ID

10089

Beschreibung

E1105 Quality of Life Assessment Form First-Line Chemotherapy and Trastuzumab With or Without Bevacizumab in Treating Patients With Metastatic Breast Cancer That Overexpresses HER-2/NEU NCT00520975 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1736308A-3F51-3856-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1736308A-3F51-3856-E044-0003BA3F9857

Stichworte

Versionen (3)
  1. 26.08.12 26.08.12 -
  2. 08.01.15 08.01.15 - Martin Dugas
  3. 25.03.15 25.03.15 - Martin Dugas
Hochgeladen am

25. März 2015

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00520975 Quality of Life

Englisch

INSTRUCTIONS: After patient is off treatment, complete this form for each required follow-up report period (see forms submission schedule).

1 Formulare  
Header
Beschreibung

Header

Alias
UMLS CUI-1
C1320722
ECOG Protocol Number
Beschreibung

Protocol Number ECOG

Datentyp

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
Beschreibung

Patient ID ECOG

Datentyp

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
Beschreibung

Generic drug form

Datentyp

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
Beschreibung

Registration Number

Datentyp

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 Initials (Last, First)
Beschreibung

Patient Initials

Datentyp

text

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

Study Number Participating Group

Datentyp

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
Beschreibung

Institution Name

Datentyp

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
Beschreibung

Trial subject ID Participating Group

Datentyp

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
Please mark an 'X' if data have been amended (Please circle amended items in red)
Beschreibung

Data amended

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Date data amended (M D Y)
Beschreibung

Data amended date

Datentyp

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
On Treatment Report Period (Maintenance 1 cycle = 3 weeks)
Beschreibung

Cycle number

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2045829
NCI Thesaurus Property
C25214
NCI Thesaurus Property-2
C25616
NCI Thesaurus ObjectClass
C15368
Quality of life
Beschreibung

Quality of life

Alias
UMLS CUI-1
C0451401
I have a lack of energy.
Beschreibung

FatigueAssessmentResponseScale

Datentyp

integer

Alias
NCI Thesaurus ValueDomain
C25664
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C25755
NCI Thesaurus ObjectClass-2
C3036
UMLS CUI-1
C3830237
I have pain.
Beschreibung

PainAssessmentResponseScale

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25664
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C25755
NCI Thesaurus ObjectClass-2
C3303
UMLS CUI-1
C0030193
I have nausea.
Beschreibung

NauseaAssessmentResponseScale

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25664
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C25755
NCI Thesaurus ObjectClass-2
C3258
UMLS CUI-1
C0027497
I have certain areas of my body where I experience significant pain
Beschreibung

SignificantPatientLocalizedPainAssessmentQualityofLifeScale

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ObjectClass-2
C41130
NCI Thesaurus Property
C20989
NCI Metathesaurus Property
CL232212
NCI Thesaurus ValueDomain
C25664
NCI Thesaurus ValueDomain-2
C17047
UMLS CUI-1
C0520962
I have been short of breath.
Beschreibung

DyspneaAssessmentResponseScale

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25664
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C25755
NCI Thesaurus ObjectClass-2
C2998
UMLS CUI-1
C0013404
I worry that my condition will get worse
Beschreibung

WorryPatientDeteriorationAssessmentQualityofLifeScale

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C16960
NCI Metathesaurus ObjectClass
C0233481
NCI Thesaurus Property
C20989
NCI Thesaurus Property-2
C25751
NCI Thesaurus ValueDomain
C25664
NCI Thesaurus ValueDomain-2
C17047
UMLS CUI-1
C3641156
I am content with the quality of my life right now
Beschreibung

PatientQualityofLifeAssessmentQualityofLifeScale

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C17047
NCI Thesaurus Property-2
C20989
NCI Thesaurus ValueDomain
C25664
NCI Thesaurus ValueDomain-2
C17047
UMLS CUI-1
C0518214
Because of my physical condition, I have trouble meeting the needs of my family.
Beschreibung

FamilyAssessmentRequiredResponseType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C25755
UMLS CUI-1
C3830235
I am bothered by side effects of treatment.
Beschreibung

ToxicityAssessmentResponseScale

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus ObjectClass-2
C27990
NCI Thesaurus Property
C25755
NCI Thesaurus ValueDomain
C25664
NCI Thesaurus ValueDomain-2
C17047
UMLS CUI-1
C2984047
I have numbness or tingling in my hands
Beschreibung

NeurotoxicityPatientParaesthesiaHandAssessmentQualityofLifeScale

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ObjectClass-2
C27961
NCI Thesaurus Property
C20989
NCI Metathesaurus Property
C0239836
NCI Thesaurus ValueDomain
C25664
NCI Thesaurus ValueDomain-2
C17047
UMLS CUI-1
C3829780
I have numbness or tingling in my feet
Beschreibung

NeurotoxicityPatientParaesthesiaFootAssessmentQualityofLifeScale

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ObjectClass-2
C27961
NCI Thesaurus Property
C20989
NCI Metathesaurus Property
CL108114
NCI Thesaurus ValueDomain
C25664
NCI Thesaurus ValueDomain-2
C17047
UMLS CUI-1
C3829781
I feel discomfort in my hands
Beschreibung

NeurotoxicityPatientHandDiscomfortAssessmentQualityofLifeScale

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ObjectClass-2
C27961
NCI Thesaurus Property
C20989
NCI Thesaurus Property-2
C32712
NCI Metathesaurus Property
CL047845
NCI Thesaurus ValueDomain
C25664
NCI Thesaurus ValueDomain-2
C17047
UMLS CUI-1
C3830164
I feel discomfort in my feet
Beschreibung

NeurotoxicityPatientFootDiscomfortAssessmentQualityofLifeScale

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ObjectClass-2
C27961
NCI Thesaurus Property
C20989
NCI Metathesaurus Property
CL050515
NCI Thesaurus ValueDomain
C25664
NCI Thesaurus ValueDomain-2
C17047
UMLS CUI-1
C3830165
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Ähnliche Modelle

INSTRUCTIONS: After patient is off treatment, complete this form for each required follow-up report period (see forms submission schedule).

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
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)
Patient Initials
Item
Patient Initials (Last, First)
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)
Data amended
Item
Please mark an 'X' if data have been amended (Please circle amended items in red)
text
C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Data amended date
Item
Date data amended (M D Y)
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
On Treatment Report Period (Maintenance 1 cycle = 3 weeks)
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 (Maintenance 1 cycle = 3 weeks)
CL Item
Cycle 5 (Cycle 5)
CL Item
Cycle 8 (cycle 8)
CL Item
Cycle 24 (Cycle 24)
CL Item
Cycle 40 (Cycle 40)
CL Item
Cycle 56 (Cycle 56)
CL Item
Cycle 72 (Cycle 72)
CL Item
End Of Treatment (End of Treatment)
Item Group
Quality of life
C0451401 (UMLS CUI-1)
Item
I have a lack of energy.
integer
C25664 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C25755 (NCI Thesaurus Property)
C3036 (NCI Thesaurus ObjectClass-2)
C3830237 (UMLS CUI-1)
CL.3
Code List
I have a lack of energy.
CL Item
Not at all (1)
C2984077 (UMLS CUI-1)
CL Item
A little bit (2)
C2984078 (UMLS CUI-1)
CL Item
Somewhat (3)
C2984079 (UMLS CUI-1)
CL Item
Quite a bit (4)
C2984080 (UMLS CUI-1)
CL Item
Very much (5)
C2984081 (UMLS CUI-1)
Item
I have pain.
text
C25664 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C25755 (NCI Thesaurus Property)
C3303 (NCI Thesaurus ObjectClass-2)
C0030193 (UMLS CUI-1)
CL.3
Code List
I have pain.
CL Item
Not at all (1)
C2984077 (UMLS CUI-1)
CL Item
A little bit (2)
C2984078 (UMLS CUI-1)
CL Item
Somewhat (3)
C2984079 (UMLS CUI-1)
CL Item
Quite a bit (4)
C2984080 (UMLS CUI-1)
CL Item
Very much (5)
C2984081 (UMLS CUI-1)
Item
I have nausea.
text
C25664 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C25755 (NCI Thesaurus Property)
C3258 (NCI Thesaurus ObjectClass-2)
C0027497 (UMLS CUI-1)
CL.3
Code List
I have nausea.
CL Item
Not at all (1)
C2984077 (UMLS CUI-1)
CL Item
A little bit (2)
C2984078 (UMLS CUI-1)
CL Item
Somewhat (3)
C2984079 (UMLS CUI-1)
CL Item
Quite a bit (4)
C2984080 (UMLS CUI-1)
CL Item
Very much (5)
C2984081 (UMLS CUI-1)
Item
I have certain areas of my body where I experience significant pain
text
C16960 (NCI Thesaurus ObjectClass)
C41130 (NCI Thesaurus ObjectClass-2)
C20989 (NCI Thesaurus Property)
CL232212 (NCI Metathesaurus Property)
C25664 (NCI Thesaurus ValueDomain)
C17047 (NCI Thesaurus ValueDomain-2)
C0520962 (UMLS CUI-1)
CL.3
Code List
I have certain areas of my body where I experience significant pain
CL Item
Not at all (1)
C2984077 (UMLS CUI-1)
CL Item
A little bit (2)
C2984078 (UMLS CUI-1)
CL Item
Somewhat (3)
C2984079 (UMLS CUI-1)
CL Item
Quite a bit (4)
C2984080 (UMLS CUI-1)
CL Item
Very much (5)
C2984081 (UMLS CUI-1)
Item
I have been short of breath.
text
C25664 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C25755 (NCI Thesaurus Property)
C2998 (NCI Thesaurus ObjectClass-2)
C0013404 (UMLS CUI-1)
CL.3
Code List
I have been short of breath.
CL Item
Not at all (1)
C2984077 (UMLS CUI-1)
CL Item
A little bit (2)
C2984078 (UMLS CUI-1)
CL Item
Somewhat (3)
C2984079 (UMLS CUI-1)
CL Item
Quite a bit (4)
C2984080 (UMLS CUI-1)
CL Item
Very much (5)
C2984081 (UMLS CUI-1)
Item
I worry that my condition will get worse
text
C16960 (NCI Thesaurus ObjectClass)
C0233481 (NCI Metathesaurus ObjectClass)
C20989 (NCI Thesaurus Property)
C25751 (NCI Thesaurus Property-2)
C25664 (NCI Thesaurus ValueDomain)
C17047 (NCI Thesaurus ValueDomain-2)
C3641156 (UMLS CUI-1)
CL.3
Code List
I worry that my condition will get worse
CL Item
Not at all (1)
C2984077 (UMLS CUI-1)
CL Item
A little bit (2)
C2984078 (UMLS CUI-1)
CL Item
Somewhat (3)
C2984079 (UMLS CUI-1)
CL Item
Quite a bit (4)
C2984080 (UMLS CUI-1)
CL Item
Very much (5)
C2984081 (UMLS CUI-1)
Item
I am content with the quality of my life right now
text
C16960 (NCI Thesaurus ObjectClass)
C17047 (NCI Thesaurus Property)
C20989 (NCI Thesaurus Property-2)
C25664 (NCI Thesaurus ValueDomain)
C17047 (NCI Thesaurus ValueDomain-2)
C0518214 (UMLS CUI-1)
CL.3
Code List
I am content with the quality of my life right now
CL Item
Not at all (1)
C2984077 (UMLS CUI-1)
CL Item
A little bit (2)
C2984078 (UMLS CUI-1)
CL Item
Somewhat (3)
C2984079 (UMLS CUI-1)
CL Item
Quite a bit (4)
C2984080 (UMLS CUI-1)
CL Item
Very much (5)
C2984081 (UMLS CUI-1)
Item
Because of my physical condition, I have trouble meeting the needs of my family.
text
C25284 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C25755 (NCI Thesaurus Property)
C3830235 (UMLS CUI-1)
CL.3
Code List
Because of my physical condition, I have trouble meeting the needs of my family.
CL Item
Not at all (1)
C2984077 (UMLS CUI-1)
CL Item
A little bit (2)
C2984078 (UMLS CUI-1)
CL Item
Somewhat (3)
C2984079 (UMLS CUI-1)
CL Item
Quite a bit (4)
C2984080 (UMLS CUI-1)
CL Item
Very much (5)
C2984081 (UMLS CUI-1)
Item
I am bothered by side effects of treatment.
text
C20989 (NCI Thesaurus ObjectClass)
C27990 (NCI Thesaurus ObjectClass-2)
C25755 (NCI Thesaurus Property)
C25664 (NCI Thesaurus ValueDomain)
C17047 (NCI Thesaurus ValueDomain-2)
C2984047 (UMLS CUI-1)
CL.3
Code List
I am bothered by side effects of treatment.
CL Item
Not at all (1)
C2984077 (UMLS CUI-1)
CL Item
A little bit (2)
C2984078 (UMLS CUI-1)
CL Item
Somewhat (3)
C2984079 (UMLS CUI-1)
CL Item
Quite a bit (4)
C2984080 (UMLS CUI-1)
CL Item
Very much (5)
C2984081 (UMLS CUI-1)
Item
I have numbness or tingling in my hands
text
C16960 (NCI Thesaurus ObjectClass)
C27961 (NCI Thesaurus ObjectClass-2)
C20989 (NCI Thesaurus Property)
C0239836 (NCI Metathesaurus Property)
C25664 (NCI Thesaurus ValueDomain)
C17047 (NCI Thesaurus ValueDomain-2)
C3829780 (UMLS CUI-1)
CL.3
Code List
I have numbness or tingling in my hands
CL Item
Not at all (1)
C2984077 (UMLS CUI-1)
CL Item
A little bit (2)
C2984078 (UMLS CUI-1)
CL Item
Somewhat (3)
C2984079 (UMLS CUI-1)
CL Item
Quite a bit (4)
C2984080 (UMLS CUI-1)
CL Item
Very much (5)
C2984081 (UMLS CUI-1)
Item
I have numbness or tingling in my feet
text
C16960 (NCI Thesaurus ObjectClass)
C27961 (NCI Thesaurus ObjectClass-2)
C20989 (NCI Thesaurus Property)
CL108114 (NCI Metathesaurus Property)
C25664 (NCI Thesaurus ValueDomain)
C17047 (NCI Thesaurus ValueDomain-2)
C3829781 (UMLS CUI-1)
CL.3
Code List
I have numbness or tingling in my feet
CL Item
Not at all (1)
C2984077 (UMLS CUI-1)
CL Item
A little bit (2)
C2984078 (UMLS CUI-1)
CL Item
Somewhat (3)
C2984079 (UMLS CUI-1)
CL Item
Quite a bit (4)
C2984080 (UMLS CUI-1)
CL Item
Very much (5)
C2984081 (UMLS CUI-1)
Item
I feel discomfort in my hands
text
C16960 (NCI Thesaurus ObjectClass)
C27961 (NCI Thesaurus ObjectClass-2)
C20989 (NCI Thesaurus Property)
C32712 (NCI Thesaurus Property-2)
CL047845 (NCI Metathesaurus Property)
C25664 (NCI Thesaurus ValueDomain)
C17047 (NCI Thesaurus ValueDomain-2)
C3830164 (UMLS CUI-1)
CL.3
Code List
I feel discomfort in my hands
CL Item
Not at all (1)
C2984077 (UMLS CUI-1)
CL Item
A little bit (2)
C2984078 (UMLS CUI-1)
CL Item
Somewhat (3)
C2984079 (UMLS CUI-1)
CL Item
Quite a bit (4)
C2984080 (UMLS CUI-1)
CL Item
Very much (5)
C2984081 (UMLS CUI-1)
Item
I feel discomfort in my feet
text
C16960 (NCI Thesaurus ObjectClass)
C27961 (NCI Thesaurus ObjectClass-2)
C20989 (NCI Thesaurus Property)
CL050515 (NCI Metathesaurus Property)
C25664 (NCI Thesaurus ValueDomain)
C17047 (NCI Thesaurus ValueDomain-2)
C3830165 (UMLS CUI-1)
CL.3
Code List
I feel discomfort in my feet
CL Item
Not at all (1)
C2984077 (UMLS CUI-1)
CL Item
A little bit (2)
C2984078 (UMLS CUI-1)
CL Item
Somewhat (3)
C2984079 (UMLS CUI-1)
CL Item
Quite a bit (4)
C2984080 (UMLS CUI-1)
CL Item
Very much (5)
C2984081 (UMLS CUI-1)
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