ID

42969

Description

NSABP B-45 Worksheet for Entry Form Studying Biological Markers of Fatigue in Women With Residual Invasive Breast Cancer Enrolled on Clinical Trial NSABP-B-45 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6461E18A-2104-98F1-E040-BB89AD4303E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6461E18A-2104-98F1-E040-BB89AD4303E7

Keywords

  1. 8/8/14 8/8/14 - Martin Dugas
  2. 8/11/14 8/11/14 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT00914043 Registration - NSABP B-45 Worksheet for Entry Form - 2846518v1.0

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

Header
Description

Header

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
Site Name
Description

ClinicalTrialSiteNameText

Data type

text

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

Birth Date

Data type

date

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

TreatingPhysicianName

Data type

text

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

Social Security Number

Data type

text

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

Gender

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS CUI-1
C0079399
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C17357
Race
Description

Race

Race (more than one may be marked)
Description

Racial Group

Data type

text

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

Person Completing Form, Last Name

Method of Payment (mark primary method only)
Description

PatientPaymentType

Data type

text

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

Ethnic Group

Data type

text

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

PatientAddressCountryCode

Data type

text

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

OtherPatientAddressCountrySpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C17649
UMLS 2011AA ObjectClass
C0205394
NCI Thesaurus ObjectClass-2
C16960
UMLS 2011AA ObjectClass-2
C0030705
NCI Thesaurus Property
C25407
UMLS 2011AA Property
C1442065
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ValueDomain-2
C25464
UMLS 2011AA ValueDomain-2
C0454664
Patient Zip Code (USA)
Description

PatientAddressPostalCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25407
UMLS 2011AA Property
C1442065
Unnamed4
Description

Unnamed4

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
Was this an IRB-approved consent form that conforms to federal and institutional guidelines for study treatment and release of required tumor blocks
Description

ClinicalStudyProtocolInstitutionalReviewBoardConsentFormSpecimenApprovalInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C16468
UMLS 2011AA Property
C0009797
NCI Thesaurus Property-2
C19157
UMLS 2011AA Property-2
C0370003
NCI Thesaurus Property-3
C16741
UMLS 2011AA Property-3
C0086911
NCI Thesaurus Property-4
C25425
UMLS 2011AA Property-4
C0205540
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
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
Did the pathology department agree to release the required blocks
Description

PathologySpecimenParaffinBlockInstitutionRequestInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus ObjectClass-2
C18189
UMLS 2011AA ObjectClass-2
C0030664
NCI Thesaurus Property
C21541
UMLS 2011AA Property
C0018704
NCI Thesaurus Property-2
C25436
UMLS 2011AA Property-2
C1533157
NCI Thesaurus Property-3
C727
UMLS 2011AA Property-3
C0030415
NCI Thesaurus Property-4
C48312
UMLS 2011AA Property-4
C1272683
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Did the patient agree to have a blood sample collected before starting study drug
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
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 complete the Quality of Life baseline form?
Description

BaselineQOLCompleteFormInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C17047
UMLS 2011AA ObjectClass
C0518214
NCI Thesaurus ObjectClass-2
C25213
UMLS 2011AA ObjectClass-2
C1442488
NCI Thesaurus Property
C19464
UMLS 2011AA Property
C0376315
NCI Thesaurus Property-2
C25250
UMLS 2011AA Property-2
C0205197
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date baseline QOL completed by patient (Month Day Year)
Description

BaselineQOLCompleteFormDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C17047
UMLS 2011AA ObjectClass
C0518214
NCI Thesaurus ObjectClass-2
C25213
UMLS 2011AA ObjectClass-2
C1442488
NCI Thesaurus Property
C19464
UMLS 2011AA Property
C0376315
NCI Thesaurus Property-2
C25250
UMLS 2011AA Property-2
C0205197
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Cardiac Conditions
Description

Cardiac Conditions

Angina pectoris that requires the use of anti-anginal medication
Description

UnstableAnginaDiseasePresentInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25594
UMLS 2011AA ObjectClass
C1518422
NCI Thesaurus ObjectClass-2
C30103
UMLS 2011AA ObjectClass-2
C0205360
NCI Thesaurus ObjectClass-3
C2991
UMLS 2011AA ObjectClass-3
C0012634
NCI Thesaurus ObjectClass-4
C51221
UMLS 2011AA ObjectClass-4
C0002962
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Serious cardiac arrythmia requiring medication?
Description

ArrhythmiaPresentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C2881
UMLS 2011AA ObjectClass
C0003811
Valvular disease with documented cardiac function compromise?
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 a history of myocardial infarction
Description

PatientPriorMyocardialInfarctionInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C27996
UMLS 2011AA Property
C0027051
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
History of documented congestive heart failure
Description

CongestiveHeartFailureHistoryInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C3080
UMLS 2011AA ObjectClass
C0018802
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
Severe conduction abnormality?
Description

HeartNerveAbnormalityInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C12466
UMLS 2011AA ObjectClass
C0027740
NCI Thesaurus Property
C9440
UMLS 2011AA Property
C1704258
Uncontrolled hypertension defined as BP > 150/90 on antihypertensive therapy
Description

UncontrolledHypertensionPresentInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C3117
UMLS 2011AA ObjectClass
C0020538
NCI Thesaurus ObjectClass-2
C48932
UMLS 2011AA ObjectClass-2
C0205318
Was there documentation of elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function
Description

PatientCardiovascularAbnormalityPersonalMedicalHistoryInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C9440
UMLS 2011AA Property
C1704258
NCI Thesaurus Property-2
C18772
UMLS 2011AA Property-2
C0262926
NCI Metathesaurus Property
C0374861
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Other Conditions
Description

Other Conditions

Has the patient had contralateral breast cancer (including DCIS) at any time
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
Has the patient had any prior cancer diagnosed?
Description

PriorCancerDiagnosisInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Is the patient deemed by her physician to be a low risk for recurrence (If yes)
Description

PhysicianRecurrentDiseaseLowRiskDiagnosisInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25741
UMLS 2011AA ObjectClass
C0031831
NCI Thesaurus Property
C38155
UMLS 2011AA Property
C0277556
NCI Thesaurus Property-2
C54722
UMLS 2011AA Property-2
C0205251
NCI Thesaurus Property-3
C15220
UMLS 2011AA Property-3
C0011900
NCI Thesaurus Property-4
C17102
UMLS 2011AA Property-4
C0035647
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has the patient been disease free for 5 years or more
Description

DiseaseStatusIndicator

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Metathesaurus Property
C0449438
Does the patient have a history of hypertensive crisis or hypertensive encephalopathy
Description

PersonHypertensionEncephalopathyPersonalMedicalHistoryInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C3117
UMLS 2011AA Property
C0020538
NCI Thesaurus Property-2
C26920
UMLS 2011AA Property-2
C0085584
NCI Thesaurus Property-3
C18772
UMLS 2011AA Property-3
C0262926
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have a history of arterial thrombotic event within the past 12 months (including catheter-related thrombus)
Description

ArteryThrombosisPatientPreviousYearPersonalMedicalHistoryInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C26891
UMLS 2011AA ObjectClass-2
C0040053
NCI Thesaurus ObjectClass-3
C12372
UMLS 2011AA ObjectClass-3
C0003842
NCI Thesaurus Property
C25627
UMLS 2011AA Property
C0205156
NCI Thesaurus Property-2
C29848
UMLS 2011AA Property-2
C0439234
NCI Thesaurus Property-3
C18772
UMLS 2011AA Property-3
C0262926
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date of thrombotic event (MM DD YYYY)
Description

ThrombosisAdverseEventObservedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass-2
C26891
UMLS 2011AA ObjectClass-2
C0040053
NCI Thesaurus Property
C25599
UMLS 2011AA Property
C1441672
Does the patient have a history of ipsilateral breast cancer (including DCIS)
Description

IpsilateralDiseasePresentInd-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
C25308
UMLS 2011AA ObjectClass-2
C0441989
Has the patient had any prior malignancies in the past 5 years other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the colon or rectum, or carcinoma in situ of the cervix that has been effectively treated? (If the patient has not been disease free for 5 years or more)
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
Does the patient have a prior history of documented cerebral vascular accident or documented transient ischemic attack?
Description

PatientTransientIschemicAttackCerebrovascularAccidentPersonalMedicalHistoryInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C29867
UMLS 2011AA ObjectClass
C0679646
NCI Thesaurus Property
C50781
UMLS 2011AA Property
C0007787
NCI Thesaurus Property-2
C3390
UMLS 2011AA Property-2
C0038454
NCI Thesaurus Property-3
C18772
UMLS 2011AA Property-3
C0262926
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has the patient had any significant non-traumatic bleeding within 6 months before study entry
Description

PatientHistoryHemorrhageEventInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25499
UMLS 2011AA Property
C0441471
NCI Thesaurus Property-2
C26791
UMLS 2011AA Property-2
C0019080
NCI Metathesaurus Property
C1321503
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date of bleeding event (MM DD YYYY)
Description

PatientHistoryHemorrhageEventDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25499
UMLS 2011AA Property
C0441471
NCI Thesaurus Property-2
C26791
UMLS 2011AA Property-2
C0019080
NCI Metathesaurus Property
C1321503
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Cardiac Risk Factors
Description

Cardiac Risk Factors

Does the patient have any first degree relatives who died from heart disease before the age of 55 (First degree relatives are parents, children, brothers, and sisters)
Description

FirstDegreeRelativeCardiovascularDisorderDeathInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C28554
UMLS 2011AA Property
C0011065
NCI Thesaurus Property-2
C2931
UMLS 2011AA Property-2
C0007222
NCI Thesaurus ObjectClass
C21481
UMLS 2011AA ObjectClass
C1517194
Hypertension requiring medical therapy (If yes, mark all categories that apply)
Description

PersonHypertensionTherapeuticProcedurePersonalMedicalHistoryInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C3117
UMLS 2011AA Property
C0020538
NCI Thesaurus Property-2
C49236
UMLS 2011AA Property-2
C0087111
NCI Thesaurus Property-3
C18772
UMLS 2011AA Property-3
C0262926
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Diabetes requiring medical therapy
Description

PersonDiabetesMellitusTherapeuticProcedurePersonalMedicalHistoryInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C2985
UMLS 2011AA Property
C0011849
NCI Thesaurus Property-2
C49236
UMLS 2011AA Property-2
C0087111
NCI Thesaurus Property-3
C18772
UMLS 2011AA Property-3
C0262926
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Hyperlipidemia requiring medical therapy
Description

PersonHyperlipidemiaTherapeuticProcedurePersonalMedicalHistoryind-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C49236
UMLS 2011AA Property
C0087111
NCI Thesaurus Property-2
C34707
UMLS 2011AA Property-2
C0020473
NCI Thesaurus Property-3
C18772
UMLS 2011AA Property-3
C0262926
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Smoking (Patient History)
Description

Smoking history

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C1519384
NCI Thesaurus ObjectClass
C17934
NCI Thesaurus Property
C18772
Section 2 - Diagnostic
Description

Section 2 - Diagnostic

Stage (Clinical)
Description

BreastTumorStageGroupingStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
NCI Thesaurus Property
C38027
UMLS 2011AA Property
C1519504
Is estrogen receptor analysis result available (from primary surgery)
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 (If yes,)
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
Date of Diagnostic Core or Incisional Biopsy (Month Day Year)
Description

SurgicalProcedureCoreBiopsyPerformedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C15680
UMLS 2011AA Property
C1318309
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
Was there any histologic evidence of invasive tumor cells in the surgical breast specimen
Description

InvasiveBreastCarcinomaHistologicallyConfirmedInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C4872
UMLS 2011AA ObjectClass
C0678222
NCI Thesaurus ObjectClass-2
C14159
UMLS 2011AA ObjectClass-2
C0205281
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
NCI Thesaurus Property-2
C25527
UMLS 2011AA Property-2
C0205462
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is progesterone receptor analysis result available (from primary surgery)
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
Was HER2 status assessed by IHC assay
Description

EpidermalGrowthFactorReceptorAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25217
UMLS 2011AA Property
C1516048
NCI Thesaurus ObjectClass
C17068
UMLS 2011AA ObjectClass
C0034802
Her2/neu expression status by immunohistochemistry
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
Date of IHC Assay (Month Day Year A copy of the report must be provided)
Description

SpecimenLaboratoryProcedureDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
Was HER2 status assessed by ISH assay (FISH, CISH, or other ISH)
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
HER2 Status by ISH Assay (If yes, If multiple ISH assays were done, and at least one was positive, the positive assay must be reported.)
Description

LaboratoryProcedureHER2/neuinsituHybridizationOutcomeType

Data type

text

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
C25284
UMLS 2011AA ValueDomain
C0332307
Was HER2-targeted therapy administered pre-operatively or post-operatively prior to study entry (If ISH assay is equivocal,)
Description

HER2/neuTherapyPriorPostSurgicalProcedureAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C17756
UMLS 2011AA ObjectClass
C0242957
NCI Thesaurus Property
C38008
UMLS 2011AA Property
C0687676
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C25382
UMLS 2011AA Property-3
C1521801
NCI Metathesaurus Property
C0038895
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is there a plan to administer HER2-targeted therapy
Description

HER2/neuTherapyPlanAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C17756
UMLS 2011AA ObjectClass
C0242957
NCI Thesaurus Property
C25619
UMLS 2011AA Property
C1301732
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date of ISH Assay (Month Day Year A copy of the report must be provided.)
Description

LaboratoryProcedureHER2/neuinsituHybridizationOutcomeDate

Data type

date

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
C25164
UMLS 2011AA ValueDomain
C0011008
Nodal Status Assessments Prior To Neoadjuvant Chemotherapy
Description

Nodal Status Assessments Prior To Neoadjuvant Chemotherapy

Was nodal FNA performed
Description

AxillaryLymphNodeFine-NeedleAspirationPriorTherapyPerformedInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15361
UMLS 2011AA ObjectClass
C1510483
NCI Thesaurus ObjectClass-2
C12904
UMLS 2011AA ObjectClass-2
C0729594
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C15368
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Was nodal FNA positive
Description

AxillaryLymphNodeCoreBiopsyFine-NeedleAspirationLymphNodeBiopsyPositiveFindingInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15680
UMLS 2011AA ObjectClass
C1318309
NCI Thesaurus ObjectClass-2
C15361
UMLS 2011AA ObjectClass-2
C1510483
NCI Thesaurus ObjectClass-3
C51900
UMLS 2011AA ObjectClass-3
C0193842
NCI Thesaurus ObjectClass-4
C12904
UMLS 2011AA ObjectClass-4
C0729594
NCI Thesaurus Property
C38758
UMLS 2011AA Property
C1514241
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Was nodal core biopsy performed
Description

AxillaryLymphNodeCoreBiopsyFine-NeedleAspirationLymphNodeBiopsyPriorClinicalStudyPerformedInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15680
UMLS 2011AA ObjectClass
C1318309
NCI Thesaurus ObjectClass-2
C15361
UMLS 2011AA ObjectClass-2
C1510483
NCI Thesaurus ObjectClass-3
C51900
UMLS 2011AA ObjectClass-3
C0193842
NCI Thesaurus ObjectClass-4
C12904
UMLS 2011AA ObjectClass-4
C0729594
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C15206
UMLS 2011AA Property-3
C0008972
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Was nodal core biopsy positive
Description

AxillaryLymphNodeCoreBiopsyLymphNodeBiopsyPositiveFindingInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15680
UMLS 2011AA ObjectClass
C1318309
NCI Thesaurus ObjectClass-2
C51900
UMLS 2011AA ObjectClass-2
C0193842
NCI Thesaurus ObjectClass-3
C12904
UMLS 2011AA ObjectClass-3
C0729594
NCI Thesaurus Property
C38758
UMLS 2011AA Property
C1514241
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Was sentinel node sampling performed
Description

SentinelNodeBiopsyInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C15189
UMLS 2011AA Property
C0005558
NCI Thesaurus ObjectClass
C12947
UMLS 2011AA ObjectClass
C1522495
Were there any positive sentinel nodes
Description

SentinelNodeBiopsyInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C15189
UMLS 2011AA Property
C0005558
NCI Thesaurus ObjectClass
C12947
UMLS 2011AA ObjectClass
C1522495
Section 3 - Neoadjuvant Chemotherapy
Description

Section 3 - Neoadjuvant Chemotherapy

Date Prior Neoadjuvant Chemotherapy Started (first neoadjuvant chemotherapy dose Month Day Year)
Description

NeoadjuvantTherapyPriorChemotherapyAdministeredBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15665
UMLS 2011AA ObjectClass
C0600558
NCI Thesaurus Property
C15632
UMLS 2011AA Property
C0392920
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C25382
UMLS 2011AA Property-3
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
Date Prior Neoadjuvant Chemotherapy Ended (last neoadjuvant chemotherapy dose Month Day Year)
Description

NeoadjuvantTherapyPriorChemotherapyAdministeredEndDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15665
UMLS 2011AA ObjectClass
C0600558
NCI Thesaurus Property
C15632
UMLS 2011AA Property
C0392920
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C25382
UMLS 2011AA Property-3
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Neoadjuvant Chemotherapy
Description

PriorChemotherapyNeoadjuvantTreatmentRegimenType

Data type

text

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C15368
NCI Thesaurus Property-2
C15665
UMLS 2011AA Property
C0600558
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Specify other chemotherapy agents (if applicable)
Description

PriorChemotherapyNeoadjuvantTreatmentSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C15368
NCI Thesaurus Property-2
C15665
UMLS 2011AA Property
C0600558
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
No. of Courses
Description

PriorChemotherapyNeoadjuvantTreatmentCount

Data type

float

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C15368
NCI Thesaurus Property-2
C15665
UMLS 2011AA Property
C0600558
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Total number of cycles completed
Description

ChemotherapyTotalCycleCompleteCount

Data type

float

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property-2
C25304
UMLS 2011AA Property-2
C0439810
NCI Thesaurus Property-3
C25472
UMLS 2011AA Property-3
C1511572
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Section 4 - Surgery After Neoadjuvant Chemotherapy
Description

Section 4 - Surgery After Neoadjuvant Chemotherapy

Tumor Laterality
Description

PrimaryTumorLateralityType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C25251
UMLS 2011AA ObjectClass-2
C0205225
NCI Thesaurus Property
C25185
UMLS 2011AA Property
C0332304
Margin Status (If mastectomy was performed,)
Description

BreastCancerSurgeryMarginStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus ObjectClass-2
C4872
UMLS 2011AA ObjectClass-2
C0678222
NCI Thesaurus Property
C25563
UMLS 2011AA Property
C0205284
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Is estrogen receptor analysis result available (from primary surgery)
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 (If yes,)
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
Does the pathology report from the breast surgery indicate on H&E staining that residual invasive in-breast disease was found in the surgical specimen
Description

BreastSurgicalProcedurePositiveHematoxylinandEosinStainingMethodAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus ObjectClass-2
C15329
UMLS 2011AA ObjectClass-2
C0543467
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Metathesaurus Property
C0205159
NCI Thesaurus Property-2
C23011
UMLS 2011AA Property-2
C0523207
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Size of residual tumor (If yes, If > 0.5 cm, refer to Protocol Table 3.)
Description

PrimaryTumorPathologicSizeType

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C25251
UMLS 2011AA ObjectClass-2
C0205225
NCI Thesaurus Property
C25610
UMLS 2011AA Property
C1521733
NCI Thesaurus Property-2
C25681
UMLS 2011AA Property-2
C0456389
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Pathologic N Stage (If no,)
Description

BreastTumorPostNeoadjuvantTherapyPathologyNStage

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
C38008
UMLS 2011AA Property
C0687676
NCI Thesaurus Property-2
C15665
UMLS 2011AA Property-2
C0600558
NCI Thesaurus Property-3
C18189
UMLS 2011AA Property-3
C0030664
NCI Thesaurus Property-4
C25580
UMLS 2011AA Property-4
C0456532
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Date of Last Surgery for staging or treatment (including re-excision of margins and any axillary staging procedures Month Day Year)
Description

PrimaryBreastNeoplasmSurgicalProcedurePerformedDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25251
UMLS 2011AA ObjectClass
C0205225
NCI Thesaurus ObjectClass-2
C15329
UMLS 2011AA ObjectClass-2
C0543467
NCI Thesaurus ObjectClass-3
C2910
UMLS 2011AA ObjectClass-3
C0042875
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Has the patient recovered from surgery
Description

SurgeryComplicationInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus Property
C2959
UMLS 2011AA Property
C0009566
Section 4 - Surgery After Neoadjuvant Chemotherapy1
Description

Section 4 - Surgery After Neoadjuvant Chemotherapy1

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 (If yes, Month Day Year)
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 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 mastectomy performed (If yes, Month Day Year)
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 lumpectomy margins histologically free of invasive tumor and DCIS, either initially or after one or more re-excisions (If mastectomy was not performed,)
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
Is progesterone receptor analysis result available (from primary surgery)
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
Was axillary staging performed
Description

AxillaryLymphNodePostNeoadjuvantTherapyEvaluationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12904
UMLS 2011AA ObjectClass
C0729594
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property-2
C38008
UMLS 2011AA Property-2
C0687676
NCI Thesaurus Property-3
C15665
UMLS 2011AA Property-3
C0600558
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the pathology report from the axillary staging procedure indicate on H&E staining that residual axillary nodal metastasis was found in the surgical specimen
Description

PositiveAxillaryNodeHematoxylinAndEosinStainingAssessmentind-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25246
UMLS 2011AA ObjectClass
C1446409
NCI Thesaurus ObjectClass-2
C12904
UMLS 2011AA ObjectClass-2
C0729594
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C23011
UMLS 2011AA Property-2
C0523207
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Size of largest focus of nodal metastasis (If yes, If > 0.5 cm, refer to Protocol Table 3)
Description

AmericanCollegeofSurgeonsOncologyGroupPatientMalignantNeoplasmSizeEligibilityDeterminationType

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C19712
UMLS 2011AA ObjectClass-2
C1515944
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
NCI Thesaurus Property-3
C25681
UMLS 2011AA Property-3
C0456389
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Will postoperative radiation therapy be administered after the patient has been entered on study
Description

AdjuvantPostoperativeRadiationTherapyAdministeredInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus ObjectClass-2
C28006
UMLS 2011AA ObjectClass-2
C0032790
NCI Thesaurus ObjectClass-3
C2140
UMLS 2011AA ObjectClass-3
C0001552
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Has the incision completely healed with no signs of infection (If yes,)
Description

SurgicalProcedureWoundInfectionAdverseEventInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C41331
UMLS 2011AA Property
C0877248
NCI Thesaurus Property-2
C45234
UMLS 2011AA Property-2
C0043241
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
Sentinel Node Biopsy Staging
Description

Sentinel Node Biopsy Staging

Was sentinel node biopsy (SNB) performed after neoadjuvant therapy
Description

BiopsySentinelLymphNodePerformedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15189
UMLS 2011AA ObjectClass
C0005558
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property-2
C12947
UMLS 2011AA Property-2
C1522495
Sentinel Node Biopsy Date (Month Day Year)
Description

SentinelNodeBiopsyDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C15189
UMLS 2011AA Property
C0005558
NCI Thesaurus ObjectClass
C12947
UMLS 2011AA ObjectClass
C1522495
Number of Sentinel Nodes Examined (AXILLARY)
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 (AXILLARY)
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
Other Axillary Staging
Description

Other Axillary Staging

Number of axillary staging procedures (other than SNB) performed after neoadjuvant therapy (If 1 or 2, list dates and nodal information)
Description

AxillaryLymphNodeStagingPerformedType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property-2
C15608
UMLS 2011AA Property-2
C0332305
NCI Thesaurus ObjectClass
C12904
UMLS 2011AA ObjectClass
C0729594
Date of procedure (Month Day Year)
Description

AxillaryLymphNodeCoreBiopsyFine-NeedleAspirationLymphNodeBiopsyPriorClinicalStudyPerformedDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15680
UMLS 2011AA ObjectClass
C1318309
NCI Thesaurus ObjectClass-2
C15361
UMLS 2011AA ObjectClass-2
C1510483
NCI Thesaurus ObjectClass-3
C51900
UMLS 2011AA ObjectClass-3
C0193842
NCI Thesaurus ObjectClass-4
C12904
UMLS 2011AA ObjectClass-4
C0729594
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C15206
UMLS 2011AA Property-3
C0008972
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Number of axillary nodes examined (Total Non-Sentinel)
Description

AxillaryNodeExaminedTotalCount

Data type

float

Alias
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus Property
C25500
UMLS 2011AA Property
C0332128
NCI Thesaurus ValueDomain-2
C25463
UMLS 2011AA ValueDomain-2
C0750480
NCI Thesaurus ObjectClass
C12904
UMLS 2011AA ObjectClass
C0729594
Number of positive axillary lymph nodes (Total Non-Sentinel)
Description

PositiveAxillaryNodeExaminedTotalCount

Data type

float

Alias
NCI Thesaurus ObjectClass
C25246
UMLS 2011AA ObjectClass
C1446409
NCI Thesaurus ObjectClass-2
C12904
UMLS 2011AA ObjectClass-2
C0729594
NCI Thesaurus Property
C25500
UMLS 2011AA Property
C0332128
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus ValueDomain-2
C25463
UMLS 2011AA ValueDomain-2
C0750480
Number of Positive Lymph Nodes (Total of all positive axillary and non-axillary nodes from all nodal staging procedures, including sentinel node biopsy)
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
Postoperative Chemotherapy
Description

Postoperative Chemotherapy

Postoperative Chemotherapy (If no, skip to B Baseline Values)
Description

ChemotherapyPostoperativeAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C28006
UMLS 2011AA Property
C0032790
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
Date Chemotherapy Began (first postoperative chemotherapy dose Month Day Year)
Description

Chemotherapy Start Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1302181
NCI Thesaurus ObjectClass
C15632
UMLS CUI-2
C3173309
NCI Thesaurus ValueDomain-2
C25431
NCI Thesaurus Property
C25382
Date Chemotherapy Ended (last postoperative chemotherapy dose Month Day Year)
Description

ChemotherapyAdministeredEndDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Types of Postoperative Chemotherapy (Mark all that apply)
Description

AdjuvantChemotherapyAdministeredRegimenType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C2140
UMLS 2011AA ObjectClass-2
C0001552
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Other, specify
Description

ChemotherapyRegimenSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C15697
UMLS 2011AA Property
C0040808
Did the patient experience chemotherapy-related toxicity (excluding alopecia, nail changes, dysgeusia, hot flashes/flushes, sexual/reproductive function)
Description

ChemotherapyToxicityEventInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25499
UMLS 2011AA Property
C0441471
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C27990
UMLS 2011AA ObjectClass-2
C0600688
Have these toxicities resolved to <= grade 1 (If yes,)
Description

ChemotherapyToxicityResolutionEventInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C27990
UMLS 2011AA ObjectClass-2
C0600688
NCI Thesaurus Property
C25499
UMLS 2011AA Property
C0441471
NCI Thesaurus Property-2
C25655
UMLS 2011AA Property-2
C1514893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Baseline Values
Description

Baseline Values

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
Hypertension requiring medical therapy (If yes, mark all categories that apply)
Description

PersonHypertensionTherapeuticProcedurePersonalMedicalHistoryInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C3117
UMLS 2011AA Property
C0020538
NCI Thesaurus Property-2
C49236
UMLS 2011AA Property-2
C0087111
NCI Thesaurus Property-3
C18772
UMLS 2011AA Property-3
C0262926
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date of most recent blood pressure assessment (Month Day Year)
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
Anti-Hypertensive Drugs (for management of hypertension)
Description

ConcomitantAntihypertensiveAgentAdministeredType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C270
UMLS 2011AA ObjectClass
C0003364
NCI Thesaurus ObjectClass-2
C25730
UMLS 2011AA ObjectClass-2
C0521115
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Other, specify
Description

ConcomitantAntihypertensiveAgentAdministeredSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C270
UMLS 2011AA ObjectClass
C0003364
NCI Thesaurus ObjectClass-2
C25730
UMLS 2011AA ObjectClass-2
C0521115
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Patient Characteristics
Description

Patient Characteristics

Patient Height
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
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
Baseline Values1
Description

Baseline Values1

QTc Interval (from ECG seconds)
Description

ElectrocardiographyDiagnosticProcedureQTcIntervalAssessmentValue

Data type

float

Measurement units
  • seconds
Alias
NCI Thesaurus ObjectClass
C38053
UMLS 2011AA ObjectClass
C1623258
NCI Thesaurus ObjectClass-2
C18020
UMLS 2011AA ObjectClass-2
C0430022
NCI Thesaurus Property
C25367
NCI Metathesaurus Property
C0489625
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
seconds
Date of EKG (Month Day Year A copy of the ECG report must be provided)
Description

DiagnosticElectrocardiogramPerformedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C25482
UMLS 2011AA ObjectClass
C0348026
NCI Metathesaurus ObjectClass
C0013798
TSH (Patient Value microIU/mL)
Description

LaboratoryProcedureThyroidStimulatingHormoneThyrotropinMeasurementOutcomeUnspecifiedValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C2280
UMLS 2011AA Property-2
C0040160
NCI Thesaurus Property-3
C64813
UMLS 2011AA Property-3
C0202230
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
TSH LLN (Lower Limit of Lab Normal microIU/mL)
Description

LaboratoryProcedureThyroidStimulatingHormoneThyrotropinMeasurementLowerLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C2280
UMLS 2011AA Property
C0040160
NCI Thesaurus Property-2
C64813
UMLS 2011AA Property-2
C0202230
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25555
UMLS 2011AA ValueDomain-2
C1518030
TSH ULN (Upper Limit of Lab Normal microIU/mL)
Description

LaboratoryProcedureThyroidStimulatingHormoneThyrotropinMeasurementUpperLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C2280
UMLS 2011AA Property
C0040160
NCI Thesaurus Property-2
C64813
UMLS 2011AA Property-2
C0202230
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
Date of Assessment (Month Day Year)
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
LVEF (% At least 2 weeks after last dose of the most recent chemotherapy regimen)
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 of LVEF (Month Day Year)
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 (A copy of the echocardiogram or MUGA scan report must be provided. If this document does not report LVEF as a whole number, see Protocol Section 5.3 for rounding instructions)
Description

Evaluation method

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2911685
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C16847
Urine Protein
Description

UrinalysisProteinLevelAmount

Data type

text

Alias
NCI Thesaurus ObjectClass
C17241
UMLS 2011AA ObjectClass
C0042014
NCI Thesaurus Property
C17021
UMLS 2011AA Property
C0033684
NCI Thesaurus ValueDomain
C25417
NCI Thesaurus Property-2
C25554
UMLS 2011AA Property-2
C0441889
Was 24-hour urine specimen collected (If >= 2+,)
Description

UrineSpecimenCollectionInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C13283
UMLS 2011AA ObjectClass
C0042036
NCI Thesaurus Property
C25453
UMLS 2011AA Property
C1516698
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
Protein from 24 hour Urine Collection (If yes, g protein per 24 hours)
Description

UrinaryProteinCollectionValue

Data type

float

Measurement units
  • g/24 hours
Alias
NCI Thesaurus Property
C25453
UMLS 2011AA Property
C1516698
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ObjectClass
C17021
UMLS 2011AA ObjectClass
C0033684
g/24 hours
Blood Counts
Description

Blood Counts

Absolute neutrophil count (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
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
Hemoglobin (g/dL)
Description

Hemoglobin

Data type

float

Alias
NCI Thesaurus Property
C16676
UMLS CUI-1
C0019046
NCI Thesaurus Property-2
C20200
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
Alkaline Phosphatase (Patient Value 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 (Upper Limit of Lab Normal 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
SGOT (AST) (Patient Value units/L)
Description

SGOT (AST)

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201899
NCI Thesaurus Property
C25202
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
SGOT (AST) ULN (Upper Limit of Lab Normal 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
SGPT (ALT) (Patient Value 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
SGPT (ALT) ULN (Upper Limit of Lab Normal 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
Total Bilirubin (Patient Value mg/dL)
Description

Bilirubin, Total

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201913
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C38037
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
Total Bilirubin ULN (Upper Limit of Lab Normal mg/dL)
Description

Bilirubin, Total ULN

Data type

float

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
C25706
Phosphate (Patient Value mg/dL)
Description

LaboratoryProcedurePhosphateMeasurementResultUnspecifiedValue

Data type

float

Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property-2
C64857
UMLS 2011AA Property-2
C0523826
Phosphate LLN (Lower Limit of Lab Normal mg/dL)
Description

LaboratoryProcedurePhosphateMeasurementResultLowerLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C64857
UMLS 2011AA Property-2
C0523826
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25555
UMLS 2011AA ValueDomain-2
C1518030
Does the patient require chronic supplementation for serum phosphate levels
Description

PhosphateSupplementsAdministrationInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ObjectClass
C1505
UMLS 2011AA ObjectClass
C0242295
NCI Metathesaurus ObjectClass
C0031603
Creatinine (Patient Value mg/dL)
Description

Creatinine, Serum

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201976
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C399
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
Creatinine ULN (Upper Limit of Lab Normal mg/dL)
Description

Creatinine, serum ULN

Data type

float

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
Does the patient have Gilbert's disease or a similar syndrome due to slow conjugation of bilirubin (If Total Bilirubin is > ULN and <= 1.5 x ULN)
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
Baseline Values2
Description

Baseline Values2

Was liver imaging performed (If AST, ALT, or alkaline phosphatase is higher than ULN)
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
Was gross extrahepatic disease identified (If yes,)
Description

GrossExtrahepaticDiseaseIdentifiedInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass-2
C28358
UMLS 2011AA ObjectClass-2
C1517058
NCI Thesaurus ObjectClass-3
C43566
UMLS 2011AA ObjectClass-3
C0439806
NCI Thesaurus Property
C25737
UMLS 2011AA Property
C0205396
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have symptomatic pancreatitis
Description

PancreatitisDiseasePresentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C3306
UMLS 2011AA ObjectClass
C0030305
NCI Thesaurus ObjectClass-2
C2991
UMLS 2011AA ObjectClass-2
C0012634
Does the patient have 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 at least one bone scan or PET scan performed (If patient has skeletal pain or alkaline phosphatase is higher than ULN)
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
Did any bone scan or PET scan demonstrate metastatic disease (If yes,)
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
Were there suspicious findings on bone scan or PET scan (If no,)
Description

DiseaseSuspiciousClinicalFindingInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25398
UMLS 2011AA Property
C0205210
NCI Metathesaurus Property
C0750493
NCI Metathesaurus Property-2
C0037088
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Were the suspicious findings confirmed as benign by x-ray, MRI, or biopsy (If yes,)
Description

BoneScanMedicalImagingConfirmedAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C17646
UMLS 2011AA ObjectClass
C0203668
NCI Thesaurus ObjectClass-2
C16831
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
NCI Thesaurus Property-2
C25367
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Amylase (units/L)
Description

LaboratoryProcedureAmylaseOutcomeUnspecifiedValue

Data type

text

Measurement units
  • U/L
Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C16284
UMLS 2011AA Property-2
C0002712
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
U/L
Amylase ULN (units/L)
Description

LaboratoryProcedureAmylaseOutcomeUpperLimitofNormalValue

Data type

text

Measurement units
  • U/L
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C16284
UMLS 2011AA Property-2
C0002712
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
U/L
Lipase (units/L)
Description

LaboratoryProcedureLipaseOutcomeUnspecifiedValue

Data type

text

Measurement units
  • U/L
Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C37988
UMLS 2011AA Property-2
C0023764
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
U/L
Lipase ULN (units/L)
Description

LaboratoryProcedureLipaseOutcomeUpperLimitofNormalValue

Data type

text

Measurement units
  • U/L
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C37988
UMLS 2011AA Property-2
C0023764
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
U/L
Other
Description

Other

ECOG Performance Status (Patient)
Description

ECOG Performance Status

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1520224
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
Is metastatic breast cancer present
Description

BreastCarcinomaMetastasisPresentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C19151
UMLS 2011AA Property-2
C0027627
NCI Thesaurus ObjectClass
C4872
UMLS 2011AA ObjectClass
C0678222
Has the patient had prior therapy with angiogenesis inhibitors, for example bevacizumab and sorafenib
Description

AngiogenesisInhibitorTherapyAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ObjectClass-2
C1742
UMLS 2011AA ObjectClass
C0596087
Does the patient have the ability to swallow oral medication
Description

PatientSwallowingAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C38028
UMLS 2011AA Property-2
C0011167
Has the patient had partial breast irradiation (PBI)
Description

PartialBreastRadiationTherapyAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus ObjectClass-2
C25378
UMLS 2011AA ObjectClass-2
C0728938
NCI Thesaurus Property
C15313
UMLS 2011AA Property
C1522449
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is there a plan to administer PBI following randomization
Description

PatientPartialBreastRadiationTherapyClinicalStudyParticipationType

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property-2
C15313
UMLS 2011AA Property-2
C1522449
NCI Thesaurus Property-3
C12971
UMLS 2011AA Property-3
C0006141
NCI Thesaurus Property-4
C25378
UMLS 2011AA Property-4
C0728938
NCI Thesaurus Property-5
C15206
UMLS 2011AA Property-5
C0008972
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Other1
Description

Other1

Does the patient require medication having proarrhythmic potential, for example terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide and flecainide
Description

SusceptibilityArrhythmiaAgentAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C2881
UMLS 2011AA ObjectClass
C0003811
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus ObjectClass-3
C16505
UMLS 2011AA ObjectClass-3
C0220898
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have a history of symptomatic peripheral vascular disease
Description

HistoryofPeripheralVascularDiseasePresentInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C66923
UMLS 2011AA ObjectClass
C1881056
Does the patient have active gastroduodenal ulcer(s) determined by endoscopy to be active?
Description

PatientGastrointestinalHistoryUlcerationInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25457
UMLS 2011AA Property
C0348080
Planned Date of Treatment Initiation (Month Day Year)
Description

TreatmentPlannedBeginDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
NCI Thesaurus Property
C25619
UMLS 2011AA Property
C1301732
Has the patient had a major surgical procedure, open biopsy or significant traumatic injury within 28 days of entry, or is there anticipation of a need for major surgical procedure during the course of the study?
Description

PersonSurgicalProcedureInjuryEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C15329
UMLS 2011AA Property
C0543467
NCI Thesaurus Property-2
C3671
UMLS 2011AA Property-2
C0043250
NCI Thesaurus Property-3
C25171
UMLS 2011AA Property-3
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date of last prior major surgery (If yes, Month Day Year)
Description

SurgicalProcedurePriorMajorPerformedDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C45368
UMLS 2011AA Property-3
C0205164
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Is the patient having ongoing treatment with therapeutic doses of warfarin
Description

PatientWarfarinTreatmentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C15368
NCI Metathesaurus Property
C0043031
Is the patient on any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy, SERMS other than tamoxifen and toremifene, systemic estrogen or progesterone replacement therapy or contraceptive products
Description

HormoneTherapyContraceptionAdministeredInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C37932
UMLS 2011AA Property
C0700589
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
Will the medication(s) be discontinued prior to randomization (If yes,)
Description

TherapyDiscontinuedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
Does the patient plan to have reconstructive surgery or other major surgical procedures during the course of the study
Description

SurgicalProcedureBreastReconstructionPerformedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus Property-2
C15354
UMLS 2011AA Property-2
C0085076
Other2
Description

Other2

Has the patient had hyperthyroidism within 6 months prior to randomization
Description

PatientHyperthyroidismPersonalMedicalHistoryInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3123
UMLS 2011AA Property
C0020550
NCI Thesaurus Property-2
C18772
UMLS 2011AA Property-2
C0262926
Date of most recent lab value indicating hyperthyroidism (Month Day Year)
Description

PatientHyperthyroidismAssayPersonalMedicalHistoryDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3123
UMLS 2011AA Property
C0020550
NCI Thesaurus Property-2
C18772
UMLS 2011AA Property-2
C0262926
NCI Thesaurus Property-3
C60819
UMLS 2011AA Property-3
C1510438
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Does the patient have a non-healing wound, skin ulcers, or incompletely healed bone fracture
Description

RelatedWoundSignificantComplicationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25648
UMLS 2011AA ObjectClass
C0439849
NCI Thesaurus ObjectClass-2
C3671
UMLS 2011AA ObjectClass-2
C0043250
NCI Thesaurus Property
C2959
UMLS 2011AA Property
C0009566
NCI Thesaurus Property-2
C41130
UMLS 2011AA Property-2
C0750502
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of the stomach or small bowel, or other disease significantly affecting gastrointestinal function
Description

GastrointestinalDiseaseAssessmentIndicator

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C13359
UMLS 2011AA ObjectClass
C0521362
NCI Thesaurus ObjectClass-2
C2991
UMLS 2011AA ObjectClass-2
C0012634
Does the patient have known bleeding diathesis or coagulopathy
Description

HematologicCoagulationDiseasePresentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C62780
UMLS 2011AA ObjectClass
C0205488
NCI Thesaurus ObjectClass-2
C2991
UMLS 2011AA ObjectClass-2
C0012634
NCI Thesaurus ObjectClass-3
C2902
UMLS 2011AA ObjectClass-3
C0005779
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
At the time of study entry, will the patient be pregnant or lactating
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
Has the patient had any investigational agents within 30 days before randomization
Description

PriorInvestigationalTherapiesAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Metathesaurus ObjectClass
C0949266
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Agent End Date (If yes, Month Day Year)
Description

Agent End Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C0806020
NCI Thesaurus Property
C25275
Footer Module
Description

Footer Module

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
Person Completing Form
Description

Person Completing Form

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date Form Completed (MM DD YYYY)
Description

Date Form Completed

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
C25367

Similar models

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

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Patient Initials
Item
Patient Initials (Last First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
ClinicalTrialSiteNameText
Item
Site Name
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15207 (NCI Thesaurus ObjectClass)
C37901 (NCI Thesaurus Property)
C0205145 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain-2)
C0027365 (UMLS 2011AA ValueDomain-2)
Birth Date
Item
Patient Birth Date (Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C0421451 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25155 (NCI Thesaurus Property)
TreatingPhysicianName
Item
Treating physician
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass-2)
C1522326 (UMLS 2011AA ObjectClass-2)
Social Security Number
Item
Patient Social Security Number (USA Only)
text
C25337 (NCI Thesaurus ValueDomain)
C1301821 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25686 (NCI Thesaurus Property)
Item
Patient Gender
text
C25372 (NCI Thesaurus ValueDomain)
C0079399 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17357 (NCI Thesaurus Property)
Code List
Patient Gender
CL Item
Female Gender (FEMALE)
C46110 (NCI Thesaurus)
C0086287 (UMLS 2011AA)
CL Item
Male Gender (MALE)
C46109 (NCI Thesaurus)
C1706180 (UMLS 2011AA)
Item Group
Race
Item
Race (more than one may be marked)
text
C25372 (NCI Thesaurus ValueDomain)
C0034510 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17049 (NCI Thesaurus Property)
Code List
Race (more than one may be marked)
CL Item
A Person Having Origins In Any Of The Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment. (American Indian or Alaska Native)
C41259 (NCI Thesaurus)
C1515945 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of The Far East, Southeast Asia, Or The Indian Subcontinent Including, For Example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, The Philippine Islands, Thailand, And Vietnam. (Asian)
C41260 (NCI Thesaurus)
C0078988 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Black Racial Groups Of Africa. Terms Such As "haitian" Or "negro" Can Be Used In Addition To "black Or African American." (Black or African American)
C16352 (NCI Thesaurus)
C0085756 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of Hawaii, Guam, Samoa, Or Other Pacific Islands. (Native Hawaiian or other Pacific Islander)
C41219 (NCI Thesaurus)
C1513907 (UMLS 2011AA)
CL Item
Could Not Be Determined Or Unsure (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of Europe, The Middle East, Or North Africa. (White)
C41261 (NCI Thesaurus)
C0007457 (UMLS 2011AA)
Item Group
Person Completing Form, Last Name
Item
Method of Payment (mark primary method only)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25371 (NCI Thesaurus Property)
C0680264 (UMLS 2011AA Property)
Code List
Method of Payment (mark primary method only)
CL Item
Private Insurance (Private Insurance)
CL Item
Medicare (Medicare)
C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)
CL Item
Medicare And Private Insurance (Medicare and Private Insurance)
CL Item
Medicaid (Medicaid)
C0025071 (NCI Metathesaurus)
CL Item
Medicaid And Medicare (Medicaid and Medicare)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Military Or Veterans Sponsored Nos (Military or Veterans Sponsored, Not Otherwise Specified (NOS))
CL Item
Military Sponsored (including Champus & Tricare) (Military Sponsored (including CHAMPUS & TRICARE))
CL Item
Veterans Sponsored (Veterans Sponsored)
CL Item
Self Pay (no Insurance) (Self Pay (No Insurance))
CL Item
No Means Of Payment (no Insurance) (No means of payment (no insurance))
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Ethnicity
text
C25372 (NCI Thesaurus ValueDomain)
C0015031 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C16564 (NCI Thesaurus Property)
Code List
Ethnicity
CL Item
A Person Of Mexican, Puerto Rican, Cuban, Central Or South American Or Other Spanish Culture Or Origin, Regardless Of Race. (HISPANIC OR LATINO)
C17459 (NCI Thesaurus)
C0086409 (UMLS 2011AA)
CL Item
A Person Not Meeting The Definition For Hispanic Or Latino. (NOT HISPANIC OR LATINO)
C41222 (NCI Thesaurus)
C1518424 (UMLS 2011AA)
CL Item
Could Not Be Determined Or Unsure (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Country of residence
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
Code List
Country of residence
CL Item
Usa (US)
CL Item
Puerto Rico (PR)
C17043 (NCI Thesaurus)
C0034044 (UMLS 2011AA)
CL Item
Canada (CA)
C16380 (NCI Thesaurus)
C0006823 (UMLS 2011AA)
CL Item
Other (Other)
OtherPatientAddressCountrySpecify
Item
Other
text
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus ObjectClass-2)
C0030705 (UMLS 2011AA ObjectClass-2)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25464 (NCI Thesaurus ValueDomain-2)
C0454664 (UMLS 2011AA ValueDomain-2)
PatientAddressPostalCode
Item
Patient Zip Code (USA)
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
Item Group
Unnamed4
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)
ClinicalStudyProtocolInstitutionalReviewBoardConsentFormSpecimenApprovalInd-2
Item
Was this an IRB-approved consent form that conforms to federal and institutional guidelines for study treatment and release of required tumor blocks
boolean
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C16468 (NCI Thesaurus Property)
C0009797 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property-2)
C0370003 (UMLS 2011AA Property-2)
C16741 (NCI Thesaurus Property-3)
C0086911 (UMLS 2011AA Property-3)
C25425 (NCI Thesaurus Property-4)
C0205540 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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)
PathologySpecimenParaffinBlockInstitutionRequestInd-2
Item
Did the pathology department agree to release the required blocks
boolean
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C18189 (NCI Thesaurus ObjectClass-2)
C0030664 (UMLS 2011AA ObjectClass-2)
C21541 (NCI Thesaurus Property)
C0018704 (UMLS 2011AA Property)
C25436 (NCI Thesaurus Property-2)
C1533157 (UMLS 2011AA Property-2)
C727 (NCI Thesaurus Property-3)
C0030415 (UMLS 2011AA Property-3)
C48312 (NCI Thesaurus Property-4)
C1272683 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientBloodSpecimenConsentInd-2
Item
Did the patient agree to have a blood sample collected before starting study drug
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)
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)
BaselineQOLCompleteFormInd-2
Item
Did the patient complete the Quality of Life baseline form?
boolean
C17047 (NCI Thesaurus ObjectClass)
C0518214 (UMLS 2011AA ObjectClass)
C25213 (NCI Thesaurus ObjectClass-2)
C1442488 (UMLS 2011AA ObjectClass-2)
C19464 (NCI Thesaurus Property)
C0376315 (UMLS 2011AA Property)
C25250 (NCI Thesaurus Property-2)
C0205197 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
BaselineQOLCompleteFormDate
Item
Date baseline QOL completed by patient (Month Day Year)
date
C17047 (NCI Thesaurus ObjectClass)
C0518214 (UMLS 2011AA ObjectClass)
C25213 (NCI Thesaurus ObjectClass-2)
C1442488 (UMLS 2011AA ObjectClass-2)
C19464 (NCI Thesaurus Property)
C0376315 (UMLS 2011AA Property)
C25250 (NCI Thesaurus Property-2)
C0205197 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Cardiac Conditions
UnstableAnginaDiseasePresentInd-3
Item
Angina pectoris that requires the use of anti-anginal medication
boolean
C25594 (NCI Thesaurus ObjectClass)
C1518422 (UMLS 2011AA ObjectClass)
C30103 (NCI Thesaurus ObjectClass-2)
C0205360 (UMLS 2011AA ObjectClass-2)
C2991 (NCI Thesaurus ObjectClass-3)
C0012634 (UMLS 2011AA ObjectClass-3)
C51221 (NCI Thesaurus ObjectClass-4)
C0002962 (UMLS 2011AA ObjectClass-4)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
ArrhythmiaPresentInd-2
Item
Serious cardiac arrythmia requiring medication?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2881 (NCI Thesaurus ObjectClass)
C0003811 (UMLS 2011AA ObjectClass)
CardiacDiseasePresentInd-2
Item
Valvular disease with documented cardiac function compromise?
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)
PatientPriorMyocardialInfarctionInd-3
Item
Does the patient have a history of myocardial infarction
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C27996 (NCI Thesaurus Property)
C0027051 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
CongestiveHeartFailureHistoryInd-2
Item
History of documented congestive heart failure
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3080 (NCI Thesaurus ObjectClass)
C0018802 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
HeartNerveAbnormalityInd-2
Item
Severe conduction abnormality?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C12466 (NCI Thesaurus ObjectClass)
C0027740 (UMLS 2011AA ObjectClass)
C9440 (NCI Thesaurus Property)
C1704258 (UMLS 2011AA Property)
UncontrolledHypertensionPresentInd-3
Item
Uncontrolled hypertension defined as BP > 150/90 on antihypertensive therapy
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C3117 (NCI Thesaurus ObjectClass)
C0020538 (UMLS 2011AA ObjectClass)
C48932 (NCI Thesaurus ObjectClass-2)
C0205318 (UMLS 2011AA ObjectClass-2)
PatientCardiovascularAbnormalityPersonalMedicalHistoryInd-2
Item
Was there documentation of elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C9440 (NCI Thesaurus Property)
C1704258 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
C0374861 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Other Conditions
ContralateralBreastCancerDiagnosisInd-2
Item
Has the patient had contralateral breast cancer (including DCIS) at any time
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)
PriorCancerDiagnosisInd-3
Item
Has the patient had any prior cancer diagnosed?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
PhysicianRecurrentDiseaseLowRiskDiagnosisInd-2
Item
Is the patient deemed by her physician to be a low risk for recurrence (If yes)
boolean
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C54722 (NCI Thesaurus Property-2)
C0205251 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C17102 (NCI Thesaurus Property-4)
C0035647 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
DiseaseStatusIndicator
Item
Has the patient been disease free for 5 years or more
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C0449438 (NCI Metathesaurus Property)
PersonHypertensionEncephalopathyPersonalMedicalHistoryInd-2
Item
Does the patient have a history of hypertensive crisis or hypertensive encephalopathy
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C3117 (NCI Thesaurus Property)
C0020538 (UMLS 2011AA Property)
C26920 (NCI Thesaurus Property-2)
C0085584 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ArteryThrombosisPatientPreviousYearPersonalMedicalHistoryInd-2
Item
Does the patient have a history of arterial thrombotic event within the past 12 months (including catheter-related thrombus)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C26891 (NCI Thesaurus ObjectClass-2)
C0040053 (UMLS 2011AA ObjectClass-2)
C12372 (NCI Thesaurus ObjectClass-3)
C0003842 (UMLS 2011AA ObjectClass-3)
C25627 (NCI Thesaurus Property)
C0205156 (UMLS 2011AA Property)
C29848 (NCI Thesaurus Property-2)
C0439234 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ThrombosisAdverseEventObservedDate
Item
Date of thrombotic event (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C26891 (NCI Thesaurus ObjectClass-2)
C0040053 (UMLS 2011AA ObjectClass-2)
C25599 (NCI Thesaurus Property)
C1441672 (UMLS 2011AA Property)
IpsilateralDiseasePresentInd-3
Item
Does the patient have a history of ipsilateral breast cancer (including DCIS)
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)
C25308 (NCI Thesaurus ObjectClass-2)
C0441989 (UMLS 2011AA ObjectClass-2)
PatientNeoplasmPersonalMedicalHistoryInd-2
Item
Has the patient had any prior malignancies in the past 5 years other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the colon or rectum, or carcinoma in situ of the cervix that has been effectively treated? (If the patient has not been disease free for 5 years or more)
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)
PatientTransientIschemicAttackCerebrovascularAccidentPersonalMedicalHistoryInd-2
Item
Does the patient have a prior history of documented cerebral vascular accident or documented transient ischemic attack?
boolean
C29867 (NCI Thesaurus ObjectClass)
C0679646 (UMLS 2011AA ObjectClass)
C50781 (NCI Thesaurus Property)
C0007787 (UMLS 2011AA Property)
C3390 (NCI Thesaurus Property-2)
C0038454 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientHistoryHemorrhageEventInd-2
Item
Has the patient had any significant non-traumatic bleeding within 6 months before study entry
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25499 (NCI Thesaurus Property)
C0441471 (UMLS 2011AA Property)
C26791 (NCI Thesaurus Property-2)
C0019080 (UMLS 2011AA Property-2)
C1321503 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientHistoryHemorrhageEventDate
Item
Date of bleeding event (MM DD YYYY)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25499 (NCI Thesaurus Property)
C0441471 (UMLS 2011AA Property)
C26791 (NCI Thesaurus Property-2)
C0019080 (UMLS 2011AA Property-2)
C1321503 (NCI Metathesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Cardiac Risk Factors
FirstDegreeRelativeCardiovascularDisorderDeathInd-2
Item
Does the patient have any first degree relatives who died from heart disease before the age of 55 (First degree relatives are parents, children, brothers, and sisters)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)
C2931 (NCI Thesaurus Property-2)
C0007222 (UMLS 2011AA Property-2)
C21481 (NCI Thesaurus ObjectClass)
C1517194 (UMLS 2011AA ObjectClass)
PersonHypertensionTherapeuticProcedurePersonalMedicalHistoryInd-2
Item
Hypertension requiring medical therapy (If yes, mark all categories that apply)
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C3117 (NCI Thesaurus Property)
C0020538 (UMLS 2011AA Property)
C49236 (NCI Thesaurus Property-2)
C0087111 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonDiabetesMellitusTherapeuticProcedurePersonalMedicalHistoryInd-2
Item
Diabetes requiring medical therapy
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C2985 (NCI Thesaurus Property)
C0011849 (UMLS 2011AA Property)
C49236 (NCI Thesaurus Property-2)
C0087111 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonHyperlipidemiaTherapeuticProcedurePersonalMedicalHistoryind-2
Item
Hyperlipidemia requiring medical therapy
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)
C34707 (NCI Thesaurus Property-2)
C0020473 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Smoking (Patient History)
text
C25180 (NCI Thesaurus ValueDomain)
C1519384 (UMLS CUI-1)
C17934 (NCI Thesaurus ObjectClass)
C18772 (NCI Thesaurus Property)
Code List
Smoking (Patient History)
CL Item
Never Smoked (Never smoked)
CL Item
Currently Smoking (Currently smoking)
CL Item
Smoked In The Past (Smoked in the past)
Item Group
Section 2 - Diagnostic
Item
Stage (Clinical)
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
C38027 (NCI Thesaurus Property)
C1519504 (UMLS 2011AA Property)
Code List
Stage (Clinical)
CL Item
T0, N1, M0 Or T1*, N1, M0 Or T2, N0, M0 (IIA)
CL Item
T2, N1, M0 Or T3, N0, M0 (IIB)
CL Item
T0, N2, M0 Or T1*, N2, M0 Or T2, N2, M0 Or T3, N1, M0 Or T3, N2, M0 (IIIA)
CL Item
T4, N0, M0 Or T4, N1, M0 Or T4, N2, M0 (IIIB)
EstrogenReceptorAnalysisPerformedInd-2
Item
Is estrogen receptor analysis result available (from primary surgery)
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 (If yes,)
text
C3262 (NCI Thesaurus ValueDomain)
C0027651 (UMLS 2011AA ValueDomain)
C17069 (NCI Thesaurus ObjectClass)
C0034804 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain-2)
C0449438 (UMLS 2011AA ValueDomain-2)
C25554 (NCI Thesaurus Property)
C0441889 (UMLS 2011AA Property)
Code List
Receptor Status, ER (If yes,)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
SurgicalProcedureCoreBiopsyPerformedDate
Item
Date of Diagnostic Core or Incisional Biopsy (Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15680 (NCI Thesaurus Property)
C1318309 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
InvasiveBreastCarcinomaHistologicallyConfirmedInd-2
Item
Was there any histologic evidence of invasive tumor cells in the surgical breast specimen
boolean
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C14159 (NCI Thesaurus ObjectClass-2)
C0205281 (UMLS 2011AA ObjectClass-2)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C25527 (NCI Thesaurus Property-2)
C0205462 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ProgesteroneReceptorAnalysisPerformedInd-2
Item
Is progesterone receptor analysis result available (from primary surgery)
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)
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)
EpidermalGrowthFactorReceptorAssessmentInd-2
Item
Was HER2 status assessed by IHC assay
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25217 (NCI Thesaurus Property)
C1516048 (UMLS 2011AA Property)
C17068 (NCI Thesaurus ObjectClass)
C0034802 (UMLS 2011AA ObjectClass)
Item
Her2/neu expression status by immunohistochemistry
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)
Code List
Her2/neu expression status by immunohistochemistry
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
CL Item
1+ (1+)
CL Item
2+ (2+)
CL Item
3+ (3+)
SpecimenLaboratoryProcedureDate
Item
Date of IHC Assay (Month Day Year A copy of the report must be provided)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
LaboratoryProcedureHER2/neuinsituHybridizationOutcomeInd-2
Item
Was HER2 status assessed by ISH assay (FISH, CISH, or other ISH)
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)
Item
HER2 Status by ISH Assay (If yes, If multiple ISH assays were done, and at least one was positive, the positive assay must be reported.)
text
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)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
HER2 Status by ISH Assay (If yes, If multiple ISH assays were done, and at least one was positive, the positive assay must be reported.)
CL Item
Equivocal (Equivocal)
C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
HER2/neuTherapyPriorPostSurgicalProcedureAdministeredInd-2
Item
Was HER2-targeted therapy administered pre-operatively or post-operatively prior to study entry (If ISH assay is equivocal,)
boolean
C15368 (NCI Thesaurus ObjectClass)
C17756 (NCI Thesaurus ObjectClass-2)
C0242957 (UMLS 2011AA ObjectClass)
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C0038895 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
HER2/neuTherapyPlanAdministeredInd-2
Item
Is there a plan to administer HER2-targeted therapy
boolean
C15368 (NCI Thesaurus ObjectClass)
C17756 (NCI Thesaurus ObjectClass-2)
C0242957 (UMLS 2011AA ObjectClass)
C25619 (NCI Thesaurus Property)
C1301732 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
LaboratoryProcedureHER2/neuinsituHybridizationOutcomeDate
Item
Date of ISH Assay (Month Day Year A copy of the report must be provided.)
date
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)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Nodal Status Assessments Prior To Neoadjuvant Chemotherapy
AxillaryLymphNodeFine-NeedleAspirationPriorTherapyPerformedInd-2
Item
Was nodal FNA performed
boolean
C15361 (NCI Thesaurus ObjectClass)
C1510483 (UMLS 2011AA ObjectClass)
C12904 (NCI Thesaurus ObjectClass-2)
C0729594 (UMLS 2011AA ObjectClass-2)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C15368 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
AxillaryLymphNodeCoreBiopsyFine-NeedleAspirationLymphNodeBiopsyPositiveFindingInd-2
Item
Was nodal FNA positive
boolean
C15680 (NCI Thesaurus ObjectClass)
C1318309 (UMLS 2011AA ObjectClass)
C15361 (NCI Thesaurus ObjectClass-2)
C1510483 (UMLS 2011AA ObjectClass-2)
C51900 (NCI Thesaurus ObjectClass-3)
C0193842 (UMLS 2011AA ObjectClass-3)
C12904 (NCI Thesaurus ObjectClass-4)
C0729594 (UMLS 2011AA ObjectClass-4)
C38758 (NCI Thesaurus Property)
C1514241 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
AxillaryLymphNodeCoreBiopsyFine-NeedleAspirationLymphNodeBiopsyPriorClinicalStudyPerformedInd-2
Item
Was nodal core biopsy performed
boolean
C15680 (NCI Thesaurus ObjectClass)
C1318309 (UMLS 2011AA ObjectClass)
C15361 (NCI Thesaurus ObjectClass-2)
C1510483 (UMLS 2011AA ObjectClass-2)
C51900 (NCI Thesaurus ObjectClass-3)
C0193842 (UMLS 2011AA ObjectClass-3)
C12904 (NCI Thesaurus ObjectClass-4)
C0729594 (UMLS 2011AA ObjectClass-4)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
AxillaryLymphNodeCoreBiopsyLymphNodeBiopsyPositiveFindingInd-2
Item
Was nodal core biopsy positive
boolean
C15680 (NCI Thesaurus ObjectClass)
C1318309 (UMLS 2011AA ObjectClass)
C51900 (NCI Thesaurus ObjectClass-2)
C0193842 (UMLS 2011AA ObjectClass-2)
C12904 (NCI Thesaurus ObjectClass-3)
C0729594 (UMLS 2011AA ObjectClass-3)
C38758 (NCI Thesaurus Property)
C1514241 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
SentinelNodeBiopsyInd-3
Item
Was sentinel node sampling performed
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
SentinelNodeBiopsyInd-2
Item
Were there any positive sentinel nodes
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
Item Group
Section 3 - Neoadjuvant Chemotherapy
NeoadjuvantTherapyPriorChemotherapyAdministeredBeginDate
Item
Date Prior Neoadjuvant Chemotherapy Started (first neoadjuvant chemotherapy dose Month Day Year)
date
C15665 (NCI Thesaurus ObjectClass)
C0600558 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus Property)
C0392920 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
NeoadjuvantTherapyPriorChemotherapyAdministeredEndDate
Item
Date Prior Neoadjuvant Chemotherapy Ended (last neoadjuvant chemotherapy dose Month Day Year)
date
C15665 (NCI Thesaurus ObjectClass)
C0600558 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus Property)
C0392920 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Neoadjuvant Chemotherapy
text
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus Property)
C15665 (NCI Thesaurus Property-2)
C0600558 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Neoadjuvant Chemotherapy
CL Item
Anthracycline (Anthracycline)
CL Item
Taxane (Taxane)
CL Item
Cyclophosphamide (Cyclophosphamide)
C405 (NCI Thesaurus)
C0010583 (UMLS 2011AA)
CL Item
Other Chemotherapy Agents (Other Chemotherapy Agents)
PriorChemotherapyNeoadjuvantTreatmentSpecify
Item
Specify other chemotherapy agents (if applicable)
text
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus Property)
C15665 (NCI Thesaurus Property-2)
C0600558 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
PriorChemotherapyNeoadjuvantTreatmentCount
Item
No. of Courses
float
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus Property)
C15665 (NCI Thesaurus Property-2)
C0600558 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
ChemotherapyTotalCycleCompleteCount
Item
Total number of cycles completed
float
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25304 (NCI Thesaurus Property-2)
C0439810 (UMLS 2011AA Property-2)
C25472 (NCI Thesaurus Property-3)
C1511572 (UMLS 2011AA Property-3)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
Item Group
Section 4 - Surgery After Neoadjuvant Chemotherapy
Item
Tumor Laterality
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C25185 (NCI Thesaurus Property)
C0332304 (UMLS 2011AA Property)
Code List
Tumor Laterality
CL Item
Left (Left)
C25229 (NCI Thesaurus)
C0205091 (UMLS 2011AA)
CL Item
Right (Right)
C25228 (NCI Thesaurus)
C0205090 (UMLS 2011AA)
Item
Margin Status (If mastectomy was performed,)
text
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C4872 (NCI Thesaurus ObjectClass-2)
C0678222 (UMLS 2011AA ObjectClass-2)
C25563 (NCI Thesaurus Property)
C0205284 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
Code List
Margin Status (If mastectomy was performed,)
CL Item
Grossly Negative And Microscopically Negative (Grossly negative and microscopically negative)
CL Item
Grossly Negative And Microscopically Positive (Grossly negative and microscopically positive)
CL Item
Grossly Positive (Grossly positive)
EstrogenReceptorAnalysisPerformedInd-2
Item
Is estrogen receptor analysis result available (from primary surgery)
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 (If yes,)
text
C3262 (NCI Thesaurus ValueDomain)
C0027651 (UMLS 2011AA ValueDomain)
C17069 (NCI Thesaurus ObjectClass)
C0034804 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain-2)
C0449438 (UMLS 2011AA ValueDomain-2)
C25554 (NCI Thesaurus Property)
C0441889 (UMLS 2011AA Property)
Code List
Receptor Status, ER (If yes,)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
BreastSurgicalProcedurePositiveHematoxylinandEosinStainingMethodAssessmentInd-2
Item
Does the pathology report from the breast surgery indicate on H&E staining that residual invasive in-breast disease was found in the surgical specimen
boolean
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS 2011AA ObjectClass-2)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C0205159 (NCI Metathesaurus Property)
C23011 (NCI Thesaurus Property-2)
C0523207 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Size of residual tumor (If yes, If > 0.5 cm, refer to Protocol Table 3.)
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25681 (NCI Thesaurus Property-2)
C0456389 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Size of residual tumor (If yes, If > 0.5 cm, refer to Protocol Table 3.)
CL Item
<=0.5 Cm (<=0.5 cm)
CL Item
>0.5 Cm (>0.5 cm)
Item
Pathologic N Stage (If no,)
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
C15665 (NCI Thesaurus Property-2)
C0600558 (UMLS 2011AA Property-2)
C18189 (NCI Thesaurus Property-3)
C0030664 (UMLS 2011AA Property-3)
C25580 (NCI Thesaurus Property-4)
C0456532 (UMLS 2011AA Property-4)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
Code List
Pathologic N Stage (If no,)
CL Item
No Regional Lymph Node Metastasis Histologically, Positive Ihc, No Ihc Cluster >0.2 Mm (ypN0(i+))
CL Item
No Regionally Lymph Node Metastasis Histologically, Positive Molecular Findings (rt-pcr) (ypN0(mol+))
PrimaryBreastNeoplasmSurgicalProcedurePerformedDate
Item
Date of Last Surgery for staging or treatment (including re-excision of margins and any axillary staging procedures Month Day Year)
date
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS 2011AA ObjectClass-2)
C2910 (NCI Thesaurus ObjectClass-3)
C0042875 (UMLS 2011AA ObjectClass-3)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
SurgeryComplicationInd-3
Item
Has the patient recovered from surgery
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C2959 (NCI Thesaurus Property)
C0009566 (UMLS 2011AA Property)
Item Group
Section 4 - Surgery After Neoadjuvant Chemotherapy1
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 (If yes, Month Day Year)
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 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 mastectomy performed (If yes, Month Day Year)
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)
LumpectomySurgicalMarginNoMicroscopicInvolvementInd-2
Item
Were lumpectomy margins histologically free of invasive tumor and DCIS, either initially or after one or more re-excisions (If mastectomy was not performed,)
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)
ProgesteroneReceptorAnalysisPerformedInd-2
Item
Is progesterone receptor analysis result available (from primary surgery)
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)
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)
AxillaryLymphNodePostNeoadjuvantTherapyEvaluationInd-2
Item
Was axillary staging performed
boolean
C12904 (NCI Thesaurus ObjectClass)
C0729594 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C38008 (NCI Thesaurus Property-2)
C0687676 (UMLS 2011AA Property-2)
C15665 (NCI Thesaurus Property-3)
C0600558 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PositiveAxillaryNodeHematoxylinAndEosinStainingAssessmentind-2
Item
Does the pathology report from the axillary staging procedure indicate on H&E staining that residual axillary nodal metastasis was found in the surgical specimen
boolean
C25246 (NCI Thesaurus ObjectClass)
C1446409 (UMLS 2011AA ObjectClass)
C12904 (NCI Thesaurus ObjectClass-2)
C0729594 (UMLS 2011AA ObjectClass-2)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C23011 (NCI Thesaurus Property-2)
C0523207 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Size of largest focus of nodal metastasis (If yes, If > 0.5 cm, refer to Protocol Table 3)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19712 (NCI Thesaurus ObjectClass-2)
C1515944 (UMLS 2011AA ObjectClass-2)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C25681 (NCI Thesaurus Property-3)
C0456389 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Size of largest focus of nodal metastasis (If yes, If > 0.5 cm, refer to Protocol Table 3)
CL Item
<=0.5 Cm (<=0.5 cm)
CL Item
>0.5 Cm (>0.5 cm)
AdjuvantPostoperativeRadiationTherapyAdministeredInd-3
Item
Will postoperative radiation therapy be administered after the patient has been entered on study
boolean
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C28006 (NCI Thesaurus ObjectClass-2)
C0032790 (UMLS 2011AA ObjectClass-2)
C2140 (NCI Thesaurus ObjectClass-3)
C0001552 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
SurgicalProcedureWoundInfectionAdverseEventInd-3
Item
Has the incision completely healed with no signs of infection (If yes,)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C45234 (NCI Thesaurus Property-2)
C0043241 (UMLS 2011AA Property-2)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
Item Group
Sentinel Node Biopsy Staging
BiopsySentinelLymphNodePerformedInd-2
Item
Was sentinel node biopsy (SNB) performed after neoadjuvant therapy
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C12947 (NCI Thesaurus Property-2)
C1522495 (UMLS 2011AA Property-2)
SentinelNodeBiopsyDate
Item
Sentinel Node Biopsy Date (Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
SentinelNodeExaminedCount
Item
Number of Sentinel Nodes Examined (AXILLARY)
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 (AXILLARY)
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)
Item Group
Other Axillary Staging
Item
Number of axillary staging procedures (other than SNB) performed after neoadjuvant therapy (If 1 or 2, list dates and nodal information)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15608 (NCI Thesaurus Property-2)
C0332305 (UMLS 2011AA Property-2)
C12904 (NCI Thesaurus ObjectClass)
C0729594 (UMLS 2011AA ObjectClass)
Code List
Number of axillary staging procedures (other than SNB) performed after neoadjuvant therapy (If 1 or 2, list dates and nodal information)
CL Item
1 (1)
CL Item
2 (2)
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
AxillaryLymphNodeCoreBiopsyFine-NeedleAspirationLymphNodeBiopsyPriorClinicalStudyPerformedDate
Item
Date of procedure (Month Day Year)
date
C15680 (NCI Thesaurus ObjectClass)
C1318309 (UMLS 2011AA ObjectClass)
C15361 (NCI Thesaurus ObjectClass-2)
C1510483 (UMLS 2011AA ObjectClass-2)
C51900 (NCI Thesaurus ObjectClass-3)
C0193842 (UMLS 2011AA ObjectClass-3)
C12904 (NCI Thesaurus ObjectClass-4)
C0729594 (UMLS 2011AA ObjectClass-4)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
AxillaryNodeExaminedTotalCount
Item
Number of axillary nodes examined (Total Non-Sentinel)
float
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
C12904 (NCI Thesaurus ObjectClass)
C0729594 (UMLS 2011AA ObjectClass)
PositiveAxillaryNodeExaminedTotalCount
Item
Number of positive axillary lymph nodes (Total Non-Sentinel)
float
C25246 (NCI Thesaurus ObjectClass)
C1446409 (UMLS 2011AA ObjectClass)
C12904 (NCI Thesaurus ObjectClass-2)
C0729594 (UMLS 2011AA ObjectClass-2)
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
LymphNodePositiveCount
Item
Number of Positive Lymph Nodes (Total of all positive axillary and non-axillary nodes from all nodal staging procedures, including sentinel node biopsy)
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 Group
Postoperative Chemotherapy
ChemotherapyPostoperativeAdministeredInd-2
Item
Postoperative Chemotherapy (If no, skip to B Baseline Values)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C28006 (NCI Thesaurus Property)
C0032790 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
Chemotherapy Start Date
Item
Date Chemotherapy Began (first postoperative chemotherapy dose Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C1302181 (UMLS CUI-1)
C15632 (NCI Thesaurus ObjectClass)
C3173309 (UMLS CUI-2)
C25431 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)
ChemotherapyAdministeredEndDate
Item
Date Chemotherapy Ended (last postoperative chemotherapy dose Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Types of Postoperative Chemotherapy (Mark all that apply)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Code List
Types of Postoperative Chemotherapy (Mark all that apply)
CL Item
Anthracycline (Anthracycline)
CL Item
Taxane (Taxane)
CL Item
Cyclophosphamide (Cyclophosphamide)
C405 (NCI Thesaurus)
C0010583 (UMLS 2011AA)
CL Item
Capecitabine (Capecitabine)
C1794 (NCI Thesaurus)
C0671970 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
ChemotherapyRegimenSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
ChemotherapyToxicityEventInd-2
Item
Did the patient experience chemotherapy-related toxicity (excluding alopecia, nail changes, dysgeusia, hot flashes/flushes, sexual/reproductive function)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25499 (NCI Thesaurus Property)
C0441471 (UMLS 2011AA Property)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C27990 (NCI Thesaurus ObjectClass-2)
C0600688 (UMLS 2011AA ObjectClass-2)
ChemotherapyToxicityResolutionEventInd-2
Item
Have these toxicities resolved to <= grade 1 (If yes,)
boolean
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C27990 (NCI Thesaurus ObjectClass-2)
C0600688 (UMLS 2011AA ObjectClass-2)
C25499 (NCI Thesaurus Property)
C0441471 (UMLS 2011AA Property)
C25655 (NCI Thesaurus Property-2)
C1514893 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Baseline Values
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)
PersonHypertensionTherapeuticProcedurePersonalMedicalHistoryInd-2
Item
Hypertension requiring medical therapy (If yes, mark all categories that apply)
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C3117 (NCI Thesaurus Property)
C0020538 (UMLS 2011AA Property)
C49236 (NCI Thesaurus Property-2)
C0087111 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
BloodPressurePhysicalExaminationMostRecentDate
Item
Date of most recent blood pressure assessment (Month Day Year)
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)
Item
Anti-Hypertensive Drugs (for management of hypertension)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C270 (NCI Thesaurus ObjectClass)
C0003364 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Code List
Anti-Hypertensive Drugs (for management of hypertension)
CL Item
Diuretic (Diuretics)
CL Item
Ace Inhibitor (ACE inhibitors)
CL Item
Alpha/beta Blocker (Alpha/beta blocker)
CL Item
Beta Blocker (Beta blockers)
CL Item
Calcium Channel Blocker (Calcium channel blockers)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
ConcomitantAntihypertensiveAgentAdministeredSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C270 (NCI Thesaurus ObjectClass)
C0003364 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item Group
Patient Characteristics
Patient Height
Item
Patient Height
float
C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
Patient Weight
Item
Patient Weight
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Item Group
Baseline Values1
ElectrocardiographyDiagnosticProcedureQTcIntervalAssessmentValue
Item
QTc Interval (from ECG seconds)
float
C38053 (NCI Thesaurus ObjectClass)
C1623258 (UMLS 2011AA ObjectClass)
C18020 (NCI Thesaurus ObjectClass-2)
C0430022 (UMLS 2011AA ObjectClass-2)
C25367 (NCI Thesaurus Property)
C0489625 (NCI Metathesaurus Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
DiagnosticElectrocardiogramPerformedDate
Item
Date of EKG (Month Day Year A copy of the ECG report must be provided)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25482 (NCI Thesaurus ObjectClass)
C0348026 (UMLS 2011AA ObjectClass)
C0013798 (NCI Metathesaurus ObjectClass)
LaboratoryProcedureThyroidStimulatingHormoneThyrotropinMeasurementOutcomeUnspecifiedValue
Item
TSH (Patient Value microIU/mL)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C2280 (NCI Thesaurus Property-2)
C0040160 (UMLS 2011AA Property-2)
C64813 (NCI Thesaurus Property-3)
C0202230 (UMLS 2011AA Property-3)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureThyroidStimulatingHormoneThyrotropinMeasurementLowerLimitofNormalValue
Item
TSH LLN (Lower Limit of Lab Normal microIU/mL)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C2280 (NCI Thesaurus Property)
C0040160 (UMLS 2011AA Property)
C64813 (NCI Thesaurus Property-2)
C0202230 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureThyroidStimulatingHormoneThyrotropinMeasurementUpperLimitofNormalValue
Item
TSH ULN (Upper Limit of Lab Normal microIU/mL)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C2280 (NCI Thesaurus Property)
C0040160 (UMLS 2011AA Property)
C64813 (NCI Thesaurus Property-2)
C0202230 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
Assessment Date
Item
Date of Assessment (Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
HeartLVEFTestPercentageValue
Item
LVEF (% At least 2 weeks after last dose of the most recent chemotherapy regimen)
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 of LVEF (Month Day Year)
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 (A copy of the echocardiogram or MUGA scan report must be provided. If this document does not report LVEF as a whole number, see Protocol Section 5.3 for rounding instructions)
text
C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
Code List
Assessment Type (A copy of the echocardiogram or MUGA scan report must be provided. If this document does not report LVEF as a whole number, see Protocol Section 5.3 for rounding instructions)
CL Item
2-d Echocardiogram (2-D Echocardiogram)
CL Item
Muga Scan (MUGA scan)
Item
Urine Protein
text
C17241 (NCI Thesaurus ObjectClass)
C0042014 (UMLS 2011AA ObjectClass)
C17021 (NCI Thesaurus Property)
C0033684 (UMLS 2011AA Property)
C25417 (NCI Thesaurus ValueDomain)
C25554 (NCI Thesaurus Property-2)
C0441889 (UMLS 2011AA Property-2)
Code List
Urine Protein
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
CL Item
1+ (1+)
CL Item
2+ (2+)
CL Item
3+ (3+)
CL Item
4+ (4+)
UrineSpecimenCollectionInd-3
Item
Was 24-hour urine specimen collected (If >= 2+,)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C13283 (NCI Thesaurus ObjectClass)
C0042036 (UMLS 2011AA ObjectClass)
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
UrinaryProteinCollectionValue
Item
Protein from 24 hour Urine Collection (If yes, g protein per 24 hours)
float
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C17021 (NCI Thesaurus ObjectClass)
C0033684 (UMLS 2011AA ObjectClass)
Item Group
Blood Counts
ANC
Item
Absolute neutrophil count (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)
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)
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)
Alkaline Phosphatase
Item
Alkaline Phosphatase (Patient Value 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 (Upper Limit of Lab Normal 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)
SGOT (AST)
Item
SGOT (AST) (Patient Value units/L)
float
C25294 (NCI Thesaurus ObjectClass)
C0201899 (UMLS CUI-1)
C25202 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue
Item
SGOT (AST) ULN (Upper Limit of Lab Normal 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)
SGPT (ALT)
Item
SGPT (ALT) (Patient Value 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
SGPT (ALT) ULN (Upper Limit of Lab Normal 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)
Bilirubin, Total
Item
Total Bilirubin (Patient Value mg/dL)
float
C25294 (NCI Thesaurus ObjectClass)
C0201913 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C38037 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Bilirubin, Total ULN
Item
Total Bilirubin ULN (Upper Limit of Lab Normal 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)
C25706 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedurePhosphateMeasurementResultUnspecifiedValue
Item
Phosphate (Patient Value mg/dL)
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C64857 (NCI Thesaurus Property-2)
C0523826 (UMLS 2011AA Property-2)
LaboratoryProcedurePhosphateMeasurementResultLowerLimitofNormalValue
Item
Phosphate LLN (Lower Limit of Lab Normal mg/dL)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C64857 (NCI Thesaurus Property-2)
C0523826 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
PhosphateSupplementsAdministrationInd-2
Item
Does the patient require chronic supplementation for serum phosphate levels
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C1505 (NCI Thesaurus ObjectClass)
C0242295 (UMLS 2011AA ObjectClass)
C0031603 (NCI Metathesaurus ObjectClass)
Creatinine, Serum
Item
Creatinine (Patient Value mg/dL)
float
C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C399 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Creatinine, serum ULN
Item
Creatinine ULN (Upper Limit of Lab Normal 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)
PatientElevatedBilirubinPersonalMedicalHistoryInd-2
Item
Does the patient have Gilbert's disease or a similar syndrome due to slow conjugation of bilirubin (If Total Bilirubin is > ULN and <= 1.5 x ULN)
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)
Item Group
Baseline Values2
LiverDiagnosticImagingAssessmentInd-2
Item
Was liver imaging performed (If AST, ALT, or alkaline phosphatase is higher than ULN)
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)
GrossExtrahepaticDiseaseIdentifiedInd-2
Item
Was gross extrahepatic disease identified (If yes,)
boolean
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C28358 (NCI Thesaurus ObjectClass-2)
C1517058 (UMLS 2011AA ObjectClass-2)
C43566 (NCI Thesaurus ObjectClass-3)
C0439806 (UMLS 2011AA ObjectClass-3)
C25737 (NCI Thesaurus Property)
C0205396 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PancreatitisDiseasePresentInd-2
Item
Does the patient have symptomatic pancreatitis
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C3306 (NCI Thesaurus ObjectClass)
C0030305 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
BonePainInd-2
Item
Does the patient have 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 at least one bone scan or PET scan performed (If patient has skeletal pain or alkaline phosphatase is higher than ULN)
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
Did any bone scan or PET scan demonstrate metastatic disease (If yes,)
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)
DiseaseSuspiciousClinicalFindingInd-2
Item
Were there suspicious findings on bone scan or PET scan (If no,)
boolean
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C0750493 (NCI Metathesaurus Property)
C0037088 (NCI Metathesaurus Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
BoneScanMedicalImagingConfirmedAssessmentInd-2
Item
Were the suspicious findings confirmed as benign by x-ray, MRI, or biopsy (If yes,)
boolean
C17646 (NCI Thesaurus ObjectClass)
C0203668 (UMLS 2011AA ObjectClass)
C16831 (NCI Thesaurus ObjectClass-2)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C25367 (NCI Thesaurus Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
LaboratoryProcedureAmylaseOutcomeUnspecifiedValue
Item
Amylase (units/L)
text
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C16284 (NCI Thesaurus Property-2)
C0002712 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureAmylaseOutcomeUpperLimitofNormalValue
Item
Amylase ULN (units/L)
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C16284 (NCI Thesaurus Property-2)
C0002712 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureLipaseOutcomeUnspecifiedValue
Item
Lipase (units/L)
text
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C37988 (NCI Thesaurus Property-2)
C0023764 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureLipaseOutcomeUpperLimitofNormalValue
Item
Lipase ULN (units/L)
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C37988 (NCI Thesaurus Property-2)
C0023764 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
Item Group
Other
Item
ECOG Performance Status (Patient)
text
C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
Code List
ECOG Performance Status (Patient)
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
BreastCarcinomaMetastasisPresentInd-2
Item
Is metastatic breast cancer present
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C19151 (NCI Thesaurus Property-2)
C0027627 (UMLS 2011AA Property-2)
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
AngiogenesisInhibitorTherapyAdministeredInd-2
Item
Has the patient had prior therapy with angiogenesis inhibitors, for example bevacizumab and sorafenib
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C1742 (NCI Thesaurus ObjectClass-2)
C0596087 (UMLS 2011AA ObjectClass)
PatientSwallowingAssessmentInd-2
Item
Does the patient have the ability to swallow oral medication
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C38028 (NCI Thesaurus Property-2)
C0011167 (UMLS 2011AA Property-2)
PartialBreastRadiationTherapyAdministeredInd-2
Item
Has the patient had partial breast irradiation (PBI)
boolean
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25378 (NCI Thesaurus ObjectClass-2)
C0728938 (UMLS 2011AA ObjectClass-2)
C15313 (NCI Thesaurus Property)
C1522449 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientPartialBreastRadiationTherapyClinicalStudyParticipationType
Item
Is there a plan to administer PBI following randomization
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C15313 (NCI Thesaurus Property-2)
C1522449 (UMLS 2011AA Property-2)
C12971 (NCI Thesaurus Property-3)
C0006141 (UMLS 2011AA Property-3)
C25378 (NCI Thesaurus Property-4)
C0728938 (UMLS 2011AA Property-4)
C15206 (NCI Thesaurus Property-5)
C0008972 (UMLS 2011AA Property-5)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Item Group
Other1
SusceptibilityArrhythmiaAgentAdministeredInd-2
Item
Does the patient require medication having proarrhythmic potential, for example terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide and flecainide
boolean
C2881 (NCI Thesaurus ObjectClass)
C0003811 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C16505 (NCI Thesaurus ObjectClass-3)
C0220898 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
HistoryofPeripheralVascularDiseasePresentInd-3
Item
Does the patient have a history of symptomatic peripheral vascular disease
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C66923 (NCI Thesaurus ObjectClass)
C1881056 (UMLS 2011AA ObjectClass)
PatientGastrointestinalHistoryUlcerationInd-2
Item
Does the patient have active gastroduodenal ulcer(s) determined by endoscopy to be active?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25457 (NCI Thesaurus Property)
C0348080 (UMLS 2011AA Property)
TreatmentPlannedBeginDate
Item
Planned Date of Treatment Initiation (Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
C25619 (NCI Thesaurus Property)
C1301732 (UMLS 2011AA Property)
PersonSurgicalProcedureInjuryEligibilityDeterminationInd-2
Item
Has the patient had a major surgical procedure, open biopsy or significant traumatic injury within 28 days of entry, or is there anticipation of a need for major surgical procedure during the course of the study?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus Property)
C0543467 (UMLS 2011AA Property)
C3671 (NCI Thesaurus Property-2)
C0043250 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
SurgicalProcedurePriorMajorPerformedDate
Item
Date of last prior major surgery (If yes, Month Day Year)
date
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C45368 (NCI Thesaurus Property-3)
C0205164 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
PatientWarfarinTreatmentInd-2
Item
Is the patient having ongoing treatment with therapeutic doses of warfarin
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C0043031 (NCI Metathesaurus Property)
HormoneTherapyContraceptionAdministeredInd-3
Item
Is the patient on any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy, SERMS other than tamoxifen and toremifene, systemic estrogen or progesterone replacement therapy or contraceptive products
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C37932 (NCI Thesaurus Property)
C0700589 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
TherapyDiscontinuedInd-2
Item
Will the medication(s) be discontinued prior to randomization (If yes,)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
SurgicalProcedureBreastReconstructionPerformedInd-2
Item
Does the patient plan to have reconstructive surgery or other major surgical procedures during the course of the study
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C15354 (NCI Thesaurus Property-2)
C0085076 (UMLS 2011AA Property-2)
Item Group
Other2
PatientHyperthyroidismPersonalMedicalHistoryInd-2
Item
Has the patient had hyperthyroidism within 6 months prior to randomization
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3123 (NCI Thesaurus Property)
C0020550 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
PatientHyperthyroidismAssayPersonalMedicalHistoryDate
Item
Date of most recent lab value indicating hyperthyroidism (Month Day Year)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3123 (NCI Thesaurus Property)
C0020550 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
C60819 (NCI Thesaurus Property-3)
C1510438 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
RelatedWoundSignificantComplicationInd-2
Item
Does the patient have a non-healing wound, skin ulcers, or incompletely healed bone fracture
boolean
C25648 (NCI Thesaurus ObjectClass)
C0439849 (UMLS 2011AA ObjectClass)
C3671 (NCI Thesaurus ObjectClass-2)
C0043250 (UMLS 2011AA ObjectClass-2)
C2959 (NCI Thesaurus Property)
C0009566 (UMLS 2011AA Property)
C41130 (NCI Thesaurus Property-2)
C0750502 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
GastrointestinalDiseaseAssessmentIndicator
Item
Does the patient have malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of the stomach or small bowel, or other disease significantly affecting gastrointestinal function
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C13359 (NCI Thesaurus ObjectClass)
C0521362 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
HematologicCoagulationDiseasePresentInd-2
Item
Does the patient have known bleeding diathesis or coagulopathy
boolean
C62780 (NCI Thesaurus ObjectClass)
C0205488 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
C2902 (NCI Thesaurus ObjectClass-3)
C0005779 (UMLS 2011AA ObjectClass-3)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientPregnancyInd-2
Item
At the time of study entry, will the patient be pregnant or lactating
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)
PriorInvestigationalTherapiesAdministeredInd-2
Item
Has the patient had any investigational agents within 30 days before randomization
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C0949266 (NCI Metathesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Agent End Date
Item
Agent End Date (If yes, Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C0806020 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)
Item Group
Footer Module
Research Comments
Item
Comments (optional)
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Person Completing Form
Item
Person Completing Form
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
Date Form Completed (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)

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