ID

7399

Description

NSABP B-45 Worksheet for Postoperative Adjuvant Hormonal Therapy Form Studying Biological Markers of Fatigue in Women With Residual Invasive Breast Cancer Enrolled on Clinical Trial NSABP-B-45 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6461E18A-2098-98F1-E040-BB89AD4303E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6461E18A-2098-98F1-E040-BB89AD4303E7

Keywords

Versions (2)
  1. 8/27/12 8/27/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

January 9, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00914043 On-Study - NSABP B-45 Worksheet for Postoperative Adjuvant Hormonal Therapy Form - 2846464v1.0

English

For women with ER and/or PgR positive tumors, the report should be submitted annually through 6 years on study, even if all postoperative adjuvant hormonal treatment is reported to have ended. If hormonal treatment ends and then resumes at a later date, a new Begin date should be reported for that hormonal agent. (Do not report hormonal therapy that was undertaken to treat breast cancer progression, recurrence, or second primary cancer.)

1 forms  
Header
Description

Header

Patient Initials (Last First Middle)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
NSABP Patient ID
Description

Patient ID NSABP

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1513905
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C15818
Unnamed Module 1
Description

Unnamed Module 1

Report Period
Description

Clinical Trial Period

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2347804
NCI Thesaurus ObjectClass
C25214
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass-2
C25651
Since being entered on study, has the patient received any postoperative adjuvant hormonal treatment? (If yes, continue If no, omit the remaining questions)
Description

PostoperativeAdjuvantHormoneTherapyPostClinicalStudyEnrollmentReceivedInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C28006
UMLS 2011AA ObjectClass
C0032790
NCI Thesaurus ObjectClass-2
C15445
UMLS 2011AA ObjectClass-2
C0279025
NCI Thesaurus ObjectClass-3
C2140
UMLS 2011AA ObjectClass-3
C0001552
NCI Thesaurus Property
C38008
UMLS 2011AA Property
C0687676
NCI Thesaurus Property-2
C25639
UMLS 2011AA Property-2
C1514756
NCI Thesaurus Property-3
C15206
UMLS 2011AA Property-3
C0008972
NCI Thesaurus Property-4
C37948
UMLS 2011AA Property-4
C1516879
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
New Data
Description

New Data

Does this report contain any new data or has any data been changed from the last report?
Description

AmendedDataProtocolSubmissionIndicator

Data type

text

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus ObjectClass-2
C25416
UMLS 2011AA ObjectClass-2
C1691222
NCI Thesaurus Property
C25320
UMLS 2011AA Property
C1507394
NCI Thesaurus Property-2
C25694
UMLS 2011AA Property-2
C1515022
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Unnamed Module 2
Description

Unnamed Module 2

Agent (OTHER HT)
Description

Agent

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
Begin date (MM DD YYYY)
Description

AdjuvantHormoneTherapyBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C2140
UMLS 2011AA ObjectClass-2
C0001552
NCI Thesaurus Property
C25431
UMLS 2011AA Property
C0439659
NCI Thesaurus Property-2
C25275
UMLS 2011AA Property-2
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
End date (MM DD YYYY)
Description

AdjuvantHormoneTherapyEndDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C2140
UMLS 2011AA ObjectClass-2
C0001552
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus Property-2
C25496
UMLS 2011AA Property-2
C2746065
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Aromatase Inhibitor
Description

Aromatase Inhibitor

Agent (OTHER HT)
Description

Agent

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
Begin date (MM DD YYYY)
Description

AdjuvantHormoneTherapyBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C2140
UMLS 2011AA ObjectClass-2
C0001552
NCI Thesaurus Property
C25431
UMLS 2011AA Property
C0439659
NCI Thesaurus Property-2
C25275
UMLS 2011AA Property-2
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
End date (MM DD YYYY)
Description

AdjuvantHormoneTherapyEndDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C2140
UMLS 2011AA ObjectClass-2
C0001552
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus Property-2
C25496
UMLS 2011AA Property-2
C2746065
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Other Ht
Description

Other Ht

Agent (OTHER HT)
Description

Agent

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
Begin date (MM DD YYYY)
Description

AdjuvantHormoneTherapyBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C2140
UMLS 2011AA ObjectClass-2
C0001552
NCI Thesaurus Property
C25431
UMLS 2011AA Property
C0439659
NCI Thesaurus Property-2
C25275
UMLS 2011AA Property-2
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
End date (MM DD YYYY)
Description

AdjuvantHormoneTherapyEndDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C2140
UMLS 2011AA ObjectClass-2
C0001552
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus Property-2
C25496
UMLS 2011AA Property-2
C2746065
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Specify (OTHER HT)
Description

HormoneTherapyOtherReceivedSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property-2
C25639
UMLS 2011AA Property-2
C1514756
Treatment Ended
Description

Treatment Ended

Has all postoperative adjuvant hormonal treatment ended?
Description

PostoperativeAdjuvantHormoneTherapyOffTreatmentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C28006
UMLS 2011AA ObjectClass
C0032790
NCI Thesaurus ObjectClass-2
C15445
UMLS 2011AA ObjectClass-2
C0279025
NCI Thesaurus ObjectClass-3
C2140
UMLS 2011AA ObjectClass-3
C0001552
NCI Thesaurus Property
C25601
UMLS 2011AA Property
C1518544
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Reason Treatment Ended (Last Postoperative Adjuvant HT)
Description

NationalSurgicalAdjuvantBreastandBowelProjectTreatmentNotAdministeredReason

Data type

text

Alias
NCI Thesaurus ObjectClass
C15818
UMLS 2011AA ObjectClass
C1513905
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Other, specify
Description

NationalSurgicalAdjuvantBreastandBowelProjectTherapyNotAdministeredSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C15818
UMLS 2011AA ObjectClass
C1513905
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Footer
Description

Footer

Comments (optional)
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Person Completing Form
Description

Person Completing Form

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date Form Completed (MM DD YYYY)
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
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Similar models

For women with ER and/or PgR positive tumors, the report should be submitted annually through 6 years on study, even if all postoperative adjuvant hormonal treatment is reported to have ended. If hormonal treatment ends and then resumes at a later date, a new Begin date should be reported for that hormonal agent. (Do not report hormonal therapy that was undertaken to treat breast cancer progression, recurrence, or second primary cancer.)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Patient Initials
Item
Patient Initials (Last First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Patient ID NSABP
Item
NSABP Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1513905 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C15818 (NCI Thesaurus Property-2)
Item Group
Unnamed Module 1
Item
Report Period
text
C25284 (NCI Thesaurus ValueDomain)
C2347804 (UMLS CUI-1)
C25214 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus ObjectClass-2)
CL.1
Code List
Report Period
CL Item
12 Months (12 months)
CL Item
24 Months (24 months)
CL Item
36 Months (36 months)
CL Item
48 Months (48 months)
CL Item
60 Months (60 months)
CL Item
72 Months (72 months)
PostoperativeAdjuvantHormoneTherapyPostClinicalStudyEnrollmentReceivedInd-2
Item
Since being entered on study, has the patient received any postoperative adjuvant hormonal treatment? (If yes, continue If no, omit the remaining questions)
boolean
C28006 (NCI Thesaurus ObjectClass)
C0032790 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus ObjectClass-2)
C0279025 (UMLS 2011AA ObjectClass-2)
C2140 (NCI Thesaurus ObjectClass-3)
C0001552 (UMLS 2011AA ObjectClass-3)
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
C25639 (NCI Thesaurus Property-2)
C1514756 (UMLS 2011AA Property-2)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-3)
C37948 (NCI Thesaurus Property-4)
C1516879 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
New Data
Item
Does this report contain any new data or has any data been changed from the last report?
text
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus ObjectClass-2)
C1691222 (UMLS 2011AA ObjectClass-2)
C25320 (NCI Thesaurus Property)
C1507394 (UMLS 2011AA Property)
C25694 (NCI Thesaurus Property-2)
C1515022 (UMLS 2011AA Property-2)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.3
Code List
Does this report contain any new data or has any data been changed from the last report?
CL Item
Yes (1)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (2)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item Group
Unnamed Module 2
Agent
Item
Agent (OTHER HT)
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
AdjuvantHormoneTherapyBeginDate
Item
Begin date (MM DD YYYY)
date
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
AdjuvantHormoneTherapyEndDate
Item
End date (MM DD YYYY)
date
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25496 (NCI Thesaurus Property-2)
C2746065 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Aromatase Inhibitor
Agent
Item
Agent (OTHER HT)
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
AdjuvantHormoneTherapyBeginDate
Item
Begin date (MM DD YYYY)
date
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
AdjuvantHormoneTherapyEndDate
Item
End date (MM DD YYYY)
date
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25496 (NCI Thesaurus Property-2)
C2746065 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Other Ht
Agent
Item
Agent (OTHER HT)
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
AdjuvantHormoneTherapyBeginDate
Item
Begin date (MM DD YYYY)
date
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
AdjuvantHormoneTherapyEndDate
Item
End date (MM DD YYYY)
date
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25496 (NCI Thesaurus Property-2)
C2746065 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
HormoneTherapyOtherReceivedSpecify
Item
Specify (OTHER HT)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property-2)
C1514756 (UMLS 2011AA Property-2)
Item Group
Treatment Ended
PostoperativeAdjuvantHormoneTherapyOffTreatmentInd-2
Item
Has all postoperative adjuvant hormonal treatment ended?
boolean
C28006 (NCI Thesaurus ObjectClass)
C0032790 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus ObjectClass-2)
C0279025 (UMLS 2011AA ObjectClass-2)
C2140 (NCI Thesaurus ObjectClass-3)
C0001552 (UMLS 2011AA ObjectClass-3)
C25601 (NCI Thesaurus Property)
C1518544 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Reason Treatment Ended (Last Postoperative Adjuvant HT)
text
C15818 (NCI Thesaurus ObjectClass)
C1513905 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
CL.5
Code List
Reason Treatment Ended (Last Postoperative Adjuvant HT)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
CL Item
Adverse Event/side Effects/complications (Adverse event/side effects/complications)
CL Item
Patient Withdrawal Or Refusal (Patient withdrawal or refusal)
CL Item
New Lesion (including Second Primary Cancer) Or Other Sign Of Progression (New lesion (including second primary cancer) or other sign of progression)
CL Item
Death (Death)
C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
NationalSurgicalAdjuvantBreastandBowelProjectTherapyNotAdministeredSpecify
Item
Other, specify
text
C15818 (NCI Thesaurus ObjectClass)
C1513905 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item Group
Footer
Research Comments
Item
Comments (optional)
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Person Completing Form
Item
Person Completing Form
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
Date Form Completed (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
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