ID

7974

Beskrivning

CALGB Solid Tumor Evaluation Form (RECIST 1.1) Sorafenib Tosylate With or Without Doxorubicin Hydrochloride in Treating Patients With Locally Advanced or Metastatic Liver Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=746D8651-FF47-E158-E040-BB89AD4366AF

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=746D8651-FF47-E158-E040-BB89AD4366AF

Nyckelord

Versioner (2)
  1. 2012-09-19 2012-09-19 -
  2. 2015-01-09 2015-01-09 - Martin Dugas
Uppladdad den

9 januari 2015

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0 Legacy
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Liver Cancer NCT01015833 On-Study - CALGB Solid Tumor Evaluation Form (RECIST 1.1) - 2946223v1.0

Engelsk

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink.

1 Formulär  
Header
Beskrivning

Header

CALGB Form
Beskrivning

Form ID CALGB

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3262252
NCI Thesaurus ObjectClass
C19464
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass-2
C25442
CALGB Study No.
Beskrivning

Protocol ID CALGB

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
CALGB Patient ID
Beskrivning

Trial subject ID CALGB

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
Date of Evaluation (MM DD YYYY)
Beskrivning

LesionAssessmentDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ValueDomain-2
C25367
Are data amended
Beskrivning

Data amended

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Unnamed2
Beskrivning

Unnamed2

Patient Initials (Last, First Middle)
Beskrivning

Patient Initials

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Patient Hospital No.
Beskrivning

Medical Record Number

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301894
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25198
Institution/Affiliate
Beskrivning

Institution Name

Datatyp

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
Beskrivning

Participating Group

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2347449
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass-2
C17005
NCI Thesaurus Property
C25364
Participating Group Study No
Beskrivning

Study Number Participating Group

Datatyp

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
Participating Group Patient ID
Beskrivning

Trial subject ID Participating Group

Datatyp

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
Report Period
Beskrivning

Report Period

Report Period (Mark one with an X.)
Beskrivning

Clinical Trial Period

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2347804
NCI Thesaurus ObjectClass
C25214
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass-2
C25651
Cycle Number (if applicable)
Beskrivning

Cycle Number

Datatyp

integer

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2045829
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
Reporting Period
Beskrivning

Reporting Period

Are there any target lesions?
Beskrivning

TargetLesionPresentInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass-2
C25702
UMLS 2011AA ObjectClass-2
C1521840
Target Lesion Site
Beskrivning

LesionTargetSite

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property-2
C25702
UMLS 2011AA Property-2
C1521840
Method of Evaluation (Mark one with an X.)
Beskrivning

Evaluation method

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2911685
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C16847
Lesion size (mm)
Beskrivning

LesionSizeNumber

Datatyp

float

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25681
UMLS 2011AA Property
C0456389
Lesion type (Mark one with an X.)
Beskrivning

LesionTargetSite

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property-2
C25702
UMLS 2011AA Property-2
C1521840
NCI Thesaurus ValueDomain
C37901
UMLS 2011AA ValueDomain
C0205145
Lesion status (Mark one with an X.)
Beskrivning

DiseaseResponseSiteStatus

Datatyp

text

Alias
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
NCI Thesaurus Property-2
C25341
UMLS 2011AA Property-2
C0450429
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Baseline Sum (mm)
Beskrivning

BaselineMalignantNeoplasmLongestDiameterSumMeasurement

Datatyp

float

Alias
NCI Thesaurus ObjectClass
C25213
UMLS 2011AA ObjectClass
C1442488
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C25285
UMLS 2011AA Property
C1301886
NCI Thesaurus Property-2
C25558
UMLS 2011AA Property-2
C1522425
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ValueDomain-2
C25697
UMLS 2011AA ValueDomain-2
C1515051
Smallest sum since baseline (mm)
Beskrivning

MalignantNeoplasmLesserPreviousLongestDiameterSumMeasurement

Datatyp

float

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C25285
UMLS 2011AA Property
C1301886
NCI Thesaurus Property-2
C25558
UMLS 2011AA Property-2
C1522425
NCI Thesaurus Property-3
C25627
UMLS 2011AA Property-3
C0205156
NCI Thesaurus Property-4
C61422
UMLS 2011AA Property-4
C0547044
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ValueDomain-2
C25697
UMLS 2011AA ValueDomain-2
C1515051
Total tumor size (mm)
Beskrivning

PersonLesionLongestMeasurementSumMeasurement

Datatyp

float

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass-2
C3824
UMLS 2011AA ObjectClass-2
C0221198
NCI Thesaurus Property
C25209
UMLS 2011AA Property
C0242485
NCI Thesaurus Property-2
C25558
UMLS 2011AA Property-2
C1522425
NCI Thesaurus Property-3
C25697
UMLS 2011AA Property-3
C1515051
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
Percent change from baseline (%)
Beskrivning

BaselineMalignantNeoplasmChangeLongestDiameterPercentageValue

Datatyp

float

Alias
NCI Thesaurus ObjectClass
C25213
UMLS 2011AA ObjectClass
C1442488
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C25285
UMLS 2011AA Property
C1301886
NCI Thesaurus Property-2
C25558
UMLS 2011AA Property-2
C1522425
NCI Thesaurus Property-3
C25446
UMLS 2011AA Property-3
C0392747
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
Percent change from smallest sum (%)
Beskrivning

MalignantNeoplasmChangeLesserPreviousLongestDiameterPercentageValue

Datatyp

float

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C25285
UMLS 2011AA Property
C1301886
NCI Thesaurus Property-2
C25558
UMLS 2011AA Property-2
C1522425
NCI Thesaurus Property-3
C25627
UMLS 2011AA Property-3
C0205156
NCI Thesaurus Property-4
C25446
UMLS 2011AA Property-4
C0392747
NCI Thesaurus Property-5
C61422
UMLS 2011AA Property-5
C0547044
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
Comments
Beskrivning

Comments

Comments
Beskrivning

Research Comments

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Non-target Lesion(s) Follow-up Evaluation
Beskrivning

Non-target Lesion(s) Follow-up Evaluation

Are there any non-target lesions
Beskrivning

NontargetLesionPresentInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass-2
C25592
UMLS 2011AA ObjectClass-2
C1518389
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
Nontarget Lesion Site
Beskrivning

LesionNontargetSite

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25592
UMLS 2011AA Property
C1518389
NCI Thesaurus Property-2
C25341
UMLS 2011AA Property-2
C0450429
Method of Evaluation (Mark one with an X.)
Beskrivning

Evaluation method

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2911685
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C16847
Overall response at this assessment (tumor Mark one with an X.)
Beskrivning

OverallLesionResponseStatus

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass-2
C25605
UMLS 2011AA ObjectClass-2
C1561607
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Lesion status (Mark one with an X.)
Beskrivning

DiseaseResponseSiteStatus

Datatyp

text

Alias
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
NCI Thesaurus Property-2
C25341
UMLS 2011AA Property-2
C0450429
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Was the appearance of any new lesions documented
Beskrivning

NewLesionAppearanceInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass-2
C25586
UMLS 2011AA ObjectClass-2
C0205314
NCI Thesaurus Property
C25377
UMLS 2011AA Property
C0700364
Specify
Beskrivning

LesionNewLocationSpecify

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25586
UMLS 2011AA Property
C0205314
NCI Thesaurus Property-2
C25341
UMLS 2011AA Property-2
C0450429
Is there symptomatic deterioration of the patient's health status
Beskrivning

ResponseSymptomaticDeteriorationInd-3

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25755
UMLS 2011AA ObjectClass
C0871261
NCI Thesaurus Property
C25269
UMLS 2011AA Property
C0231220
NCI Thesaurus Property-2
C25751
UMLS 2011AA Property-2
C0868945
Overall Response
Beskrivning

Overall Response

Completed by (Last name, First name)
Beskrivning

Person Completing Form

Datatyp

text

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

Form Completion Date

Datatyp

date

Alias
NCI Thesaurus ObjectClass
C19464
UMLS CUI-1
C1549507
NCI Thesaurus Property
C25250
NCI Thesaurus Property-2
C25604
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Tillbaka till toppen

Similar models

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink.

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Header
Form ID CALGB
Item
CALGB Form
text
C25337 (NCI Thesaurus ValueDomain)
C3262252 (UMLS CUI-1)
C19464 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus ObjectClass-2)
Protocol ID CALGB
Item
CALGB Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Trial subject ID CALGB
Item
CALGB Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
LesionAssessmentDate
Item
Date of Evaluation (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain-2)
Data amended
Item
Are data amended
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Unnamed2
Patient Initials
Item
Patient Initials (Last, First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Medical Record Number
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (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)
Participating Group
Item
Participating Group
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Study No
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)
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
Report Period
Item
Report Period (Mark one with an X.)
text
C25284 (NCI Thesaurus ValueDomain)
C2347804 (UMLS CUI-1)
C25214 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus ObjectClass-2)
CL.2
Code List
Report Period (Mark one with an X.)
CL Item
Baseline (Baseline)
C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)
CL Item
Restaging (Restaging)
CL Item
Post-treatment (Post-Treatment)
CL024863 (NCI Metathesaurus)
Cycle Number
Item
Cycle Number (if applicable)
integer
C25337 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
Item Group
Reporting Period
TargetLesionPresentInd-2
Item
Are there any target lesions?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25702 (NCI Thesaurus ObjectClass-2)
C1521840 (UMLS 2011AA ObjectClass-2)
LesionTargetSite
Item
Target Lesion Site
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25702 (NCI Thesaurus Property-2)
C1521840 (UMLS 2011AA Property-2)
Item
Method of Evaluation (Mark one with an X.)
text
C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
CL.8
Code List
Method of Evaluation (Mark one with an X.)
CL Item
Ct Scan (CT scan)
CL Item
X-ray (X-ray)
CL Item
Mri (MRI (NMR))
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
LesionSizeNumber
Item
Lesion size (mm)
float
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25681 (NCI Thesaurus Property)
C0456389 (UMLS 2011AA Property)
Item
Lesion type (Mark one with an X.)
text
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25702 (NCI Thesaurus Property-2)
C1521840 (UMLS 2011AA Property-2)
C37901 (NCI Thesaurus ValueDomain)
C0205145 (UMLS 2011AA ValueDomain)
CL.5
Code List
Lesion type (Mark one with an X.)
CL Item
Non-nodal (Non-nodal)
CL Item
Lymph Node (Lymph node)
C12745 (NCI Thesaurus)
C0024204 (UMLS 2011AA)
Item
Lesion status (Mark one with an X.)
text
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C25341 (NCI Thesaurus Property-2)
C0450429 (UMLS 2011AA Property-2)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.9
Code List
Lesion status (Mark one with an X.)
CL Item
Absent (Absent)
C48190 (NCI Thesaurus)
C0332197 (UMLS 2011AA)
CL Item
Present (Present)
C25626 (NCI Thesaurus)
C0150312 (UMLS 2011AA)
CL Item
Progression (Unequivocal progression)
C25331 (NCI Thesaurus)
CL Item
New Lesion (New lesion)
CL Item
Not Evaluable (Not evaluable)
BaselineMalignantNeoplasmLongestDiameterSumMeasurement
Item
Baseline Sum (mm)
float
C25213 (NCI Thesaurus ObjectClass)
C1442488 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25558 (NCI Thesaurus Property-2)
C1522425 (UMLS 2011AA Property-2)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25697 (NCI Thesaurus ValueDomain-2)
C1515051 (UMLS 2011AA ValueDomain-2)
MalignantNeoplasmLesserPreviousLongestDiameterSumMeasurement
Item
Smallest sum since baseline (mm)
float
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25558 (NCI Thesaurus Property-2)
C1522425 (UMLS 2011AA Property-2)
C25627 (NCI Thesaurus Property-3)
C0205156 (UMLS 2011AA Property-3)
C61422 (NCI Thesaurus Property-4)
C0547044 (UMLS 2011AA Property-4)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25697 (NCI Thesaurus ValueDomain-2)
C1515051 (UMLS 2011AA ValueDomain-2)
PersonLesionLongestMeasurementSumMeasurement
Item
Total tumor size (mm)
float
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C3824 (NCI Thesaurus ObjectClass-2)
C0221198 (UMLS 2011AA ObjectClass-2)
C25209 (NCI Thesaurus Property)
C0242485 (UMLS 2011AA Property)
C25558 (NCI Thesaurus Property-2)
C1522425 (UMLS 2011AA Property-2)
C25697 (NCI Thesaurus Property-3)
C1515051 (UMLS 2011AA Property-3)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
BaselineMalignantNeoplasmChangeLongestDiameterPercentageValue
Item
Percent change from baseline (%)
float
C25213 (NCI Thesaurus ObjectClass)
C1442488 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25558 (NCI Thesaurus Property-2)
C1522425 (UMLS 2011AA Property-2)
C25446 (NCI Thesaurus Property-3)
C0392747 (UMLS 2011AA Property-3)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
MalignantNeoplasmChangeLesserPreviousLongestDiameterPercentageValue
Item
Percent change from smallest sum (%)
float
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25558 (NCI Thesaurus Property-2)
C1522425 (UMLS 2011AA Property-2)
C25627 (NCI Thesaurus Property-3)
C0205156 (UMLS 2011AA Property-3)
C25446 (NCI Thesaurus Property-4)
C0392747 (UMLS 2011AA Property-4)
C61422 (NCI Thesaurus Property-5)
C0547044 (UMLS 2011AA Property-5)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Item Group
Non-target Lesion(s) Follow-up Evaluation
NontargetLesionPresentInd-2
Item
Are there any non-target lesions
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25592 (NCI Thesaurus ObjectClass-2)
C1518389 (UMLS 2011AA ObjectClass-2)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
LesionNontargetSite
Item
Nontarget Lesion Site
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25592 (NCI Thesaurus Property)
C1518389 (UMLS 2011AA Property)
C25341 (NCI Thesaurus Property-2)
C0450429 (UMLS 2011AA Property-2)
Item
Method of Evaluation (Mark one with an X.)
text
C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
CL.8
Code List
Method of Evaluation (Mark one with an X.)
CL Item
Ct Scan (CT scan)
CL Item
X-ray (X-ray)
CL Item
Mri (MRI (NMR))
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Item
Overall response at this assessment (tumor Mark one with an X.)
text
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25605 (NCI Thesaurus ObjectClass-2)
C1561607 (UMLS 2011AA ObjectClass-2)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.10
Code List
Overall response at this assessment (tumor Mark one with an X.)
CL Item
Complete Response (Complete Response)
CL Item
Partial Response (Partial Response)
CL Item
Stable Disease (Stable disease)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
CL Item
Progressive Disease (Progressive Disease)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
CL Item
Not Evaluable (Not evaluable)
Item
Lesion status (Mark one with an X.)
text
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C25341 (NCI Thesaurus Property-2)
C0450429 (UMLS 2011AA Property-2)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.9
Code List
Lesion status (Mark one with an X.)
CL Item
Absent (Absent)
C48190 (NCI Thesaurus)
C0332197 (UMLS 2011AA)
CL Item
Present (Present)
C25626 (NCI Thesaurus)
C0150312 (UMLS 2011AA)
CL Item
Progression (Unequivocal progression)
C25331 (NCI Thesaurus)
CL Item
New Lesion (New lesion)
CL Item
Not Evaluable (Not evaluable)
NewLesionAppearanceInd-2
Item
Was the appearance of any new lesions documented
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25586 (NCI Thesaurus ObjectClass-2)
C0205314 (UMLS 2011AA ObjectClass-2)
C25377 (NCI Thesaurus Property)
C0700364 (UMLS 2011AA Property)
LesionNewLocationSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C25341 (NCI Thesaurus Property-2)
C0450429 (UMLS 2011AA Property-2)
ResponseSymptomaticDeteriorationInd-3
Item
Is there symptomatic deterioration of the patient's health status
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25269 (NCI Thesaurus Property)
C0231220 (UMLS 2011AA Property)
C25751 (NCI Thesaurus Property-2)
C0868945 (UMLS 2011AA Property-2)
Item Group
Overall Response
Person Completing Form
Item
Completed by (Last name, First name)
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Form Completion Date
Item
Date Form Originally Completed (MM DD YYYY)
date
C19464 (NCI Thesaurus ObjectClass)
C1549507 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C25604 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
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