ID

43427

Description

NSABP Protocol B-47 Worksheet for Form Entry A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women With Node- Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=942D0C00-2D04-589C-E040-BB89AD433FFB

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=942D0C00-2D04-589C-E040-BB89AD433FFB

Keywords

Versions (4)
  1. 8/8/14 8/8/14 - Martin Dugas
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT01275677 Registration - NSABP Protocol B-47 Worksheet for Form Entry - 3155372v1.0

English

No Instruction available.

1 forms  
  1. StudyEvent: NSABP Protocol B-47 Worksheet for Form Entry
    1. No Instruction available.
Header
Description

Header

Patient Initials (Last, First Middle)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
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
Unnamed4
Description

Unnamed4

Site Name
Description

ClinicalTrialSiteName64CharacterText

Data type

text

Alias
NCI Thesaurus ObjectClass
C71104
UMLS 2011AA ObjectClass
C0008976
NCI Thesaurus ObjectClass-2
C37901
UMLS 2011AA ObjectClass-2
C0205145
NCI Thesaurus Property
C42614
UMLS 2011AA Property
C0027365
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ValueDomain-2
C45253
UMLS 2011AA ValueDomain-2
C1547402
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
Intended chemotherapy regimen
Description

ClinicalTrialProtocolChemotherapyAdministeredType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus ObjectClass-2
C15632
UMLS 2011AA ObjectClass-2
C0392920
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Date Informed Consent Signed (Month Day Year)
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
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
Did the patient consent to use of blood samples for research related to this study?
Description

PatientBloodSpecimenConsentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C12434
UMLS 2011AA Property
C0229664
NCI Thesaurus Property-2
C19157
UMLS 2011AA Property-2
C0370003
NCI Thesaurus Property-3
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Did the patient consent to use of blood samples for the B-47 Menstrual History study?
Description

PatientCorrelativeStudyBloodSpecimenConsentIndicator

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C12434
UMLS 2011AA Property
C0229664
NCI Thesaurus Property-2
C19157
UMLS 2011AA Property-2
C0370003
NCI Thesaurus Property-3
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus Property-4
C16100
UMLS 2011AA Property-4
C1511524
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Did the patient consent to future contact about more research?
Description

TissueSpecimenMalignantNeoplasmRelatedResearchConsentInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12801
UMLS 2011AA ObjectClass
C0040300
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C15319
NCI Thesaurus Property-2
C25648
UMLS 2011AA Property
C0439849
NCI Thesaurus Property-3
C9305
UMLS 2011AA Property-2
C0006826
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Section 2 - Diagnostic
Description

Section 2 - Diagnostic

IHC Staining Score (If multiple IHC assays were performed, report the one with the highest staining intensity score. Please refer to Protocol - Section 4.2.7 for more information. - A copy of the IHC report must be provided.)
Description

BreastCytogeneticsHER2/neuPolyclonalAntibodyTestScore

Data type

text

Alias
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus ObjectClass-2
C16487
UMLS 2011AA ObjectClass-2
C0010802
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property-2
C17756
UMLS 2011AA Property-2
C0242957
NCI Thesaurus Property-3
C61381
UMLS 2011AA Property-3
C0312586
NCI Thesaurus ValueDomain
C25338
UMLS 2011AA ValueDomain
C0449820
HER2 gene copy number (If multiple assay results were performed, report the assay result with the highest HER2 gene copy number.)
Description

LaboratoryProcedureFluorescenceinsituHybridizationHER2/neuCopyNumberPolymorphismOutcomeValue

Data type

float

Was HER2 status assessed by ISH assay
Description

LaboratoryProcedureHER2/neuinsituHybridizationOutcomeInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C17562
UMLS 2011AA Property
C0162788
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus Property-3
C17756
UMLS 2011AA Property-3
C0242957
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Was HER2 to CEP17 ratio performed?
Description

LaboratoryProcedureHER2/neuChromosome17ProbeFluorescenceInSituHybridizationPerformedInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C17563
UMLS 2011AA Property
C0162789
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus Property-3
C17756
UMLS 2011AA Property-3
C0242957
NCI Thesaurus Property-4
C43523
UMLS 2011AA Property-4
C1704681
NCI Thesaurus Property-5
C13212
UMLS 2011AA Property-5
C0008659
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
HER2 to CEP17 ratio (If multiple HER2 to CEP17 ratios were performed, report the highest one.)
Description

LaboratoryProcedureHER2/neuChromosome17ProbeFluorescenceInSituHybridizationPerformedRatioValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C17563
UMLS 2011AA Property
C0162789
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus Property-3
C17756
UMLS 2011AA Property-3
C0242957
NCI Thesaurus Property-4
C43523
UMLS 2011AA Property-4
C1704681
NCI Thesaurus Property-5
C13212
UMLS 2011AA Property-5
C0008659
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C44256
UMLS 2011AA ValueDomain-2
C0456603
Section 4 - Surgery After Neoadjuvant Chemotherapy1
Description

Section 4 - Surgery After Neoadjuvant Chemotherapy1

Does the patient have unilateral invasive adenocarcinoma of the breast on histologic examination?
Description

BreastPrimaryInvasiveAdenocarcinomaHistologicallyConfirmedInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C2852
UMLS 2011AA ObjectClass
C0001418
NCI Thesaurus ObjectClass-2
C25251
UMLS 2011AA ObjectClass-2
C0205225
NCI Thesaurus ObjectClass-3
C12971
UMLS 2011AA ObjectClass-3
C0006141
NCI Thesaurus ObjectClass-4
C14159
UMLS 2011AA ObjectClass-4
C0205281
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
NCI Thesaurus Property-2
C25527
UMLS 2011AA Property-2
C0205462
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Tumor Laterality
Description

BreastSurgicalPathologySpecimenLateralityNCIConceptCode

Data type

text

Alias
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus ObjectClass-3
C16958
UMLS 2011AA ObjectClass-3
C0030669
NCI Thesaurus Property
C25185
UMLS 2011AA Property
C0332304
NCI Thesaurus ValueDomain
C43516
UMLS 2011AA ValueDomain
C1705251
Was lumpectomy performed?
Description

SurgicalProcedureLumpectomyExcisionalBiopsyPerformed

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus Property
C15755
UMLS 2011AA Property
C0024885
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus Property-3
C15385
UMLS 2011AA Property-3
C0184921
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date lumpectomy performed
Description

LumpectomyPerformedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15755
UMLS 2011AA ObjectClass
C0024885
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
Was total mastectomy performed?
Description

TotalMastectomyPerformedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C15281
UMLS 2011AA ObjectClass
C0024886
Date Total Mastectomy Performed
Description

TotalMastectomyPerformedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C15281
UMLS 2011AA ObjectClass
C0024886
Were mastectomy margins free of gross residual tumor?
Description

SurgicalMarginMastectomyNoMicroscopicInvolvementInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C41227
UMLS 2011AA ObjectClass
C0229985
NCI Thesaurus Property
C49487
UMLS 2011AA Property
C1298908
NCI Thesaurus Property-2
C15277
UMLS 2011AA Property-2
C0024881
NCI Thesaurus Property-3
C25252
UMLS 2011AA Property-3
C0205288
NCI Thesaurus Property-4
C25548
UMLS 2011AA Property-4
C1314939
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Were mastectomy margins microscopically positive?
Description

SurgicalMarginMastectomyMicroscopicInvolvementInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C41227
UMLS 2011AA ObjectClass
C0229985
NCI Thesaurus Property
C15277
UMLS 2011AA Property
C0024881
NCI Thesaurus Property-2
C25252
UMLS 2011AA Property-2
C0205288
NCI Thesaurus Property-3
C25548
UMLS 2011AA Property-3
C1314939
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Will post-mastectomy RT of the chest wall be administered?
Description

ChestWallRadiationTherapyPostMastectomyAdministrationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus ObjectClass-2
C62484
UMLS 2011AA ObjectClass-2
C0205076
NCI Thesaurus Property
C15277
UMLS 2011AA Property
C0024881
NCI Thesaurus Property-2
C38008
UMLS 2011AA Property-2
C0687676
NCI Thesaurus Property-3
C25409
UMLS 2011AA Property-3
C1533734
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Were lumpectomy margins histologically free of invasive tumor and DCIS, either initially or after one or more re-excisions?
Description

LumpectomySurgicalMarginNoMicroscopicInvolvementInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15755
UMLS 2011AA ObjectClass
C0024885
NCI Thesaurus ObjectClass-2
C41227
UMLS 2011AA ObjectClass-2
C0229985
NCI Thesaurus Property
C25252
UMLS 2011AA Property
C0205288
NCI Thesaurus Property-2
C25548
UMLS 2011AA Property-2
C1314939
NCI Metathesaurus Property
C0028423
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Was estrogen receptor status determined from the primary tumor?
Description

EstrogenReceptorAnalysisPerformedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25391
UMLS 2011AA ObjectClass
C0936012
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass-2
C17069
UMLS 2011AA ObjectClass-2
C0034804
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
Was progesterone receptor status determined from the primary tumor?
Description

ProgesteroneReceptorAnalysisPerformedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25391
UMLS 2011AA ObjectClass
C0936012
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass-2
C17075
UMLS 2011AA ObjectClass-2
C0034833
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
Histologic Type (Mark predominant tumor type.)
Description

BreastTumorHistologicCategory

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus Property
C25526
UMLS 2011AA Property
C0205462
NCI Thesaurus Property-2
C25161
UMLS 2011AA Property-2
C0008902
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ValueDomain-2
C25526
UMLS 2011AA ValueDomain-2
C0205462
Other specify
Description

Histologic Type, other

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1299220
NCI Thesaurus ObjectClass
C3262
NCI Thesaurus Property
C25526
NCI Thesaurus Property-2
C25161
Histologic Grade (Use combined histologic grade classification.)
Description

BreastCarcinomaCombinedHistologicGradeCategory

Data type

text

Alias
NCI Thesaurus Property
C25454
UMLS 2011AA Property
C0205195
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C4872
UMLS 2011AA ObjectClass
C0678222
NCI Thesaurus Property-2
C18000
UMLS 2011AA Property-2
C0919553
Was Oncotype DX Recurrence Score determined?
Description

LaboratoryProcedureOncotypeDXBreastCancerAssayResultInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C52159
UMLS 2011AA Property-2
C1709318
Oncotype DX Recurrence Score (A copy of the report must be provided.)
Description

LaboratoryProcedureOncotypeDXBreastCancerAssayResultScore

Data type

float

Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C52159
UMLS 2011AA Property-2
C1709318
NCI Thesaurus ValueDomain
C25338
UMLS 2011AA ValueDomain
C0449820
Was sentinel lymphadenectomy performed?
Description

SentinelNodeSurgicalDissectionInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C12947
UMLS 2011AA ObjectClass
C1522495
NCI Thesaurus Property
C15227
UMLS 2011AA Property
C0012737
Date of Sentinel Lymphadenectomy
Description

SentinelNodeDissectionDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C12947
UMLS 2011AA ObjectClass
C1522495
NCI Thesaurus Property
C15227
UMLS 2011AA Property
C0012737
Number of Sentinel Nodes Examined
Description

SentinelNodeExaminedCount

Data type

float

Alias
NCI Thesaurus Property
C25500
UMLS 2011AA Property
C0332128
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ObjectClass
C12947
UMLS 2011AA ObjectClass
C1522495
Number of Positive Sentinel Nodes
Description

SentinelNodePositiveAssessmentCount

Data type

float

Alias
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Metathesaurus Property
C0205159
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ObjectClass
C12947
UMLS 2011AA ObjectClass
C1522495
Total Number of Positive Nodes (Pathologic; all procedures)
Description

LymphNodePositiveCount

Data type

float

Alias
NCI Thesaurus Property
C25246
UMLS 2011AA Property
C1446409
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Surgical Procedure for Evaluation of Pathological Nodal Status
Description

SurgicalProcedureLymphadenectomyPerformedType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus Property-2
C15275
UMLS 2011AA Property-2
C0024203
Date of Last Surgery for Breast Cancer Treatment or Staging
Description

SurgicalProcedureMalignantBreastNeoplasmPerformedLastDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property-2
C9335
UMLS 2011AA Property-2
C0006142
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25551
UMLS 2011AA ValueDomain-2
C1517741
Pathologic T Stage
Description

BreastTumorSeventhPathologicTStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus Property
C25610
UMLS 2011AA Property
C1521733
NCI Thesaurus Property-2
C25728
UMLS 2011AA Property-2
C0475455
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Pathologic N Stage (pathologic evaluation of ipsilateral nodes)
Description

BreastTumorPathologicNStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus Property
C25610
UMLS 2011AA Property
C1521733
NCI Thesaurus Property-2
C25580
UMLS 2011AA Property-2
C0456532
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Patient Characteristics
Description

Patient Characteristics

Patient 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
Patient 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
Date of Assessment
Description

Assessment Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985720
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C38000
Date of Assessment
Description

Assessment Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985720
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C38000
Blood Pressure, Systolic (most recent)
Description

Systolic blood pressure

Data type

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0871470
NCI Thesaurus Property
C25214
NCI Thesaurus ObjectClass
C25298
Blood pressure, Diastolic (most recent)
Description

Diastolic blood pressure

Data type

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0428883
NCI Thesaurus Property
C25214
NCI Thesaurus ObjectClass
C25299
Date of most recent blood pressure assessment
Description

BloodPressurePhysicalExaminationMostRecentDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C54706
UMLS 2011AA ObjectClass
C0005823
NCI Thesaurus ValueDomain-2
C25577
UMLS 2011AA ValueDomain-2
C1513491
Are anti-hypertensive medication(s) needed to sustain systolic BP <= 150 mmHg and diastolic BP <= 90 mmHg?
Description

HypertensionTreatmentReceivedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C3117
UMLS 2011AA ObjectClass
C0020538
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ObjectClass-2
C15368
LVEF (%)
Description

HeartLVEFTestPercentageValue

Data type

float

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property-2
C37946
UMLS 2011AA Property-2
C2700377
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
%
Date LVEF performed
Description

HeartLVEFTestDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property-2
C37946
UMLS 2011AA Property-2
C2700377
Assessment Type
Description

Evaluation method

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2911685
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C16847
Section 3 (continued)
Description

Section 3 (continued)

ANC
Description

LaboratoryProcedureAbsoluteNeutrophilCountAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25367
NCI Thesaurus Property-2
C63321
UMLS 2011AA Property
C0948762
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
ANC (thousand/mm^3)
Description

ANC

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0948762
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C63321
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
Date of Collection
Description

LaboratoryProcedureAbsoluteNeutrophilCountResultDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C63321
UMLS 2011AA Property-2
C0948762
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Platelet Count
Description

LaboratoryProcedurePlateletAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25367
NCI Thesaurus Property-2
C12520
UMLS 2011AA Property
C0005821
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Platelet count (thousand/mm^3)
Description

Platelets

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0005821
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C12520
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
Date of Collection
Description

Platelets date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0005821
NCI Thesaurus Property
C20200
UMLS CUI-2
C0011008
NCI Thesaurus Property-2
C12520
NCI Thesaurus ObjectClass
C25294
Hemoglobin
Description

LaboratoryProcedureHemoglobinAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25367
NCI Thesaurus Property-2
C16676
UMLS 2011AA Property
C0019046
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Hemoglobin (g/dL)
Description

Hemoglobin

Data type

float

Measurement units
  • g/dL
Alias
NCI Thesaurus Property
C16676
UMLS CUI-1
C0019046
NCI Thesaurus Property-2
C20200
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
g/dL
Date of Collection
Description

Hemoglobin Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0019046
NCI Thesaurus Property
C16676
UMLS CUI-2
C0011008
NCI Thesaurus Property-2
C20200
NCI Thesaurus ObjectClass
C25294
Section 3 (continued)
Description

Section 3 (continued)

AST
Description

LaboratoryProcedureAspartateAminotransferaseMeasurementAssessmentsInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C64467
UMLS 2011AA Property
C0201899
AST (units/L)
Description

SGOT (AST)

Data type

float

Measurement units
  • U/L
Alias
NCI Thesaurus Property
C25202
UMLS CUI-1
C0201899
NCI Thesaurus Property-2
C20200
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
U/L
AST ULN (units/L)
Description

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
Date of Collection
Description

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
ALT (required only when SGOT AST is not available)
Description

LaboratoryProcedureSerumGlutamicPyruvicTransaminasePerformedInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C25293
UMLS 2011AA Property-2
C0376147
ALT (units/L)
Description

SGPT (ALT)

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201836
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C25293
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
ALT ULN (units/L)
Description

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C25293
UMLS 2011AA Property-2
C0376147
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
Date of Collection
Description

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultDate

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
C25293
UMLS 2011AA Property-2
C0376147
Alkaline Phosphatase
Description

LaboratoryProcedureAlkalinePhosphataseAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C16276
UMLS 2011AA Property
C0002059
Alkaline Phosphatase (units/L)
Description

Alkaline Phosphatase

Data type

float

Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0201850
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus Property-2
C16276
Alkaline Phosphatase ULN (units/L)
Description

Alkaline Phosphatase ULN

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0151420
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C16276
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
Date of Collection
Description

LaboratoryProcedureAlkalinePhosphataseResultDate

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
C16276
UMLS 2011AA Property-2
C0002059
Total Bilirubin
Description

LaboratoryProcedureBilirubinAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25367
NCI Thesaurus Property-2
C305
UMLS 2011AA Property
C0005437
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Total Bilirubin
Description

LaboratoryProcedureTotalBilirubinResultSpecifiedValue

Data type

float

Measurement units
  • 1000/uL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C38037
UMLS 2011AA Property-2
C0201913
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C38024
UMLS 2011AA ValueDomain-2
C0205369
1000/uL
Total bilirubin ULN (mg/dL)
Description

Bilirubin, Total ULN

Data type

float

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201913
NCI Thesaurus Property
C20200
UMLS CUI-2
C1519815
NCI Thesaurus Property-2
C38037
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C38024
NCI Thesaurus ValueDomain-3
C25706
mg/dL
Date of Collection
Description

LaboratoryProcedureBilirubinOutcomeDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C305
UMLS 2011AA Property-2
C0005437
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Serum Creatinine
Description

LaboratoryProcedureCreatinineAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25367
NCI Thesaurus Property-2
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Serum creatinine (mg/dL)
Description

Creatinine, Serum

Data type

float

Measurement units
  • mg/dL
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0201976
NCI Thesaurus Property-2
C399
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
mg/dL
Serum Creatinine ULN (mg/dL)
Description

Creatinine, serum ULN

Data type

float

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201976
NCI Thesaurus Property
C20200
UMLS CUI-2
C1519815
NCI Thesaurus Property-2
C399
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
mg/dL
Date of Collection
Description

LaboratoryProcedureCreatinineClearanceOutcomeDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C25747
UMLS 2011AA Property-2
C0373595
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Baseline Values2
Description

Baseline Values2

Was liver imaging performed? (CT, MRI, PET scan, or PET-CT)
Description

LiverDiagnosticImagingAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C16502
UMLS 2011AA ObjectClass
C0011923
NCI Thesaurus ObjectClass-2
C12392
UMLS 2011AA ObjectClass-2
C0023884
Does liver imaging demonstrate metastatic disease?
Description

LiverMetastasisDiagnosticImagingPresentInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12392
UMLS 2011AA ObjectClass
C0023884
NCI Thesaurus ObjectClass-2
C19151
UMLS 2011AA ObjectClass-2
C0027627
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C16502
UMLS 2011AA Property-2
C0011923
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Date of Assessment
Description

LiverDiagnosticImagingAssessmentDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C16502
UMLS 2011AA ObjectClass
C0011923
NCI Thesaurus ObjectClass-2
C12392
UMLS 2011AA ObjectClass-2
C0023884
Does the patient have unexplained bone pain?
Description

BonePainInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C3303
UMLS 2011AA Property
C0030193
NCI Thesaurus ObjectClass
C12366
UMLS 2011AA ObjectClass
C0262950
Was bone scan, PET-CT scan, or PET scan performed?
Description

BoneScanMedicalImagingAssessmentInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C17646
UMLS 2011AA ObjectClass
C0203668
NCI Thesaurus ObjectClass-2
C16831
Does bone scan, PET-CT scan, or PET scan demonstrate metastatic disease?
Description

BoneScanMagneticResonanceImagingDiagnosticImagingMetastaticMalignantNeoplasmtotheBonePresentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C17646
UMLS 2011AA ObjectClass
C0203668
NCI Thesaurus ObjectClass-2
C16502
UMLS 2011AA ObjectClass-2
C0011923
NCI Thesaurus ObjectClass-3
C16809
UMLS 2011AA ObjectClass-3
C0024485
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C3580
UMLS 2011AA Property-2
C0153690
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date of Assessment (if applicable)
Description

BoneAssessmentDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C12366
UMLS 2011AA ObjectClass
C0262950
Is bilirubin elevation due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin?
Description

PatientElevatedBilirubinPersonalMedicalHistoryInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C27088
UMLS 2011AA Property
C0311468
NCI Thesaurus Property-2
C18772
UMLS 2011AA Property-2
C0262926
Was chest imaging performed?
Description

DiagnosticImagingChestAssessmentInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C16502
UMLS 2011AA ObjectClass
C0011923
NCI Thesaurus Property-2
C25389
UMLS 2011AA Property-2
C0817096
Did chest imaging demonstrate metastatic disease?
Description

ChestDiagnosticImagingMetastasisPresentInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16502
UMLS 2011AA ObjectClass
C0011923
NCI Thesaurus ObjectClass-2
C25389
UMLS 2011AA ObjectClass-2
C0817096
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C19151
UMLS 2011AA Property-2
C0027627
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Date chest imaging performed
Description

DiagnosticImagingChestAssessmentDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C16502
UMLS 2011AA ObjectClass
C0011923
NCI Thesaurus Property-2
C25389
UMLS 2011AA Property-2
C0817096
Section 4 - Patient History
Description

Section 4 - Patient History

Was the breast cancer staged as T4, including inflammatory breast cancer?
Description

InflammatoryBreastCarcinomaPresentIndicator

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C4001
UMLS 2011AA ObjectClass
C0278601
Is there definitive clinical or radiologic evidence of metastatic disease for this patient?
Description

MetastaticNeoplasmConfirmedDiagnosisInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
NCI Thesaurus Property-2
C15220
UMLS 2011AA Property-2
C0011900
NCI Thesaurus ObjectClass
C3261
UMLS 2011AA ObjectClass
C2939420
Did the patient have synchronous or previous contralateral invasive breast cancer?
Description

ContralateralBreastCancerDiagnosisInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus ObjectClass-3
C25307
UMLS 2011AA ObjectClass-3
C0441988
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have a history of ipsilateral invasive breast cancer or ipsilateral DCIS?
Description

RecurrentIpsilateralBreastNeoplasmDiagnosisInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus ObjectClass-3
C14173
UMLS 2011AA ObjectClass-3
C2945760
NCI Thesaurus ObjectClass-4
C25308
UMLS 2011AA ObjectClass-4
C0441989
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have a history of non-breast malignancies within the past 5 years?
Description

PersonNoMalignantBreastNeoplasmPersonalMedicalHistoryInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C49487
UMLS 2011AA Property
C1298908
NCI Thesaurus Property-2
C18772
UMLS 2011AA Property-2
C0262926
NCI Thesaurus Property-3
C9335
UMLS 2011AA Property-3
C0006142
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Were the other malignancies limited to one or more of the following: in situ cancers treated only by local excision, and basal and squamous cell carcinomas of the skin?
Description

PatientNeoplasmPersonalMedicalHistoryInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3262
UMLS 2011AA Property
C0027651
NCI Thesaurus Property-2
C18772
UMLS 2011AA Property-2
C0262926
Has the patient had previous therapy with anthracyclines, taxanes, or trastuzumab for any malignancy?
Description

PatientChemotherapyPersonalMedicalHistoryPlatinum-BasedTaxaneCompoundTherapeuticProcedureInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C49236
UMLS 2011AA Property
C0087111
NCI Thesaurus Property-2
C18772
UMLS 2011AA Property-2
C0262926
NCI Thesaurus Property-3
C25620
UMLS 2011AA Property-3
C1514162
NCI Thesaurus Property-4
C1490
UMLS 2011AA Property-4
C0796419
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has the patient had chemotherapy or HER2-targeted therapy administered for the currently diagnosed breast cancer?
Description

PriorBreastCarcinomaChemotherapyAdministeredIndicator

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus ObjectClass-3
C4872
UMLS 2011AA ObjectClass-3
C0678222
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Has the patient had whole breast RT prior to randomization or partial breast RT that cannot be completed on or before the date of randomization?
Description

PersonBreastRadiationTherapyCompleteRandomizationInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property-2
C25196
UMLS 2011AA Property-2
C0034656
NCI Thesaurus Property-3
C15313
UMLS 2011AA Property-3
C1522449
NCI Thesaurus Property-4
C12971
UMLS 2011AA Property-4
C0006141
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Will the patient receive continued endocrine therapy with any hormonal agent such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor after randomization?
Description

PersonEndocrineTherapyAromataseInhibitorRandomizationInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25196
UMLS 2011AA Property
C0034656
NCI Thesaurus Property-2
C15445
UMLS 2011AA Property-2
C0279025
NCI Thesaurus Property-3
C1740
UMLS 2011AA Property-3
C0593802
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Will the patient receive continued sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy after randomization?
Description

PersonEndocrineTherapyRandomizationInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25196
UMLS 2011AA Property
C0034656
NCI Thesaurus Property-2
C15445
UMLS 2011AA Property-2
C0279025
Does the patient have angina pectoris that requires the use of anti-anginal medication?
Description

AnginaDiseasePresentInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass-2
C51221
UMLS 2011AA ObjectClass-2
C0002962
Does the patient have ventricular arrhythmias except for benign premature ventricular contractions?
Description

ArrhythmiaHistoryInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C2881
UMLS 2011AA ObjectClass
C0003811
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
Does the patient have supraventricular or nodal arrhythmias requiring a pacemaker or not controlled with medication?
Description

DiseaseorDisorderSupraventricularArrhythmiaNodalArrhythmiaPresentInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C27045
UMLS 2011AA Property-2
C0264893
NCI Thesaurus Property-3
C27158
UMLS 2011AA Property-3
C0428974
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Does the patient have a conduction abnormality requiring a pacemaker?
Description

DiseaseorDisorderHeartConductionDisorderBiventricularPacemakerPresentInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C80460
UMLS 2011AA Property-2
C1719274
NCI Thesaurus Property-3
C78245
UMLS 2011AA Property-3
C0264886
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Does the patient have valvular disease with documented compromise in cardiac function?
Description

CardiacDiseasePresentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
Does the patient have symptomatic pericarditis?
Description

DiseaseorDisorderPericarditisPresentChronicDiseaseInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property-2
C34915
UMLS 2011AA Property-2
C0031046
Does the patient have a history of documented CHF?
Description

SymptomaticCongestiveHeartFailurePresentInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C3080
UMLS 2011AA ObjectClass
C0018802
NCI Thesaurus ObjectClass-2
C25269
UMLS 2011AA ObjectClass-2
C0231220
Does the patient have a history of documented cardiomyopathy?
Description

DiseaseorDisorderCardiomyopathyPresentInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property-2
C34830
UMLS 2011AA Property-2
C0878544
Does the patient have a history of myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function?
Description

PatientCerebrovascularAccidentMyocardialInfarctionPersonalMedicalHistoryInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C27996
UMLS 2011AA Property
C0027051
NCI Thesaurus Property-2
C3390
UMLS 2011AA Property-2
C0038454
NCI Thesaurus Property-3
C18772
UMLS 2011AA Property-3
C0262926
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Does the patient have any other cardiac disease (history of and/or active disease) that would preclude the use of drugs included in the treatment regimen?
Description

DiseaseorDisorderCardiacHeartPersonalMedicalHistoryInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus ObjectClass-2
C13306
UMLS 2011AA ObjectClass-2
C1522601
NCI Thesaurus ObjectClass-3
C2991
UMLS 2011AA ObjectClass-3
C0012634
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Does the patient have active hepatitis B or hepatitis C with abnormal liver function tests?
Description

HepaticInfectionPersonalMedicalHistoryInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C13308
UMLS 2011AA ObjectClass
C0205054
NCI Metathesaurus ObjectClass
C0021311
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
Does the patient have intrinsic lung disease resulting in dyspnea?
Description

DyspneaDiseasePresentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C2998
UMLS 2011AA ObjectClass
C0013404
NCI Thesaurus ObjectClass-2
C2991
UMLS 2011AA ObjectClass-2
C0012634
Does the patient have poorly controlled diabetes mellitus?
Description

PatientLesserControlDiabetesMellitusEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C2985
UMLS 2011AA Property
C0011849
NCI Thesaurus Property-2
C61299
UMLS 2011AA Property-2
C2587213
NCI Thesaurus Property-3
C25171
UMLS 2011AA Property-3
C0013893
NCI Thesaurus Property-4
C61422
UMLS 2011AA Property-4
C0547044
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have active infection or chronic infection requiring chronic suppressive antibiotics?
Description

ChronicDiseaseInfectionInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C26726
UMLS 2011AA Property
C0009450
NCI Thesaurus ObjectClass-2
C14141
UMLS 2011AA ObjectClass-2
C0205191
Does the patient have a nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2, per the CTCAE v4.0?
Description

PatientCentralNervousSystemDiseaseorDisorderEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C12438
UMLS 2011AA Property
C3714787
NCI Thesaurus Property-2
C2991
UMLS 2011AA Property-2
C0012634
NCI Thesaurus Property-3
C25171
UMLS 2011AA Property-3
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have any conditions that would prohibit administration of corticosteroids?
Description

DiseaseorDisorderRestrictionCorticosteroidAdministrationPresentInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C2322
UMLS 2011AA Property-2
C0001617
NCI Thesaurus Property-3
C25409
UMLS 2011AA Property-3
C1533734
NCI Thesaurus Property-4
C53452
UMLS 2011AA Property-4
C0443288
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Does the patient have known hypersensitivity reaction to any of the study drugs or excipients, e.g. polysorbate 80 and Cremophor EL?
Description

PatientClinicalStudyAgentHypersensitivityPersonalMedicalHistoryInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3114
UMLS 2011AA Property
C0020517
NCI Thesaurus Property-2
C1708
UMLS 2011AA Property-2
C0450442
NCI Thesaurus Property-3
C15206
UMLS 2011AA Property-3
C0008972
NCI Thesaurus Property-4
C18772
UMLS 2011AA Property-4
C0262926
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have chronic daily treatment with corticosteroids with a dose >= 10 mg/day methylprednisolone equivalent (excluding inhaled steroids)?
Description

PatientCorticosteroidUsePersonalMedicalHistoryInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C2322
UMLS 2011AA Property
C0001617
NCI Thesaurus Property-2
C18772
UMLS 2011AA Property-2
C0262926
NCI Thesaurus Property-3
C25340
UMLS 2011AA Property-3
C0457083
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up?
Description

SystemicDiseaseHistoryInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
Does the patient have psychiatric or addictive disorders or other condition that, in the opinion of the investigator, would preclude the patient from meeting the study requirements?
Description

PatientStudyRequirementInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C38015
Has the patient used any investigational product within the past 30 days?
Description

PatientInvestigationalClinicalTrialCurrentParticipationExclusionCriteriaInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property-2
C25471
UMLS 2011AA Property-2
C0521116
NCI Thesaurus Property-3
C15207
NCI Thesaurus Property-4
C28041
UMLS 2011AA Property-3
C1517586
NCI Thesaurus Property-5
C25370
UMLS 2011AA Property-4
C0680251
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is patient a woman of childbearing potential?
Description

FemalePatientPotentialPregnancyInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C16576
UMLS 2011AA ObjectClass-2
C0086287
NCI Thesaurus Property
C25742
UMLS 2011AA Property
C0032961
NCI Metathesaurus Property
C0237399
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Was a pregnancy test performed?
Description

PatientPregnancyTestIndicator

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Metathesaurus Property
C0032976
Date of pregnancy test
Description

PatientMostRecentPregnancyTestDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Metathesaurus Property
C0032976
NCI Thesaurus Property
C25577
UMLS 2011AA Property
C1513491
Is the patient pregnant or lactating at time of study entry?
Description

PatientPregnancyInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25742
UMLS 2011AA Property
C0032961
Does the patient have an ECOG performance status of 0 or 1?
Description

EasternCooperativeOncologyGroupPerformanceStatusAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C25491
UMLS 2011AA ObjectClass
C1512162
NCI Metathesaurus ObjectClass
CL092952
Section 5 - Menapausal Status
Description

Section 5 - Menapausal Status

Has the patient had a hysterectomy?
Description

HysterectomyPerformedInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C15256
UMLS 2011AA ObjectClass
C0020699
Date of Hysterectomy (Please provide surgical report.)
Description

HysterectomyPerformedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C15256
UMLS 2011AA ObjectClass
C0020699
Has the patient had any spontaneous menses in the past 12 months?
Description

MensesOccurrenceInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus ObjectClass
C3232
UMLS 2011AA ObjectClass
C0025344
Date of last menstrual period (If unsure of the date, please provide a close approximation.)
Description

LastMenstrualCycleOccurrenceDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25551
UMLS 2011AA ObjectClass
C1517741
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus ObjectClass-2
C16838
UMLS 2011AA ObjectClass-2
C0025329
Has the patient had both ovaries removed?
Description

OvaryRemovedInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12404
UMLS 2011AA ObjectClass
C0029939
NCI Thesaurus Property
C25650
UMLS 2011AA Property
C0849355
Date both (or second) ovaries were removed (Please provide all surgical reports related to oophorectomies. If unsure of the date, please report a close approximation.)
Description

OvaryRemovedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C12404
UMLS 2011AA ObjectClass
C0029939
NCI Thesaurus Property
C25650
UMLS 2011AA Property
C0849355
Has the patient had a documented estradiol level in the postmenopausal range according to local institutional/laboratory standard? (If yes, please provide documentation of estradiol level.)
Description

PersonEstradiolMeasurementPostmenopausalEvaluationAssessmentInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property-2
C15421
UMLS 2011AA Property-2
C0232970
NCI Thesaurus Property-3
C74782
UMLS 2011AA Property-3
C0337434
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Footer
Description

Footer

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
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1 forms
  1. StudyEvent: NSABP Protocol B-47 Worksheet for Form Entry
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Patient Initials
Item
Patient Initials (Last, First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
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
Unnamed4
ClinicalTrialSiteName64CharacterText
Item
Site Name
text
C71104 (NCI Thesaurus ObjectClass)
C0008976 (UMLS 2011AA ObjectClass)
C37901 (NCI Thesaurus ObjectClass-2)
C0205145 (UMLS 2011AA ObjectClass-2)
C42614 (NCI Thesaurus Property)
C0027365 (UMLS 2011AA Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C45253 (NCI Thesaurus ValueDomain-2)
C1547402 (UMLS 2011AA ValueDomain-2)
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)
Item
Intended chemotherapy regimen
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus ObjectClass-2)
C0392920 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.1
Code List
Intended chemotherapy regimen
CL Item
Tc: Docetaxel 75 Mg/m2 And Cyclophosphamide 600 Mg/m2 (iv) (TC: docetaxel 75 mg/m2 and cyclophosphamide 600 mg/m2 (IV))
CL Item
Ac - Wp: Doxorubicin 60 Mg/m2 And Cyclophosphamide 600 Mg/m2 (iv) Followed By Paclitaxel 80 Mg/m2 (iv) (AC - WP: doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 (IV) followed by paclitaxel 80 mg/m2 (IV))
InformedConsentFormSignedDate
Item
Date Informed Consent Signed (Month Day Year)
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)
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)
PatientBloodSpecimenConsentInd-2
Item
Did the patient consent to use of blood samples for research related to this study?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12434 (NCI Thesaurus Property)
C0229664 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property-2)
C0370003 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-3)
C1511481 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Did the patient consent to use of blood samples for the B-47 Menstrual History study?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12434 (NCI Thesaurus Property)
C0229664 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property-2)
C0370003 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-3)
C1511481 (UMLS 2011AA Property-3)
C16100 (NCI Thesaurus Property-4)
C1511524 (UMLS 2011AA Property-4)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.4
Code List
Did the patient consent to use of blood samples for the B-47 Menstrual History study?
CL Item
Yes: C49488 (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No: C49487 (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
TissueSpecimenMalignantNeoplasmRelatedResearchConsentInd-3
Item
Did the patient consent to future contact about more research?
boolean
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C15319 (NCI Thesaurus Property)
C25648 (NCI Thesaurus Property-2)
C0439849 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-3)
C0006826 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Item Group
Section 2 - Diagnostic
Item
IHC Staining Score (If multiple IHC assays were performed, report the one with the highest staining intensity score. Please refer to Protocol - Section 4.2.7 for more information. - A copy of the IHC report must be provided.)
text
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C16487 (NCI Thesaurus ObjectClass-2)
C0010802 (UMLS 2011AA ObjectClass-2)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C17756 (NCI Thesaurus Property-2)
C0242957 (UMLS 2011AA Property-2)
C61381 (NCI Thesaurus Property-3)
C0312586 (UMLS 2011AA Property-3)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
CL.6
Code List
IHC Staining Score (If multiple IHC assays were performed, report the one with the highest staining intensity score. Please refer to Protocol - Section 4.2.7 for more information. - A copy of the IHC report must be provided.)
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
CL Item
1+ (1+)
CL Item
2+ (2+)
CL Item
3+ (3+)
LaboratoryProcedureFluorescenceinsituHybridizationHER2/neuCopyNumberPolymorphismOutcomeValue
Item
HER2 gene copy number (If multiple assay results were performed, report the assay result with the highest HER2 gene copy number.)
float
LaboratoryProcedureHER2/neuinsituHybridizationOutcomeInd-2
Item
Was HER2 status assessed by ISH assay
boolean
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17562 (NCI Thesaurus Property)
C0162788 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C17756 (NCI Thesaurus Property-3)
C0242957 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
LaboratoryProcedureHER2/neuChromosome17ProbeFluorescenceInSituHybridizationPerformedInd-3
Item
Was HER2 to CEP17 ratio performed?
boolean
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17563 (NCI Thesaurus Property)
C0162789 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C17756 (NCI Thesaurus Property-3)
C0242957 (UMLS 2011AA Property-3)
C43523 (NCI Thesaurus Property-4)
C1704681 (UMLS 2011AA Property-4)
C13212 (NCI Thesaurus Property-5)
C0008659 (UMLS 2011AA Property-5)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
LaboratoryProcedureHER2/neuChromosome17ProbeFluorescenceInSituHybridizationPerformedRatioValue
Item
HER2 to CEP17 ratio (If multiple HER2 to CEP17 ratios were performed, report the highest one.)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17563 (NCI Thesaurus Property)
C0162789 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C17756 (NCI Thesaurus Property-3)
C0242957 (UMLS 2011AA Property-3)
C43523 (NCI Thesaurus Property-4)
C1704681 (UMLS 2011AA Property-4)
C13212 (NCI Thesaurus Property-5)
C0008659 (UMLS 2011AA Property-5)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C44256 (NCI Thesaurus ValueDomain-2)
C0456603 (UMLS 2011AA ValueDomain-2)
Item Group
Section 4 - Surgery After Neoadjuvant Chemotherapy1
BreastPrimaryInvasiveAdenocarcinomaHistologicallyConfirmedInd-3
Item
Does the patient have unilateral invasive adenocarcinoma of the breast on histologic examination?
boolean
C2852 (NCI Thesaurus ObjectClass)
C0001418 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C12971 (NCI Thesaurus ObjectClass-3)
C0006141 (UMLS 2011AA ObjectClass-3)
C14159 (NCI Thesaurus ObjectClass-4)
C0205281 (UMLS 2011AA ObjectClass-4)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C25527 (NCI Thesaurus Property-2)
C0205462 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Item
Tumor Laterality
text
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C16958 (NCI Thesaurus ObjectClass-3)
C0030669 (UMLS 2011AA ObjectClass-3)
C25185 (NCI Thesaurus Property)
C0332304 (UMLS 2011AA Property)
C43516 (NCI Thesaurus ValueDomain)
C1705251 (UMLS 2011AA ValueDomain)
CL.10
Code List
Tumor Laterality
CL Item
Left Breast (Left breast)
CL Item
Right Breast (Right breast)
SurgicalProcedureLumpectomyExcisionalBiopsyPerformed
Item
Was lumpectomy performed?
boolean
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C15755 (NCI Thesaurus Property)
C0024885 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C15385 (NCI Thesaurus Property-3)
C0184921 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
LumpectomyPerformedDate
Item
Date lumpectomy performed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15755 (NCI Thesaurus ObjectClass)
C0024885 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
TotalMastectomyPerformedInd-2
Item
Was total mastectomy performed?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15281 (NCI Thesaurus ObjectClass)
C0024886 (UMLS 2011AA ObjectClass)
TotalMastectomyPerformedDate
Item
Date Total Mastectomy Performed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15281 (NCI Thesaurus ObjectClass)
C0024886 (UMLS 2011AA ObjectClass)
SurgicalMarginMastectomyNoMicroscopicInvolvementInd-2
Item
Were mastectomy margins free of gross residual tumor?
boolean
C41227 (NCI Thesaurus ObjectClass)
C0229985 (UMLS 2011AA ObjectClass)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C15277 (NCI Thesaurus Property-2)
C0024881 (UMLS 2011AA Property-2)
C25252 (NCI Thesaurus Property-3)
C0205288 (UMLS 2011AA Property-3)
C25548 (NCI Thesaurus Property-4)
C1314939 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
SurgicalMarginMastectomyMicroscopicInvolvementInd-2
Item
Were mastectomy margins microscopically positive?
boolean
C41227 (NCI Thesaurus ObjectClass)
C0229985 (UMLS 2011AA ObjectClass)
C15277 (NCI Thesaurus Property)
C0024881 (UMLS 2011AA Property)
C25252 (NCI Thesaurus Property-2)
C0205288 (UMLS 2011AA Property-2)
C25548 (NCI Thesaurus Property-3)
C1314939 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ChestWallRadiationTherapyPostMastectomyAdministrationInd-2
Item
Will post-mastectomy RT of the chest wall be administered?
boolean
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C62484 (NCI Thesaurus ObjectClass-2)
C0205076 (UMLS 2011AA ObjectClass-2)
C15277 (NCI Thesaurus Property)
C0024881 (UMLS 2011AA Property)
C38008 (NCI Thesaurus Property-2)
C0687676 (UMLS 2011AA Property-2)
C25409 (NCI Thesaurus Property-3)
C1533734 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
LumpectomySurgicalMarginNoMicroscopicInvolvementInd-2
Item
Were lumpectomy margins histologically free of invasive tumor and DCIS, either initially or after one or more re-excisions?
boolean
C15755 (NCI Thesaurus ObjectClass)
C0024885 (UMLS 2011AA ObjectClass)
C41227 (NCI Thesaurus ObjectClass-2)
C0229985 (UMLS 2011AA ObjectClass-2)
C25252 (NCI Thesaurus Property)
C0205288 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property-2)
C1314939 (UMLS 2011AA Property-2)
C0028423 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
EstrogenReceptorAnalysisPerformedInd-2
Item
Was estrogen receptor status determined from the primary tumor?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25391 (NCI Thesaurus ObjectClass)
C0936012 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C17069 (NCI Thesaurus ObjectClass-2)
C0034804 (UMLS 2011AA ObjectClass-2)
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)
CL.18
Code List
Receptor Status, ER
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
ProgesteroneReceptorAnalysisPerformedInd-2
Item
Was progesterone receptor status determined from the primary tumor?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25391 (NCI Thesaurus ObjectClass)
C0936012 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C17075 (NCI Thesaurus ObjectClass-2)
C0034833 (UMLS 2011AA ObjectClass-2)
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)
CL.20
Code List
Receptor Status, PgR
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
Item
Histologic Type (Mark predominant tumor type.)
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property-2)
C0008902 (UMLS 2011AA Property-2)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C25526 (NCI Thesaurus ValueDomain-2)
C0205462 (UMLS 2011AA ValueDomain-2)
CL.21
Code List
Histologic Type (Mark predominant tumor type.)
CL Item
Ductal (Ductal)
C25732 (NCI Thesaurus)
C1512083 (UMLS 2011AA)
CL Item
Lobular (Lobular)
C25557 (NCI Thesaurus)
C0205417 (UMLS 2011AA)
C25557 (NCI Thesaurus-3)
C0205417 (UMLS 2011AA-4)
CL Item
Other Specify (Other)
Histologic Type, other
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1299220 (UMLS CUI-1)
C3262 (NCI Thesaurus ObjectClass)
C25526 (NCI Thesaurus Property)
C25161 (NCI Thesaurus Property-2)
Item
Histologic Grade (Use combined histologic grade classification.)
text
C25454 (NCI Thesaurus Property)
C0205195 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus Property-2)
C0919553 (UMLS 2011AA Property-2)
CL.22
Code List
Histologic Grade (Use combined histologic grade classification.)
CL Item
Low (Low)
CL124342 (NCI Metathesaurus)
CL Item
Intermediate (Intermediate)
C0205103 (NCI Metathesaurus)
CL Item
High (High)
C25227 (NCI Thesaurus)
C0205250 (UMLS 2011AA)
LaboratoryProcedureOncotypeDXBreastCancerAssayResultInd-2
Item
Was Oncotype DX Recurrence Score determined?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C52159 (NCI Thesaurus Property-2)
C1709318 (UMLS 2011AA Property-2)
LaboratoryProcedureOncotypeDXBreastCancerAssayResultScore
Item
Oncotype DX Recurrence Score (A copy of the report must be provided.)
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C52159 (NCI Thesaurus Property-2)
C1709318 (UMLS 2011AA Property-2)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
SentinelNodeSurgicalDissectionInd-2
Item
Was sentinel lymphadenectomy performed?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
C15227 (NCI Thesaurus Property)
C0012737 (UMLS 2011AA Property)
SentinelNodeDissectionDate
Item
Date of Sentinel Lymphadenectomy
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
C15227 (NCI Thesaurus Property)
C0012737 (UMLS 2011AA Property)
SentinelNodeExaminedCount
Item
Number of Sentinel Nodes Examined
float
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
SentinelNodePositiveAssessmentCount
Item
Number of Positive Sentinel Nodes
float
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C0205159 (NCI Metathesaurus Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
LymphNodePositiveCount
Item
Total Number of Positive Nodes (Pathologic; all procedures)
float
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
Item
Surgical Procedure for Evaluation of Pathological Nodal Status
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C15275 (NCI Thesaurus Property-2)
C0024203 (UMLS 2011AA Property-2)
CL.25
Code List
Surgical Procedure for Evaluation of Pathological Nodal Status
CL Item
Regional Lymph Node Dissection Sentinel Lymph Node (Sentinel lymphadenectomy alone)
C48935 (NCI Thesaurus)
C1709883 (UMLS 2011AA)
C12947 (NCI Thesaurus-3)
C1522495 (UMLS 2011AA-4)
CL Item
Sentinel Lymph Node Biopsy With Axillary Lymph Node Dissection (Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes)
C47854 (NCI Thesaurus)
C1710051 (UMLS 2011AA)
CL Item
Axillary Lymph Node Dissection (Axillary lymphadenectomy with or without SN isolation procedure)
C15677 (NCI Thesaurus)
C0193867 (UMLS 2011AA)
SurgicalProcedureMalignantBreastNeoplasmPerformedLastDate
Item
Date of Last Surgery for Breast Cancer Treatment or Staging
date
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C9335 (NCI Thesaurus Property-2)
C0006142 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25551 (NCI Thesaurus ValueDomain-2)
C1517741 (UMLS 2011AA ValueDomain-2)
Item
Pathologic T Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property-2)
C0475455 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
CL.26
Code List
Pathologic T Stage
CL Item
Microinvasion 0.1 Cm Or Less In Greatest Dimension (pT1mi)
CL Item
Tumor More Than 0.1 Cm But Not More Than 0.5 Cm In Greatest Dimension (pT1a)
CL Item
Tumor More Than 0.5 Cm But Not More Than 1 Cm In Greatest Dimension (pT1b)
CL Item
Tumor More Than 1 Cm But Not More Than 2 Cm In Greatest Dimension (pT1c)
CL Item
Tumor More Than 2 Cm But Not More Than 5 Cm In Greatest Dimension (pT2)
CL Item
Tumor More Than 5 Cm In Greatest Dimension (pT3)
Item
Pathologic N Stage (pathologic evaluation of ipsilateral nodes)
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property-2)
C0456532 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
CL.27
Code List
Pathologic N Stage (pathologic evaluation of ipsilateral nodes)
CL Item
No Regional Lymph Node Metastasis Histologically, No Additional Examination For Isolated Tumor Cells (itc) (pN0)
CL Item
Micrometastasis (>0.2 Mm But <=2.0 Mm) (pN1mi)
CL Item
Metastasis In 1 To 3 Axillary Lymph Nodes (pN1a)
CL Item
Metastasis In Internal Mammary Nodes With Microscopic Disease Detected By Sln Dissection But Not Clinically Apparent (pN1b)
CL Item
Metastasis In 1 To 3 Axillary Lymph Nodes And In Internal Mammary Lymph Nodes With Microscopic Disease Detected By Sln Dissection But Not Clinically Apparent. (pN1c)
CL Item
Metastasis In 4 To 9 Axillary Lymph Nodes (at Least 1 Tumor Deposit >2.0 Mm) (pN2a)
CL Item
Metastasis In Clinically Apparent* Internal Mammary Lymph Nodes In The Absence Of Axillary Lymph Node Metastasis (pN2b)
CL Item
Metastasis In >=10 Axillary Lymph Nodes (at Least 1 Tumor Deposit >2.0 Mm); Or, Metastasis To The Infraclavicular Lymph Nodes (pN3a)
CL Item
Metastasis In Clinically Apparent* Ipsilateral Internal Mammary Lymph Nodes In The Presence Of >=1 Positive Axillary Lymph Node(s); Or, In >3 Axillary Lymph Nodes And In Internal Mammary Lymph Nodes With Microscopic Disease Detected By Sentinel Lymph Node (pN3b)
Item Group
Patient Characteristics
Patient Height
Item
Patient Height (cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
Patient Weight
Item
Patient Weight (kg)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Assessment Date
Item
Date of Assessment
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
Assessment Date
Item
Date of Assessment
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
Systolic blood pressure
Item
Blood Pressure, Systolic (most recent)
float
C25209 (NCI Thesaurus ValueDomain)
C0871470 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25298 (NCI Thesaurus ObjectClass)
Diastolic blood pressure
Item
Blood pressure, Diastolic (most recent)
float
C25209 (NCI Thesaurus ValueDomain)
C0428883 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25299 (NCI Thesaurus ObjectClass)
BloodPressurePhysicalExaminationMostRecentDate
Item
Date of most recent blood pressure assessment
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C54706 (NCI Thesaurus ObjectClass)
C0005823 (UMLS 2011AA ObjectClass)
C25577 (NCI Thesaurus ValueDomain-2)
C1513491 (UMLS 2011AA ValueDomain-2)
HypertensionTreatmentReceivedInd-2
Item
Are anti-hypertensive medication(s) needed to sustain systolic BP <= 150 mmHg and diastolic BP <= 90 mmHg?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3117 (NCI Thesaurus ObjectClass)
C0020538 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass-2)
HeartLVEFTestPercentageValue
Item
LVEF (%)
float
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property-2)
C2700377 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
HeartLVEFTestDate
Item
Date LVEF performed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property-2)
C2700377 (UMLS 2011AA Property-2)
Item
Assessment Type
text
C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
CL.29
Code List
Assessment Type
CL Item
2-d Echocardiogram (2-D Echocardiogram)
CL Item
Muga Scan (MUGA scan)
Item Group
Section 3 (continued)
LaboratoryProcedureAbsoluteNeutrophilCountAssessmentInd-2
Item
ANC
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C63321 (NCI Thesaurus Property-2)
C0948762 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
ANC
Item
ANC (thousand/mm^3)
float
C25294 (NCI Thesaurus ObjectClass)
C0948762 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C63321 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureAbsoluteNeutrophilCountResultDate
Item
Date of Collection
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C63321 (NCI Thesaurus Property-2)
C0948762 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
LaboratoryProcedurePlateletAssessmentInd-2
Item
Platelet Count
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C12520 (NCI Thesaurus Property-2)
C0005821 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Platelets
Item
Platelet count (thousand/mm^3)
float
C25294 (NCI Thesaurus ObjectClass)
C0005821 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C12520 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Platelets date
Item
Date of Collection
date
C25164 (NCI Thesaurus ValueDomain)
C0005821 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
LaboratoryProcedureHemoglobinAssessmentInd-2
Item
Hemoglobin
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C16676 (NCI Thesaurus Property-2)
C0019046 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Hemoglobin
Item
Hemoglobin (g/dL)
float
C16676 (NCI Thesaurus Property)
C0019046 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Hemoglobin Date
Item
Date of Collection
date
C25164 (NCI Thesaurus ValueDomain)
C0019046 (UMLS CUI-1)
C16676 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
Item Group
Section 3 (continued)
LaboratoryProcedureAspartateAminotransferaseMeasurementAssessmentsInd-2
Item
AST
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C64467 (NCI Thesaurus Property-2)
C0201899 (UMLS 2011AA Property)
SGOT (AST)
Item
AST (units/L)
float
C25202 (NCI Thesaurus Property)
C0201899 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue
Item
AST ULN (units/L)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultDate
Item
Date of Collection
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
LaboratoryProcedureSerumGlutamicPyruvicTransaminasePerformedInd-3
Item
ALT (required only when SGOT AST is not available)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25293 (NCI Thesaurus Property-2)
C0376147 (UMLS 2011AA Property-2)
SGPT (ALT)
Item
ALT (units/L)
float
C25294 (NCI Thesaurus ObjectClass)
C0201836 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C25293 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue
Item
ALT ULN (units/L)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property-2)
C0376147 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultDate
Item
Date of Collection
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)
C25293 (NCI Thesaurus Property-2)
C0376147 (UMLS 2011AA Property-2)
LaboratoryProcedureAlkalinePhosphataseAssessmentInd-2
Item
Alkaline Phosphatase
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C16276 (NCI Thesaurus Property-2)
C0002059 (UMLS 2011AA Property)
Alkaline Phosphatase
Item
Alkaline Phosphatase (units/L)
float
C20200 (NCI Thesaurus Property)
C0201850 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C16276 (NCI Thesaurus Property-2)
Alkaline Phosphatase ULN
Item
Alkaline Phosphatase ULN (units/L)
float
C25294 (NCI Thesaurus ObjectClass)
C0151420 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C16276 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureAlkalinePhosphataseResultDate
Item
Date of Collection
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)
C16276 (NCI Thesaurus Property-2)
C0002059 (UMLS 2011AA Property-2)
LaboratoryProcedureBilirubinAssessmentInd-2
Item
Total Bilirubin
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C305 (NCI Thesaurus Property-2)
C0005437 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
LaboratoryProcedureTotalBilirubinResultSpecifiedValue
Item
Total Bilirubin
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property-2)
C0201913 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C0205369 (UMLS 2011AA ValueDomain-2)
Bilirubin, Total ULN
Item
Total bilirubin ULN (mg/dL)
float
C25294 (NCI Thesaurus ObjectClass)
C0201913 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C38037 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C25706 (NCI Thesaurus ValueDomain-3)
LaboratoryProcedureBilirubinOutcomeDate
Item
Date of Collection
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property-2)
C0005437 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
LaboratoryProcedureCreatinineAssessmentInd-2
Item
Serum Creatinine
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C399 (NCI Thesaurus Property-2)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Creatinine, Serum
Item
Serum creatinine (mg/dL)
float
C20200 (NCI Thesaurus Property)
C0201976 (UMLS CUI-1)
C399 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Creatinine, serum ULN
Item
Serum Creatinine ULN (mg/dL)
float
C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C399 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureCreatinineClearanceOutcomeDate
Item
Date of Collection
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25747 (NCI Thesaurus Property-2)
C0373595 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Item Group
Baseline Values2
LiverDiagnosticImagingAssessmentInd-2
Item
Was liver imaging performed? (CT, MRI, PET scan, or PET-CT)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C12392 (NCI Thesaurus ObjectClass-2)
C0023884 (UMLS 2011AA ObjectClass-2)
LiverMetastasisDiagnosticImagingPresentInd-3
Item
Does liver imaging demonstrate metastatic disease?
boolean
C12392 (NCI Thesaurus ObjectClass)
C0023884 (UMLS 2011AA ObjectClass)
C19151 (NCI Thesaurus ObjectClass-2)
C0027627 (UMLS 2011AA ObjectClass-2)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C16502 (NCI Thesaurus Property-2)
C0011923 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
LiverDiagnosticImagingAssessmentDate
Item
Date of Assessment
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C12392 (NCI Thesaurus ObjectClass-2)
C0023884 (UMLS 2011AA ObjectClass-2)
BonePainInd-2
Item
Does the patient have unexplained bone pain?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3303 (NCI Thesaurus Property)
C0030193 (UMLS 2011AA Property)
C12366 (NCI Thesaurus ObjectClass)
C0262950 (UMLS 2011AA ObjectClass)
BoneScanMedicalImagingAssessmentInd-3
Item
Was bone scan, PET-CT scan, or PET scan performed?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C17646 (NCI Thesaurus ObjectClass)
C0203668 (UMLS 2011AA ObjectClass)
C16831 (NCI Thesaurus ObjectClass-2)
BoneScanMagneticResonanceImagingDiagnosticImagingMetastaticMalignantNeoplasmtotheBonePresentInd-2
Item
Does bone scan, PET-CT scan, or PET scan demonstrate metastatic disease?
boolean
C17646 (NCI Thesaurus ObjectClass)
C0203668 (UMLS 2011AA ObjectClass)
C16502 (NCI Thesaurus ObjectClass-2)
C0011923 (UMLS 2011AA ObjectClass-2)
C16809 (NCI Thesaurus ObjectClass-3)
C0024485 (UMLS 2011AA ObjectClass-3)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C3580 (NCI Thesaurus Property-2)
C0153690 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
BoneAssessmentDate
Item
Date of Assessment (if applicable)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C12366 (NCI Thesaurus ObjectClass)
C0262950 (UMLS 2011AA ObjectClass)
PatientElevatedBilirubinPersonalMedicalHistoryInd-2
Item
Is bilirubin elevation due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C27088 (NCI Thesaurus Property)
C0311468 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
DiagnosticImagingChestAssessmentInd-3
Item
Was chest imaging performed?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C25389 (NCI Thesaurus Property-2)
C0817096 (UMLS 2011AA Property-2)
ChestDiagnosticImagingMetastasisPresentInd-3
Item
Did chest imaging demonstrate metastatic disease?
boolean
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C25389 (NCI Thesaurus ObjectClass-2)
C0817096 (UMLS 2011AA ObjectClass-2)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C19151 (NCI Thesaurus Property-2)
C0027627 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
DiagnosticImagingChestAssessmentDate
Item
Date chest imaging performed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C25389 (NCI Thesaurus Property-2)
C0817096 (UMLS 2011AA Property-2)
Item Group
Section 4 - Patient History
InflammatoryBreastCarcinomaPresentIndicator
Item
Was the breast cancer staged as T4, including inflammatory breast cancer?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C4001 (NCI Thesaurus ObjectClass)
C0278601 (UMLS 2011AA ObjectClass)
MetastaticNeoplasmConfirmedDiagnosisInd-2
Item
Is there definitive clinical or radiologic evidence of metastatic disease for this patient?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C3261 (NCI Thesaurus ObjectClass)
C2939420 (UMLS 2011AA ObjectClass)
ContralateralBreastCancerDiagnosisInd-2
Item
Did the patient have synchronous or previous contralateral invasive breast cancer?
boolean
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C25307 (NCI Thesaurus ObjectClass-3)
C0441988 (UMLS 2011AA ObjectClass-3)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
RecurrentIpsilateralBreastNeoplasmDiagnosisInd-2
Item
Does the patient have a history of ipsilateral invasive breast cancer or ipsilateral DCIS?
boolean
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C14173 (NCI Thesaurus ObjectClass-3)
C2945760 (UMLS 2011AA ObjectClass-3)
C25308 (NCI Thesaurus ObjectClass-4)
C0441989 (UMLS 2011AA ObjectClass-4)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonNoMalignantBreastNeoplasmPersonalMedicalHistoryInd-2
Item
Does the patient have a history of non-breast malignancies within the past 5 years?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
C9335 (NCI Thesaurus Property-3)
C0006142 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientNeoplasmPersonalMedicalHistoryInd-2
Item
Were the other malignancies limited to one or more of the following: in situ cancers treated only by local excision, and basal and squamous cell carcinomas of the skin?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus Property)
C0027651 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
PatientChemotherapyPersonalMedicalHistoryPlatinum-BasedTaxaneCompoundTherapeuticProcedureInd-2
Item
Has the patient had previous therapy with anthracyclines, taxanes, or trastuzumab for any malignancy?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
C25620 (NCI Thesaurus Property-3)
C1514162 (UMLS 2011AA Property-3)
C1490 (NCI Thesaurus Property-4)
C0796419 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PriorBreastCarcinomaChemotherapyAdministeredIndicator
Item
Has the patient had chemotherapy or HER2-targeted therapy administered for the currently diagnosed breast cancer?
boolean
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C4872 (NCI Thesaurus ObjectClass-3)
C0678222 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
PersonBreastRadiationTherapyCompleteRandomizationInd-3
Item
Has the patient had whole breast RT prior to randomization or partial breast RT that cannot be completed on or before the date of randomization?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25196 (NCI Thesaurus Property-2)
C0034656 (UMLS 2011AA Property-2)
C15313 (NCI Thesaurus Property-3)
C1522449 (UMLS 2011AA Property-3)
C12971 (NCI Thesaurus Property-4)
C0006141 (UMLS 2011AA Property-4)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PersonEndocrineTherapyAromataseInhibitorRandomizationInd-3
Item
Will the patient receive continued endocrine therapy with any hormonal agent such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor after randomization?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
C15445 (NCI Thesaurus Property-2)
C0279025 (UMLS 2011AA Property-2)
C1740 (NCI Thesaurus Property-3)
C0593802 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PersonEndocrineTherapyRandomizationInd-3
Item
Will the patient receive continued sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy after randomization?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
C15445 (NCI Thesaurus Property-2)
C0279025 (UMLS 2011AA Property-2)
AnginaDiseasePresentInd-3
Item
Does the patient have angina pectoris that requires the use of anti-anginal medication?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C51221 (NCI Thesaurus ObjectClass-2)
C0002962 (UMLS 2011AA ObjectClass-2)
ArrhythmiaHistoryInd-3
Item
Does the patient have ventricular arrhythmias except for benign premature ventricular contractions?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C2881 (NCI Thesaurus ObjectClass)
C0003811 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
DiseaseorDisorderSupraventricularArrhythmiaNodalArrhythmiaPresentInd-3
Item
Does the patient have supraventricular or nodal arrhythmias requiring a pacemaker or not controlled with medication?
boolean
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C27045 (NCI Thesaurus Property-2)
C0264893 (UMLS 2011AA Property-2)
C27158 (NCI Thesaurus Property-3)
C0428974 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
DiseaseorDisorderHeartConductionDisorderBiventricularPacemakerPresentInd-3
Item
Does the patient have a conduction abnormality requiring a pacemaker?
boolean
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C80460 (NCI Thesaurus Property-2)
C1719274 (UMLS 2011AA Property-2)
C78245 (NCI Thesaurus Property-3)
C0264886 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CardiacDiseasePresentInd-2
Item
Does the patient have valvular disease with documented compromise in cardiac function?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
DiseaseorDisorderPericarditisPresentChronicDiseaseInd-3
Item
Does the patient have symptomatic pericarditis?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C34915 (NCI Thesaurus Property-2)
C0031046 (UMLS 2011AA Property-2)
SymptomaticCongestiveHeartFailurePresentInd-3
Item
Does the patient have a history of documented CHF?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C3080 (NCI Thesaurus ObjectClass)
C0018802 (UMLS 2011AA ObjectClass)
C25269 (NCI Thesaurus ObjectClass-2)
C0231220 (UMLS 2011AA ObjectClass-2)
DiseaseorDisorderCardiomyopathyPresentInd-3
Item
Does the patient have a history of documented cardiomyopathy?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C34830 (NCI Thesaurus Property-2)
C0878544 (UMLS 2011AA Property-2)
PatientCerebrovascularAccidentMyocardialInfarctionPersonalMedicalHistoryInd-3
Item
Does the patient have a history of myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C27996 (NCI Thesaurus Property)
C0027051 (UMLS 2011AA Property)
C3390 (NCI Thesaurus Property-2)
C0038454 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
DiseaseorDisorderCardiacHeartPersonalMedicalHistoryInd-3
Item
Does the patient have any other cardiac disease (history of and/or active disease) that would preclude the use of drugs included in the treatment regimen?
boolean
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C13306 (NCI Thesaurus ObjectClass-2)
C1522601 (UMLS 2011AA ObjectClass-2)
C2991 (NCI Thesaurus ObjectClass-3)
C0012634 (UMLS 2011AA ObjectClass-3)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
HepaticInfectionPersonalMedicalHistoryInd-3
Item
Does the patient have active hepatitis B or hepatitis C with abnormal liver function tests?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C0021311 (NCI Metathesaurus ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
DyspneaDiseasePresentInd-2
Item
Does the patient have intrinsic lung disease resulting in dyspnea?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2998 (NCI Thesaurus ObjectClass)
C0013404 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
PatientLesserControlDiabetesMellitusEligibilityDeterminationInd-2
Item
Does the patient have poorly controlled diabetes mellitus?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C2985 (NCI Thesaurus Property)
C0011849 (UMLS 2011AA Property)
C61299 (NCI Thesaurus Property-2)
C2587213 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C61422 (NCI Thesaurus Property-4)
C0547044 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ChronicDiseaseInfectionInd-3
Item
Does the patient have active infection or chronic infection requiring chronic suppressive antibiotics?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C14141 (NCI Thesaurus ObjectClass-2)
C0205191 (UMLS 2011AA ObjectClass-2)
PatientCentralNervousSystemDiseaseorDisorderEligibilityDeterminationInd-2
Item
Does the patient have a nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2, per the CTCAE v4.0?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12438 (NCI Thesaurus Property)
C3714787 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
DiseaseorDisorderRestrictionCorticosteroidAdministrationPresentInd-3
Item
Does the patient have any conditions that would prohibit administration of corticosteroids?
boolean
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2322 (NCI Thesaurus Property-2)
C0001617 (UMLS 2011AA Property-2)
C25409 (NCI Thesaurus Property-3)
C1533734 (UMLS 2011AA Property-3)
C53452 (NCI Thesaurus Property-4)
C0443288 (UMLS 2011AA Property-4)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PatientClinicalStudyAgentHypersensitivityPersonalMedicalHistoryInd-2
Item
Does the patient have known hypersensitivity reaction to any of the study drugs or excipients, e.g. polysorbate 80 and Cremophor EL?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3114 (NCI Thesaurus Property)
C0020517 (UMLS 2011AA Property)
C1708 (NCI Thesaurus Property-2)
C0450442 (UMLS 2011AA Property-2)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-3)
C18772 (NCI Thesaurus Property-4)
C0262926 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientCorticosteroidUsePersonalMedicalHistoryInd-2
Item
Does the patient have chronic daily treatment with corticosteroids with a dose >= 10 mg/day methylprednisolone equivalent (excluding inhaled steroids)?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C2322 (NCI Thesaurus Property)
C0001617 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
C25340 (NCI Thesaurus Property-3)
C0457083 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
SystemicDiseaseHistoryInd-2
Item
Does the patient have other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
PatientStudyRequirementInd-2
Item
Does the patient have psychiatric or addictive disorders or other condition that, in the opinion of the investigator, would preclude the patient from meeting the study requirements?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C38015 (NCI Thesaurus Property)
PatientInvestigationalClinicalTrialCurrentParticipationExclusionCriteriaInd-2
Item
Has the patient used any investigational product within the past 30 days?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C15207 (NCI Thesaurus Property-3)
C28041 (NCI Thesaurus Property-4)
C1517586 (UMLS 2011AA Property-3)
C25370 (NCI Thesaurus Property-5)
C0680251 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
FemalePatientPotentialPregnancyInd-2
Item
Is patient a woman of childbearing potential?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16576 (NCI Thesaurus ObjectClass-2)
C0086287 (UMLS 2011AA ObjectClass-2)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
C0237399 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientPregnancyTestIndicator
Item
Was a pregnancy test performed?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C0032976 (NCI Metathesaurus Property)
PatientMostRecentPregnancyTestDate
Item
Date of pregnancy test
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C0032976 (NCI Metathesaurus Property)
C25577 (NCI Thesaurus Property)
C1513491 (UMLS 2011AA Property)
PatientPregnancyInd-2
Item
Is the patient pregnant or lactating at time of study entry?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
EasternCooperativeOncologyGroupPerformanceStatusAssessmentInd-2
Item
Does the patient have an ECOG performance status of 0 or 1?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25491 (NCI Thesaurus ObjectClass)
C1512162 (UMLS 2011AA ObjectClass)
CL092952 (NCI Metathesaurus ObjectClass)
Item Group
Section 5 - Menapausal Status
HysterectomyPerformedInd-3
Item
Has the patient had a hysterectomy?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15256 (NCI Thesaurus ObjectClass)
C0020699 (UMLS 2011AA ObjectClass)
HysterectomyPerformedDate
Item
Date of Hysterectomy (Please provide surgical report.)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15256 (NCI Thesaurus ObjectClass)
C0020699 (UMLS 2011AA ObjectClass)
MensesOccurrenceInd-3
Item
Has the patient had any spontaneous menses in the past 12 months?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C3232 (NCI Thesaurus ObjectClass)
C0025344 (UMLS 2011AA ObjectClass)
LastMenstrualCycleOccurrenceDate
Item
Date of last menstrual period (If unsure of the date, please provide a close approximation.)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25551 (NCI Thesaurus ObjectClass)
C1517741 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C16838 (NCI Thesaurus ObjectClass-2)
C0025329 (UMLS 2011AA ObjectClass-2)
Item
Has the patient had both ovaries removed?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12404 (NCI Thesaurus ObjectClass)
C0029939 (UMLS 2011AA ObjectClass)
C25650 (NCI Thesaurus Property)
C0849355 (UMLS 2011AA Property)
CL.84
Code List
Has the patient had both ovaries removed?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
OvaryRemovedDate
Item
Date both (or second) ovaries were removed (Please provide all surgical reports related to oophorectomies. If unsure of the date, please report a close approximation.)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C12404 (NCI Thesaurus ObjectClass)
C0029939 (UMLS 2011AA ObjectClass)
C25650 (NCI Thesaurus Property)
C0849355 (UMLS 2011AA Property)
PersonEstradiolMeasurementPostmenopausalEvaluationAssessmentInd-3
Item
Has the patient had a documented estradiol level in the postmenopausal range according to local institutional/laboratory standard? (If yes, please provide documentation of estradiol level.)
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C15421 (NCI Thesaurus Property-2)
C0232970 (UMLS 2011AA Property-2)
C74782 (NCI Thesaurus Property-3)
C0337434 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Item Group
Footer
Research Comments
Item
Comments (optional)
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
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