ID
6527
Description
CALGB 40302 TREATMENT AND RESPONSE SUMMARY FORM (SUBSET OF PATIENTS) Fulvestrant With or Without Lapatinib in Treating Postmenopausal Women With Stage III or Stage IV Breast Cancer That is Hormone Receptor-Positive NCT00390455 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F5BC1727-9755-553F-E034-0003BA3F9857
Link
Keywords
Versions (2)
- 8/26/12 8/26/12 -
- 1/8/15 1/8/15 - Martin Dugas
Uploaded on
January 8, 2015
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License
Creative Commons BY-NC 3.0 Legacy
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TREATMENT AND RESPONSE SUMMARY FORM Breast Cancer (NCT00390455)
INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink.
- StudyEvent: CALGB 40302 TREATMENT AND RESPONSE SUMMARY FORM (SUBSET OF PATIENTS)
Description
Lapatinib/placebo
Description
Cycle Number Chemotherapeutics
Data type
text
Alias
- NCI Thesaurus ValueDomain
- C25337
- UMLS CUI-1
- C2045829
- NCI Thesaurus Property
- C25471
- NCI Thesaurus ObjectClass
- C15368
- NCI Thesaurus Property-2
- C25379
Description
Chemotherapy Cycle Start Date
Data type
date
Alias
- NCI Thesaurus ValueDomain
- C25164
- UMLS CUI-1
- C1302181
- NCI Thesaurus ObjectClass
- C15368
- NCI Thesaurus ValueDomain-2
- C25431
- UMLS CUI-2
- C3173309
- NCI Thesaurus Property
- C25379
Description
Chemotherapy Cycle End Date
Data type
date
Alias
- NCI Thesaurus ValueDomain
- C25164
- UMLS CUI-1
- C1302181
- NCI Thesaurus ObjectClass
- C15368
- NCI Thesaurus Property
- C25379
- UMLS CUI-2
- C0806020
Description
PillsReceivedCount
Data type
text
Alias
- NCI Thesaurus Property
- C25639
- UMLS 2011AA Property
- C1514756
- NCI Thesaurus ValueDomain
- C25463
- UMLS 2011AA ValueDomain
- C0750480
- NCI Thesaurus ObjectClass
- C25394
- UMLS 2011AA ObjectClass
- C0994475
Description
Agent dose prescribed
Data type
float
Alias
- NCI Thesaurus ObjectClass
- C28180
- UMLS CUI-1
- C0678766
- NCI Thesaurus ObjectClass-2
- C1708
- UMLS CUI-2
- C0278329
- NCI Thesaurus Property
- C25256
- NCI Thesaurus ValueDomain
- C25488
- NCI Thesaurus ValueDomain-2
- C1708
Description
PillsRemainingCount
Data type
float
Alias
- NCI Thesaurus ValueDomain
- C25463
- UMLS 2011AA ValueDomain
- C0750480
- NCI Thesaurus ObjectClass
- C25394
- UMLS 2011AA ObjectClass
- C0994475
- NCI Thesaurus Property
- C25649
- UMLS 2011AA Property
- C1527428
Description
AgentActualDose
Data type
float
Alias
- NCI Thesaurus ValueDomain
- C25337
- UMLS 2011AA ValueDomain
- C0237753
- NCI Thesaurus ObjectClass
- C25488
- UMLS 2011AA ObjectClass
- C0178602
- NCI Thesaurus ObjectClass-2
- C25274
- UMLS 2011AA ObjectClass-2
- C0237400
- NCI Thesaurus Property
- C25382
- UMLS 2011AA Property
- C1521801
Description
Dose Modification
Data type
text
Alias
- NCI Thesaurus ValueDomain
- C25180
- UMLS CUI-1
- C1707811
- NCI Thesaurus ObjectClass
- C25256
- NCI Thesaurus Property
- C25572
- NCI Thesaurus ValueDomain-2
- C25572
Description
DoseModificationAmount
Data type
float
Alias
- NCI Thesaurus ObjectClass
- C25488
- UMLS 2011AA ObjectClass
- C0178602
- NCI Thesaurus ValueDomain
- C25417
- NCI Thesaurus Property
- C25572
Description
PlannedDoseModificationSpecify
Data type
text
Alias
- NCI Thesaurus ValueDomain
- C25685
- UMLS 2011AA ValueDomain
- C1521902
- NCI Thesaurus ObjectClass
- C25619
- UMLS 2011AA ObjectClass
- C1301732
- NCI Thesaurus ObjectClass-2
- C25488
- UMLS 2011AA ObjectClass-2
- C0178602
- NCI Thesaurus Property
- C25572
Description
DoseDelayedInd-3
Data type
boolean
Alias
- NCI Thesaurus ValueDomain
- C38148
- UMLS 2011AA ValueDomain
- C1512699
- NCI Thesaurus Property
- C25477
- NCI Thesaurus ObjectClass
- C25488
- UMLS 2011AA ObjectClass
- C0178602
Description
Treatment delay duration
Data type
float
Alias
- NCI Thesaurus ValueDomain
- C25301
- UMLS CUI-1
- C0087111
- NCI Thesaurus ObjectClass
- C15368
- NCI Thesaurus ValueDomain-2
- C25463
- UMLS CUI-2
- C2985752
- NCI Thesaurus Property
- C25476
Description
BladderTreatmentDelayedCycleReason
Data type
text
Alias
- NCI Thesaurus ObjectClass
- C12414
- UMLS 2011AA ObjectClass
- C0005682
- NCI Thesaurus ObjectClass-2
- C15368
- NCI Thesaurus Property
- C25477
- NCI Thesaurus Property-2
- C25472
- UMLS 2011AA Property
- C1511572
- NCI Thesaurus ValueDomain
- C25638
- UMLS 2011AA ValueDomain
- C0392360
Description
Fluvestrant
Description
FulvestrantAgentFirstDayAdministeredDose
Data type
float
Alias
- NCI Thesaurus ObjectClass
- C1379
- UMLS 2011AA ObjectClass
- C0701491
- NCI Thesaurus ObjectClass-2
- C1708
- UMLS 2011AA ObjectClass-2
- C0450442
- NCI Thesaurus Property
- C25301
- UMLS 2011AA Property
- C0439228
- NCI Thesaurus Property-2
- C25509
- UMLS 2011AA Property-2
- C1279901
- NCI Thesaurus Property-3
- C25382
- UMLS 2011AA Property-3
- C1521801
- NCI Thesaurus ValueDomain
- C25488
- UMLS 2011AA ValueDomain
- C0178602
Description
FulvestrantAgentFirstCourseAdministeredDose
Data type
float
Alias
- NCI Thesaurus ObjectClass
- C1379
- UMLS 2011AA ObjectClass
- C0701491
- NCI Thesaurus ObjectClass-2
- C1708
- UMLS 2011AA ObjectClass-2
- C0450442
- NCI Thesaurus Property
- C25509
- UMLS 2011AA Property
- C1279901
- NCI Thesaurus Property-2
- C25379
- UMLS 2011AA Property-2
- C0750729
- NCI Thesaurus Property-3
- C25382
- UMLS 2011AA Property-3
- C1521801
- NCI Thesaurus ValueDomain
- C25488
- UMLS 2011AA ValueDomain
- C0178602
Description
TreatmentDelayedReasonText
Data type
text
Alias
- NCI Thesaurus ValueDomain
- C25704
- UMLS 2011AA ValueDomain
- C1527021
- NCI Thesaurus ObjectClass
- C15368
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Description
Laboratory Values
Description
HeartLVEFTestPercentageValue
Data type
float
Measurement units
- %
Alias
- NCI Thesaurus ObjectClass
- C12727
- UMLS 2011AA ObjectClass
- C0018787
- NCI Thesaurus Property
- C25294
- UMLS 2011AA Property
- C0022885
- NCI Thesaurus Property-2
- C37946
- UMLS 2011AA Property-2
- C2700377
- NCI Thesaurus ValueDomain
- C25613
- UMLS 2011AA ValueDomain
- C0439165
- NCI Thesaurus ValueDomain-2
- C25712
- UMLS 2011AA ValueDomain-2
- C1522609
Description
INR
Data type
float
Alias
- NCI Thesaurus Property
- C20200
- UMLS CUI-1
- C0525032
- NCI Thesaurus ObjectClass
- C25294
- NCI Thesaurus Property-2
- C25352
- NCI Thesaurus ValueDomain
- C25712
Description
LaboratoryProcedureGranulocyteResultCount
Data type
float
Measurement units
- 1000/uL
Alias
- NCI Thesaurus Property
- C20200
- UMLS 2011AA Property
- C1274040
- NCI Thesaurus Property-2
- C12530
- UMLS 2011AA Property-2
- C0018183
- NCI Thesaurus ValueDomain
- C25463
- UMLS 2011AA ValueDomain
- C0750480
- NCI Thesaurus ObjectClass
- C25294
- UMLS 2011AA ObjectClass
- C0022885
Description
HematologyPlateletLabUnspecifiedValue
Data type
float
Alias
- NCI Thesaurus Property
- C20200
- UMLS 2011AA Property
- C1274040
- NCI Thesaurus ObjectClass
- C25294
- UMLS 2011AA ObjectClass
- C0022885
Description
RenalCreatinineLabSpecifiedValue
Data type
float
Measurement units
- mg/dL
Alias
- NCI Thesaurus ObjectClass
- C25225
- UMLS 2011AA ObjectClass
- C0022646
- NCI Thesaurus Property
- C399
- UMLS 2011AA Property
- C0010294
- NCI Thesaurus Property-2
- C25294
- UMLS 2011AA Property-2
- C0022885
- NCI Thesaurus ValueDomain
- C25712
- UMLS 2011AA ValueDomain
- C1522609
Description
HepaticBilirubinLabValue
Data type
float
Measurement units
- mg/dL
Alias
- NCI Thesaurus Property
- C20200
- UMLS 2011AA Property
- C1274040
- NCI Thesaurus Property-2
- C305
- UMLS 2011AA Property-2
- C0005437
- NCI Thesaurus ObjectClass
- C25294
- UMLS 2011AA ObjectClass
- C0022885
- NCI Thesaurus ValueDomain
- C25712
- UMLS 2011AA ValueDomain
- C1522609
Description
HepaticSGOT(AST)LabUnspecifiedValue
Data type
float
Alias
- NCI Thesaurus ObjectClass
- C13308
- UMLS 2011AA ObjectClass
- C0205054
- NCI Thesaurus Property
- C25202
- UMLS 2011AA Property
- C0242192
- NCI Thesaurus Property-2
- C37984
- UMLS 2011AA Property-2
- C0022877
- NCI Thesaurus ValueDomain
- C38046
- UMLS 2011AA ValueDomain
- C0205370
- NCI Thesaurus ValueDomain-2
- C25712
- UMLS 2011AA ValueDomain-2
- C1522609
Description
HepaticSGPT(ALT)LabUnspecifiedValue
Data type
float
Alias
- NCI Thesaurus ObjectClass
- C13308
- UMLS 2011AA ObjectClass
- C0205054
- NCI Thesaurus Property
- C37984
- UMLS 2011AA Property
- C0022877
- NCI Thesaurus Property-2
- C25293
- UMLS 2011AA Property-2
- C0376147
- NCI Thesaurus ValueDomain
- C38046
- UMLS 2011AA ValueDomain
- C0205370
- NCI Thesaurus ValueDomain-2
- C25712
- UMLS 2011AA ValueDomain-2
- C1522609
Description
Response Assessment
Description
TumorResponseInd-3
Data type
boolean
Alias
- NCI Thesaurus ValueDomain
- C38148
- UMLS 2011AA ValueDomain
- C1512699
- NCI Thesaurus ObjectClass
- C3262
- UMLS 2011AA ObjectClass
- C0027651
- NCI Thesaurus Property
- C25755
- UMLS 2011AA Property
- C0871261
- NCI Thesaurus ValueDomain-2
- C25755
- UMLS 2011AA ValueDomain-2
- C0871261
Description
Partial Response First Observed Date
Data type
date
Alias
- NCI Thesaurus ObjectClass
- C25755
- UMLS CUI-1
- C1521726
- NCI Thesaurus ObjectClass-2
- C25378
- UMLS CUI-2
- C1115465
- NCI Thesaurus Property
- C25509
- NCI Thesaurus Property-2
- C25599
- NCI Thesaurus ValueDomain
- C25164
- NCI Thesaurus ValueDomain-2
- C25367
Description
Complete Response First Observed Date
Data type
date
Alias
- NCI Thesaurus ObjectClass
- C25755
- UMLS CUI-1
- C0677874
- NCI Thesaurus ObjectClass-2
- C25250
- UMLS CUI-2
- C1115465
- NCI Thesaurus Property
- C25509
- NCI Thesaurus Property-2
- C25599
- NCI Thesaurus ValueDomain
- C25164
- NCI Thesaurus ValueDomain-2
- C25367
Description
DiseaseNewProgressionInd-2
Data type
boolean
Alias
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
- NCI Thesaurus Property
- C25586
- UMLS 2011AA Property
- C0205314
- NCI Thesaurus Property-2
- C25331
- NCI Thesaurus ObjectClass
- C2991
- UMLS 2011AA ObjectClass
- C0012634
Description
SpecimenNotSubmittedSpecify
Data type
text
Alias
- NCI Thesaurus ValueDomain
- C25685
- UMLS 2011AA ValueDomain
- C1521902
- NCI Thesaurus Property
- C25594
- UMLS 2011AA Property
- C1518422
- NCI Thesaurus ObjectClass
- C19157
- UMLS 2011AA ObjectClass
- C0370003
- NCI Thesaurus Property-2
- C25695
- UMLS 2011AA Property-2
- C1515023
Description
ResponseLastDocumentedDate
Data type
date
Alias
- NCI Thesaurus ObjectClass
- C25755
- UMLS 2011AA ObjectClass
- C0871261
- NCI Thesaurus Property
- C25551
- UMLS 2011AA Property
- C1517741
- NCI Thesaurus Property-2
- C25356
- UMLS 2011AA Property-2
- C1301725
- NCI Thesaurus ValueDomain
- C25164
- UMLS 2011AA ValueDomain
- C0011008
- NCI Thesaurus ValueDomain-2
- C25367
Description
Yes,specify
Data type
text
Description
ProgressionFirstObservedDate
Data type
date
Alias
- NCI Thesaurus ObjectClass
- C25331
- NCI Thesaurus Property
- C25509
- UMLS 2011AA Property
- C1279901
- NCI Thesaurus Property-2
- C25599
- UMLS 2011AA Property-2
- C1441672
- NCI Thesaurus ValueDomain
- C25164
- UMLS 2011AA ValueDomain
- C0011008
- NCI Thesaurus ValueDomain-2
- C25367
Description
ProgressionCriteriaType
Data type
text
Alias
- NCI Thesaurus ValueDomain
- C25284
- UMLS 2011AA ValueDomain
- C0332307
- NCI Thesaurus ObjectClass
- C25331
- NCI Thesaurus Property
- C25466
- UMLS 2011AA Property
- C0243161
Description
ProgressionAssessmentSpecify
Data type
text
Alias
- NCI Thesaurus ValueDomain
- C25685
- UMLS 2011AA ValueDomain
- C1521902
- NCI Thesaurus Property
- C20989
- UMLS 2011AA Property
- C0031809
- NCI Thesaurus ObjectClass
- C25331
Description
Person Completing Form
Data type
text
Alias
- NCI Thesaurus ValueDomain
- C25191
- UMLS CUI-1
- C1550483
- NCI Thesaurus ObjectClass
- C25657
- NCI Thesaurus Property
- C25364
Description
Date Form Completed
Data type
date
Alias
- NCI Thesaurus ValueDomain
- C25164
- UMLS CUI-1
- C1115437
- NCI Thesaurus ObjectClass
- C40988
- NCI Thesaurus Property
- C25250
- NCI Thesaurus ValueDomain-2
- C25367
Similar models
INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink.
- StudyEvent: CALGB 40302 TREATMENT AND RESPONSE SUMMARY FORM (SUBSET OF PATIENTS)
C3262252 (UMLS CUI-1)
C19464 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus ObjectClass-2)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
C0421459 (UMLS CUI-1)
C16960 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
C16696 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
C3694716 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C25365 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
C2045829 (UMLS CUI-1)
C25471 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property-2)
C1302181 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus ValueDomain-2)
C3173309 (UMLS CUI-2)
C25379 (NCI Thesaurus Property)
C1302181 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
C0806020 (UMLS CUI-2)
C1514756 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25394 (NCI Thesaurus ObjectClass)
C0994475 (UMLS 2011AA ObjectClass)
C0678766 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass-2)
C0278329 (UMLS CUI-2)
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C25649 (NCI Thesaurus Property)
C1527428 (UMLS 2011AA Property)
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C0178602 (UMLS 2011AA ObjectClass)
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C25488 (NCI Thesaurus ObjectClass-2)
C0178602 (UMLS 2011AA ObjectClass-2)
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C0178602 (UMLS 2011AA ObjectClass)
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C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C0205054 (UMLS 2011AA ObjectClass)
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C0022877 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property-2)
C0376147 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C1512699 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C25755 (NCI Thesaurus ValueDomain-2)
C0871261 (UMLS 2011AA ValueDomain-2)
C1521726 (UMLS CUI-1)
C25378 (NCI Thesaurus ObjectClass-2)
C1115465 (UMLS CUI-2)
C25509 (NCI Thesaurus Property)
C25599 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C0677874 (UMLS CUI-1)
C25250 (NCI Thesaurus ObjectClass-2)
C1115465 (UMLS CUI-2)
C25509 (NCI Thesaurus Property)
C25599 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C1512698 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C25331 (NCI Thesaurus Property-2)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C1521902 (UMLS 2011AA ValueDomain)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25695 (NCI Thesaurus Property-2)
C1515023 (UMLS 2011AA Property-2)
C0871261 (UMLS 2011AA ObjectClass)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
C25356 (NCI Thesaurus Property-2)
C1301725 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25599 (NCI Thesaurus Property-2)
C1441672 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C0332307 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus ObjectClass)
C25466 (NCI Thesaurus Property)
C0243161 (UMLS 2011AA Property)
C1521902 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25331 (NCI Thesaurus ObjectClass)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)