ID

23297

Description

RTOG 1115 QF: Phase III RT + Standard ADT vs RT + Enhanced ADT + TAK-700 EQ-5D Form Hormone Therapy, Radiation Therapy, and Steroid 17alpha-monooxygenase TAK-700 in Treating Patients With High-Risk Prostate Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AE8F0868-7FC2-FEC9-E040-BB89AD4357E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AE8F0868-7FC2-FEC9-E040-BB89AD4357E7

Keywords

  1. 7/2/17 7/2/17 -
Uploaded on

July 2, 2017

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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RTOG 1115 QF: Phase III RT + Standard ADT vs RT + Enhanced ADT + TAK-700 EQ-5D Form

INSTRUCTIONS: This page must be completed by the medical staff (nurse, data manager, physician, etc.) Questionnaires for all time points are required even if submission time points deviate from the specified intervals. Only patient death or documented patient refusal will be an acceptable reason for omission of the QOL questionnaires. However, this page must be completed and submitted for every time point on the calendar regardless of whether the QOL questionnaire was completed. Every effort possible should be made to collect the data on time

Unnamed Module 1
Description

Unnamed Module 1

RTOG Study No.
Description

Protocol ID RTOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1514695
NCI Thesaurus Property
C19778
NCI Thesaurus Property-2
C25364
Case #
Description

RadiationTherapyOncologyGroupPatientCaseIdentifierNumber

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C19778
UMLS 2011AA ObjectClass-2
C1514695
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C49152
UMLS 2011AA Property-2
C1706256
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
Institution Name
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Institution No.
Description

Institution Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
UMLS CUI-2
C0805701
NCI Thesaurus Property
C25364
Patient Initials
Description

Patient Initials

Data type

text

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

Trial subject ID RTOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1514695
NCI Thesaurus Property
C19778
NCI Thesaurus Property-2
C25364
Amended data
Description

Data amended

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Unamed Module 2
Description

Unamed Module 2

Time point
Description

AssessmentPeriodType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
Other specify
Description

AssessmentPeriodSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
Did the patient complete any items on the questionnaire?
Description

PatientQuestionnaireCompleteInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property-2
C17048
UMLS 2011AA Property-2
C0034394
Date Questionnaire Completed
Description

QualityofLifeCompleteAssessmentDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C17047
UMLS 2011AA ObjectClass
C0518214
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property-2
C25367
Reason Questionnaire was not Completed
Description

Incomplete documentation, reason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1548386
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C0566251
NCI Metathesaurus Property
C0034394
Patient refused for other reason, specify
Description

PatientRefuseIncompleteQuestionnaireSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Metathesaurus Property
C0034394
NCI Thesaurus Property
C49160
UMLS 2011AA Property
C0205257
NCI Thesaurus Property-2
C49161
UMLS 2011AA Property-2
C1705116
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Other reason, specify
Description

PatientIncompleteQuestionnaireOtherSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ValueDomain-2
C17649
UMLS 2011AA ValueDomain-2
C0205394
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Metathesaurus Property
C0034394
Did the patient require any assistance in completing the questionnaire?
Description

PatientQuestionnaireAssistanceInd

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17048
UMLS 2011AA Property
C0034394
NCI Metathesaurus Property
C0018896
Extent of assistance given
Description

PatientQuestionnaireAssistanceType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17048
UMLS 2011AA Property
C0034394
NCI Metathesaurus Property
C0018896
Combination of above, specify
Description

PatientQuestionnaireAssistanceCombinedSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17048
UMLS 2011AA Property
C0034394
NCI Metathesaurus Property
C0018896
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ValueDomain-2
C25454
UMLS 2011AA ValueDomain-2
C0205195
Other, specify
Description

PatientQuestionnaireAssistanceOtherSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17048
UMLS 2011AA Property
C0034394
NCI Metathesaurus Property
C0018896
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ValueDomain-2
C17649
UMLS 2011AA ValueDomain-2
C0205394
Specify the person who assisted the patient
Description

PatientQuestionnaireAssistancePersonCategory

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17048
UMLS 2011AA Property
C0034394
NCI Metathesaurus Property
C0018896
NCI Thesaurus ValueDomain
C25190
UMLS 2011AA ValueDomain
C0027361
NCI Thesaurus ValueDomain-2
C25372
UMLS 2011AA ValueDomain-2
C0683312
Specify method of completion
Description

PatientQuestionnaireCompleteMethodofCollectionType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property-2
C17048
UMLS 2011AA Property-2
C0034394
Your own health state today
Description

PatientHealthScore

Data type

float

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25178
UMLS 2011AA Property
C0018684
NCI Thesaurus ValueDomain
C25338
UMLS 2011AA ValueDomain
C0449820
Comments
Description

Research Comments

Data type

text

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

Responsible Person Signature

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus ObjectClass-2
C25657
NCI Thesaurus Property
C25678
Date Form Originally Completed
Description

Form Completion Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C19464
UMLS CUI-1
C1549507
NCI Thesaurus Property
C25250
NCI Thesaurus Property-2
C25604
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Unamed Module 2
Description

Unamed Module 2

EQ-5D Questionnaire
Description

EQ-5D Questionnaire

Data type

text

Alias
UMLS CUI [1]
C2733251
Your Own Health State Today
Description

Your Own Health State Today

Your own health state today
Description

PatientHealthScore

Data type

float

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25178
UMLS 2011AA Property
C0018684
NCI Thesaurus ValueDomain
C25338
UMLS 2011AA ValueDomain
C0449820

Similar models

INSTRUCTIONS: This page must be completed by the medical staff (nurse, data manager, physician, etc.) Questionnaires for all time points are required even if submission time points deviate from the specified intervals. Only patient death or documented patient refusal will be an acceptable reason for omission of the QOL questionnaires. However, this page must be completed and submitted for every time point on the calendar regardless of whether the QOL questionnaire was completed. Every effort possible should be made to collect the data on time

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Unnamed Module 1
Protocol ID RTOG
Item
RTOG Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1514695 (UMLS CUI-2)
C19778 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
RadiationTherapyOncologyGroupPatientCaseIdentifierNumber
Item
Case #
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19778 (NCI Thesaurus ObjectClass-2)
C1514695 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C49152 (NCI Thesaurus Property-2)
C1706256 (UMLS 2011AA Property-2)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
Institution Name
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Institution Number
Item
Institution No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Trial subject ID RTOG
Item
RTOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1514695 (UMLS CUI-2)
C19778 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Data amended
Item
Amended data
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Unamed Module 2
Item
Time point
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
Code List
Time point
CL Item
Baseline (baseline)
C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)
CL Item
Pretreatment (Pretreatment)
CL Item
Last Week Of Radiation Therapy (Last week of RT)
CL Item
12 Months From Start Of Treatment (12 months from start of treatment)
CL Item
30 Months From Start Of Treatment (30 months from start of treatment)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
AssessmentPeriodSpecify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
PatientQuestionnaireCompleteInd-2
Item
Did the patient complete any items on the questionnaire?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C17048 (NCI Thesaurus Property-2)
C0034394 (UMLS 2011AA Property-2)
QualityofLifeCompleteAssessmentDate
Item
Date Questionnaire Completed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ObjectClass)
C0518214 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus Property-2)
Item
Reason Questionnaire was not Completed
text
C25638 (NCI Thesaurus ValueDomain)
C1548386 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C0034394 (NCI Metathesaurus Property)
Code List
Reason Questionnaire was not Completed
CL Item
Not Applicable, Questionnaire Was Completed (Not applicable, questionnaire was completed)
CL Item
Patient Refused Due To Illness (Patient refused due to illness)
CL Item
Patient Refused For Other Reason (Patient refused for other reason)
CL Item
Patient Unable To Be Contacted (Patient unable to be contacted)
CL Item
Institution Error (Institutional error)
CL Item
Tool Not Availalble In Patient's Language (Tool not available in patient's language)
CL Item
Other Reason (Other reason)
PatientRefuseIncompleteQuestionnaireSpecify
Item
Patient refused for other reason, specify
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C0034394 (NCI Metathesaurus Property)
C49160 (NCI Thesaurus Property)
C0205257 (UMLS 2011AA Property)
C49161 (NCI Thesaurus Property-2)
C1705116 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
PatientIncompleteQuestionnaireOtherSpecify
Item
Other reason, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus ValueDomain-2)
C0205394 (UMLS 2011AA ValueDomain-2)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C0034394 (NCI Metathesaurus Property)
Item
Did the patient require any assistance in completing the questionnaire?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17048 (NCI Thesaurus Property)
C0034394 (UMLS 2011AA Property)
C0018896 (NCI Metathesaurus Property)
Code List
Did the patient require any assistance in completing the questionnaire?
CL Item
Not Applicable (Not applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown If Assistance Given (Unknown if assistance given)
Item
Extent of assistance given
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17048 (NCI Thesaurus Property)
C0034394 (UMLS 2011AA Property)
C0018896 (NCI Metathesaurus Property)
Code List
Extent of assistance given
CL Item
Not Applicable (Not applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
CL Item
Read Items To Patient (Read items to patient)
CL Item
Interpreted Items For Patient (Interpreted items for patient)
CL Item
Marked Items Per Patient's Response (Marked items per patient's response)
CL Item
Combination Of Above (Combination of above)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
PatientQuestionnaireAssistanceCombinedSpecify
Item
Combination of above, specify
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17048 (NCI Thesaurus Property)
C0034394 (UMLS 2011AA Property)
C0018896 (NCI Metathesaurus Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25454 (NCI Thesaurus ValueDomain-2)
C0205195 (UMLS 2011AA ValueDomain-2)
PatientQuestionnaireAssistanceOtherSpecify
Item
Other, specify
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17048 (NCI Thesaurus Property)
C0034394 (UMLS 2011AA Property)
C0018896 (NCI Metathesaurus Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus ValueDomain-2)
C0205394 (UMLS 2011AA ValueDomain-2)
Item
Specify the person who assisted the patient
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17048 (NCI Thesaurus Property)
C0034394 (UMLS 2011AA Property)
C0018896 (NCI Metathesaurus Property)
C25190 (NCI Thesaurus ValueDomain)
C0027361 (UMLS 2011AA ValueDomain)
C25372 (NCI Thesaurus ValueDomain-2)
C0683312 (UMLS 2011AA ValueDomain-2)
Code List
Specify the person who assisted the patient
CL Item
Not Applicable (Not applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
CL Item
Staff Member (Staff member)
CL Item
Family (Family)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Unknown (Unknown)
Item
Specify method of completion
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C17048 (NCI Thesaurus Property-2)
C0034394 (UMLS 2011AA Property-2)
Code List
Specify method of completion
CL Item
At Appointment (At appointment)
CL Item
By Mail (By mail)
CL Item
By Telephone (By telephone)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
PatientHealthScore
Item
Your own health state today
float
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25178 (NCI Thesaurus Property)
C0018684 (UMLS 2011AA Property)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Responsible Person Signature
Item
Signature of Person Completing This Form
text
C25704 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C25657 (NCI Thesaurus ObjectClass-2)
C25678 (NCI Thesaurus Property)
Form Completion Date
Item
Date Form Originally Completed
date
C19464 (NCI Thesaurus ObjectClass)
C1549507 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C25604 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Unamed Module 2
EQ-5D Questionnaire
Item
EQ-5D Questionnaire
text
C2733251 (UMLS CUI [1])
Item Group
Your Own Health State Today
PatientHealthScore
Item
Your own health state today
float
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25178 (NCI Thesaurus Property)
C0018684 (UMLS 2011AA Property)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)

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