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

Clinical Trial

Registration

Breast Neoplasms

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

model
Details

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

1 forms

StudyEvent: NSABP B-45 Worksheet for Entry Form
1. 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

Header Module

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)

Gender

Item

Patient Gender

text

C25372 (NCI Thesaurus ValueDomain)
C0079399 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17357 (NCI Thesaurus Property)

CL.1

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)

Race

Item Group

Race

Racial Group

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)

CL.2

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)

Demographics

Item Group

Person Completing Form, Last Name

PatientPaymentType

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)

CL.3

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)

Ethnic Group

Item

Ethnicity

text

C25372 (NCI Thesaurus ValueDomain)
C0015031 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C16564 (NCI Thesaurus Property)

CL.4

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)

PatientAddressCountryCode

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)

CL.5

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

Protocol Administration

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)

Cardiac Conditions

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)

Other Conditions

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)

Cardiac Risk Factors

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)

Smoking history

Item

Smoking (Patient History)

text

C25180 (NCI Thesaurus ValueDomain)
C1519384 (UMLS CUI-1)
C17934 (NCI Thesaurus ObjectClass)
C18772 (NCI Thesaurus Property)

CL.34

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)

SECTION 2 - Diagnostic

Item Group

Section 2 - Diagnostic

BreastTumorStageGroupingStage

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)

CL.35

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)

ERLevelTumorStatus

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)

CL.57

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)

PgRStatusType

Item

Receptor Status, PgR

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17075 (NCI Thesaurus ObjectClass)
C0034833 (UMLS 2011AA ObjectClass)
C0678257 (NCI Metathesaurus Property)

CL.66

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)

BreastCytogeneticsHER2/neuPolyclonalAntibodyTestScore

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)

CL.42

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)

LaboratoryProcedureHER2/neuinsituHybridizationOutcomeType

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)

CL.44

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)

Nodal Status Assessments PRIOR TO NEOADJUVANT CHEMOTHERAPY

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)

SECTION 3 - NEOADJUVANT CHEMOTHERAPY

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

PriorChemotherapyNeoadjuvantTreatmentRegimenType

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)

CL.53

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)

SECTION 4 - SURGERY AFTER NEOADJUVANT CHEMOTHERAPY

Item Group

Section 4 - Surgery After Neoadjuvant Chemotherapy

PrimaryTumorLateralityType

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)

CL.54

Code List

Tumor Laterality

CL Item

Left (Left)

C25229 (NCI Thesaurus)
C0205091 (UMLS 2011AA)

CL Item

Right (Right)

C25228 (NCI Thesaurus)
C0205090 (UMLS 2011AA)

BreastCancerSurgeryMarginStatus

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)

CL.55

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

ERLevelTumorStatus

Item

Receptor Status, ER (If yes,)

text

CL.57

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)

PrimaryTumorPathologicSizeType

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)

CL.59

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)

BreastTumorPostNeoadjuvantTherapyPathologyNStage

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)

CL.60

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)

SECTION 4 - SURGERY AFTER NEOADJUVANT CHEMOTHERAPY1

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)

PgRStatusType

Item

Receptor Status, PgR

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17075 (NCI Thesaurus ObjectClass)
C0034833 (UMLS 2011AA ObjectClass)
C0678257 (NCI Metathesaurus Property)

CL.66

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)

AmericanCollegeofSurgeonsOncologyGroupPatientMalignantNeoplasmSizeEligibilityDeterminationType

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)

CL.69

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)

Sentinel Node Biopsy Staging

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)

Other Axillary Staging

Item Group

Other Axillary Staging

AxillaryLymphNodeStagingPerformedType

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)

CL.73

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)

Postoperative Chemotherapy

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)

AdjuvantChemotherapyAdministeredRegimenType

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)

CL.75

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)

Baseline Values

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

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)

ConcomitantAntihypertensiveAgentAdministeredType

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)

CL.79

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)

Patient Characteristics

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)

Baseline Values1

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)

Evaluation method

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)

CL.80

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)

UrinalysisProteinLevelAmount

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)

CL.81

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)

Blood Counts

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)

Baseline Values2

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)

Other

Item Group

Other

ECOG Performance Status

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)

CL.93

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)

Other1

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)

Other2

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)

Footer Module

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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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

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