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
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)
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)
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)
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)
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)
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)
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)
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial