ID

3214

Beschreibung

Gynecologic Oncology Group Solid Tumor Evaluation Form (D2M version 3) Gemcitabine Hydrochloride and Docetaxel Followed by Doxorubicin Hydrochloride or Observation in Treating Patients With High-Risk Uterine Leiomyosarcoma Previously Removed by Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8D1826DA-E799-F792-E040-BB89AD433BF7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8D1826DA-E799-F792-E040-BB89AD433BF7

Stichworte

Versionen (2)
  1. 19.09.12 19.09.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
Hochgeladen am

19. September 2012

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy
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Sarcoma NCT01533207 On-Study - Gynecologic Oncology Group Solid Tumor Evaluation Form (D2M version 3) - 3127207v1.0

Englisch

No Instruction available.

1 Formulare  
  1. StudyEvent: Gynecologic Oncology Group Solid Tumor Evaluation Form (D2M version 3)
    1. No Instruction available.
Header Module
Beschreibung

Header Module

Date form originally completed (m d y)
Beschreibung

FormOriginalCompleteDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C19464
UMLS 2011AA ObjectClass
C0376315
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property
C25604
UMLS 2011AA Property
C0205313
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
Date form amended (m d y)
Beschreibung

FormAmendedCompleteDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C19464
UMLS 2011AA ObjectClass
C0376315
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
Person amending form, last name
Beschreibung

ResponsiblePersonReportingChangeLastName

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Patient Initials (First, Middle, Last)
Beschreibung

PatientInitialsName

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Patient Study ID
Beschreibung

PatientGynecologicOncologyGroupIdentifierNumber

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25521
UMLS 2011AA Property
C1512288
Person completing form, last name
Beschreibung

ResponsiblePersonLastName

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25551
UMLS 2011AA Property
C1517741
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
Target Lesion(s) Evaluation
Beschreibung

Target Lesion(s) Evaluation

Did the patient have measurable disease at baseline
Beschreibung

MeasurableDiseaseBaselinePresentInd-3

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass
C37894
UMLS 2011AA ObjectClass
C1513040
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property
C25213
UMLS 2011AA Property
C1442488
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ValueDomain
C9305
UMLS 2011AA ValueDomain
C0006826
Assessment
Beschreibung

AssessmentPeriodSpecify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
Site of Lesion
Beschreibung

LesionSite

Datentyp

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
Method of Evaluation (Method of evaluation *)
Beschreibung

AssessmentMethodType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
Lymph node
Beschreibung

LymphNodeInvolvementInd-3

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
NCI Thesaurus Property
C25547
Date of evaluation (m d y)
Beschreibung

LesionAssessmentDate

Datentyp

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
C25367
Tumor Size (cm) (Please report the longest diameter for non-nodal target lesions. The short axis should be reported for nodal target lesions)
Beschreibung

TumorSizeDiameterMeasurement

Datentyp

double

Maßeinheiten
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25681
UMLS 2011AA Property
C0456389
cm
Sum of diameters (cm)
Beschreibung

SumLesionDiameterMeasurement

Datentyp

double

Maßeinheiten
  • cm
Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass
C25697
UMLS 2011AA ObjectClass
C1515051
NCI Thesaurus Property
C25285
UMLS 2011AA Property
C1301886
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ValueDomain
C25285
UMLS 2011AA ValueDomain
C1301886
cm
Non-target Lesion(s) Evaluation
Beschreibung

Non-target Lesion(s) Evaluation

Were there any non-target lesions reported at baseline
Beschreibung

LesionNontargetBaselineLocationInd-3

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25592
UMLS 2011AA Property
C1518389
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property
C25213
UMLS 2011AA Property
C1442488
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ValueDomain
C9305
UMLS 2011AA ValueDomain
C0006826
Site of Lesion
Beschreibung

LesionSite

Datentyp

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
Method of Evaluation (Method of evaluation *)
Beschreibung

AssessmentMethodType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
Date of evaluation (m d y)
Beschreibung

LesionAssessmentDate

Datentyp

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
C25367
Follow-up status of lesion
Beschreibung

Non-TargetLesionFollow-upStatus

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass
C25592
UMLS 2011AA ObjectClass
C1518389
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
New Target Lesion(s) At Follow-up Evaluation
Beschreibung

New Target Lesion(s) At Follow-up Evaluation

Was the appearance of any new lesions documented (since the baseline evaluation)
Beschreibung

NewLesionAppearanceInd-2

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus Property
C25377
UMLS 2011AA Property
C0700364
Site of Lesion
Beschreibung

LesionSite

Datentyp

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
Method of Evaluation (Method of evaluation *)
Beschreibung

AssessmentMethodType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
Date of evaluation (m d y)
Beschreibung

LesionAssessmentDate

Datentyp

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
C25367
Overall Response
Beschreibung

Overall Response

Time point response
Beschreibung

GynecologicMalignantNeoplasmResponseStatus

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C50995
UMLS 2011AA Property
C1704632
NCI Thesaurus ObjectClass
C28016
UMLS 2011AA ObjectClass
C0205480
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Overall best confirmed response
Beschreibung

GynecologicMalignantNeoplasmOverallConfirmationResponseStatus

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass
C28016
UMLS 2011AA ObjectClass
C0205480
NCI Thesaurus Property
C25605
UMLS 2011AA Property
C1561607
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
NCI Thesaurus Property
C50995
UMLS 2011AA Property
C1704632
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Overall best response (unconfirmed)
Beschreibung

BestOverallNeoplasmResponseType

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass
C25605
UMLS 2011AA ObjectClass
C1561607
NCI Thesaurus ObjectClass
C25432
UMLS 2011AA ObjectClass
C1522427
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
PR First Observed Date (m d y)
Beschreibung

PartialResponseFirstObservedDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C25755
UMLS 2011AA ObjectClass
C0871261
NCI Thesaurus ObjectClass
C25378
UMLS 2011AA ObjectClass
C0728938
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property
C25599
UMLS 2011AA Property
C1441672
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
Response Confirmed Date, PR (m d y)
Beschreibung

PartialResponseConfirmedDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25755
UMLS 2011AA ObjectClass
C0871261
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
NCI Thesaurus ObjectClass
C25378
UMLS 2011AA ObjectClass
C0728938
CR First Observed Date (m d y)
Beschreibung

CompleteResponseFirstObservedDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C25755
UMLS 2011AA ObjectClass
C0871261
NCI Thesaurus ObjectClass
C25250
UMLS 2011AA ObjectClass
C0205197
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property
C25599
UMLS 2011AA Property
C1441672
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
Response Confirmed Date, CR (m d y)
Beschreibung

CompleteResponseConfirmedDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25755
UMLS 2011AA ObjectClass
C0871261
NCI Thesaurus ObjectClass
C25250
UMLS 2011AA ObjectClass
C0205197
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
Comments
Beschreibung

Comments

Comments
Beschreibung

ResearchCommentsText

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411
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1 Formulare
  1. StudyEvent: Gynecologic Oncology Group Solid Tumor Evaluation Form (D2M version 3)
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Header Module
FormOriginalCompleteDate
Item
Date form originally completed (m d y)
date
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25604 (NCI Thesaurus Property)
C0205313 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
FormAmendedCompleteDate
Item
Date form amended (m d y)
date
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
ResponsiblePersonReportingChangeLastName
Item
Person amending form, last name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientInitialsName
Item
Patient Initials (First, Middle, Last)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
PatientGynecologicOncologyGroupIdentifierNumber
Item
Patient Study ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25521 (NCI Thesaurus Property)
C1512288 (UMLS 2011AA Property)
ResponsiblePersonLastName
Item
Person completing form, last name
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
Item Group
Target Lesion(s) Evaluation
Item
Did the patient have measurable disease at baseline
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C37894 (NCI Thesaurus ObjectClass)
C1513040 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ValueDomain)
C0006826 (UMLS 2011AA ValueDomain)
CL.1
Code List
Did the patient have measurable disease at baseline
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
AssessmentPeriodSpecify
Item
Assessment
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
LesionSite
Item
Site of Lesion
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)
Item
Method of Evaluation (Method of evaluation *)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
CL.8
Code List
Method of Evaluation (Method of evaluation *)
CL Item
Clinical Examination (pe) (Clinical examination)
CL Item
Chest X-ray (Chest X-ray)
CL Item
Ct Scan (CT scan)
CL Item
Pet/ct Scan (PET/CT scan)
CL Item
Mri (MRI (NMR))
CL Item
Not Evaluated (Not evaluated)
CL Item
Positron Emission Tomography (FDG-PET)
C17007 (NCI Thesaurus)
C0032743 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Item
Lymph node
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)
CL.2
Code List
Lymph node
CL Item
No (NO)
CL Item
Yes (YES)
LesionAssessmentDate
Item
Date of evaluation (m d y)
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)
TumorSizeDiameterMeasurement
Item
Tumor Size (cm) (Please report the longest diameter for non-nodal target lesions. The short axis should be reported for nodal target lesions)
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25681 (NCI Thesaurus Property)
C0456389 (UMLS 2011AA Property)
SumLesionDiameterMeasurement
Item
Sum of diameters (cm)
double
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25697 (NCI Thesaurus ObjectClass)
C1515051 (UMLS 2011AA ObjectClass)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25285 (NCI Thesaurus ValueDomain)
C1301886 (UMLS 2011AA ValueDomain)
Item Group
Non-target Lesion(s) Evaluation
Item
Were there any non-target lesions reported at baseline
text
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25592 (NCI Thesaurus Property)
C1518389 (UMLS 2011AA Property)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ValueDomain)
C0006826 (UMLS 2011AA ValueDomain)
CL.4
Code List
Were there any non-target lesions reported at baseline
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
LesionSite
Item
Site of Lesion
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)
Item
Method of Evaluation (Method of evaluation *)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
CL.8
Code List
Method of Evaluation (Method of evaluation *)
CL Item
Clinical Examination (pe) (Clinical examination)
CL Item
Chest X-ray (Chest X-ray)
CL Item
Ct Scan (CT scan)
CL Item
Pet/ct Scan (PET/CT scan)
CL Item
Mri (MRI (NMR))
CL Item
Not Evaluated (Not evaluated)
CL Item
Positron Emission Tomography (FDG-PET)
C17007 (NCI Thesaurus)
C0032743 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
LesionAssessmentDate
Item
Date of evaluation (m d y)
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)
Item
Follow-up status of lesion
text
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25592 (NCI Thesaurus ObjectClass)
C1518389 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.6
Code List
Follow-up status of lesion
CL Item
Complete Response (Complete response)
CL Item
Non Cr/ Non Pd (Non-CR/ Non-PD)
CL Item
Unequivocal Pd (Unequivocal PD)
CL Item
N/a - Baseline (N/A - Baseline)
Item Group
New Target Lesion(s) At Follow-up Evaluation
Item
Was the appearance of any new lesions documented (since the baseline evaluation)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C25377 (NCI Thesaurus Property)
C0700364 (UMLS 2011AA Property)
CL.7
Code List
Was the appearance of any new lesions documented (since the baseline evaluation)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LesionSite
Item
Site of Lesion
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)
Item
Method of Evaluation (Method of evaluation *)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
CL.8
Code List
Method of Evaluation (Method of evaluation *)
CL Item
Clinical Examination (pe) (Clinical examination)
CL Item
Chest X-ray (Chest X-ray)
CL Item
Ct Scan (CT scan)
CL Item
Pet/ct Scan (PET/CT scan)
CL Item
Mri (MRI (NMR))
CL Item
Not Evaluated (Not evaluated)
CL Item
Positron Emission Tomography (FDG-PET)
C17007 (NCI Thesaurus)
C0032743 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
LesionAssessmentDate
Item
Date of evaluation (m d y)
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)
Item Group
Overall Response
Item
Time point response
text
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C50995 (NCI Thesaurus Property)
C1704632 (UMLS 2011AA Property)
C28016 (NCI Thesaurus ObjectClass)
C0205480 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.9
Code List
Time point response
CL Item
Complete Response (Complete response)
C25250 (NCI Thesaurus)
C0205197 (UMLS 2011AA)
C50995 (NCI Thesaurus)
C1704632 (UMLS 2011AA)
CL Item
Stable Disease (Stable Disease)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
CL Item
Partial Response (Partial Response)
CL Item
Pd (Progressive Disease)
CL Item
Not Evaluable (Not evaluable)
C62222 (NCI Thesaurus)
C1883425 (UMLS 2011AA)
CL Item
Not Applicable - Baseline (N/A - Baseline)
CL Item
Biologic Progression Only (Biologic progression only)
Item
Overall best confirmed response
text
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C28016 (NCI Thesaurus ObjectClass)
C0205480 (UMLS 2011AA ObjectClass)
C25605 (NCI Thesaurus Property)
C1561607 (UMLS 2011AA Property)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C50995 (NCI Thesaurus Property)
C1704632 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.10
Code List
Overall best confirmed response
CL Item
Complete Response (Complete response)
C25250 (NCI Thesaurus)
C0205197 (UMLS 2011AA)
C50995 (NCI Thesaurus)
C1704632 (UMLS 2011AA)
CL Item
Stable Disease (Stable Disease)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
CL Item
Partial Response (Partial Response)
CL Item
Not Applicable - Baseline (N/A - Baseline)
CL Item
Not Evaluable (Not evaluable)
C62222 (NCI Thesaurus)
C1883425 (UMLS 2011AA)
CL Item
Non-measurable Disease At Baseline (Non-measurable disease at baseline)
CL Item
Pd (Progressive Disease)
Item
Overall best response (unconfirmed)
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25605 (NCI Thesaurus ObjectClass)
C1561607 (UMLS 2011AA ObjectClass)
C25432 (NCI Thesaurus ObjectClass)
C1522427 (UMLS 2011AA ObjectClass)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.11
Code List
Overall best response (unconfirmed)
CL Item
Complete Response (CR)
CL Item
Stable Disease (SD)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
CL Item
Partial Response (PR)
C18212 (NCI Thesaurus)
CL Item
N/a - Baseline (N/A - Baseline)
CL Item
Not Evaluable (ne) (NE)
CL Item
Non-measurable Disease At Baseline (Non-measurable disease at baseline)
CL Item
Progressive Disease (PD)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
PartialResponseFirstObservedDate
Item
PR First Observed Date (m d y)
date
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25378 (NCI Thesaurus ObjectClass)
C0728938 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25599 (NCI Thesaurus Property)
C1441672 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
PartialResponseConfirmedDate
Item
Response Confirmed Date, PR (m d y)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C25378 (NCI Thesaurus ObjectClass)
C0728938 (UMLS 2011AA ObjectClass)
CompleteResponseFirstObservedDate
Item
CR First Observed Date (m d y)
date
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus ObjectClass)
C0205197 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25599 (NCI Thesaurus Property)
C1441672 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
CompleteResponseConfirmedDate
Item
Response Confirmed Date, CR (m d y)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus ObjectClass)
C0205197 (UMLS 2011AA ObjectClass)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
Item Group
Comments
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
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