English

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

1 forms  
ECOG clinical trial administrative data
Description

ECOG clinical trial administrative data

ECOG Protocol Number
Description

Protocol Number ECOG

Data type

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

Data type

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

Data type

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

Data type

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)
Description

Patient Initials

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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
Description

On Treatment Report Period

On Treatment Report Period
Description

Cycle number

Data type

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 Report Period
Description

Off Treatment Report Period

Off Treatment Report Period
Description

PersonOff-TreatmentTimePeriodType

Data type

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 (If not completed, enter date scheduled per E1609 protocol.)
Description

Assessment Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985720
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C38000
Section Ii - E1a05 Qol Assessment Not Completed
Description

Section Ii - E1a05 Qol Assessment Not Completed

Was the Assessment Form completed? (E1609 QOL)
Description

AssessmentFormCompletedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C19464
UMLS 2011AA ObjectClass
C0376315
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus ObjectClass-2
C25367
Section Ii - Assessments Not Completed
Description

Section Ii - Assessments Not Completed

Patient refusal
Description

Quality-of-LifeAssessmentPatientRefuseIncompleteInd-2

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Was Assessment self-administered?
Description

AssessmentSelf-AdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25217
UMLS 2011AA ObjectClass
C1516048
NCI Thesaurus Property
C25670
UMLS 2011AA Property
C1519231
How Was The Patient Assisted
Description

How Was The Patient Assisted

Were the questions read aloud to patient
Description

Quality-of-LifeAssessmentSpeechAssistanceInd-2

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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
Patient Bowel Function/uniscale Questionnaire: Who Assisted Or Completed Assessment?
Description

Patient Bowel Function/uniscale Questionnaire: Who Assisted Or Completed Assessment?

Staff
Description

Quality-of-LifeAssessmentMedicalStaffCompleteInd-2

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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
Comments
Description

Comments

Investigator Signature
Description

Investigator Signature

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
NCI Thesaurus ObjectClass
C17089
Investigator Signature Date
Description

Investigator Signature Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
UMLS CUI-2
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C17089
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INSTRUCTIONS: After patient is off treatment, complete this form for each required follow-up report period (see forms submission schedule).

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
ECOG clinical trial administrative data
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)
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
On Treatment Report Period
Item
On Treatment Report Period
text
C25284 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25616 (NCI Thesaurus Property-2)
C15368 (NCI Thesaurus ObjectClass)
CL.1
Code List
On Treatment Report Period
CL Item
Baseline (baseline)
C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)
C25213 (NCI Thesaurus-3)
C1442488 (UMLS 2011AA-4)
CL Item
Week 12 (Week 12)
CL Item
Week 24 (Week 24)
CL Item
Week 36 (Week 36)
CL Item
Week 48 (Week 48)
CL Item
Week 60 (Week 60)
CL Item
At Completion Of Treatment (At Completion of Treatment)
Item Group
Off Treatment Report Period
Item
Off Treatment Report Period
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.2
Code List
Off Treatment Report Period
CL Item
Qol 24 Weeks Follow-up (QOL 24 Weeks Follow-Up)
CL Item
Qol 48 Weeks Follow-up (QOL 48 Weeks Follow-Up)
Item Group
Section I
Assessment Date
Item
Assessment date (If not completed, enter date scheduled per E1609 protocol.)
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
Item Group
Section Ii - E1a05 Qol Assessment Not Completed
AssessmentFormCompletedInd-2
Item
Was the Assessment Form completed? (E1609 QOL)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ObjectClass-2)
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
AssessmentSelf-AdministeredInd-2
Item
Was Assessment self-administered?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25217 (NCI Thesaurus ObjectClass)
C1516048 (UMLS 2011AA ObjectClass)
C25670 (NCI Thesaurus Property)
C1519231 (UMLS 2011AA Property)
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
Patient Bowel Function/uniscale Questionnaire: 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)
Item Group
Comments
Investigator Signature
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
Investigator Signature Date
Item
Investigator Signature Date
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)
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