Neoplasms, Breast NCT00490139 On-Study - BIG 2-06 / NCCTG N063D / EGF106708 - Screening - 2646496v1.0 - Portal für Medizinische Datenmodelle (MDM-Portal)

InstitutionIdentifierNumber

Item

Centre No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

PatientCoordinatingIdentifierNumber

Item

Subject No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25462 (NCI Thesaurus Property)
C0700114 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

NCCTGPatientN063DInclusionClinicalTrialEligibilityCriteriaType

Item

Inclusion Criteria

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25581 (NCI Thesaurus ObjectClass)
C1518419 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25532 (NCI Thesaurus Property)
C1512693 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.1

Code List

Inclusion Criteria

CL Item

>= 18 Years Of Age (Age >= 18 years)

CL Item

Baseline Lvef > 50% Measured By Echocardiography Or Muga Scan After Completion Of All Anthracycline-based (neo-) Adjuvant Chemotherapy And Prior To The Targeted Therapy(ies) (Baseline LVEF > 50% measured by echocardiography or MUGA scan after completion of all anthracycline-based (neo-) adjuvant chemotherapy and prior to the targeted therapy(ies))

CL Item

Completion Of All Necessary Baseline Laboratory And Radiological Investigations (Completion of all necessary baseline laboratory and radiological investigations)

CL Item

Eastern Cooperative Oncology Group (ecog) Performance Status < 1 (Eastern Cooperative Oncology Group (ECOG) performance status < 1)

CL Item

Known Hormone Receptor Status (er/pgr Or Er Alone) (Known hormone receptor status (ER/PgR or ER alone))

CL Item

Must Have Received At Least Four Cycles Of An Approved Anthracycline-based (neo-) Adjuvant Chemotherapy Regimen (Must have received at least four cycles of an approved anthracycline-based (neo-) adjuvant chemotherapy regimen)

CL Item

Non-metastatic Operable Primary Invasive Adenocarcinoma Of The Breast (Non-metastatic operable primary invasive adenocarcinoma of the breast)

CL Item

Overexpression And/or Amplification Of Her2 In The Invasive Component Of The Primary Tumor (Overexpression and/or amplification of HER2 in the invasive component of the primary tumor)

CL Item

Signed Written Informed Consent (Signed written informed consent)

NCCTGPatientN063DExclusionClinicalTrialEligibilityCriteriaType

Item

Exclusion Criteria

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25581 (NCI Thesaurus ObjectClass)
C1518419 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.2

Code List

Exclusion Criteria

CL Item

(neo-) Or Adjuvant Chemotherapy Using Peripheral Stem Cell Or Bone Marrow Stem Cell Support ((Neo-) or adjuvant chemotherapy using peripheral stem cell or bone marrow stem cell support)

CL Item

Any Clinically Staged T4 Tumor, Including Inflammatory Breast Cancer (Any clinically staged T4 tumor, including inflammatory breast cancer)

CL Item

Any Of The Following Abnormal Laboratory Tests Immediately Prior To Randomization (Any of the following abnormal laboratory tests immediately prior to randomization (see list in instructions))

CL Item

Any Prior Mediastinal Irradiation Except Internal Mammary Node Irradiation For The Present Breast Cancer (Any prior mediastinal irradiation except internal mammary node irradiation for the present)

CL Item

Bilateral Tumors (Bilateral tumors)

CL Item

Concomitant Use Of Cyp3a4 Inhibitors Or Inducers (Concomitant use of CYP3A4 inhibitors or inducers)

CL Item

Concurrent Anti-cancer Treatment In Another Investigational Trial With Hormone Therapy Or Immunotherapy (Concurrent anti-cancer treatment in another investigational trial with hormone therapy or immunotherapy)

CL Item

Concurrent Anti-cancer Treatment, Except Hormonal Therapy (Concurrent anti-cancer treatment, except hormonal therapy)

CL Item

History Of Any Prior (ipsi- And/or Contralateral) Invasive Breast Carcinoma (History of any prior (ipsi- and/or contralateral) invasive breast carcinoma)

CL Item

Malabsorption Syndrome, Disease Significantly Affecting Gastrointestinal Function, Or Resection Of The Stomach Or Small Bowel, Or Person Unable To Swallow Oral Medication (Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, or person unable to swallow oral medication)

CL Item

Maximum Cumulative Dose Of Doxorubicin >360mg/m2 Or Maximum Cumulative Dose Of Epirubicin >720mg/m2 Or Any Prior Anthracyclines Unrelated To The Present Breast Cancer (Maximum cumulative dose of doxorubicin >360mg/m2 or maximum cumulative dose of epirubicin >720mg/m2 or any prior anthracyclines unrelated to the present breast cancer)

CL Item

Multifocal Tumors (Multifocal tumors)

CL Item

Other Concurrent Serious Diseases That May Interfere With Planned Treatment Including Severe Pulmonary Conditions/illness (Other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions/illness)

CL Item

Past Or Current History Of Malignant Neoplasms, Except For Curatively Treated Basal And Squamous Cell Carcinoma Of The Skin Or Carcinoma In Situ Of The Cervix (Past or current history of malignant neoplasms, except for curatively treated basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix)

CL Item

Patients With Positive Or Suspicious Internal Mammary Nodes Identified By Sentinel Node Technique Which Have Not Been Irradiated Or Will Not Be Irradiated, Or Patients With Supraclavicular Lymph Node Involvement (Patients with positive or suspicious internal mammary nodes identified by sentinel node technique which have not been irradiated or will not be irradiated, or patients with supraclavicular lymph node involvement)

CL Item

Pregnant Or Lactating Women (Pregnant or lactating women)

CL Item

Prior Use Of Anti-her2 Therapy For Any Reason Or Other Prior Biologic Or Immunotherapy For Breast Cancer (Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for breast cancer)

CL Item

Serious Cardiac Illness Or Medical Conditions (Serious cardiac illness or medical conditions (including...))

CL Item

Unresolved Or Unstable Serious Adverse Event From Prior Adjuvant Chemotherapy Or Radiotherapy (Unresolved or unstable serious adverse event from prior adjuvant chemotherapy or radiotherapy)

CL Item

Women Of Childbearing Potential Including Women Whose Last Menstrual Period Was <1 Year Ago Who Are Unable Or Unwilling To Use Adequate Contraceptive Measures During Study Treatment (Women of childbearing potential including women whose last menstrual period was <1 year ago who are unable or unwilling to use adequate contraceptive measures during study treatment)

PatientRandomizationDate

Item

Date of Randomization

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)

ProtocolTreatmentArmAssignmentType

Item

Assigned Treatment Arm

text

C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass)
C0442711 (UMLS 2011AA ObjectClass)
C32141 (NCI Thesaurus Property)
C1140618 (UMLS 2011AA Property)
C25426 (NCI Thesaurus Property)
C1516050 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.3

Code List

Assigned Treatment Arm

CL Item

Trastuzumab (Trastuzumab alone)

C1647 (NCI Thesaurus)
C0338204 (UMLS 2011AA)

CL Item

Lapatinib (Lapatinib alone)

C26653 (NCI Thesaurus)
C1173538 (UMLS 2011AA)

CL Item

Trastuzumab Followed By Lapatinib (Trastuzumab followed by Lapatinib)

CL Item

Lapatinib In Combination With Trastuzumab (Lapatinib in combination with Trastuzumab)

InformedConsentFormSignedDate

Item

Date Informed Consent Signed

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)

SpecimenRelatedGeneticResearchConsentDate

Item

Date of consent [for] pharmacogenetic research

date

C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C25648 (NCI Thesaurus Property)
C0439849 (UMLS 2011AA Property)
C17938 (NCI Thesaurus Property)
C0314603 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

PatientBloodSpecimenConsentInd-2

Item

Did the patient consent to donate blood sample

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12434 (NCI Thesaurus Property)
C0229664 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.4

Code List

Did the patient consent to donate blood sample

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PatientTissueBankingConsentInd-2

Item

Did the patient consent to tumor tissue

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C0087095 (NCI Metathesaurus Property)

CL.5

Code List

Did the patient consent to tumor tissue

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PersonAdditionalBloodBiospecimenResearchConsentInd-2

Item

Did the patient consent to donate additional blood sample

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C12434 (NCI Thesaurus Property)
C0229664 (UMLS 2011AA Property)
C25406 (NCI Thesaurus Property)
C1524062 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.6

Code List

Did the patient consent to donate additional blood sample

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

TissueSpecimenMalignantNeoplasmRelatedResearchConsentInd-3

Item

Did the patient consent to donate fresh/frozen tissue

text

C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C25648 (NCI Thesaurus Property)
C0439849 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.7

Code List

Did the patient consent to donate fresh/frozen tissue

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PatientBirthDate

Item

Date of Birth

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C25155 (NCI Thesaurus Property)
C0005615 (UMLS 2011AA Property)

PatientGenderCategory

Item

Patient Gender

text

C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17357 (NCI Thesaurus Property)
C0079399 (UMLS 2011AA Property)

CL.8

Code List

Patient Gender

CL Item

Female Gender (FEMALE)

C46110 (NCI Thesaurus)
C0015780 (UMLS 2011AA)

CL Item

Male Gender (MALE)

C46109 (NCI Thesaurus)
C1706180 (UMLS 2011AA)

PatientRaceNCCTGType

Item

Race

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17049 (NCI Thesaurus Property)
C0034510 (UMLS 2011AA Property)

CL.9

Code List

Race

CL Item

American Indian Or Alaska Native (American Indian or Alaska Native)

C41259 (NCI Thesaurus)
C1515945 (UMLS 2011AA)

CL Item

Asian - Central/south Asian Heritage (Asian)

CL Item

Asian: East Asian Heritage (Asian)

CL Item

Asian: Japanese Heritage (Asian)

CL Item

Asian: South East Asia Heritage (Asian)

CL Item

African American (Black or African American/African Heritage)

C16352 (NCI Thesaurus)
C0085756 (UMLS 2011AA)

CL Item

Native Hawaiian Or Other Pacific Islander (Native Hawaiian or Other Pacific Islander)

CL025744 (NCI Metathesaurus)

CL Item

White: Arabic/north African Heritage (White)

CL Item

White: White/caucasian European Heritage (White)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

PatientRaceSpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17049 (NCI Thesaurus Property)
C0034510 (UMLS 2011AA Property)

PatientEthnicGroupCategory

Item

Ethnicity

text

C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16564 (NCI Thesaurus Property)
C0015031 (UMLS 2011AA Property)

CL.10

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)

PatientMenopauseCategory

Item

Menopausal Status

text

C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3231 (NCI Thesaurus Property)
C0025320 (UMLS 2011AA Property)
C3231 (NCI Thesaurus ValueDomain)
C0025320 (UMLS 2011AA ValueDomain)

CL.11

Code List

Menopausal Status

CL Item

Pre (<6 Mo Since Lmp And No Prior Bilateral Ovariectomy And Not On Estrogen Replacement) (Pre (<6 mo since LMP AND no prior bilateral ovariectomy AND not on estrogen replacement))

CL Item

Post (prior Bilateral Ovariectomy Or >12 Mo Since Lmp With No Prior Hysterectomy) (Post (prior bilateral ovariectomy OR >12 mo since LMP with no prior hysterectomy))

CL Item

Above Categories Not Applicable And Age <50 (Above categories not applicable AND Age < 50)

CL Item

Above Categories Not Applicable And Age >= 50 (Above categories not applicable AND Age >= 50)

LastMenstrualCycleOccurrenceDate

Item

Date of last menstrual cycle

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25551 (NCI Thesaurus ObjectClass)
C1517741 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C16838 (NCI Thesaurus ObjectClass)
C0025329 (UMLS 2011AA ObjectClass)

PatientMostRecentPregnancyTestDate

Item

Date of pregnancy test

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C0032976 (NCI Metathesaurus Property)
C25577 (NCI Thesaurus Property)
C1513491 (UMLS 2011AA Property)

LaboratoryProcedurePregnancyResultInd

Item

Pregnancy test

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

CL.12

Code List

Pregnancy test

CL Item

Positive (positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Negative (negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Not Applicable, Not Female Of Child-bearing Potential (not applicable, not female of child-bearing potential)

HysterectomyPerformedInd-3

Item

Has the patient had a hysterectomy?

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15256 (NCI Thesaurus ObjectClass)
C0020699 (UMLS 2011AA ObjectClass)

CL.13

Code List

Has the patient had a hysterectomy?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

HysterectomyPerformedDate

Item

Hysterectomy (date)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15256 (NCI Thesaurus ObjectClass)
C0020699 (UMLS 2011AA ObjectClass)

UnilateralOophorectomyPerformedInd-2

Item

Unilateral ovariectomy/oophorectomy

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C28012 (NCI Thesaurus ObjectClass)
C0205092 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15291 (NCI Thesaurus ObjectClass)
C0029936 (UMLS 2011AA ObjectClass)

CL.14

Code List

Unilateral ovariectomy/oophorectomy

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

UnilateralOophorectomyPerformedAnatomicSite

Item

Specify side

text

C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C28012 (NCI Thesaurus ObjectClass)
C0205092 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15291 (NCI Thesaurus ObjectClass)
C0029936 (UMLS 2011AA ObjectClass)

CL.15

Code List

Specify side

CL Item

Left (Left)

C25229 (NCI Thesaurus)
C0205091 (UMLS 2011AA)

CL Item

Right (Right)

C25228 (NCI Thesaurus)
C0205090 (UMLS 2011AA)

UnilateralOophorectomyPerformedDate

Item

Unilateral oophorectomy Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C28012 (NCI Thesaurus ObjectClass)
C0205092 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15291 (NCI Thesaurus ObjectClass)
C0029936 (UMLS 2011AA ObjectClass)

PatientPhysicalExaminationDate

Item

Date of Physical Exam

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)

PatientPhysicalExaminationStatus

Item

Physical exam

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.16

Code List

Physical exam

CL Item

Normal (Normal)

C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)

CL Item

Abnormal - Clinically Significant (Abnormal - Clinically significant)

CL Item

Abnormal - Not Clinically Significant (Abnormal - Not clinically significant)

PatientHeightMeasurement

Item

Height (cm)

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS 2011AA Property)

PatientWeightMeasurement

Item

Weight (Kg)

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25208 (NCI Thesaurus Property)
C0043100 (UMLS 2011AA Property)

PersonBodySurfaceAreaValue

Item

BSA (m^2)

double

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS 2011AA Property)

Systolic blood pressure

Item

Blood Pressure, Systolic

double

C25209 (NCI Thesaurus ValueDomain)
C0871470 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25298 (NCI Thesaurus ObjectClass)

Diastolic blood pressure

Item

Blood pressure, Diastolic

double

C25209 (NCI Thesaurus ValueDomain)
C0428883 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25299 (NCI Thesaurus ObjectClass)

PatientVitalSignsHeartRatePhysicalExaminationValue

Item

Heart Rate (beats/min)

double

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C49672 (NCI Thesaurus Property)
C1704752 (UMLS 2011AA Property)
C49677 (NCI Thesaurus Property)
C0018810 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Item

ECOG Performance Status

text

C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain)
C1512162 (UMLS 2011AA ValueDomain)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)

CL.17

Code List

ECOG Performance Status

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)

CL Item

Dead (5)

DiagnosticElectrocardiogramPerformedDate

Item

Date of EKG

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)

DiagnosticElectrocardiogramPerformedStatus

Item

Result

text

C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25482 (NCI Thesaurus ObjectClass)
C0348026 (UMLS 2011AA ObjectClass)
C0013798 (NCI Metathesaurus ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.18

Code List

Result

CL Item

Normal (Normal)

C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)

CL Item

Abnormal - Not Clinically Significant (Abnormal - Not clinically significant)

CL Item

Abnormal - Clinically Significant (Abnormal - Clinically significant)

HeartLVEFTestDate

Item

Date of LVEF

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)
C2700377 (UMLS 2011AA Property)

HeartLVEFTestPercentageValue

Item

LVEF

double

C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property)
C2700377 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

AssessmentMethodType

Item

Method of Evaluation

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)

CL.19

Code List

Method of Evaluation

CL Item

Echocardiogram (Echocardiogram)

C37945 (NCI Thesaurus)
C2243117 (UMLS 2011AA)

CL Item

Muga Scan (MUGA scan)

HeartLVEFTestStatus

Item

Result

text

C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property)
C2700377 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.20

Code List

Result

CL Item

Normal (Normal)

C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)

CL Item

Abnormal - Not Clinically Significant (Abnormal - Not clinically significant)

CL Item

Abnormal - Clinically Significant (Abnormal - Clinically significant)

SymptomaticCongestiveHeartFailurePresentInd-3

Item

Symptomatic CHF

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C3080 (NCI Thesaurus ObjectClass)
C0018802 (UMLS 2011AA ObjectClass)
C25269 (NCI Thesaurus ObjectClass)
C0231220 (UMLS 2011AA ObjectClass)

CL.21

Code List

Symptomatic CHF

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CardiacPerformanceStatusAssessmentFunctionScale

Item

NYHA classification

text

C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C13306 (NCI Thesaurus ObjectClass)
C1522601 (UMLS 2011AA ObjectClass)
CL092952 (NCI Metathesaurus ObjectClass)

CL.22

Code List

NYHA classification

CL Item

Patients With Cardiac Disease But Without Resulting Limitation Of Physical Activity. Ordinary Physical Activity Does Not Cause Undue Fatigue, Palpitation, Dyspnea Or Anginal Pain. (Class I)

CL Item

Patients With Cardiac Disease Resulting In Slight Limitation Of Physical Activity. They Are Comfortable At Rest. Ordinary Physical Activity Results In Fatigue, Palpitation, Dyspnea Or Anginal Pain. (Class II)

CL Item

Patients With Cardiac Disease Resulting In Marked Limitation Of Physical Activity. They Are Comfortable At Rest. Less Than Ordinary Activity Causes Fatigue, Palpitation, Dyspnea Or Anginal Pain. (Class III)

CL Item

Patients With Cardiac Disease Resulting In Inability To Carry On Any Physical Activity Without Discomfort. Symptoms Of Heart Failure Or The Anginal Syndrome May Be Present Even At Rest. If Any Physical Activity Is Undertaken, Discomfort Increases. (Class IV)

PathologyTissueSpecimenAntibodyStainingMethodType

Item

Staining Antibody

text

C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C18189 (NCI Thesaurus ObjectClass)
C0030664 (UMLS 2011AA ObjectClass)
C16295 (NCI Thesaurus Property)
C0003241 (UMLS 2011AA Property)
C23010 (NCI Thesaurus Property)
C0487602 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.23

Code List

Staining Antibody

CL Item

Dako Herceptest [tm] (DAKO Herceptest [TM])

CL Item

Dako A0485 (DAKO A0485)

CL Item

Cb-11/ventana Kit (CB-11/Ventana Kit)

CL Item

Tab-250 (TAB-250)

CL Item

Ncl-c-erbb2-316 (NCL-c-erbB2-316)

CL Item

Other Specify (Other)

PathologyTissueSpecimenAntibodyStainingMethodText

Item

Other specify

text

C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C18189 (NCI Thesaurus ObjectClass)
C0030664 (UMLS 2011AA ObjectClass)
C16295 (NCI Thesaurus Property)
C0003241 (UMLS 2011AA Property)
C23010 (NCI Thesaurus Property)
C0487602 (UMLS 2011AA Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)

LaboratoryProcedureHER2/neuImmunohistochemistryResultStatus

Item

IHC Result

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C16722 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17756 (NCI Thesaurus Property)
C0242957 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.31

Code List

IHC Result

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Equivocal (Equivocal)

C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Non-interpretable (Non-interpretable)

PathologyTissueSpecimenCompleteMembraneStainMalignantCellPercentageValue

Item

Percentage of invasive tumor cells with complete membrane staining

double

C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C18189 (NCI Thesaurus ObjectClass)
C0030664 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C14143 (NCI Thesaurus Property)
C0205282 (UMLS 2011AA Property)
C12508 (NCI Thesaurus Property)
C0007634 (UMLS 2011AA Property)
C12749 (NCI Thesaurus Property)
C0025255 (UMLS 2011AA Property)
C841 (NCI Thesaurus Property)
C0038128 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

FISHAssessmentTestType

Item

FISH Kit or Test Type

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C17563 (NCI Thesaurus ObjectClass)
C0162789 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)

CL.25

Code List

FISH Kit or Test Type

CL Item

Vysis/path Vysion[tm] (Vysis/PathVysion)

CL Item

Other Specify (Other)

FISHAssessmentTestSpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C17563 (NCI Thesaurus ObjectClass)
C0162789 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)

FISHCytologyResultType

Item

FISH Result

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16491 (NCI Thesaurus ObjectClass)
C0010819 (UMLS 2011AA ObjectClass)
C17563 (NCI Thesaurus ObjectClass)
C0162789 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)

CL.32

Code List

FISH Result

CL Item

Amplified (Amplified)

CL Item

Equivocal (Equivocal)

C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)

CL Item

Not Amplified (Not amplified)

CL Item

Non-interpretable (Non-interpretable)

FISHAssessmentChromosome17ResultHER2NeuNumber

Item

FISH HER2/neu chromosome 17 Ratio

double

C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C17563 (NCI Thesaurus ObjectClass)
C0162789 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C13212 (NCI Thesaurus Property)
C0008659 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C17756 (NCI Thesaurus ValueDomain)
C0242957 (UMLS 2011AA ValueDomain)

FluorescenceinsituHybridizationDiagnosticProcedureChromosome17SignalResultCount

Item

Chromosome 17 copy number

text

C17563 (NCI Thesaurus ObjectClass)
C0162789 (UMLS 2011AA ObjectClass)
C18020 (NCI Thesaurus ObjectClass)
C0430022 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C13212 (NCI Thesaurus Property)
C0008659 (UMLS 2011AA Property)
C43382 (NCI Thesaurus Property)
C1710082 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

CL.27

Code List

Chromosome 17 copy number

CL Item

Polysomy (Polysomy)

C36331 (NCI Thesaurus)
C1514212 (UMLS 2011AA)

CL Item

Monosomy (Monosomy)

C3239 (NCI Thesaurus)
C0026499 (UMLS 2011AA)

CL Item

Normal (Normal)

C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)

SpecimenLaboratoryProcedureDate

Item

Sample test date

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)

SpecimenLaboratoryProcedureDate

Item

Sample test date

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)

SpecimenLaboratoryProcedureDate

Item

Sample test date

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)

AssessmentMethodText

Item

Not done

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)

AssessmentMethodText

Item

Not done

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)

AssessmentMethodText

Item

Not done

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)

ChromogenicinsituHybridizationDiagnosticProcedureAssessmentType

Item

CISH Kit or Test Type

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25217 (NCI Thesaurus Property)
C1516048 (UMLS 2011AA Property)
C40960 (NCI Thesaurus ObjectClass)
C1516514 (UMLS 2011AA ObjectClass)
C18020 (NCI Thesaurus ObjectClass)
C0430022 (UMLS 2011AA ObjectClass)

CL.28

Code List

CISH Kit or Test Type

CL Item

Ventana Inform (Ventana INFORM)

CL Item

Other Specify (Other)

ChromogenicinsituHybridizationDiagnosticProcedureAssessmentSpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25217 (NCI Thesaurus Property)
C1516048 (UMLS 2011AA Property)
C40960 (NCI Thesaurus ObjectClass)
C1516514 (UMLS 2011AA ObjectClass)
C18020 (NCI Thesaurus ObjectClass)
C0430022 (UMLS 2011AA ObjectClass)

ChromogenicinsituHybridizationDiagnosticProcedureResultType

Item

CISH Result

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C40960 (NCI Thesaurus ObjectClass)
C1516514 (UMLS 2011AA ObjectClass)
C18020 (NCI Thesaurus ObjectClass)
C0430022 (UMLS 2011AA ObjectClass)

CL.29

Code List

CISH Result

CL Item

Amplification (Amplified)

C25418 (NCI Thesaurus)
C1521871 (UMLS 2011AA)

CL Item

Equivocal (Equivocal)

C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)

CL Item

Not Amplified (Not amplified)

ChromogenicinsituHybridizationDiagnosticProcedureChromosome17SignalResultCount

Item

Chromosome 17 copy number

text

C40960 (NCI Thesaurus ObjectClass)
C1516514 (UMLS 2011AA ObjectClass)
C18020 (NCI Thesaurus ObjectClass)
C0430022 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C13212 (NCI Thesaurus Property)
C0008659 (UMLS 2011AA Property)
C43382 (NCI Thesaurus Property)
C1710082 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

CL.30

Code List

Chromosome 17 copy number

CL Item

Polysomy (Polysomy)

C36331 (NCI Thesaurus)
C1514212 (UMLS 2011AA)

CL Item

Monosomy (Monosomy)

C3239 (NCI Thesaurus)
C0026499 (UMLS 2011AA)

CL Item

Normal (Normal)

C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)

PathologyCoreFacilityLaboratoryIdentifierNumber

Item

Central Lab ID Number

text

C37984 (NCI Thesaurus ObjectClass)
C0022877 (UMLS 2011AA ObjectClass)
C18189 (NCI Thesaurus ObjectClass)
C0030664 (UMLS 2011AA ObjectClass)
C15896 (NCI Thesaurus ObjectClass)
C1511521 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)

LaboratoryProcedureHER2/neuImmunohistochemistryResultStatus

Item

IHC Result

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C16722 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17756 (NCI Thesaurus Property)
C0242957 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.31

Code List

IHC Result

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Equivocal (Equivocal)

C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Non-interpretable (Non-interpretable)

PathologyTissueSpecimenCompleteMembraneStainMalignantCellPercentageValue

Item

Percentage of invasive tumor cells with complete membrane staining

double

C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C18189 (NCI Thesaurus ObjectClass)
C0030664 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C14143 (NCI Thesaurus Property)
C0205282 (UMLS 2011AA Property)
C12508 (NCI Thesaurus Property)
C0007634 (UMLS 2011AA Property)
C12749 (NCI Thesaurus Property)
C0025255 (UMLS 2011AA Property)
C841 (NCI Thesaurus Property)
C0038128 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

FISHCytologyResultType

Item

FISH Result

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16491 (NCI Thesaurus ObjectClass)
C0010819 (UMLS 2011AA ObjectClass)
C17563 (NCI Thesaurus ObjectClass)
C0162789 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)

CL.32

Code List

FISH Result

CL Item

Amplified (Amplified)

CL Item

Equivocal (Equivocal)

C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)

CL Item

Not Amplified (Not amplified)

CL Item

Non-interpretable (Non-interpretable)

FISHAssessmentChromosome17ResultHER2NeuNumber

Item

FISH HER2/neu chromosome 17 Ratio

double

C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C17563 (NCI Thesaurus ObjectClass)
C0162789 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C13212 (NCI Thesaurus Property)
C0008659 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C17756 (NCI Thesaurus ValueDomain)
C0242957 (UMLS 2011AA ValueDomain)

SpecimenLaboratoryProcedureDate

Item

Sample test date

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)

SpecimenLaboratoryProcedureDate

Item

Sample test date

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)

LaboratoryProcedureEstrogenReceptorPositiveCellResultPercentageValue

Item

ER % cells stained positive

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12508 (NCI Thesaurus Property)
C0007634 (UMLS 2011AA Property)
C17069 (NCI Thesaurus Property)
C0034804 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureProgesteroneReceptorPositiveCellResultPercentageValue

Item

PgR % cells stained positive

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12508 (NCI Thesaurus Property)
C0007634 (UMLS 2011AA Property)
C17075 (NCI Thesaurus Property)
C0034833 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

CancerInitialDiagnosisDate

Item

Date of Initial Pathologic Diagnosis

date

C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

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)
C0205225 (UMLS 2011AA ObjectClass)
C25185 (NCI Thesaurus Property)
C0332304 (UMLS 2011AA Property)

CL.33

Code List

Tumor Laterality

CL Item

Left (Left)

C25229 (NCI Thesaurus)
C0205091 (UMLS 2011AA)

CL Item

Right (Right)

C25228 (NCI Thesaurus)
C0205090 (UMLS 2011AA)

PrimaryTumorSizeMeasurement

Item

Clinical Size of Tumor

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C25681 (NCI Thesaurus Property)
C0456389 (UMLS 2011AA Property)

BreastTumorClinicalNStage

Item

Clinical N Stage

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property)
C0456532 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.34

Code List

Clinical N Stage

CL Item

No Regional Lymph Node Metastasis (N0)

CL Item

Metastasis To Movable Ipsilateral Axillary Lymph Node(s) (N1)

CL Item

Metastasis To Ipsilateral Axillary Lymph Node(s) Fixed Or Matted, Or In Clinically Apparent* Ipsilateral Internal Mammary Nodes In The Absence Of Clinically Evident Lymph Node Metastasis (N2)

CL Item

Metastasis In Ipsilateral Infraclavicular Lymph Node(s) With Or Without Axillary Lymph Node Involvement, Or In Clinically Apparent* Ipsilateral Internal Mammary Lymph Node(s) And In The Presence Of Clinically Evident Axillary Lymph Node Metastasis; Or, Me (N3)

PathologicTumorPrimarySizeMeasurement

Item

Pathologic Primary Tumor Size

double

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25610 (NCI Thesaurus ObjectClass)
C1521733 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus Property)
C0205225 (UMLS 2011AA Property)
C25681 (NCI Thesaurus Property)
C0456389 (UMLS 2011AA Property)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)

TumorMarginInd-3

Item

Margin involvement

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25563 (NCI Thesaurus Property)
C0205284 (UMLS 2011AA Property)

CL.35

Code List

Margin involvement

CL Item

Yes (YES)

CL Item

No (NO)

NeoplasmMarginInvolvedType

Item

Margin involvement

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)
C25563 (NCI Thesaurus ObjectClass)
C0205284 (UMLS 2011AA ObjectClass)

CL.36

Code List

Margin involvement

CL Item

Non-resectable Deep Margins (Non-resectable deep margins)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

BreastTumorHistologicCategory

Item

Histologic Type

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)

CL.37

Code List

Histologic Type

CL Item

Ductal Nos (Ductal NOS)

CL Item

Lobular (Lobular)

C25557 (NCI Thesaurus)
C0205417 (UMLS 2011AA)
C25557 (NCI Thesaurus)
C0205417 (UMLS 2011AA)

CL Item

Mixed Ductal And Lobular (Mixed ductal and lobular)

CL Item

Apocrine (Apocrine)

CL Item

Tubulolobular (Tubulolobular)

CL Item

Micropapillary (Micropapillary)

CL Item

Cribriform (Cribriform)

C25731 (NCI Thesaurus)
C1621425 (UMLS 2011AA)
C25731 (NCI Thesaurus)
C1621425 (UMLS 2011AA)

CL Item

Mucinous Adenocarcinoma (Mucinous)

C26712 (NCI Thesaurus)
C0007130 (UMLS 2011AA)
C26712 (NCI Thesaurus)
C0007130 (UMLS 2011AA)

CL Item

Invasive Nos (Invasive NOS)

CL Item

Medullary Carcinoma (Medullary)

C8998 (NCI Thesaurus)

CL Item

Other Specify (Other)

TumorHistologicCategorySpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)

CISDiagnosisInd-3

Item

Is carcinoma in situ present

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C2917 (NCI Thesaurus ObjectClass)
C0007099 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)

CL.38

Code List

Is carcinoma in situ present

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

Stage0BreastCancerHistologicCategory

Item

Histologic type

text

C3641 (NCI Thesaurus ObjectClass)
C0154084 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)

CL.39

Code List

Histologic type

CL Item

Ductal Breast Carcinoma In Situ (DCIS)

C2924 (NCI Thesaurus)
C0007124 (UMLS 2011AA)

CL Item

Lobular Carcinoma In Situ (LCIS)

CL Item

Mixed Ductal And Lobular (Mixed DCIS & LCIS)

Paget'sDiseasePresentInd-3

Item

Is Paget's disease of the nipple present?

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C3292 (NCI Thesaurus ObjectClass)
C0029401 (UMLS 2011AA ObjectClass)

CL.40

Code List

Is Paget's disease of the nipple present?

CL Item

No (NO)

CL Item

Yes (YES)

BreastTumorHistologicGrade

Item

Histologic Grade

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)

CL.41

Code List

Histologic Grade

CL Item

Gx Grade Cannot Be Assessed (GX)

CL Item

G1 Low Combined Histologic Grade (favorable) (G1)

CL Item

G2 Intermediate Combined Histologic Grade (moderately Favorable) (G2)

CL Item

G3 High Combined Histologic Grade (unfavorable) (G3)

PositiveLymphNodeInvolvementType

Item

Lymph node involvement

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)

CL.42

Code List

Lymph node involvement

CL Item

Not Applicable (Not applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

CL Item

Node Negative, No Neoadjuvant Chemotherapy (Node negative, no neoadjuvant chemotherapy)

CL Item

1-3 Positive Nodes, No Neoadjuvant Chemotherapy (1-3 positive nodes, no neoadjuvant chemotherapy)

CL Item

>= 4 Positive Nodes, No Neoadjuvant Chemotherapy (>= 4 positive nodes, no neoadjuvant chemotherapy)

ChemotherapyOccurrenceInterval

Item

Timing of chemotherapy

text

C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25543 (NCI Thesaurus ValueDomain)
C1272706 (UMLS 2011AA ValueDomain)

CL.43

Code List

Timing of chemotherapy

CL Item

Sequential (Sequentially)

C49153 (NCI Thesaurus)
C1705294 (UMLS 2011AA)

CL Item

Concurrent (Concurrently with targeted therapy)

C25456 (NCI Thesaurus)
C0205420 (UMLS 2011AA)

BloodSpecimenCollectionDate

Item

Date Collected

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus Property)

LaboratoryProcedureResultStatus

Item

Result

text

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.44

Code List

Result

CL Item

Normal (Normal)

C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)

CL Item

Abnormal - Not Clinically Significant (Abnormal - Not clinically significant)

CL Item

Abnormal - Clinically Significant (Abnormal - Clinically significant)

PathologyCoreFacilityLaboratoryIdentifierName

Item

Laboratory Name

text

C37984 (NCI Thesaurus ObjectClass)
C0022877 (UMLS 2011AA ObjectClass)
C18189 (NCI Thesaurus ObjectClass)
C0030664 (UMLS 2011AA ObjectClass)
C15896 (NCI Thesaurus ObjectClass)
C1511521 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)

LaboratoryProcedureEstrogenReceptorPositiveCellResultPercentageValue

Item

ER % cells stained positive

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12508 (NCI Thesaurus Property)
C0007634 (UMLS 2011AA Property)
C17069 (NCI Thesaurus Property)
C0034804 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

PathologyAddressCityName

Item

City

text

C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
C18189 (NCI Thesaurus ObjectClass)
C0030664 (UMLS 2011AA ObjectClass)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)

LaboratoryProcedureProgesteroneReceptorPositiveCellResultPercentageValue

Item

PgR % cells stained positive

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12508 (NCI Thesaurus Property)
C0007634 (UMLS 2011AA Property)
C17075 (NCI Thesaurus Property)
C0034833 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

PathologyAddressPostalCode

Item

Postal Code

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
C18189 (NCI Thesaurus ObjectClass)
C0030664 (UMLS 2011AA ObjectClass)

ERLevelTumorStatus

Item

ER Status

text

C3262 (NCI Thesaurus ValueDomain)
C0027651 (UMLS 2011AA ValueDomain)
C17069 (NCI Thesaurus ObjectClass)
C0034804 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25554 (NCI Thesaurus Property)
C0441889 (UMLS 2011AA Property)

CL.45

Code List

ER Status

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

EstrogenReceptorAnalysisPerformedInd-2

Item

Is estrogen receptor analysis result available

text

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)
C0034804 (UMLS 2011AA ObjectClass)

CL.46

Code List

Is estrogen receptor analysis result available

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

BreastCarcinomaEstrogenReceptorTumorMarkerCytosolProteinAssessmentValue

Item

Estrogen receptor value

double

C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C17220 (NCI Thesaurus ObjectClass)
C0041365 (UMLS 2011AA ObjectClass)
C17069 (NCI Thesaurus ObjectClass)
C0034804 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C17021 (NCI Thesaurus Property)
C0033684 (UMLS 2011AA Property)
C61554 (NCI Thesaurus Property)
C1383501 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureEstrogenReceptorIntensityDistributionResultScore

Item

H-score

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17069 (NCI Thesaurus Property)
C0034804 (UMLS 2011AA Property)
C25539 (NCI Thesaurus Property)
C0522510 (UMLS 2011AA Property)
C45273 (NCI Thesaurus Property)
C1704711 (UMLS 2011AA Property)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)

EstrogenReceptorPercentageIntensityStainDescriptionScore

Item

Allred score

double

C17069 (NCI Thesaurus ObjectClass)
C0034804 (UMLS 2011AA ObjectClass)
C25613 (NCI Thesaurus Property)
C0439165 (UMLS 2011AA Property)
C25539 (NCI Thesaurus Property)
C0522510 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C0038128 (NCI Metathesaurus Property)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)

CL.47

Code List

Allred score

CL Item

0 (0)

C0919414 (NCI Metathesaurus)

CL Item

1 (1)

CL Item

2 (2)

C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)

CL Item

3 (3)

CL Item

4 (4)

CL Item

5 (5)

CL Item

6 (6)

CL Item

7 (7)

CL Item

8 (8)

EstrogenReceptorPercentageIntensityStainDescriptionRemmeleScore

Item

Remmele score

text

C17069 (NCI Thesaurus ObjectClass)
C0034804 (UMLS 2011AA ObjectClass)
C25613 (NCI Thesaurus Property)
C0439165 (UMLS 2011AA Property)
C25539 (NCI Thesaurus Property)
C0522510 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C0038128 (NCI Metathesaurus Property)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)

EstrogenReceptorPercentageIntensityStainDescriptionOtherScore

Item

Other

text

C17069 (NCI Thesaurus ObjectClass)
C0034804 (UMLS 2011AA ObjectClass)
C25613 (NCI Thesaurus Property)
C0439165 (UMLS 2011AA Property)
C25539 (NCI Thesaurus Property)
C0522510 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C0038128 (NCI Metathesaurus Property)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)

EstrogenReceptorPercentageIntensityStainOtherDescriptionText

Item

Method

text

C17069 (NCI Thesaurus ObjectClass)
C0034804 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25613 (NCI Thesaurus Property)
C0439165 (UMLS 2011AA Property)
C25539 (NCI Thesaurus Property)
C0522510 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C0038128 (NCI Metathesaurus Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)

EstrogenReceptorPercentageIntensityStainRangeDescriptionText

Item

Range

text

C17069 (NCI Thesaurus ObjectClass)
C0034804 (UMLS 2011AA ObjectClass)
C25613 (NCI Thesaurus Property)
C0439165 (UMLS 2011AA Property)
C25539 (NCI Thesaurus Property)
C0522510 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C0038128 (NCI Metathesaurus Property)
C38013 (NCI Thesaurus Property)
C1514721 (UMLS 2011AA Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)

PgRStatusType

Item

PgR Status

text

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

CL.48

Code List

PgR Status

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

ProgesteroneReceptorAnalysisPerformedInd-2

Item

Is progesterone receptor analysis result available

text

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)
C0034833 (UMLS 2011AA ObjectClass)

CL.49

Code List

Is progesterone receptor analysis result available

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

BreastCarcinomaProgesteroneReceptorTumorMarkerCytosolProteinAssessmentValue

Item

Progesterone receptor value

double

C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C17220 (NCI Thesaurus ObjectClass)
C0041365 (UMLS 2011AA ObjectClass)
C17075 (NCI Thesaurus ObjectClass)
C0034833 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C17021 (NCI Thesaurus Property)
C0033684 (UMLS 2011AA Property)
C61554 (NCI Thesaurus Property)
C1383501 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureProgesteroneReceptorIntensityDistributionResultScore

Item

H-score

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17075 (NCI Thesaurus Property)
C0034833 (UMLS 2011AA Property)
C25539 (NCI Thesaurus Property)
C0522510 (UMLS 2011AA Property)
C45273 (NCI Thesaurus Property)
C1704711 (UMLS 2011AA Property)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)

ProgesteroneReceptorPercentageIntensityStainDescriptionScore

Item

Allred score

double

C17075 (NCI Thesaurus ObjectClass)
C0034833 (UMLS 2011AA ObjectClass)
C25613 (NCI Thesaurus Property)
C0439165 (UMLS 2011AA Property)
C25539 (NCI Thesaurus Property)
C0522510 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C0038128 (NCI Metathesaurus Property)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)

CL.50

Code List

Allred score

CL Item

0 (0)

C0919414 (NCI Metathesaurus)

CL Item

1 (1)

CL Item

2 (2)

C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)

CL Item

3 (3)

CL Item

4 (4)

CL Item

5 (5)

CL Item

6 (6)

CL Item

7 (7)

CL Item

8 (8)

ProgesteroneReceptorPercentageIntensityStainDescriptionRemmeleScore

Item

Remmele score

text

C17075 (NCI Thesaurus ObjectClass)
C0034833 (UMLS 2011AA ObjectClass)
C25613 (NCI Thesaurus Property)
C0439165 (UMLS 2011AA Property)
C25539 (NCI Thesaurus Property)
C0522510 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C0038128 (NCI Metathesaurus Property)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)

ProgesteroneReceptorPercentageIntensityStainDescriptionOtherScore

Item

Other

text

C17075 (NCI Thesaurus ObjectClass)
C0034833 (UMLS 2011AA ObjectClass)
C25613 (NCI Thesaurus Property)
C0439165 (UMLS 2011AA Property)
C25539 (NCI Thesaurus Property)
C0522510 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C0038128 (NCI Metathesaurus Property)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)

ProgesteroneReceptorPercentageIntensityStainOtherDescriptionText

Item

Method

text

C17075 (NCI Thesaurus ObjectClass)
C0034833 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25613 (NCI Thesaurus Property)
C0439165 (UMLS 2011AA Property)
C25539 (NCI Thesaurus Property)
C0522510 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C0038128 (NCI Metathesaurus Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)

ProgesteroneReceptorPercentageIntensityStainRangeDescriptionText

Item

Range

text

C17075 (NCI Thesaurus ObjectClass)
C0034833 (UMLS 2011AA ObjectClass)
C25613 (NCI Thesaurus Property)
C0439165 (UMLS 2011AA Property)
C25539 (NCI Thesaurus Property)
C0522510 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C0038128 (NCI Metathesaurus Property)
C38013 (NCI Thesaurus Property)
C1514721 (UMLS 2011AA Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)

SentinelNodeBiopsyInd-3

Item

Was sentinel node sampling performed

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)

CL.51

Code List

Was sentinel node sampling performed

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

SentinelNodeBiopsyDate

Item

Sentinel Node Biopsy Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)

LymphNodeLateralityType

Item

Laterality

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25185 (NCI Thesaurus Property)
C0332304 (UMLS 2011AA Property)

CL.52

Code List

Laterality

CL Item

Left (left)

C25229 (NCI Thesaurus)
C0205091 (UMLS 2011AA)

CL Item

Right (right)

C25228 (NCI Thesaurus)
C0205090 (UMLS 2011AA)

AxillarySentinelLymphNodeExaminedType

Item

Axillary sentinel node biopsy

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C13351 (NCI Thesaurus ObjectClass)
C0004454 (UMLS 2011AA ObjectClass)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)

CL.53

Code List

Axillary sentinel node biopsy

CL Item

Negative (negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

InternalMammarySentinelNodeExaminedType

Item

Internal sentinel mammary nodes biopsy

text

C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
C25234 (NCI Thesaurus ObjectClass)
C0205102 (UMLS 2011AA ObjectClass)
C43595 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.54

Code List

Internal sentinel mammary nodes biopsy

CL Item

Negative (negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

AssessmentMethodText

Item

Not done

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)

AssessmentMethodText

Item

Not done

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)

BreastPrimarySurgicalProcedurePerformedType

Item

Primary breast cancer surgery

text

C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.55

Code List

Primary breast cancer surgery

CL Item

Lumpectomy (Lumpectomy)

C15755 (NCI Thesaurus)
C0024885 (UMLS 2011AA)

CL Item

Quandrantectomy / Segmentectomy (Quandrantectomy / Segmentectomy)

CL Item

Partial Mastectomy (Partial Mastectomy)

CL Item

Modified Radical Mastectomy (Modified radical mastectomy)

C15278 (NCI Thesaurus)
C0024883 (UMLS 2011AA)

CL Item

Radical Mastectomy (Radical Mastectomy)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

BreastPrimarySurgicalProcedurePerformedSpecify

Item

Specify

text

C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

InvolvedOrganLateralityType

Item

Laterality

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25547 (NCI Thesaurus ObjectClass)
C13018 (NCI Thesaurus ObjectClass)
C0178784 (UMLS 2011AA ObjectClass)
C25185 (NCI Thesaurus Property)
C0332304 (UMLS 2011AA Property)

CL.57

Code List

Laterality

CL Item

Left (left)

C25229 (NCI Thesaurus)
C0205091 (UMLS 2011AA)

CL Item

Right (right)

C25228 (NCI Thesaurus)
C0205090 (UMLS 2011AA)

PrimarySurgeryDate

Item

Primary Surgery Date

date

C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

AxillarySurgeryDissectionDate

Item

Date of Axillary Dissection

date

C13351 (NCI Thesaurus ObjectClass)
C0004454 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C15227 (NCI Thesaurus Property)
C0012737 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

InvolvedOrganLateralityType

Item

Laterality

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25547 (NCI Thesaurus ObjectClass)
C13018 (NCI Thesaurus ObjectClass)
C0178784 (UMLS 2011AA ObjectClass)
C25185 (NCI Thesaurus Property)
C0332304 (UMLS 2011AA Property)

CL.57

Code List

Laterality

CL Item

Left (left)

C25229 (NCI Thesaurus)
C0205091 (UMLS 2011AA)

CL Item

Right (right)

C25228 (NCI Thesaurus)
C0205090 (UMLS 2011AA)

LymphNodeExaminedCount

Item

Number of Lymph Nodes Examined

double

C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

LymphNodePositiveCount

Item

Number of Positive Lymph Nodes

double

C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

LargestLymphNodeSizeType

Item

Largest tumor deposit

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25550 (NCI Thesaurus ObjectClass)
C0443228 (UMLS 2011AA ObjectClass)
C25681 (NCI Thesaurus Property)
C0456389 (UMLS 2011AA Property)

CL.58

Code List

Largest tumor deposit

CL Item

None Detected (None detected)

CL Item

Isolated Tumor Cells Alone (Isolated tumor cells alone)

CL Item

Micromets (Micrometastases)

C38486 (NCI Thesaurus)
C1513276 (UMLS 2011AA)

CL Item

Macrometastases (Macrometastases)

CL Item

Not Measured (Not measured)

AssessmentMethodText

Item

Not done

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)

AgentName

Item

Agent Name

text

C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)

CumulativeAgentTotalDose

Item

Total Dose

double

C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25470 (NCI Thesaurus ObjectClass)
C1511559 (UMLS 2011AA ObjectClass)
C25304 (NCI Thesaurus Property)
C0439810 (UMLS 2011AA Property)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)

AgentInitialDose

Item

Initial Dose

double

C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)

PriorTreatmentCourseCount

Item

Total No. of Cycles

double

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)

PriorTreatmentRegimenType

Item

Prior Treatment Regimen Type

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)

CL.59

Code List

Prior Treatment Regimen Type

CL Item

Neoadjuvant Therapy (Neoadjuvant)

C15665 (NCI Thesaurus)
C0600558 (UMLS 2011AA)

CL Item

Adjuvant (Adjuvant)

C25722 (NCI Thesaurus)
C1522673 (UMLS 2011AA)

AgentBeginDate

Item

Date Started

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)

AgentEndDate

Item

Date Stopped

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)

CardiovascularDiseasePresentInd-2

Item

Has the patient suffered cardiovascular disease?

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25292 (NCI Thesaurus ObjectClass)
C0007226 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)

CL.60

Code List

Has the patient suffered cardiovascular disease?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PatientMedicalConditionText

Item

Medical condition

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25457 (NCI Thesaurus Property)
C0348080 (UMLS 2011AA Property)

PatientMedicalConditionStatus

Item

Medical condition

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25457 (NCI Thesaurus Property)
C0348080 (UMLS 2011AA Property)

CL.65

Code List

Medical condition

CL Item

Resolved (Resolved)

C49498 (NCI Thesaurus)
C1709863 (UMLS 2011AA)

CL Item

Current (Current)

C25471 (NCI Thesaurus)
C0521116 (UMLS 2011AA)

CommonToxicityCriteriaAdverseEventGrade

Item

CTC Adverse Event Grade

double

C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CL.66

Code List

CTC Adverse Event Grade

CL Item

No Adverse Event Or Within Normal Limits (0)

CL Item

Mild Adverse Event (1)

C41338 (NCI Thesaurus)
C1513302 (UMLS 2011AA)

CL Item

Moderate Adverse Event (2)

C41339 (NCI Thesaurus)
C1513374 (UMLS 2011AA)

CL Item

Severe Adverse Event (3)

C41340 (NCI Thesaurus)
C1519275 (UMLS 2011AA)

CL Item

Life-threatening Or Disabling Adverse Event (4)

CL Item

Death Related To Adverse Event (5)

C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)

TherapyRequiredInd-2

Item

Treatment Required

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25652 (NCI Thesaurus Property)
C1514873 (UMLS 2011AA Property)

CL.67

Code List

Treatment Required

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PatientSystemicDiseaseAssessmentInd-2

Item

Has the patient been assessed for systemic disease

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C9229 (NCI Thesaurus Property)
C0442893 (UMLS 2011AA Property)

CL.64

Code List

Has the patient been assessed for systemic disease

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PatientMedicalConditionText

Item

Medical condition

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25457 (NCI Thesaurus Property)
C0348080 (UMLS 2011AA Property)

PatientMedicalConditionStatus

Item

Medical condition

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25457 (NCI Thesaurus Property)
C0348080 (UMLS 2011AA Property)

CL.65

Code List

Medical condition

CL Item

Resolved (Resolved)

C49498 (NCI Thesaurus)
C1709863 (UMLS 2011AA)

CL Item

Current (Current)

C25471 (NCI Thesaurus)
C0521116 (UMLS 2011AA)

CommonToxicityCriteriaAdverseEventGrade

Item

CTC Adverse Event Grade

double

C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CL.66

Code List

CTC Adverse Event Grade

CL Item

No Adverse Event Or Within Normal Limits (0)

CL Item

Mild Adverse Event (1)

C41338 (NCI Thesaurus)
C1513302 (UMLS 2011AA)

CL Item

Moderate Adverse Event (2)

C41339 (NCI Thesaurus)
C1513374 (UMLS 2011AA)

CL Item

Severe Adverse Event (3)

C41340 (NCI Thesaurus)
C1519275 (UMLS 2011AA)

CL Item

Life-threatening Or Disabling Adverse Event (4)

CL Item

Death Related To Adverse Event (5)

C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)

TherapyRequiredInd-2

Item

Treatment Required

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25652 (NCI Thesaurus Property)
C1514873 (UMLS 2011AA Property)

CL.67

Code List

Treatment Required

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

ImagingMethodAnatomicSite

Item

Type of radiological examination

text

C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)

CL.68

Code List

Type of radiological examination

CL Item

Abdominal Ct-scan (Abdominal CT-scan)

CL Item

Bilateral Mammogram (Bilateral mammogram)

CL Item

Bone Scan (Bone scan (scintigraphy))

C17646 (NCI Thesaurus)
C0203668 (UMLS 2011AA)

CL Item

Bone X-ray (Bone X-ray)

CL Item

Ct Scan Of Chest (Chest CT-scan)

CL Item

Chest X-ray (Chest X-Ray)

CL Item

Left Mammogram, Only (Left mammogram, only)

CL Item

Right Mammogram, Only (Right mammogram, only)

ImagingMethodType

Item

Type of radiological examination (Other examinations)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)

CL.70

Code List

Type of radiological examination (Other examinations)

CL Item

Bone Scan (Bone scan)

C17646 (NCI Thesaurus)
C0203668 (UMLS 2011AA)

CL Item

Computed Tomography (CT scan)

C17204 (NCI Thesaurus)
C0040405 (UMLS 2011AA)

CL Item

Endoscopy (Endoscopy)

C16546 (NCI Thesaurus)
C0014245 (UMLS 2011AA)

CL Item

Lymphangiogram (Lymphangiogram)

C16805 (NCI Thesaurus)
C0024219 (UMLS 2011AA)

CL Item

Mammography (Mammography)

C16818 (NCI Thesaurus)
C0024671 (UMLS 2011AA)

CL Item

Magnetic Resonance Imaging (MRI)

C16809 (NCI Thesaurus)
C0024485 (UMLS 2011AA)

CL Item

Nuclear Scan (Nuclear scan)

CL Item

Positron Emission Tomography (PET scan)

C17007 (NCI Thesaurus)
C0032743 (UMLS 2011AA)

CL Item

Pet/ct Scan (PET/CT scan)

CL Item

Transvaginal Ultrasound (Transvaginal Ultrasound)

C17644 (NCI Thesaurus)
C0203418 (UMLS 2011AA)

CL Item

Ultrasound (Ultrasound)

C0041621 (NCI Metathesaurus)

CL Item

X-ray (X-ray)

C17262 (NCI Thesaurus)
C0017011 (UMLS 2011AA)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

ImagingMethodSpecify

Item

Specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)

DiagnosticImagingAnatomicSite

Item

Anatomical site

text

C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C25421 (NCI Thesaurus Property)
C0002808 (UMLS 2011AA Property)

CL.71

Code List

Anatomical site

CL Item

Abdomen/abdominal Wall (Abdomen/abdominal wall)

CL Item

Abdomen (Abdomen)

C12664 (NCI Thesaurus)
C0230168 (UMLS 2011AA)

CL Item

Bone (Bone)

C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)

CL Item

Bladder (Bladder)

C12414 (NCI Thesaurus)
C0005682 (UMLS 2011AA)

CL Item

Breast (Breast)

C12971 (NCI Thesaurus)
C0006141 (UMLS 2011AA)

CL Item

Colon (Colon)

C12382 (NCI Thesaurus)
C0009368 (UMLS 2011AA)

CL Item

Colorectal (Colorectal)

C13363 (NCI Thesaurus)
C0555952 (UMLS 2011AA)

CL Item

Central Nervous System (CNS)

C12438 (NCI Thesaurus)
C0927232 (UMLS 2011AA)

CL Item

Chest (Chest)

C25389 (NCI Thesaurus)
C0817096 (UMLS 2011AA)

CL Item

Cervix Uteri (Cervix)

C12311 (NCI Thesaurus)
C0007874 (UMLS 2011AA)

CL Item

Esophagus (Esophagus/Oesophagus)

C12389 (NCI Thesaurus)
C0014876 (UMLS 2011AA)

CL Item

Head And Neck (Head and Neck)

C12418 (NCI Thesaurus)
C0460004 (UMLS 2011AA)

CL Item

Heart (Heart)

C12727 (NCI Thesaurus)
C0018787 (UMLS 2011AA)

CL Item

Kidney (Kidney)

C12415 (NCI Thesaurus)
C0022646 (UMLS 2011AA)

CL Item

Lung (Lung)

C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)

CL Item

Lymph Node (Lymph Node)

C12745 (NCI Thesaurus)
C0024204 (UMLS 2011AA)

CL Item

Liver (Liver)

C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)

CL Item

Mouth (Oral Cavity)

C0922752 (NCI Metathesaurus)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Ovary (Ovary)

C12404 (NCI Thesaurus)
C0029939 (UMLS 2011AA)

CL Item

Pleura (Pleura)

C12469 (NCI Thesaurus)
C0032225 (UMLS 2011AA)

CL Item

Peritoneum (Peritoneum)

C12770 (NCI Thesaurus)
C0031153 (UMLS 2011AA)

CL Item

Prostate Gland (Prostate)

C12410 (NCI Thesaurus)
C0033572 (UMLS 2011AA)

CL Item

Pancreas (Pancreas)

C12393 (NCI Thesaurus)
C0030274 (UMLS 2011AA)

CL Item

Pelvis (Pelvis)

C12767 (NCI Thesaurus)
C0030797 (UMLS 2011AA)

CL Item

Rectum (Rectum)

C12390 (NCI Thesaurus)
C0034896 (UMLS 2011AA)

CL Item

Stomach (Stomach)

C12391 (NCI Thesaurus)
C0038351 (UMLS 2011AA)

CL Item

Small Intestine (Small Intestine)

C12386 (NCI Thesaurus)
C0021852 (UMLS 2011AA)

CL Item

Skin (Skin)

C12470 (NCI Thesaurus)
C1123023 (UMLS 2011AA)

CL Item

Spleen (Spleen)

C12432 (NCI Thesaurus)
C0037993 (UMLS 2011AA)

CL Item

Thyroid Gland (Thyroid)

C12400 (NCI Thesaurus)
C0040132 (UMLS 2011AA)

CL Item

Testis (Testicle)

C12412 (NCI Thesaurus)
C0039597 (UMLS 2011AA)

DiagnosticImagingProcedureDate

Item

Date of test

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C25218 (NCI Thesaurus Property)
C1948041 (UMLS 2011AA Property)

DiagnosticImagingProcedureDate

Item

Date of test

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C25218 (NCI Thesaurus Property)
C1948041 (UMLS 2011AA Property)

DiagnosticImagingAbnormalityInd-2

Item

Are there any clinically significant abnormalities

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C9440 (NCI Thesaurus Property)
C1704258 (UMLS 2011AA Property)

CL.72

Code List

Are there any clinically significant abnormalities

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

DiagnosticImagingAbnormalityInd-2

Item

Are there any clinically significant abnormalities

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C9440 (NCI Thesaurus Property)
C1704258 (UMLS 2011AA Property)

CL.72

Code List

Are there any clinically significant abnormalities

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

DiagnosticImagingAbnormalitySpecify

Item

Specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C9440 (NCI Thesaurus Property)
C1704258 (UMLS 2011AA Property)

DiagnosticImagingAbnormalitySpecify

Item

Specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C9440 (NCI Thesaurus Property)
C1704258 (UMLS 2011AA Property)

AssessmentMethodText

Item

Not done

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)

BloodSpecimenCollectionType

Item

Type of tissue

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus Property)

CL.73

Code List

Type of tissue

CL Item

Ffpe Tumor Block (FFPE tumor block)

CL Item

Blood Sample For Pgx (Blood sample for PGx)

CL Item

Tumor Tissue For Pgx (Tumor tissue for PGx)

CL Item

Additional Blood Sample For Ctc (circulating Tumor Cells) (Additional blood sample for CTC (circulating tumor cells))

CL Item

Additional Blood Sample For Proteomics (Additional blood sample for Proteomics)

CL Item

Additional Fresh Frozen Tumor Samples (Additional fresh frozen tumor samples)

BloodSpecimenCollectionDate

Item

Date Collected

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus Property)

TranslationalResearchTissueSpecimenObtainInd-3

Item

Was sample obtained

text

C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C15862 (NCI Thesaurus ObjectClass)
C1519620 (UMLS 2011AA ObjectClass)
C52349 (NCI Thesaurus Property)
C1301820 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.74

Code List

Was sample obtained

CL Item

No (NO)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (YES)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

ID

Beschreibung

Link

Stichworte

Versionen (4)

Hochgeladen am

DOI

Lizenz

Modell Kommentare :

Itemgroup Kommentare für :

Item Kommentare für :

Neoplasms, Breast NCT00490139 On-Study - BIG 2-06 / NCCTG N063D / EGF106708 - Screening - 2646496v1.0

No Instruction available.

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