ID

10791

Description

E3805 Assessment Compliance Form (Form No. 2443) NCT00309985 Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=04B03C24-3EEB-4047-E044-0003BA3F9857

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=04B03C24-3EEB-4047-E044-0003BA3F9857

Mots-clés

Versions (3)
  1. 19/09/2012 19/09/2012 -
  2. 08/01/2015 08/01/2015 - Martin Dugas
  3. 08/06/2015 08/06/2015 -
Téléchargé le

8 juin 2015

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy
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E3805 Assessment Compliance Form (Form No. 2443) NCT00309985

Anglais

INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of registration. Keep a copy for your files.

1 Formulaires  
Header
Description

Header

ECOG Protocol Number
Description

Protocol Number ECOG

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Patient ID
Description

Patient ID ECOG

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
DCI Name
Description

Generic drug form

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C3242750
NCI Thesaurus Property
C19464
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus ObjectClass-2
C25452
Registration Step
Description

Registration Number

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
Patient demographics
Description

Patient demographics

ECOG Protocol Number
Description

Protocol Number ECOG

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Patient ID
Description

Patient ID ECOG

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
Patient Initials
Description

Patient Initials

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Participating Group Protocol Number
Description

Study Number Participating Group

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Institution/Affiliate
Description

Institution Name

Type de données

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Participating Group Patient ID
Description

Trial subject ID Participating Group

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Data amendment
Description

Data amendment

Please mark an 'X' if data have been amended.
Description

Data amended

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Date data amended
Description

Data amended date

Type de données

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
UMLS CUI-2
C0011008
NCI Thesaurus Property
C25416
NCI Thesaurus ValueDomain-2
C25367
Baseline
Description

Baseline

Reporting Period (Choose one x)
Description

Clinical Trial Period

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2347804
NCI Thesaurus ObjectClass
C25214
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass-2
C25651
On Treatment
Description

On Treatment

On Treatment Report Period (Arm A since start of treatment)
Description

Cycle number

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2045829
NCI Thesaurus Property
C25214
NCI Thesaurus Property-2
C25616
NCI Thesaurus ObjectClass
C15368
Off Treatment
Description

Off Treatment

Off Treatment Report Period (since registration Choose one x)
Description

PersonOff-TreatmentTimePeriodType

Type de données

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25601
UMLS 2011AA Property-2
C1518544
NCI Thesaurus Property-3
C25207
UMLS 2011AA Property-3
C0040223
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Section I
Description

Section I

Assessment Date
Description

AssessmentDate

Type de données

date

Section Ii - Assessments Not Completed
Description

Section Ii - Assessments Not Completed

Were all the quality of life forms completed for this timepoint
Description

Quality-of-LifeAssessmentReportPeriodCompleteInd-2

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property-2
C25616
UMLS 2011AA Property-2
C1948053
NCI Thesaurus Property-3
C25375
UMLS 2011AA Property-3
C0684224
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Section Ii - Assessments Not Completed
Description

Section Ii - Assessments Not Completed

Patient refusal
Description

Quality-of-LifeAssessmentPatientRefuseIncompleteInd-2

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
NCI Thesaurus Property
C16960
UMLS 2011AA Property
C0030705
NCI Thesaurus Property-2
C49160
UMLS 2011AA Property-2
C0205257
NCI Thesaurus Property-3
C49161
UMLS 2011AA Property-3
C1705116
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Unable to accomodate disability or language needs
Description

Quality-of-LifeAssessmentPatientDisabilityIncompleteInd-2

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
NCI Thesaurus Property
C16960
UMLS 2011AA Property
C0030705
NCI Thesaurus Property-2
C49160
UMLS 2011AA Property-2
C0205257
NCI Thesaurus Property-3
C21007
UMLS 2011AA Property-3
C0231170
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Specify disability or language
Description

Quality-of-LifeAssessmentPatientDisabilityIncompleteSpecify

Type de données

text

Alias
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
NCI Thesaurus Property
C16960
UMLS 2011AA Property
C0030705
NCI Thesaurus Property-2
C49160
UMLS 2011AA Property-2
C0205257
NCI Thesaurus Property-3
C21007
UMLS 2011AA Property-3
C0231170
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Patient did not show up in clinic/office
Description

Quality-of-LifeAssessmentPatientAbsentIncompleteInd-2

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
NCI Thesaurus Property
C16960
UMLS 2011AA Property
C0030705
NCI Thesaurus Property-2
C49160
UMLS 2011AA Property-2
C0205257
NCI Thesaurus Property-3
C48190
UMLS 2011AA Property-3
C0332197
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Specify reason patient did not show up
Description

Quality-of-LifeAssessmentPatientAbsentIncompleteSpecify

Type de données

text

Alias
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
NCI Thesaurus Property
C16960
UMLS 2011AA Property
C0030705
NCI Thesaurus Property-2
C49160
UMLS 2011AA Property-2
C0205257
NCI Thesaurus Property-3
C48190
UMLS 2011AA Property-3
C0332197
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Staff unavailable
Description

Quality-of-LifeAssessmentMedicalStaffUnavailableIncompleteInd-2

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
NCI Thesaurus Property
C49160
UMLS 2011AA Property
C0205257
NCI Thesaurus Property-2
C25594
UMLS 2011AA Property-2
C1518422
NCI Thesaurus Property-3
C25429
UMLS 2011AA Property-3
C0470187
NCI Metathesaurus Property
C0025106
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient not given form by staff
Description

Quality-of-LifeAssessmentPatientNotAdministeredIncompleteInd-2

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
NCI Thesaurus Property
C16960
UMLS 2011AA Property
C0030705
NCI Thesaurus Property-2
C49160
UMLS 2011AA Property-2
C0205257
NCI Thesaurus Property-3
C25594
UMLS 2011AA Property-3
C1518422
NCI Thesaurus Property-4
C25382
UMLS 2011AA Property-4
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient too ill
Description

Quality-of-LifeAssessmentPatientSicknessIncompleteInd-2

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
NCI Thesaurus Property
C16960
UMLS 2011AA Property
C0030705
NCI Thesaurus Property-2
C49160
UMLS 2011AA Property-2
C0205257
NCI Metathesaurus Property
C0221423
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient expired
Description

Quality-of-LifeAssessmentPatientDeathIncompleteInd-2

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
NCI Thesaurus Property
C16960
UMLS 2011AA Property
C0030705
NCI Thesaurus Property-2
C49160
UMLS 2011AA Property-2
C0205257
NCI Thesaurus Property-3
C28554
UMLS 2011AA Property-3
C0011065
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Assessment not required per protocol
Description

Quality-of-LifeAssessmentNotRequiredIncompleteInd-2

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
NCI Thesaurus Property
C49160
UMLS 2011AA Property
C0205257
NCI Thesaurus Property-2
C25594
UMLS 2011AA Property-2
C1518422
NCI Thesaurus Property-3
C25652
UMLS 2011AA Property-3
C1514873
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Specify reason assessment is not required
Description

Quality-of-LifeAssessmentNotRequiredIncompleteSpecify

Type de données

text

Alias
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
NCI Thesaurus Property
C49160
UMLS 2011AA Property
C0205257
NCI Thesaurus Property-2
C25594
UMLS 2011AA Property-2
C1518422
NCI Thesaurus Property-3
C25652
UMLS 2011AA Property-3
C1514873
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Staff thought patient too ill
Description

Quality-of-LifeAssessmentMedicalStaffPatientSicknessIncompleteInd-2

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
NCI Thesaurus Property
C16960
UMLS 2011AA Property
C0030705
NCI Thesaurus Property-2
C49160
UMLS 2011AA Property-2
C0205257
NCI Metathesaurus Property
C0221423
NCI Metathesaurus Property-2
C0025106
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Other
Description

Quality-of-LifeAssessmentOtherIncompleteInd-2

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C49160
UMLS 2011AA Property-2
C0205257
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
Specify other reason
Description

Quality-of-LifeAssessmentOtherIncompleteSpecify

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C49160
UMLS 2011AA Property-2
C0205257
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
Section Iii - Assessment Completed
Description

Section Iii - Assessment Completed

How Was The Patient Assisted
Description

How Was The Patient Assisted

Were the questions read aloud to patient
Description

Quality-of-LifeAssessmentSpeechAssistanceInd-2

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Metathesaurus Property
C0018896
NCI Thesaurus Property
C38025
UMLS 2011AA Property
C0037817
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
Did the patient require clarification of questions or instructions
Description

Quality-of-LifeAssessmentDefinitionAssistanceInd-2

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Metathesaurus Property
C0018896
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
NCI Thesaurus Property
C42777
UMLS 2011AA Property
C1704788
Did the patient require other assistance
Description

Quality-of-LifeAssessmentOtherRequiredAssistanceInd-2

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Metathesaurus Property
C0018896
NCI Thesaurus Property-2
C25652
UMLS 2011AA Property-2
C1514873
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Were the forms completed independently by another person
Description

Quality-of-LifeAssessmentOtherPersonCompleteInd-2

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C25190
UMLS 2011AA Property-2
C0027361
NCI Thesaurus Property-3
C25250
UMLS 2011AA Property-3
C0205197
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
What Was The Reason For Assistance
Description

What Was The Reason For Assistance

Did the patient have a language difficulty (questions needed to tbe translated)
Description

Quality-of-LifeAssessmentLanguageProblemAssistanceInd-2

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
NCI Metathesaurus Property
C0018896
NCI Thesaurus Property
C28020
UMLS 2011AA Property
C0033213
NCI Thesaurus Property-2
C16779
UMLS 2011AA Property-2
C0023008
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Specify language
Description

Quality-of-LifeAssessmentLanguageProblemAssistanceSpecify

Type de données

text

Alias
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
NCI Metathesaurus Property
C0018896
NCI Thesaurus Property
C28020
UMLS 2011AA Property
C0033213
NCI Thesaurus Property-2
C16779
UMLS 2011AA Property-2
C0023008
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Did the patient have a literacy difficulty (patient could not read well enough)
Description

Quality-of-LifeAssessmentPatientLiteracyProblemAssistanceInd-2

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
NCI Thesaurus Property
C16960
UMLS 2011AA Property
C0030705
NCI Metathesaurus Property
C0018896
NCI Thesaurus Property-2
C28020
UMLS 2011AA Property-2
C0033213
NCI Thesaurus Property-3
C49162
UMLS 2011AA Property-3
C0023864
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Was the patient disabled
Description

Quality-of-LifeAssessmentPatientDisabilityAssistanceInd-2

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
NCI Thesaurus Property
C16960
UMLS 2011AA Property
C0030705
NCI Metathesaurus Property
C0018896
NCI Thesaurus Property-2
C21007
UMLS 2011AA Property-2
C0231170
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Specify disability
Description

Quality-of-LifeAssessmentPatientDisabilityAssistanceSpecify

Type de données

text

Alias
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
NCI Thesaurus Property
C16960
UMLS 2011AA Property
C0030705
NCI Metathesaurus Property
C0018896
NCI Thesaurus Property-2
C21007
UMLS 2011AA Property-2
C0231170
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Were the forms completed via a telephone interview
Description

Quality-of-LifeAssessmentTelephoneInterviewAssistanceInd-2

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
NCI Metathesaurus Property
C0018896
NCI Thesaurus Property
C25395
UMLS 2011AA Property
C0039457
NCI Thesaurus Property-2
C16751
UMLS 2011AA Property-2
C0021822
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Other
Description

Quality-of-LifeAssessmentOtherAssistanceInd-2

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Metathesaurus Property
C0018896
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
Specify other reason
Description

Quality-of-LifeAssessmentOtherAssistanceSpecify

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Metathesaurus Property
C0018896
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
Who Assisted Or Completed Assessment
Description

Who Assisted Or Completed Assessment

Staff
Description

Quality-of-LifeAssessmentMedicalStaffCompleteInd-2

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
NCI Metathesaurus Property
C0025106
Family
Description

Quality-of-LifeAssessmentPatientFamilyMemberCompleteInd-2

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
NCI Thesaurus Property
C16960
UMLS 2011AA Property
C0030705
NCI Thesaurus Property-2
C25250
UMLS 2011AA Property-2
C0205197
NCI Thesaurus Property-3
C41256
UMLS 2011AA Property-3
C0086282
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Friend
Description

Quality-of-LifeAssessmentPatientFriendsCompleteInd-2

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
NCI Thesaurus Property
C16960
UMLS 2011AA Property
C0030705
NCI Thesaurus Property-2
C25250
UMLS 2011AA Property-2
C0205197
NCI Metathesaurus Property
C0079382
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Other
Description

Quality-of-LifeAssessmentOtherCompleteInd-2

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C25250
UMLS 2011AA Property-2
C0205197
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
Specify other person
Description

Quality-of-LifeAssessmentOtherCompleteSpecify

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C25250
UMLS 2011AA Property-2
C0205197
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
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Similar models

INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of registration. Keep a copy for your files.

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Header
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Generic drug form
Item
DCI Name
text
C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)
Registration Number
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Item Group
Patient demographics
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (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)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Item Group
Data amendment
Data amended
Item
Please mark an 'X' if data have been amended.
text
C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Data amended date
Item
Date data amended
date
C25164 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Baseline
Item
Reporting Period (Choose one x)
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
Reporting Period (Choose one x)
CL Item
Baseline (Baseline)
C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)
Item Group
On Treatment
Item
On Treatment Report Period (Arm A since start of treatment)
text
C25284 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25616 (NCI Thesaurus Property-2)
C15368 (NCI Thesaurus ObjectClass)
CL.2
Code List
On Treatment Report Period (Arm A since start of treatment)
CL Item
Week 12 (Week 12)
Item Group
Off Treatment
Item
Off Treatment Report Period (since registration Choose one x)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25601 (NCI Thesaurus Property-2)
C1518544 (UMLS 2011AA Property-2)
C25207 (NCI Thesaurus Property-3)
C0040223 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.3
Code List
Off Treatment Report Period (since registration Choose one x)
CL Item
3 Months (3 months post registration)
CL Item
6 Months (6 months post registration)
CL Item
9 Months (9 months post registration)
CL Item
12 Months (12 months post registration)
Item Group
Section I
AssessmentDate
Item
Assessment Date
date
Item Group
Section Ii - Assessments Not Completed
Quality-of-LifeAssessmentReportPeriodCompleteInd-2
Item
Were all the quality of life forms completed for this timepoint
boolean
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25616 (NCI Thesaurus Property-2)
C1948053 (UMLS 2011AA Property-2)
C25375 (NCI Thesaurus Property-3)
C0684224 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Section Ii - Assessments Not Completed
Quality-of-LifeAssessmentPatientRefuseIncompleteInd-2
Item
Patient refusal
boolean
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C49160 (NCI Thesaurus Property-2)
C0205257 (UMLS 2011AA Property-2)
C49161 (NCI Thesaurus Property-3)
C1705116 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Quality-of-LifeAssessmentPatientDisabilityIncompleteInd-2
Item
Unable to accomodate disability or language needs
boolean
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C49160 (NCI Thesaurus Property-2)
C0205257 (UMLS 2011AA Property-2)
C21007 (NCI Thesaurus Property-3)
C0231170 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Quality-of-LifeAssessmentPatientDisabilityIncompleteSpecify
Item
Specify disability or language
text
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C49160 (NCI Thesaurus Property-2)
C0205257 (UMLS 2011AA Property-2)
C21007 (NCI Thesaurus Property-3)
C0231170 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Quality-of-LifeAssessmentPatientAbsentIncompleteInd-2
Item
Patient did not show up in clinic/office
boolean
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C49160 (NCI Thesaurus Property-2)
C0205257 (UMLS 2011AA Property-2)
C48190 (NCI Thesaurus Property-3)
C0332197 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Quality-of-LifeAssessmentPatientAbsentIncompleteSpecify
Item
Specify reason patient did not show up
text
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C49160 (NCI Thesaurus Property-2)
C0205257 (UMLS 2011AA Property-2)
C48190 (NCI Thesaurus Property-3)
C0332197 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Quality-of-LifeAssessmentMedicalStaffUnavailableIncompleteInd-2
Item
Staff unavailable
boolean
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C49160 (NCI Thesaurus Property)
C0205257 (UMLS 2011AA Property)
C25594 (NCI Thesaurus Property-2)
C1518422 (UMLS 2011AA Property-2)
C25429 (NCI Thesaurus Property-3)
C0470187 (UMLS 2011AA Property-3)
C0025106 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Quality-of-LifeAssessmentPatientNotAdministeredIncompleteInd-2
Item
Patient not given form by staff
boolean
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C49160 (NCI Thesaurus Property-2)
C0205257 (UMLS 2011AA Property-2)
C25594 (NCI Thesaurus Property-3)
C1518422 (UMLS 2011AA Property-3)
C25382 (NCI Thesaurus Property-4)
C1521801 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Quality-of-LifeAssessmentPatientSicknessIncompleteInd-2
Item
Patient too ill
boolean
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C49160 (NCI Thesaurus Property-2)
C0205257 (UMLS 2011AA Property-2)
C0221423 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Quality-of-LifeAssessmentPatientDeathIncompleteInd-2
Item
Patient expired
boolean
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C49160 (NCI Thesaurus Property-2)
C0205257 (UMLS 2011AA Property-2)
C28554 (NCI Thesaurus Property-3)
C0011065 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Quality-of-LifeAssessmentNotRequiredIncompleteInd-2
Item
Assessment not required per protocol
boolean
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C49160 (NCI Thesaurus Property)
C0205257 (UMLS 2011AA Property)
C25594 (NCI Thesaurus Property-2)
C1518422 (UMLS 2011AA Property-2)
C25652 (NCI Thesaurus Property-3)
C1514873 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Quality-of-LifeAssessmentNotRequiredIncompleteSpecify
Item
Specify reason assessment is not required
text
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C49160 (NCI Thesaurus Property)
C0205257 (UMLS 2011AA Property)
C25594 (NCI Thesaurus Property-2)
C1518422 (UMLS 2011AA Property-2)
C25652 (NCI Thesaurus Property-3)
C1514873 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Quality-of-LifeAssessmentMedicalStaffPatientSicknessIncompleteInd-2
Item
Staff thought patient too ill
boolean
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C49160 (NCI Thesaurus Property-2)
C0205257 (UMLS 2011AA Property-2)
C0221423 (NCI Metathesaurus Property)
C0025106 (NCI Metathesaurus Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Quality-of-LifeAssessmentOtherIncompleteInd-2
Item
Other
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C49160 (NCI Thesaurus Property-2)
C0205257 (UMLS 2011AA Property-2)
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
Quality-of-LifeAssessmentOtherIncompleteSpecify
Item
Specify other reason
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C49160 (NCI Thesaurus Property-2)
C0205257 (UMLS 2011AA Property-2)
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
Item Group
Section Iii - Assessment Completed
Item Group
How Was The Patient Assisted
Quality-of-LifeAssessmentSpeechAssistanceInd-2
Item
Were the questions read aloud to patient
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C0018896 (NCI Metathesaurus Property)
C38025 (NCI Thesaurus Property)
C0037817 (UMLS 2011AA Property)
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
Quality-of-LifeAssessmentDefinitionAssistanceInd-2
Item
Did the patient require clarification of questions or instructions
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C0018896 (NCI Metathesaurus Property)
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C42777 (NCI Thesaurus Property)
C1704788 (UMLS 2011AA Property)
Quality-of-LifeAssessmentOtherRequiredAssistanceInd-2
Item
Did the patient require other assistance
boolean
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C0018896 (NCI Metathesaurus Property)
C25652 (NCI Thesaurus Property-2)
C1514873 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Quality-of-LifeAssessmentOtherPersonCompleteInd-2
Item
Were the forms completed independently by another person
boolean
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25190 (NCI Thesaurus Property-2)
C0027361 (UMLS 2011AA Property-2)
C25250 (NCI Thesaurus Property-3)
C0205197 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
What Was The Reason For Assistance
Quality-of-LifeAssessmentLanguageProblemAssistanceInd-2
Item
Did the patient have a language difficulty (questions needed to tbe translated)
boolean
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C0018896 (NCI Metathesaurus Property)
C28020 (NCI Thesaurus Property)
C0033213 (UMLS 2011AA Property)
C16779 (NCI Thesaurus Property-2)
C0023008 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Quality-of-LifeAssessmentLanguageProblemAssistanceSpecify
Item
Specify language
text
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C0018896 (NCI Metathesaurus Property)
C28020 (NCI Thesaurus Property)
C0033213 (UMLS 2011AA Property)
C16779 (NCI Thesaurus Property-2)
C0023008 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Quality-of-LifeAssessmentPatientLiteracyProblemAssistanceInd-2
Item
Did the patient have a literacy difficulty (patient could not read well enough)
boolean
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C0018896 (NCI Metathesaurus Property)
C28020 (NCI Thesaurus Property-2)
C0033213 (UMLS 2011AA Property-2)
C49162 (NCI Thesaurus Property-3)
C0023864 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Quality-of-LifeAssessmentPatientDisabilityAssistanceInd-2
Item
Was the patient disabled
boolean
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C0018896 (NCI Metathesaurus Property)
C21007 (NCI Thesaurus Property-2)
C0231170 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Quality-of-LifeAssessmentPatientDisabilityAssistanceSpecify
Item
Specify disability
text
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C0018896 (NCI Metathesaurus Property)
C21007 (NCI Thesaurus Property-2)
C0231170 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Quality-of-LifeAssessmentTelephoneInterviewAssistanceInd-2
Item
Were the forms completed via a telephone interview
boolean
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C0018896 (NCI Metathesaurus Property)
C25395 (NCI Thesaurus Property)
C0039457 (UMLS 2011AA Property)
C16751 (NCI Thesaurus Property-2)
C0021822 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Quality-of-LifeAssessmentOtherAssistanceInd-2
Item
Other
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C0018896 (NCI Metathesaurus Property)
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
Quality-of-LifeAssessmentOtherAssistanceSpecify
Item
Specify other reason
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C0018896 (NCI Metathesaurus Property)
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
Item Group
Who Assisted Or Completed Assessment
Quality-of-LifeAssessmentMedicalStaffCompleteInd-2
Item
Staff
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C0025106 (NCI Metathesaurus Property)
Quality-of-LifeAssessmentPatientFamilyMemberCompleteInd-2
Item
Family
boolean
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C25250 (NCI Thesaurus Property-2)
C0205197 (UMLS 2011AA Property-2)
C41256 (NCI Thesaurus Property-3)
C0086282 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Quality-of-LifeAssessmentPatientFriendsCompleteInd-2
Item
Friend
boolean
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C25250 (NCI Thesaurus Property-2)
C0205197 (UMLS 2011AA Property-2)
C0079382 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Quality-of-LifeAssessmentOtherCompleteInd-2
Item
Other
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25250 (NCI Thesaurus Property-2)
C0205197 (UMLS 2011AA Property-2)
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
Quality-of-LifeAssessmentOtherCompleteSpecify
Item
Specify other person
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25250 (NCI Thesaurus Property-2)
C0205197 (UMLS 2011AA Property-2)
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
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