PatientInitialsName
Item
Patient Initials (Last, First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
PatientSSNNumber
Item
Patient Social Security Number (USA only)
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25686 (NCI Thesaurus Property)
C1301821 (UMLS 2011AA Property)
ClinicalTrialSiteName64CharacterText
Item
Site Name
text
C71104 (NCI Thesaurus ObjectClass)
C0008976 (UMLS 2011AA ObjectClass)
C37901 (NCI Thesaurus ObjectClass)
C0205145 (UMLS 2011AA ObjectClass)
C42614 (NCI Thesaurus Property)
C0027365 (UMLS 2011AA Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C45253 (NCI Thesaurus ValueDomain)
C1547402 (UMLS 2011AA ValueDomain)
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)
C1522326 (UMLS 2011AA ObjectClass)
Item
Intended chemotherapy regimen
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Code List
Intended chemotherapy regimen
CL Item
Tc: Docetaxel 75 Mg/m2 And Cyclophosphamide 600 Mg/m2 (iv) (TC: docetaxel 75 mg/m2 and cyclophosphamide 600 mg/m2 (IV))
CL Item
Ac - Wp: Doxorubicin 60 Mg/m2 And Cyclophosphamide 600 Mg/m2 (iv) Followed By Paclitaxel 80 Mg/m2 (iv) (AC - WP: doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 (IV) followed by paclitaxel 80 mg/m2 (IV))
InformedConsentFormSignedDate
Item
Date Informed Consent Signed (Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
Item
Has the patient authorized the release of Protected Health Information to the NSABP?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
Code List
Has the patient authorized the release of Protected Health Information to the NSABP?
CL Item
Yes: C49488 (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No: C49487 (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Did the patient consent to use of blood samples for research related to this study?
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)
Code List
Did the patient consent to use of blood samples for research related to this study?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Did the patient consent to use of blood samples for the B-47 Menstrual History study?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12434 (NCI Thesaurus Property)
C0229664 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C16100 (NCI Thesaurus Property)
C1511524 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Code List
Did the patient consent to use of blood samples for the B-47 Menstrual History study?
CL Item
Yes: C49488 (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No: C49487 (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
Item
Did the patient consent to future contact about more research?
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)
Code List
Did the patient consent to future contact about more research?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
IHC Staining Score (If multiple IHC assays were performed, report the one with the highest staining intensity score. Please refer to Protocol - Section 4.2.7 for more information. - A copy of the IHC report must be provided.)
text
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C16487 (NCI Thesaurus ObjectClass)
C0010802 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C17756 (NCI Thesaurus Property)
C0242957 (UMLS 2011AA Property)
C61381 (NCI Thesaurus Property)
C0312586 (UMLS 2011AA Property)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
Code List
IHC Staining Score (If multiple IHC assays were performed, report the one with the highest staining intensity score. Please refer to Protocol - Section 4.2.7 for more information. - A copy of the IHC report must be provided.)
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
LaboratoryProcedureFluorescenceinsituHybridizationHER2/neuCopyNumberPolymorphismOutcomeValue
Item
HER2 gene copy number (If multiple assay results were performed, report the assay result with the highest HER2 gene copy number.)
double
Item
Was HER2 status assessed by ISH assay
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17562 (NCI Thesaurus Property)
C0162788 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17756 (NCI Thesaurus Property)
C0242957 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Was HER2 status assessed by ISH assay
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Was HER2 to CEP17 ratio performed?
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17563 (NCI Thesaurus Property)
C0162789 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C17756 (NCI Thesaurus Property)
C0242957 (UMLS 2011AA Property)
C43523 (NCI Thesaurus Property)
C1704681 (UMLS 2011AA Property)
C13212 (NCI Thesaurus Property)
C0008659 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
Was HER2 to CEP17 ratio performed?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureHER2/neuChromosome17ProbeFluorescenceInSituHybridizationPerformedRatioValue
Item
HER2 to CEP17 ratio (If multiple HER2 to CEP17 ratios were performed, report the highest one.)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17563 (NCI Thesaurus Property)
C0162789 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C17756 (NCI Thesaurus Property)
C0242957 (UMLS 2011AA Property)
C43523 (NCI Thesaurus Property)
C1704681 (UMLS 2011AA Property)
C13212 (NCI Thesaurus Property)
C0008659 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C44256 (NCI Thesaurus ValueDomain)
C0456603 (UMLS 2011AA ValueDomain)
Item
Does the patient have unilateral invasive adenocarcinoma of the breast on histologic examination?
text
C2852 (NCI Thesaurus ObjectClass)
C0001418 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C14159 (NCI Thesaurus ObjectClass)
C0205281 (UMLS 2011AA ObjectClass)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C25527 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
Does the patient have unilateral invasive adenocarcinoma of the breast on histologic examination?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Tumor Laterality
text
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C16958 (NCI Thesaurus ObjectClass)
C0030669 (UMLS 2011AA ObjectClass)
C25185 (NCI Thesaurus Property)
C0332304 (UMLS 2011AA Property)
C43516 (NCI Thesaurus ValueDomain)
C1705251 (UMLS 2011AA ValueDomain)
Code List
Tumor Laterality
CL Item
Left Breast (Left breast)
CL Item
Right Breast (Right breast)
Item
Was lumpectomy performed?
text
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C15755 (NCI Thesaurus Property)
C0024885 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15385 (NCI Thesaurus Property)
C0184921 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Was lumpectomy performed?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LumpectomyPerformedDate
Item
Date lumpectomy performed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15755 (NCI Thesaurus ObjectClass)
C0024885 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
Item
Was total mastectomy performed?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15281 (NCI Thesaurus ObjectClass)
C0024886 (UMLS 2011AA ObjectClass)
Code List
Was total mastectomy performed?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
TotalMastectomyPerformedDate
Item
Date Total Mastectomy Performed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15281 (NCI Thesaurus ObjectClass)
C0024886 (UMLS 2011AA ObjectClass)
Item
Were mastectomy margins free of gross residual tumor?
text
C41227 (NCI Thesaurus ObjectClass)
C0229985 (UMLS 2011AA ObjectClass)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C15277 (NCI Thesaurus Property)
C0024881 (UMLS 2011AA Property)
C25252 (NCI Thesaurus Property)
C0205288 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Were mastectomy margins free of gross residual tumor?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Were mastectomy margins microscopically positive?
text
C41227 (NCI Thesaurus ObjectClass)
C0229985 (UMLS 2011AA ObjectClass)
C15277 (NCI Thesaurus Property)
C0024881 (UMLS 2011AA Property)
C25252 (NCI Thesaurus Property)
C0205288 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Were mastectomy margins microscopically positive?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Will post-mastectomy RT of the chest wall be administered?
text
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C62484 (NCI Thesaurus ObjectClass)
C0205076 (UMLS 2011AA ObjectClass)
C15277 (NCI Thesaurus Property)
C0024881 (UMLS 2011AA Property)
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Will post-mastectomy RT of the chest wall be administered?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Were lumpectomy margins histologically free of invasive tumor and DCIS, either initially or after one or more re-excisions?
text
C15755 (NCI Thesaurus ObjectClass)
C0024885 (UMLS 2011AA ObjectClass)
C41227 (NCI Thesaurus ObjectClass)
C0229985 (UMLS 2011AA ObjectClass)
C25252 (NCI Thesaurus Property)
C0205288 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C0028423 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Were lumpectomy margins histologically free of invasive tumor and DCIS, either initially or after one or more re-excisions?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Was estrogen receptor status determined from the primary tumor?
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)
Code List
Was estrogen receptor status determined from the primary tumor?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Receptor Status, ER
text
C3262 (NCI Thesaurus ValueDomain)
C0027651 (UMLS 2011AA ValueDomain)
C17069 (NCI Thesaurus ObjectClass)
C0034804 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25554 (NCI Thesaurus Property)
C0441889 (UMLS 2011AA Property)
Code List
Receptor Status, ER
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
Item
Was progesterone receptor status determined from the primary tumor?
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)
Code List
Was progesterone receptor status determined from the primary tumor?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Receptor Status, PgR
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17075 (NCI Thesaurus ObjectClass)
C0034833 (UMLS 2011AA ObjectClass)
C0678257 (NCI Metathesaurus Property)
Code List
Receptor Status, PgR
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
Item
Histologic Type (Mark predominant tumor 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)
Code List
Histologic Type (Mark predominant tumor type.)
CL Item
Ductal (Ductal)
C25732 (NCI Thesaurus)
C1512083 (UMLS 2011AA)
CL Item
Lobular (Lobular)
C25557 (NCI Thesaurus)
C0205417 (UMLS 2011AA)
C25557 (NCI Thesaurus)
C0205417 (UMLS 2011AA)
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)
Item
Histologic Grade (Use combined histologic grade classification.)
text
C25454 (NCI Thesaurus Property)
C0205195 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus Property)
C0919553 (UMLS 2011AA Property)
Code List
Histologic Grade (Use combined histologic grade classification.)
CL Item
Low (Low)
CL124342 (NCI Metathesaurus)
CL Item
Intermediate (Intermediate)
C0205103 (NCI Metathesaurus)
CL Item
High (High)
C25227 (NCI Thesaurus)
C0205250 (UMLS 2011AA)
Item
Was Oncotype DX Recurrence Score determined?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C52159 (NCI Thesaurus Property)
C1709318 (UMLS 2011AA Property)
Code List
Was Oncotype DX Recurrence Score determined?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureOncotypeDXBreastCancerAssayResultScore
Item
Oncotype DX Recurrence Score (A copy of the report must be provided.)
double
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C52159 (NCI Thesaurus Property)
C1709318 (UMLS 2011AA Property)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
Item
Was sentinel lymphadenectomy performed?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
C15227 (NCI Thesaurus Property)
C0012737 (UMLS 2011AA Property)
Code List
Was sentinel lymphadenectomy performed?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
SentinelNodeDissectionDate
Item
Date of Sentinel Lymphadenectomy
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
C15227 (NCI Thesaurus Property)
C0012737 (UMLS 2011AA Property)
SentinelNodeExaminedCount
Item
Number of Sentinel Nodes Examined
double
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
double
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C0205159 (NCI Metathesaurus Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
LymphNodePositiveCount
Item
Total Number of Positive Nodes (Pathologic; all procedures)
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)
Item
Surgical Procedure for Evaluation of Pathological Nodal Status
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C15275 (NCI Thesaurus Property)
C0024203 (UMLS 2011AA Property)
Code List
Surgical Procedure for Evaluation of Pathological Nodal Status
CL Item
Regional Lymph Node Dissection Sentinel Lymph Node (Sentinel lymphadenectomy alone)
C48935 (NCI Thesaurus)
C1709883 (UMLS 2011AA)
C12947 (NCI Thesaurus)
C1522495 (UMLS 2011AA)
CL Item
Sentinel Lymph Node Biopsy With Axillary Lymph Node Dissection (Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes)
C47854 (NCI Thesaurus)
C1710051 (UMLS 2011AA)
CL Item
Axillary Lymph Node Dissection (Axillary lymphadenectomy with or without SN isolation procedure)
C15677 (NCI Thesaurus)
C0193867 (UMLS 2011AA)
SurgicalProcedureMalignantBreastNeoplasmPerformedLastDate
Item
Date of Last Surgery for Breast Cancer Treatment or Staging
date
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C9335 (NCI Thesaurus Property)
C0006142 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25551 (NCI Thesaurus ValueDomain)
C1517741 (UMLS 2011AA ValueDomain)
Item
Pathologic T Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property)
C0475455 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
Code List
Pathologic T Stage
CL Item
Microinvasion 0.1 Cm Or Less In Greatest Dimension (pT1mi)
CL Item
Tumor More Than 0.1 Cm But Not More Than 0.5 Cm In Greatest Dimension (pT1a)
CL Item
Tumor More Than 0.5 Cm But Not More Than 1 Cm In Greatest Dimension (pT1b)
CL Item
Tumor More Than 1 Cm But Not More Than 2 Cm In Greatest Dimension (pT1c)
CL Item
Tumor More Than 2 Cm But Not More Than 5 Cm In Greatest Dimension (pT2)
CL Item
Tumor More Than 5 Cm In Greatest Dimension (pT3)
Item
Pathologic N Stage (pathologic evaluation of ipsilateral nodes)
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property)
C0456532 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
Code List
Pathologic N Stage (pathologic evaluation of ipsilateral nodes)
CL Item
No Regional Lymph Node Metastasis Histologically, No Additional Examination For Isolated Tumor Cells (itc) (pN0)
CL Item
Micrometastasis (>0.2 Mm But <=2.0 Mm) (pN1mi)
CL Item
Metastasis In 1 To 3 Axillary Lymph Nodes (pN1a)
CL Item
Metastasis In Internal Mammary Nodes With Microscopic Disease Detected By Sln Dissection But Not Clinically Apparent (pN1b)
CL Item
Metastasis In 1 To 3 Axillary Lymph Nodes And In Internal Mammary Lymph Nodes With Microscopic Disease Detected By Sln Dissection But Not Clinically Apparent. (pN1c)
CL Item
Metastasis In 4 To 9 Axillary Lymph Nodes (at Least 1 Tumor Deposit >2.0 Mm) (pN2a)
CL Item
Metastasis In Clinically Apparent* Internal Mammary Lymph Nodes In The Absence Of Axillary Lymph Node Metastasis (pN2b)
CL Item
Metastasis In >=10 Axillary Lymph Nodes (at Least 1 Tumor Deposit >2.0 Mm); Or, Metastasis To The Infraclavicular Lymph Nodes (pN3a)
CL Item
Metastasis In Clinically Apparent* Ipsilateral Internal Mammary Lymph Nodes In The Presence Of >=1 Positive Axillary Lymph Node(s); Or, In >3 Axillary Lymph Nodes And In Internal Mammary Lymph Nodes With Microscopic Disease Detected By Sentinel Lymph Node (pN3b)
PatientHeightMeasurement
Item
Patient 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
Patient 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)
AssessmentPerformedDate
Item
Date of Assessment
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
AssessmentPerformedDate
Item
Date of Assessment
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
Systolic blood pressure
Item
Blood Pressure, Systolic (most recent)
double
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)
double
C25209 (NCI Thesaurus ValueDomain)
C0428883 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25299 (NCI Thesaurus ObjectClass)
BloodPressurePhysicalExaminationMostRecentDate
Item
Date of most recent blood pressure assessment
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C54706 (NCI Thesaurus ObjectClass)
C0005823 (UMLS 2011AA ObjectClass)
C25577 (NCI Thesaurus ValueDomain)
C1513491 (UMLS 2011AA ValueDomain)
Item
Are anti-hypertensive medication(s) needed to sustain systolic BP <= 150 mmHg and diastolic BP <= 90 mmHg?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3117 (NCI Thesaurus ObjectClass)
C0020538 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
Code List
Are anti-hypertensive medication(s) needed to sustain systolic BP <= 150 mmHg and diastolic BP <= 90 mmHg?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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)
HeartLVEFTestDate
Item
Date LVEF performed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property)
C2700377 (UMLS 2011AA Property)
Item
Assessment Type
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)
Code List
Assessment Type
CL Item
2-d Echocardiogram (2-D Echocardiogram)
CL Item
Muga Scan (MUGA scan)
Item
ANC
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C63321 (NCI Thesaurus Property)
C0948762 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureAbsoluteNeutrophilCountResultUnspecifiedValue
Item
ANC (thousand/mm^3)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C63321 (NCI Thesaurus Property)
C0948762 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureAbsoluteNeutrophilCountResultDate
Item
Date of Collection
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C63321 (NCI Thesaurus Property)
C0948762 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Item
Platelet Count
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C12520 (NCI Thesaurus Property)
C0005821 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedurePlateletResultUnspecifiedValue
Item
Platelet count (thousand/mm^3)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12520 (NCI Thesaurus Property)
C0005821 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedurePlateletResultDate
Item
Date of Collection
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12520 (NCI Thesaurus Property)
C0005821 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Item
Hemoglobin
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureHemoglobinResultSpecifiedValue
Item
Hemoglobin (g/dL)
double
C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureHemoglobinResultDate
Item
Date of Collection
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Item
AST
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C64467 (NCI Thesaurus Property)
C0201899 (UMLS 2011AA Property)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultSpecifiedValue
Item
AST (units/L)
double
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue
Item
AST ULN (units/L)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultDate
Item
Date of Collection
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Item
ALT (required only when SGOT AST is not available)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25293 (NCI Thesaurus Property)
C0376147 (UMLS 2011AA Property)
Code List
ALT (required only when SGOT AST is not available)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUnspecifiedValue
Item
ALT (units/L)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property)
C0376147 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue
Item
ALT ULN (units/L)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property)
C0376147 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultDate
Item
Date of Collection
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25293 (NCI Thesaurus Property)
C0376147 (UMLS 2011AA Property)
Item
Alkaline Phosphatase
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C16276 (NCI Thesaurus Property)
C0002059 (UMLS 2011AA Property)
Code List
Alkaline Phosphatase
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureAlkalinePhosphataseResultValue
Item
Alkaline Phosphatase (units/L)
double
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C16276 (NCI Thesaurus Property)
C0002059 (UMLS 2011AA Property)
LaboratoryProcedureAlkalinePhosphataseResultUpperLimitNormalValue
Item
Alkaline Phosphatase ULN (units/L)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C16276 (NCI Thesaurus Property)
C0002059 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
LaboratoryProcedureAlkalinePhosphataseResultDate
Item
Date of Collection
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C16276 (NCI Thesaurus Property)
C0002059 (UMLS 2011AA Property)
Item
Total Bilirubin
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C305 (NCI Thesaurus Property)
C0005437 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Code List
Total Bilirubin
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureTotalBilirubinResultSpecifiedValue
Item
Total Bilirubin
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property)
C0201913 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain)
C0205369 (UMLS 2011AA ValueDomain)
LaboratoryProcedureTotalBilirubinResultSpecifiedUpperLimitofNormalValue
Item
Total bilirubin ULN (mg/dL)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property)
C0201913 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain)
C0205369 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
LaboratoryProcedureBilirubinOutcomeDate
Item
Date of Collection
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property)
C0005437 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Item
Serum Creatinine
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Code List
Serum Creatinine
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureCreatinineResultSpecifiedValue
Item
Serum creatinine (mg/dL)
double
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureCreatinineResultUpperLimitofNormalValue
Item
Serum Creatinine ULN (mg/dL)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
LaboratoryProcedureCreatinineClearanceOutcomeDate
Item
Date of Collection
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25747 (NCI Thesaurus Property)
C0373595 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Item
Was liver imaging performed? (CT, MRI, PET scan, or PET-CT)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C12392 (NCI Thesaurus ObjectClass)
C0023884 (UMLS 2011AA ObjectClass)
Code List
Was liver imaging performed? (CT, MRI, PET scan, or PET-CT)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does liver imaging demonstrate metastatic disease?
text
C12392 (NCI Thesaurus ObjectClass)
C0023884 (UMLS 2011AA ObjectClass)
C19151 (NCI Thesaurus ObjectClass)
C0027627 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C16502 (NCI Thesaurus Property)
C0011923 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
Does liver imaging demonstrate metastatic disease?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LiverDiagnosticImagingAssessmentDate
Item
Date of Assessment
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C12392 (NCI Thesaurus ObjectClass)
C0023884 (UMLS 2011AA ObjectClass)
Item
Does the patient have unexplained bone pain?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3303 (NCI Thesaurus Property)
C0030193 (UMLS 2011AA Property)
C12366 (NCI Thesaurus ObjectClass)
C0262950 (UMLS 2011AA ObjectClass)
Code List
Does the patient have unexplained bone pain?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Was bone scan, PET-CT scan, or PET scan performed?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C17646 (NCI Thesaurus ObjectClass)
C0203668 (UMLS 2011AA ObjectClass)
C16831 (NCI Thesaurus ObjectClass)
Code List
Was bone scan, PET-CT scan, or PET scan performed?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does bone scan, PET-CT scan, or PET scan demonstrate metastatic disease?
text
C17646 (NCI Thesaurus ObjectClass)
C0203668 (UMLS 2011AA ObjectClass)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C16809 (NCI Thesaurus ObjectClass)
C0024485 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C3580 (NCI Thesaurus Property)
C0153690 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Does bone scan, PET-CT scan, or PET scan demonstrate metastatic disease?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
BoneAssessmentDate
Item
Date of Assessment (if applicable)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C12366 (NCI Thesaurus ObjectClass)
C0262950 (UMLS 2011AA ObjectClass)
Item
Is bilirubin elevation due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin?
text
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)
C0262926 (UMLS 2011AA Property)
Code List
Is bilirubin elevation due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Was chest imaging performed?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C25389 (NCI Thesaurus Property)
C0817096 (UMLS 2011AA Property)
Code List
Was chest imaging performed?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Did chest imaging demonstrate metastatic disease?
text
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C25389 (NCI Thesaurus ObjectClass)
C0817096 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C19151 (NCI Thesaurus Property)
C0027627 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
Did chest imaging demonstrate metastatic disease?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
DiagnosticImagingChestAssessmentDate
Item
Date chest imaging performed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C25389 (NCI Thesaurus Property)
C0817096 (UMLS 2011AA Property)
Item
Was the breast cancer staged as T4, including inflammatory breast cancer?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C4001 (NCI Thesaurus ObjectClass)
C0278601 (UMLS 2011AA ObjectClass)
Code List
Was the breast cancer staged as T4, including inflammatory breast cancer?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is there definitive clinical or radiologic evidence of metastatic disease for this patient?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C3261 (NCI Thesaurus ObjectClass)
C2939420 (UMLS 2011AA ObjectClass)
Code List
Is there definitive clinical or radiologic evidence of metastatic disease for this patient?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Did the patient have synchronous or previous contralateral invasive breast cancer?
text
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25307 (NCI Thesaurus ObjectClass)
C0441988 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Did the patient have synchronous or previous contralateral invasive breast cancer?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have a history of ipsilateral invasive breast cancer or ipsilateral DCIS?
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C14173 (NCI Thesaurus ObjectClass)
C2945760 (UMLS 2011AA ObjectClass)
C25308 (NCI Thesaurus ObjectClass)
C0441989 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Does the patient have a history of ipsilateral invasive breast cancer or ipsilateral DCIS?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have a history of non-breast malignancies within the past 5 years?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C9335 (NCI Thesaurus Property)
C0006142 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Does the patient have a history of non-breast malignancies within the past 5 years?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Were the other malignancies limited to one or more of the following: in situ cancers treated only by local excision, and basal and squamous cell carcinomas of the skin?
text
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)
C0262926 (UMLS 2011AA Property)
Code List
Were the other malignancies limited to one or more of the following: in situ cancers treated only by local excision, and basal and squamous cell carcinomas of the skin?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Has the patient had previous therapy with anthracyclines, taxanes, or trastuzumab for any malignancy?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C25620 (NCI Thesaurus Property)
C1514162 (UMLS 2011AA Property)
C1490 (NCI Thesaurus Property)
C0796419 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Has the patient had previous therapy with anthracyclines, taxanes, or trastuzumab for any malignancy?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Has the patient had chemotherapy or HER2-targeted therapy administered for the currently diagnosed breast cancer?
text
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Code List
Has the patient had chemotherapy or HER2-targeted therapy administered for the currently diagnosed breast cancer?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Has the patient had whole breast RT prior to randomization or partial breast RT that cannot be completed on or before the date of randomization?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
C15313 (NCI Thesaurus Property)
C1522449 (UMLS 2011AA Property)
C12971 (NCI Thesaurus Property)
C0006141 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
Has the patient had whole breast RT prior to randomization or partial breast RT that cannot be completed on or before the date of randomization?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Will the patient receive continued endocrine therapy with any hormonal agent such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor after randomization?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
C15445 (NCI Thesaurus Property)
C0279025 (UMLS 2011AA Property)
C1740 (NCI Thesaurus Property)
C0593802 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
Will the patient receive continued endocrine therapy with any hormonal agent such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor after randomization?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Will the patient receive continued sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy after randomization?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
C15445 (NCI Thesaurus Property)
C0279025 (UMLS 2011AA Property)
Code List
Will the patient receive continued sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy after randomization?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have angina pectoris that requires the use of anti-anginal medication?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C51221 (NCI Thesaurus ObjectClass)
C0002962 (UMLS 2011AA ObjectClass)
Code List
Does the patient have angina pectoris that requires the use of anti-anginal medication?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have ventricular arrhythmias except for benign premature ventricular contractions?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C2881 (NCI Thesaurus ObjectClass)
C0003811 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
Code List
Does the patient have ventricular arrhythmias except for benign premature ventricular contractions?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have supraventricular or nodal arrhythmias requiring a pacemaker or not controlled with medication?
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C27045 (NCI Thesaurus Property)
C0264893 (UMLS 2011AA Property)
C27158 (NCI Thesaurus Property)
C0428974 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
Does the patient have supraventricular or nodal arrhythmias requiring a pacemaker or not controlled with medication?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have a conduction abnormality requiring a pacemaker?
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C80460 (NCI Thesaurus Property)
C1719274 (UMLS 2011AA Property)
C78245 (NCI Thesaurus Property)
C0264886 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
Does the patient have a conduction abnormality requiring a pacemaker?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have valvular disease with documented compromise in cardiac function?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
Code List
Does the patient have valvular disease with documented compromise in cardiac function?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have symptomatic pericarditis?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C34915 (NCI Thesaurus Property)
C0031046 (UMLS 2011AA Property)
Code List
Does the patient have symptomatic pericarditis?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have a history of documented 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)
Code List
Does the patient have a history of documented CHF?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have a history of documented cardiomyopathy?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C34830 (NCI Thesaurus Property)
C0878544 (UMLS 2011AA Property)
Code List
Does the patient have a history of documented cardiomyopathy?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have a history of myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C27996 (NCI Thesaurus Property)
C0027051 (UMLS 2011AA Property)
C3390 (NCI Thesaurus Property)
C0038454 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
Does the patient have a history of myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have any other cardiac disease (history of and/or active disease) that would preclude the use of drugs included in the treatment regimen?
text
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C13306 (NCI Thesaurus ObjectClass)
C1522601 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
Does the patient have any other cardiac disease (history of and/or active disease) that would preclude the use of drugs included in the treatment regimen?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have active hepatitis B or hepatitis C with abnormal liver function tests?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C0021311 (NCI Metathesaurus ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
Code List
Does the patient have active hepatitis B or hepatitis C with abnormal liver function tests?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have intrinsic lung disease resulting in dyspnea?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2998 (NCI Thesaurus ObjectClass)
C0013404 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
Code List
Does the patient have intrinsic lung disease resulting in dyspnea?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have poorly controlled diabetes mellitus?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C2985 (NCI Thesaurus Property)
C0011849 (UMLS 2011AA Property)
C61299 (NCI Thesaurus Property)
C2587213 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C61422 (NCI Thesaurus Property)
C0547044 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Does the patient have poorly controlled diabetes mellitus?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have active infection or chronic infection requiring chronic suppressive antibiotics?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C14141 (NCI Thesaurus ObjectClass)
C0205191 (UMLS 2011AA ObjectClass)
Code List
Does the patient have active infection or chronic infection requiring chronic suppressive antibiotics?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have a nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2, per the CTCAE v4.0?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12438 (NCI Thesaurus Property)
C0927232 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Does the patient have a nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2, per the CTCAE v4.0?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have any conditions that would prohibit administration of corticosteroids?
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2322 (NCI Thesaurus Property)
C0001617 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C53452 (NCI Thesaurus Property)
C0443288 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
Does the patient have any conditions that would prohibit administration of corticosteroids?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have known hypersensitivity reaction to any of the study drugs or excipients, e.g. polysorbate 80 and Cremophor EL?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3114 (NCI Thesaurus Property)
C0020517 (UMLS 2011AA Property)
C1708 (NCI Thesaurus Property)
C0450442 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property)
C0008972 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Does the patient have known hypersensitivity reaction to any of the study drugs or excipients, e.g. polysorbate 80 and Cremophor EL?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have chronic daily treatment with corticosteroids with a dose >= 10 mg/day methylprednisolone equivalent (excluding inhaled steroids)?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C2322 (NCI Thesaurus Property)
C0001617 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Does the patient have chronic daily treatment with corticosteroids with a dose >= 10 mg/day methylprednisolone equivalent (excluding inhaled steroids)?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
Code List
Does the patient have other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have psychiatric or addictive disorders or other condition that, in the opinion of the investigator, would preclude the patient from meeting the study requirements?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C38015 (NCI Thesaurus Property)
Code List
Does the patient have psychiatric or addictive disorders or other condition that, in the opinion of the investigator, would preclude the patient from meeting the study requirements?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Has the patient used any investigational product within the past 30 days?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C15207 (NCI Thesaurus Property)
C28041 (NCI Thesaurus Property)
C1517586 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Has the patient used any investigational product within the past 30 days?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is patient a woman of childbearing potential?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16576 (NCI Thesaurus ObjectClass)
C0015780 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
C0237399 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Is patient a woman of childbearing potential?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Was a pregnancy test performed?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C0032976 (NCI Metathesaurus Property)
Code List
Was a pregnancy test performed?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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)
Item
Is the patient pregnant or lactating at time of study entry?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
Code List
Is the patient pregnant or lactating at time of study entry?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have an ECOG performance status of 0 or 1?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25491 (NCI Thesaurus ObjectClass)
C1512162 (UMLS 2011AA ObjectClass)
CL092952 (NCI Metathesaurus ObjectClass)
Code List
Does the patient have an ECOG performance status of 0 or 1?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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)
Code List
Has the patient had a hysterectomy?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
HysterectomyPerformedDate
Item
Date of Hysterectomy (Please provide surgical report.)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15256 (NCI Thesaurus ObjectClass)
C0020699 (UMLS 2011AA ObjectClass)
Item
Has the patient had any spontaneous menses in the past 12 months?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C3232 (NCI Thesaurus ObjectClass)
C0025344 (UMLS 2011AA ObjectClass)
Code List
Has the patient had any spontaneous menses in the past 12 months?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LastMenstrualCycleOccurrenceDate
Item
Date of last menstrual period (If unsure of the date, please provide a close approximation.)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25551 (NCI Thesaurus ObjectClass)
C1517741 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C16838 (NCI Thesaurus ObjectClass)
C0025329 (UMLS 2011AA ObjectClass)
Item
Has the patient had both ovaries removed?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12404 (NCI Thesaurus ObjectClass)
C0029939 (UMLS 2011AA ObjectClass)
C25650 (NCI Thesaurus Property)
C0849355 (UMLS 2011AA Property)
Code List
Has the patient had both ovaries removed?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
OvaryRemovedDate
Item
Date both (or second) ovaries were removed (Please provide all surgical reports related to oophorectomies. If unsure of the date, please report a close approximation.)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C12404 (NCI Thesaurus ObjectClass)
C0029939 (UMLS 2011AA ObjectClass)
C25650 (NCI Thesaurus Property)
C0849355 (UMLS 2011AA Property)
Item
Has the patient had a documented estradiol level in the postmenopausal range according to local institutional/laboratory standard? (If yes, please provide documentation of estradiol level.)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C15421 (NCI Thesaurus Property)
C0232970 (UMLS 2011AA Property)
C74782 (NCI Thesaurus Property)
C0337434 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
Has the patient had a documented estradiol level in the postmenopausal range according to local institutional/laboratory standard? (If yes, please provide documentation of estradiol level.)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)