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS CUI-1
C0015031
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C16564
Country of residence
Description

PatientAddressCountryCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25407
UMLS 2011AA Property
C1442065
Country of Residence (Other)
Description

Country of current residence

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C3258975
NCI Thesaurus ValueDomain
C25464
NCI Thesaurus Property
C25407
NCI Thesaurus ValueDomain-2
C42614
Patient Zip Code (USA)
Description

PatientAddressPostalCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25407
UMLS 2011AA Property
C1442065
Consent
Description

Consent

Patient consents to
Description

PatientConsentType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
Unnamed4
Description

Unnamed4

Date Informed Consent Signed
Description

InformedConsentFormSignedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
Planned Date of Treatment Initiation (Should begin within 30 days following randomization. Allow 7+ days after randomization for drug distribution.)
Description

TreatmentPlannedBeginDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
NCI Thesaurus Property
C25619
UMLS 2011AA Property
C1301732
Has the patient authorized the release of Protected Health Information to the NSABP?
Description

PatientPHIConsentIndicator

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
Date of Pre-entry History & Physical Exam (must be within 3 months prior to randomization)
Description

PersonalMedicalHistoryPhysicalExaminationPerformedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass-2
C18772
UMLS 2011AA ObjectClass-2
C0262926
Date of Most Recent Mammogram (must be within 12 months prior to randomization)
Description

MammogramPerformedMostRecentDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C20178
UMLS 2011AA ObjectClass
C0024671
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ValueDomain-2
C25577
UMLS 2011AA ValueDomain-2
C1513491
Did the patient have a bilateral mastectomy
Description

BilateralMastectomyPerformedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15277
UMLS 2011AA ObjectClass
C0024881
NCI Thesaurus ObjectClass-2
C13332
UMLS 2011AA ObjectClass-2
C0238767
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
Date of Most Recent Bone Mineral Density Test (BMDmust be within 12 months prior to randomization)
Description

BoneMineralDensityAssessmentMostRecentDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C61545
UMLS 2011AA ObjectClass
C0177804
NCI Thesaurus ValueDomain-2
C25577
UMLS 2011AA ValueDomain-2
C1513491
Lumbar-Sacral Spine
Description

BoneMineralDensityLumbarSacralVertebraResultScore

Data type

float

Alias
NCI Thesaurus ObjectClass
C49566
UMLS 2011AA ObjectClass
C1704651
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C34004
UMLS 2011AA Property-2
C0024090
NCI Thesaurus Property-3
C12853
UMLS 2011AA Property-3
C1261045
NCI Thesaurus ValueDomain
C25338
UMLS 2011AA ValueDomain
C0449820
Total Hip
Description

BoneMineralDensityHipResultScore

Data type

float

Alias
NCI Thesaurus Property
C64193
UMLS 2011AA Property
C0019552
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ObjectClass
C61545
UMLS 2011AA ObjectClass
C0177804
NCI Thesaurus ValueDomain
C25338
UMLS 2011AA ValueDomain
C0449820
Femoral Neck
Description

BoneMineralDensityFemoralNeckResultScore

Data type

float

Alias
NCI Thesaurus Property
C12717
UMLS 2011AA Property
C0015811
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ObjectClass
C61545
UMLS 2011AA ObjectClass
C0177804
NCI Thesaurus ValueDomain
C25338
UMLS 2011AA ValueDomain
C0449820
Date of Protocol-Qualifying Lipid Profile
Description

LaboratoryProcedureLipidResultDate

Data type

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-2
C616
UMLS 2011AA Property-2
C0023779
Date of Initial Breast Cancer Diagnosis
Description

BreastNeoplasmFirstDiagnosisDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C15220
UMLS 2011AA Property-2
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Date of Prior Primary Surgery
Description

PrimarySurgeryPriorPerformedDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25251
UMLS 2011AA ObjectClass
C0205225
NCI Thesaurus ObjectClass-2
C15329
UMLS 2011AA ObjectClass-2
C0543467
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Type of surgery
Description

BreastCarcinomaTherapyAdministeredType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C4872
UMLS 2011AA ObjectClass
C0678222
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Pathologic Lymph Node Assessment
Description

LymphNodePathologicInvolvementType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25610
UMLS 2011AA Property
C1521733
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
NCI Thesaurus Property-2
C25548
UMLS 2011AA Property-2
C1314939
Receptor Status, ER
Description

ERLevelTumorStatus

Data type

text

Alias
NCI Thesaurus ValueDomain
C3262
UMLS 2011AA ValueDomain
C0027651
NCI Thesaurus ObjectClass
C17069
UMLS 2011AA ObjectClass
C0034804
NCI Thesaurus ValueDomain-2
C25688
UMLS 2011AA ValueDomain-2
C0449438
NCI Thesaurus Property
C25554
UMLS 2011AA Property
C0441889
Receptor Status, PgR
Description

PgRStatusType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C17075
UMLS 2011AA ObjectClass
C0034833
NCI Metathesaurus Property
C0678257
Was HER2 testing performed
Description

EpidermalGrowthFactorReceptorAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25217
UMLS 2011AA Property
C1516048
NCI Thesaurus ObjectClass
C17068
UMLS 2011AA ObjectClass
C0034802
HER-2/neu status
Description

HER2/neuStatusType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C17756
UMLS 2011AA ObjectClass
C0242957
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Therapy Status
Description

Therapy Status

Did this patient receive any tamoxifen?
Description

PriorTamoxifenAdministeredInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C855
UMLS 2011AA ObjectClass
C0039286
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Total Duration (Must be =< 36 months)
Description

PriorTamoxifenAdministeredMonthDuration

Data type

float

Alias
NCI Thesaurus ObjectClass
C855
UMLS 2011AA ObjectClass
C0039286
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C29846
UMLS 2011AA ValueDomain
C0439231
NCI Thesaurus ValueDomain-2
C25330
UMLS 2011AA ValueDomain-2
C0449238
Tamoxifen Treatment End Date
Description

TamoxifenTreatmentEndDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C855
UMLS 2011AA ObjectClass
C0039286
NCI Thesaurus Property
C15368
NCI Thesaurus ValueDomain-2
C25496
UMLS 2011AA ValueDomain-2
C2746065
Cumulative Duration of AIs (# months)
Description

PriorAromataseInhibitorReceivedMonthDuration

Data type

float

Alias
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C1740
UMLS 2011AA ObjectClass-2
C0593802
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ValueDomain
C29846
UMLS 2011AA ValueDomain
C0439231
NCI Thesaurus ValueDomain-2
C25330
UMLS 2011AA ValueDomain-2
C0449238
Which aromatase inhibitor was most recently being taken
Description

AromataseInhibitorMostRecentReceivedText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ObjectClass
C1740
UMLS 2011AA ObjectClass
C0593802
NCI Thesaurus Property-2
C25577
UMLS 2011AA Property-2
C1513491
Is the patient currently receiving an AI
Description

AromataseInhibitorCurrentAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus ObjectClass
C1740
UMLS 2011AA ObjectClass
C0593802
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
Aromatase inhibitor treatment end date
Description

AromataseInhibitorHormoneTherapyAdministeredEndDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C1740
UMLS 2011AA ObjectClass-2
C0593802
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Was the patient on the B-42 Letrozole Registration Program
Description

NationalSurgicalAdjuvantBreastandBowelProjectPatientLetrozoleClinicalStudyEnrollmentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C15818
UMLS 2011AA ObjectClass-2
C1513905
NCI Thesaurus Property
C1527
UMLS 2011AA Property
C0246421
NCI Thesaurus Property-2
C15206
UMLS 2011AA Property-2
C0008972
NCI Thesaurus Property-3
C37948
UMLS 2011AA Property-3
C1516879
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Registration number (If Yes,)
Description

PatientNationalSurgicalAdjuvantBreastProjectLetrozoleRegistrationIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C1527
UMLS 2011AA Property-2
C0246421
Unnamed4
Description

Unnamed4

In the opinion of the investigator, is the patient eligible?
Description

Eligibility for trial

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1302261
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25171
Has the patient participated in any other NSABP trial
Description

PersonNationalSurgicalAdjuvantBreastandBowelProjectClinicalStudyParticipationInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property-2
C15818
UMLS 2011AA Property-2
C1513905
NCI Thesaurus Property-3
C15206
UMLS 2011AA Property-3
C0008972
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Patient ID#
Description

PersonNationalSurgicalAdjuvantBreastandBowelProjectClinicalStudyParticipationNumber

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property-2
C15818
UMLS 2011AA Property-2
C1513905
NCI Thesaurus Property-3
C15206
UMLS 2011AA Property-3
C0008972
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
Patient Characteristics
Description

Patient Characteristics

Height (cm)
Description

Patient Height

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0489786
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
cm
Weight (kg)
Description

Patient Weight

Data type

float

Measurement units
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
Cardiac History
Description

Cardiac History

Medical Condition
Description

PatientMedicalConditionCurrentType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25261
UMLS 2011AA Property
C0205476
NCI Thesaurus Property-2
C25457
UMLS 2011AA Property-2
C0348080
Medications (in the 12 months prior to study entry)
Description

ConcomitantMedicationUseInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ObjectClass-2
C25730
UMLS 2011AA ObjectClass-2
C0521115
NCI Thesaurus Property
C25340
UMLS 2011AA Property
C0457083
Comments (Optional)
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Cardiac History - Other
Description

Cardiac History - Other

Has the patient smoked daily for at least 3 months at any time since her breast cancer diagnosis
Description

PostDiagnosisSmokingDailyUseInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C38008
UMLS 2011AA ObjectClass
C0687676
NCI Thesaurus ObjectClass-2
C15220
UMLS 2011AA ObjectClass-2
C0011900
NCI Thesaurus ObjectClass-3
C17934
UMLS 2011AA ObjectClass-3
C0453996
NCI Thesaurus Property
C25473
UMLS 2011AA Property
C0332173
NCI Metathesaurus Property
C0449865
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have any first degree relatives who died from heart disease before the age of 55 ("First degree relatives" include parent, children, brothers, and sisters)
Description

FirstDegreeRelativeCardiovascularDisorderDeathInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C28554
UMLS 2011AA Property
C0011065
NCI Thesaurus Property-2
C2931
UMLS 2011AA Property-2
C0007222
NCI Thesaurus ObjectClass
C21481
UMLS 2011AA ObjectClass
C1517194
Concomitant Medications
Description

Concomitant Medications

Agent Category
Description

AgentClassificationName

Data type

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25161
UMLS 2011AA Property
C0008902
NCI Metathesaurus ValueDomain
C0027365
Agent Name
Description

Agent

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
Taking at time of randomization?
Description

AgentDuringRandomizationAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25196
UMLS 2011AA Property
C0034656
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus Property-3
C25490
UMLS 2011AA Property-3
C0347984
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Continuing after Randomization
Description

AgentPostRandomizationAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25196
UMLS 2011AA Property
C0034656
NCI Thesaurus Property-2
C38008
UMLS 2011AA Property-2
C0687676
NCI Thesaurus Property-3
C25382
UMLS 2011AA Property-3
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Footer Module
Description

Footer Module

Completed by
Description

Person Completing Form

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date
Description

ResponsiblePersonSignatureDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass-2
C25657
UMLS 2011AA ObjectClass-2
C1273518
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316

Similar models

Submit every 6 months from date of randomization for the first 5 years; yearly thereafter, and when a protocol event occurs. Fax Form F to 412-622-2111

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Patient Initials Last
Item
Last
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1517741 (UMLS CUI-2)
C25536 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
Patient Initials First
Item
First
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C0205435 (UMLS CUI-2)
C25536 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
PatientMiddleInitialsName
Item
Middle
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)
C25569 (NCI Thesaurus Property-2)
C0444598 (UMLS 2011AA Property-2)
ClinicalTrialSiteNameText
Item
Site Name
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15207 (NCI Thesaurus ObjectClass)
C37901 (NCI Thesaurus Property)
C0205145 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain-2)
C0027365 (UMLS 2011AA ValueDomain-2)
Patient Birth Date
Item
Patient Birth Date
date
C25164 (NCI Thesaurus ValueDomain)
C0421451 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25155 (NCI Thesaurus Property)
TreatingPhysicianName
Item
Treating physician
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass-2)
C1522326 (UMLS 2011AA ObjectClass-2)
Social Security Number
Item
Patient Social Security Number (USA Only)
text
C25337 (NCI Thesaurus ValueDomain)
C1301821 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25686 (NCI Thesaurus Property)
Item Group
Unnamed2
Item
Eligibility Criteria
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15818 (NCI Thesaurus ObjectClass-2)
C1513905 (UMLS 2011AA ObjectClass-2)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
Code List
Eligibility Criteria
CL Item
Postmenopausal (Postmenopausal)
C15421 (NCI Thesaurus)
C0232970 (UMLS 2011AA)
CL Item
Disease-free From Initial Breast Cancer Diagnosis (Disease-free from initial breast cancer diagnosis)
CL Item
Histologically-confirmed Invasive Breast Carcinoma By Diagnostic Core Needle Biopsy Or Final Pathologic Evaluation Of Surgical Specimen (Histologically-confirmed invasive breast carcinoma by diagnostic core needle biopsy or final pathologic evaluation of surgical specimen)
CL Item
Primary Tumor Was Er-positive And/or Pgr-positive (Primary tumor was ER-positive and/or PgR-positive)
CL Item
No History Of Non-traumatic Osteoporotic Bone Fractures (No history of non-traumatic osteoporotic bone fractures)
CL Item
No Diagnosis Of Bilateral Breast Cancer Including Dcis (synchronous Or Metachronous) (No diagnosis of bilateral breast cancer including DCIS (synchronous or metachronous))
CL Item
No Other Malignancies Within Past 5 Years (No other malignancies within past 5 years)
CL Item
Not Currently On Sex Hormonal Therapy (Not currently on sex hormonal therapy)
CL Item
All Other Protocol Criteria Met (All other protocol criteria met)
Item Group
Race
Item
Race
text
C25372 (NCI Thesaurus ValueDomain)
C0034510 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17049 (NCI Thesaurus Property)
Code List
Race
CL Item
A Person Having Origins In Any Of The Original Peoples Of Europe, The Middle East, Or North Africa. (White)
C41261 (NCI Thesaurus)
C0007457 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Black Racial Groups Of Africa. Terms Such As "haitian" Or "negro" Can Be Used In Addition To "black Or African American." (Black or African American)
C16352 (NCI Thesaurus)
C0085756 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of Hawaii, Guam, Samoa, Or Other Pacific Islands. (Native Hawaiian or other Pacific Islander)
C41219 (NCI Thesaurus)
C1513907 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of The Far East, Southeast Asia, Or The Indian Subcontinent Including, For Example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, The Philippine Islands, Thailand, And Vietnam. (Asian)
C41260 (NCI Thesaurus)
C0078988 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment. (American Indian or Alaska Native)
C41259 (NCI Thesaurus)
C1515945 (UMLS 2011AA)
CL Item
Could Not Be Determined Or Unsure (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item Group
Person Completing Form, Last Name
Item
Method of Payment (mark primary method only)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25371 (NCI Thesaurus Property)
C0680264 (UMLS 2011AA Property)
Code List
Method of Payment (mark primary method 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
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Military Or Veterans Sponsored Nos (Military or Veterans Sponsored, Not Otherwise Specified (NOS))
CL Item
Military Sponsored (including Champus & Tricare) (Military Sponsored (including CHAMPUS & 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)
Item
Ethnicity
text
C25372 (NCI Thesaurus ValueDomain)
C0015031 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C16564 (NCI Thesaurus Property)
Code List
Ethnicity
CL Item
A Person Of Mexican, Puerto Rican, Cuban, Central Or South American Or Other Spanish Culture Or Origin, Regardless Of Race. (HISPANIC OR LATINO)
C17459 (NCI Thesaurus)
C0086409 (UMLS 2011AA)
CL Item
A Person Not Meeting The Definition For Hispanic Or Latino. (NOT HISPANIC OR LATINO)
C41222 (NCI Thesaurus)
C1518424 (UMLS 2011AA)
CL Item
Could Not Be Determined Or Unsure (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Country of residence
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
Code List
Country of residence
CL Item
Usa (US)
CL Item
Puerto Rico (PR)
C17043 (NCI Thesaurus)
C0034044 (UMLS 2011AA)
CL Item
Canada (CA)
C16380 (NCI Thesaurus)
C0006823 (UMLS 2011AA)
CL Item
Other (Other)
Country of current residence
Item
Country of Residence (Other)
text
C16960 (NCI Thesaurus ObjectClass)
C3258975 (UMLS CUI-1)
C25464 (NCI Thesaurus ValueDomain)
C25407 (NCI Thesaurus Property)
C42614 (NCI Thesaurus ValueDomain-2)
PatientAddressPostalCode
Item
Patient Zip Code (USA)
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
Item Group
Consent
Item
Patient consents to
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
Code List
Patient consents to
CL Item
Future Cancer Research (Future Cancer Research)
CL Item
Future Contact (Future Contact)
CL Item
Future Other Research (Future Other Research)
Item Group
Unnamed4
InformedConsentFormSignedDate
Item
Date Informed Consent Signed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
TreatmentPlannedBeginDate
Item
Planned Date of Treatment Initiation (Should begin within 30 days following randomization. Allow 7+ days after randomization for drug distribution.)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
C25619 (NCI Thesaurus Property)
C1301732 (UMLS 2011AA Property)
PatientPHIConsentIndicator
Item
Has the patient authorized the release of Protected Health Information to the NSABP?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
PersonalMedicalHistoryPhysicalExaminationPerformedDate
Item
Date of Pre-entry History & Physical Exam (must be within 3 months prior to randomization)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C18772 (NCI Thesaurus ObjectClass-2)
C0262926 (UMLS 2011AA ObjectClass-2)
MammogramPerformedMostRecentDate
Item
Date of Most Recent Mammogram (must be within 12 months prior to randomization)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20178 (NCI Thesaurus ObjectClass)
C0024671 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25577 (NCI Thesaurus ValueDomain-2)
C1513491 (UMLS 2011AA ValueDomain-2)
BilateralMastectomyPerformedInd-2
Item
Did the patient have a bilateral mastectomy
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15277 (NCI Thesaurus ObjectClass)
C0024881 (UMLS 2011AA ObjectClass)
C13332 (NCI Thesaurus ObjectClass-2)
C0238767 (UMLS 2011AA ObjectClass-2)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
BoneMineralDensityAssessmentMostRecentDate
Item
Date of Most Recent Bone Mineral Density Test (BMDmust be within 12 months prior to randomization)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C61545 (NCI Thesaurus ObjectClass)
C0177804 (UMLS 2011AA ObjectClass)
C25577 (NCI Thesaurus ValueDomain-2)
C1513491 (UMLS 2011AA ValueDomain-2)
BoneMineralDensityLumbarSacralVertebraResultScore
Item
Lumbar-Sacral Spine
float
C49566 (NCI Thesaurus ObjectClass)
C1704651 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C34004 (NCI Thesaurus Property-2)
C0024090 (UMLS 2011AA Property-2)
C12853 (NCI Thesaurus Property-3)
C1261045 (UMLS 2011AA Property-3)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
BoneMineralDensityHipResultScore
Item
Total Hip
float
C64193 (NCI Thesaurus Property)
C0019552 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C61545 (NCI Thesaurus ObjectClass)
C0177804 (UMLS 2011AA ObjectClass)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
BoneMineralDensityFemoralNeckResultScore
Item
Femoral Neck
float
C12717 (NCI Thesaurus Property)
C0015811 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C61545 (NCI Thesaurus ObjectClass)
C0177804 (UMLS 2011AA ObjectClass)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
LaboratoryProcedureLipidResultDate
Item
Date of Protocol-Qualifying Lipid Profile
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)
C616 (NCI Thesaurus Property-2)
C0023779 (UMLS 2011AA Property-2)
BreastNeoplasmFirstDiagnosisDate
Item
Date of Initial Breast Cancer Diagnosis
date
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
PrimarySurgeryPriorPerformedDate
Item
Date of Prior Primary Surgery
date
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS 2011AA ObjectClass-2)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Type of surgery
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Code List
Type of surgery
CL Item
Lumpectomy + Axillary Staging + Rt (Lumpectomy + Axillary Staging + RT)
CL Item
Total Mastectomy + Axillary Staging (Total Mastectomy + Axillary Staging)
Item
Pathologic Lymph Node Assessment
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property-2)
C1314939 (UMLS 2011AA Property-2)
Code List
Pathologic Lymph Node Assessment
CL Item
Negative (negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
Item
Receptor Status, ER
text
C3262 (NCI Thesaurus ValueDomain)
C0027651 (UMLS 2011AA ValueDomain)
C17069 (NCI Thesaurus ObjectClass)
C0034804 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain-2)
C0449438 (UMLS 2011AA ValueDomain-2)
C25554 (NCI Thesaurus Property)
C0441889 (UMLS 2011AA Property)
Code List
Receptor Status, ER
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Receptor Status, PgR
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17075 (NCI Thesaurus ObjectClass)
C0034833 (UMLS 2011AA ObjectClass)
C0678257 (NCI Metathesaurus Property)
Code List
Receptor Status, PgR
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
EpidermalGrowthFactorReceptorAssessmentInd-2
Item
Was HER2 testing performed
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25217 (NCI Thesaurus Property)
C1516048 (UMLS 2011AA Property)
C17068 (NCI Thesaurus ObjectClass)
C0034802 (UMLS 2011AA ObjectClass)
Item
HER-2/neu status
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17756 (NCI Thesaurus ObjectClass)
C0242957 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
HER-2/neu status
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
PriorTamoxifenAdministeredInd-3
Item
Did this patient receive any tamoxifen?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C855 (NCI Thesaurus ObjectClass)
C0039286 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
PriorTamoxifenAdministeredMonthDuration
Item
Total Duration (Must be =< 36 months)
float
C855 (NCI Thesaurus ObjectClass)
C0039286 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C29846 (NCI Thesaurus ValueDomain)
C0439231 (UMLS 2011AA ValueDomain)
C25330 (NCI Thesaurus ValueDomain-2)
C0449238 (UMLS 2011AA ValueDomain-2)
TamoxifenTreatmentEndDate
Item
Tamoxifen Treatment End Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C855 (NCI Thesaurus ObjectClass)
C0039286 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C25496 (NCI Thesaurus ValueDomain-2)
C2746065 (UMLS 2011AA ValueDomain-2)
PriorAromataseInhibitorReceivedMonthDuration
Item
Cumulative Duration of AIs (# months)
float
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C1740 (NCI Thesaurus ObjectClass-2)
C0593802 (UMLS 2011AA ObjectClass-2)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C29846 (NCI Thesaurus ValueDomain)
C0439231 (UMLS 2011AA ValueDomain)
C25330 (NCI Thesaurus ValueDomain-2)
C0449238 (UMLS 2011AA ValueDomain-2)
AromataseInhibitorMostRecentReceivedText
Item
Which aromatase inhibitor was most recently being taken
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C1740 (NCI Thesaurus ObjectClass)
C0593802 (UMLS 2011AA ObjectClass)
C25577 (NCI Thesaurus Property-2)
C1513491 (UMLS 2011AA Property-2)
AromataseInhibitorCurrentAdministeredInd-2
Item
Is the patient currently receiving an AI
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C1740 (NCI Thesaurus ObjectClass)
C0593802 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
AromataseInhibitorHormoneTherapyAdministeredEndDate
Item
Aromatase inhibitor treatment end date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C1740 (NCI Thesaurus ObjectClass-2)
C0593802 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
NationalSurgicalAdjuvantBreastandBowelProjectPatientLetrozoleClinicalStudyEnrollmentInd-2
Item
Was the patient on the B-42 Letrozole Registration Program
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15818 (NCI Thesaurus ObjectClass-2)
C1513905 (UMLS 2011AA ObjectClass-2)
C1527 (NCI Thesaurus Property)
C0246421 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property-2)
C0008972 (UMLS 2011AA Property-2)
C37948 (NCI Thesaurus Property-3)
C1516879 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientNationalSurgicalAdjuvantBreastProjectLetrozoleRegistrationIdentifierNumber
Item
Registration number (If Yes,)
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1527 (NCI Thesaurus Property-2)
C0246421 (UMLS 2011AA Property-2)
Eligibility for trial
Item
In the opinion of the investigator, is the patient eligible?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1302261 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25171 (NCI Thesaurus Property)
PersonNationalSurgicalAdjuvantBreastandBowelProjectClinicalStudyParticipationInd-3
Item
Has the patient participated in any other NSABP trial
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C15818 (NCI Thesaurus Property-2)
C1513905 (UMLS 2011AA Property-2)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PersonNationalSurgicalAdjuvantBreastandBowelProjectClinicalStudyParticipationNumber
Item
Patient ID#
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C15818 (NCI Thesaurus Property-2)
C1513905 (UMLS 2011AA Property-2)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-3)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
Item Group
Patient Characteristics
Patient Height
Item
Height (cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
Patient Weight
Item
Weight (kg)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Item Group
Cardiac History
Item
Medical Condition
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25457 (NCI Thesaurus Property-2)
C0348080 (UMLS 2011AA Property-2)
Code List
Medical Condition
CL Item
Hypertension (hypertension)
C3117 (NCI Thesaurus)
C0020538 (UMLS 2011AA)
CL Item
Ischemic Heart Disease (Ischemic Heart Disease)
C50625 (NCI Thesaurus)
C0151744 (UMLS 2011AA)
CL Item
Congestive Heart Failure (Congestive Heart Failure)
C3080 (NCI Thesaurus)
C0018802 (UMLS 2011AA)
CL Item
Atrial Fibrillation: C50466 (Atrial Arrhythmia)
C50466 (NCI Thesaurus)
C0004238 (UMLS 2011AA)
CL Item
Ventricular Arrhythmia (Ventricular Arrhythmia)
C26924 (NCI Thesaurus)
C0085612 (UMLS 2011AA)
CL Item
Diabetes (diabetes)
CL Item
Elevated Fasting Lipid Profile (Elevated Fasting Lipid Profile)
ConcomitantMedicationUseInd-3
Item
Medications (in the 12 months prior to study entry)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
Research Comments
Item
Comments (Optional)
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Item Group
Cardiac History - Other
PostDiagnosisSmokingDailyUseInd-2
Item
Has the patient smoked daily for at least 3 months at any time since her breast cancer diagnosis
boolean
C38008 (NCI Thesaurus ObjectClass)
C0687676 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus ObjectClass-2)
C0011900 (UMLS 2011AA ObjectClass-2)
C17934 (NCI Thesaurus ObjectClass-3)
C0453996 (UMLS 2011AA ObjectClass-3)
C25473 (NCI Thesaurus Property)
C0332173 (UMLS 2011AA Property)
C0449865 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
FirstDegreeRelativeCardiovascularDisorderDeathInd-2
Item
Does the patient have any first degree relatives who died from heart disease before the age of 55 ("First degree relatives" include parent, children, brothers, and sisters)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)
C2931 (NCI Thesaurus Property-2)
C0007222 (UMLS 2011AA Property-2)
C21481 (NCI Thesaurus ObjectClass)
C1517194 (UMLS 2011AA ObjectClass)
Item Group
Concomitant Medications
Item
Agent Category
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
C0027365 (NCI Metathesaurus ValueDomain)
Code List
Agent Category
CL Item
Bisphosphonate (Bisphosphonate)
CL Item
Calcium (Calcium)
C331 (NCI Thesaurus)
C0006675 (UMLS 2011AA)
CL Item
Other Medication For Bone Density (Other Medication for Bone Density)
CL Item
Lipid Lowering Drug (Lipid Lowering Drug)
CL Item
Cardiovascular Medication #1 (Cardiovascular Medication #1)
CL Item
Cardiovascular Medication #2 (Cardiovascular Medication #2)
CL Item
Cardiovascular Medication #3 (Cardiovascular Medication #3)
Agent
Item
Agent Name
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
AgentDuringRandomizationAdministeredInd-2
Item
Taking at time of randomization?
boolean
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25490 (NCI Thesaurus Property-3)
C0347984 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
AgentPostRandomizationAdministeredInd-2
Item
Continuing after Randomization
boolean
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
C38008 (NCI Thesaurus Property-2)
C0687676 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Footer Module
Person Completing Form
Item
Completed by
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
ResponsiblePersonSignatureDate
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass-2)
C1273518 (UMLS 2011AA ObjectClass-2)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)

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