ID

11171

Description

KS Evaluation and Clinical Benefit Form: RK1 NCT00310128 Combination Chemotherapy Followed by Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed or Refractory AIDS-Related Non-Hodgkin's Lymphoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0059EF25-C95F-0C32-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0059EF25-C95F-0C32-E044-0003BA3F9857

Keywords

  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 6/21/15 6/21/15 -
Uploaded on

June 21, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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KS Evaluation and Clinical Benefit Form: RK1 NCT00310128

No Instruction available.

  1. StudyEvent: KS Evaluation and Clinical Benefit Form: RK1
    1. No Instruction available.
Patient demographics
Description

Patient demographics

Center
Description

NCIInstitutionIdentifierCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass-2
C19202
UMLS 2011AA ObjectClass-2
C1513882
Protocol
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
Participant ID
Description

Patient Study ID

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25462
NCI Thesaurus Property-2
C25364
Visit Number
Description

Visit number

Data type

float

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1549755
NCI Thesaurus ObjectClass
C16696
NCI Thesaurus Property
C25385
Assessment date
Description

LesionAssessmentDate

Data type

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
Time period
Description

Clinical Trial Period

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2347804
NCI Thesaurus ObjectClass
C25214
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass-2
C25651
History And Symptoms
Description

History And Symptoms

Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Are there any GI lesions present at this evaluation
Description

GastrointestinalSymptomPresentInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C13359
UMLS 2011AA ObjectClass
C0521362
NCI Thesaurus ObjectClass-2
C4876
UMLS 2011AA ObjectClass-2
C1457887
NCI Thesaurus Property
C4876
UMLS 2011AA Property
C1457887
Does the patient have other related pulmonary symptoms
Description

ChronicDiseasePulmonaryInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass-2
C14141
UMLS 2011AA ObjectClass-2
C0205191
NCI Metathesaurus Property
CL317978
Patient symptoms of oral cavity lesions
Description

Patientsymptomsoforalcavitylesions

Data type

text

Does the patient have other related oral cavity symptoms
Description

Doesthepatienthaveotherrelatedoralcavitysymptoms

Data type

boolean

Specify
Description

Specify

Data type

text

GI Symptoms
Description

GISymptoms

Data type

text

Specify
Description

Specify

Data type

text

Patient symptoms
Description

Patientsymptoms

Data type

text

Specify
Description

Specify

Data type

text

Is the patient experiencing tumor-related pain
Description

Isthepatientexperiencingtumor-relatedpain

Data type

boolean

Is the patient on analgesics
Description

Isthepatientonanalgesics

Data type

text

What was the average pain experienced by the patient over the last 24 hours
Description

Whatwastheaveragepainexperiencedbythepatientoverthelast24hours

Data type

text

Pain
Description

Pain

Data type

text

Anatomic Site of Worst Pain
Description

AnatomicSiteofWorstPain

Data type

text

Patient symptoms of edema
Description

Patientsymptomsofedema

Data type

text

Patient symptoms of periorbital edema
Description

Patientsymptomsofperiorbitaledema

Data type

text

Patient symptoms of scrotal/genital swelling
Description

Patientsymptomsofscrotal/genitalswelling

Data type

text

Patient symptoms of foot KS
Description

PatientsymptomsoffootKS

Data type

text

Evaluation Of Cutaneous Lesions
Description

Evaluation Of Cutaneous Lesions

Representative Area
Description

LesionSiteICD-OCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
Specify number of lesions
Description

LesionCount

Data type

float

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
At entry, does the patient have >=50 lesions
Description

Atentry,doesthepatienthave>=50lesions

Data type

boolean

Total Number Raised Lesions
Description

TotalNumberRaisedLesions

Data type

text

Total Number Flat Lesions
Description

TotalNumberFlatLesions

Data type

text

Total Number New Lesions
Description

TotalNumberNewLesions

Data type

text

Character of cutaneous Lesions
Description

CharacterofcutaneousLesions

Data type

text

Evaluation Of Marker Lesions
Description

Evaluation Of Marker Lesions

Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Specify number of lesions
Description

LesionCount

Data type

float

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
Site Code
Description

SiteCode

Data type

text

Specify
Description

Specify

Data type

text

Evaluation Of Foot Ks
Description

Evaluation Of Foot Ks

Compared to previous evaluation
Description

LesionFollow-UpAssessmentType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
Date of Evaluation
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
Foot KS
Description

FootKS

Data type

text

Photos taken
Description

Photostaken

Data type

boolean

Physical findings
Description

Physicalfindings

Data type

boolean

Specify
Description

Specify

Data type

text

Evaluation Of Oral Cavity
Description

Evaluation Of Oral Cavity

Date of Evaluation
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
Number of flat lesions
Description

FlatLesionQuantityNumber

Data type

float

Measurement units
  • %
Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
NCI Metathesaurus ObjectClass
C0205324
%
Are there lesions which are not countable or measurable
Description

Non-Measurable Disease

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1334988
NCI Thesaurus Property
C25626
NCI Thesaurus ObjectClass
C2991
NCI Thesaurus ObjectClass-2
C25589
Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Assessment date
Description

LesionAssessmentDate

Data type

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
Assessment date
Description

LesionAssessmentDate

Data type

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 there any GI lesions present at this evaluation
Description

GastrointestinalSymptomPresentInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C13359
UMLS 2011AA ObjectClass
C0521362
NCI Thesaurus ObjectClass-2
C4876
UMLS 2011AA ObjectClass-2
C1457887
NCI Thesaurus Property
C4876
UMLS 2011AA Property
C1457887
Specify number of lesions
Description

LesionCount

Data type

float

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
Sites
Description

HeadandNeckTumorPrimaryLocation

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12418
UMLS 2011AA ObjectClass-2
C0460004
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property-2
C25251
UMLS 2011AA Property-2
C0205225
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
Evaluation method
Description

Evaluation method

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C16847
UMLS CUI-1
C2911685
Evaluation method
Description

Evaluation method

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C16847
UMLS CUI-1
C2911685
Pleural effusion
Description

Pleural Effusion

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0032227
NCI Thesaurus ObjectClass
C12468
NCI Thesaurus Property
C3003
NCI Thesaurus Property-2
C25223
Are there any oral cavity lesions present at this evaluation
Description

Arethereanyoralcavitylesionspresentatthisevaluation

Data type

text

Number of raised lesions
Description

Numberofraisedlesions

Data type

text

Are oral symptoms related to Kaposi's Sarcoma
Description

AreoralsymptomsrelatedtoKaposi'sSarcoma

Data type

text

Explain
Description

Explain

Data type

text

Kaposi's Sarcoma Present
Description

Kaposi'sSarcomaPresent

Data type

boolean

Photos taken
Description

Photostaken

Data type

boolean

Oral lesions
Description

Orallesions

Data type

text

Are there any GI symptoms related to Kaposi's Sarcoma
Description

ArethereanyGIsymptomsrelatedtoKaposi'sSarcoma

Data type

boolean

Explain
Description

Explain

Data type

text

Performed
Description

Performed

Data type

boolean

Are there any pulmonary KS lesions present at this evaluation
Description

ArethereanypulmonaryKSlesionspresentatthisevaluation

Data type

text

Indicate if the lesions are measurable or evaluable
Description

Indicateifthelesionsaremeasurableorevaluable

Data type

text

Are there any pulmonary symptoms related to Kaposi's Sarcoma
Description

ArethereanypulmonarysymptomsrelatedtoKaposi'sSarcoma

Data type

boolean

Explain
Description

Explain

Data type

text

Performed
Description

Performed

Data type

boolean

Number of new lesions
Description

Numberofnewlesions

Data type

text

Lesions Measurements
Description

Lesions Measurements

Site of Lesion
Description

Lesion Site, Primary

Data type

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS CUI-1
C0449695
NCI Thesaurus ObjectClass
C3824
NCI Thesaurus Property
C25341
Dimension 1
Description

TumorLargestDimensionMeasurement

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25550
UMLS 2011AA Property
C0443228
NCI Thesaurus Property-2
C25483
UMLS 2011AA Property-2
C0439534
cm
Dimension 2
Description

TumorSecondDimensionMeasurement

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25666
UMLS 2011AA Property
C0205436
NCI Thesaurus Property-2
C25483
UMLS 2011AA Property-2
C0439534
cm
Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Bronchoscopy date
Description

BronchoscopyPerformedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16366
UMLS 2011AA ObjectClass
C0006290
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
Bronchoscopy Performed
Description

BronchoscopyPerformed

Data type

boolean

Any other tests peformed
Description

Anyothertestspeformed

Data type

boolean

Other tests
Description

Othertests

Data type

text

Edema Evaluation
Description

Edema Evaluation

Compared to previous evaluation
Description

LesionFollow-UpAssessmentType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
Is there any tumor-associated edema at this evaluation
Description

Isthereanytumor-associatededemaatthisevaluation

Data type

boolean

Edema Site
Description

EdemaSite

Data type

text

Other, specify
Description

Other,specify

Data type

text

Edema present
Description

Edemapresent

Data type

boolean

Edema Evaluation
Description

EdemaEvaluation

Data type

text

Evaluation Of Extremity Edema
Description

Evaluation Of Extremity Edema

Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Status of edema
Description

Statusofedema

Data type

text

Specific location
Description

Specificlocation

Data type

text

Limb Girth
Description

LimbGirth

Data type

text

Evaluation Of Periorbital Edema
Description

Evaluation Of Periorbital Edema

Date of Evaluation
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
Photos taken
Description

Photostaken

Data type

boolean

Physical findings
Description

Physicalfindings

Data type

boolean

Specify
Description

Specify

Data type

text

Evaluation Of Scrotal/genital Swelling
Description

Evaluation Of Scrotal/genital Swelling

Photos taken
Description

Photostaken

Data type

boolean

Date
Description

Date

Data type

text

Physical findings
Description

Physicalfindings

Data type

boolean

Specify
Description

Specify

Data type

text

Evaluation Of Visceral Disease
Description

Evaluation Of Visceral Disease

Has a visceral disease evaluation been done since the last KS evaluation
Description

Documented clinical assessment for this cancer

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1522577
NCI Thesaurus Property
C16033
UMLS CUI-2
C0006826
NCI Thesaurus ObjectClass
C9305
NCI Thesaurus Property-2
C25365
Date of Evaluation
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
Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Procedure
Description

ProcedureName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25218
UMLS 2011AA ObjectClass
C1948041
NCI Thesaurus ObjectClass-2
C71104
UMLS 2011AA ObjectClass-2
C0008976
NCI Thesaurus Property
C42614
UMLS 2011AA Property
C0027365
Specify Procedure
Description

Evaluation method, specify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C2911685
NCI Thesaurus ObjectClass
C20989
UMLS CUI-2
C1521902
NCI Thesaurus Property
C16847
Has an evaluation for visceral disease been done
Description

Hasanevaluationforvisceraldiseasebeendone

Data type

boolean

Site of Lesion
Description

SiteofLesion

Data type

text

KS involvement
Description

KSinvolvement

Data type

text

Visceral Evaluation
Description

VisceralEvaluation

Data type

text

Interventions (in Addition To Study Drug Therapy)
Description

Interventions (in Addition To Study Drug Therapy)

Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Antiemetics
Description

AntiemeticTherapyAdministeredInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C267
UMLS 2011AA ObjectClass
C0003297
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Blood transfusions
Description

TransfusionReceivedInd

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ObjectClass
C15408
Steroids
Description

CorticosteroidAdministrationInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus ObjectClass
C2322
UMLS 2011AA ObjectClass
C0001617
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
Analgesics
Description

ChronicAnalgesicsAdminInd

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Analgesics
Description

ChronicAnalgesicsAdminInd

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Analgesics
Description

ChronicAnalgesicsAdminInd

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Local anesthetic/analgesic
Description

Localanesthetic/analgesic

Data type

boolean

Local interventions to KS lesions
Description

LocalinterventionstoKSlesions

Data type

boolean

Others
Description

Others

Data type

boolean

Specify
Description

Specify

Data type

text

Others
Description

Others

Data type

boolean

Specify
Description

Specify

Data type

text

Oxygen
Description

Oxygen

Data type

boolean

Bronchodilators
Description

Bronchodilators

Data type

boolean

Cough suppressant
Description

Coughsuppressant

Data type

boolean

Others
Description

Others

Data type

boolean

Specify
Description

Specify

Data type

text

Diuretics
Description

Diuretics

Data type

boolean

Others
Description

Others

Data type

boolean

Specify
Description

Specify

Data type

text

Local Therapy
Description

LocalTherapy

Data type

boolean

Others
Description

Others

Data type

boolean

Specify
Description

Specify

Data type

text

Others
Description

Others

Data type

boolean

Specify
Description

Specify

Data type

text

Uses cane, wheelchair
Description

Usescane,wheelchair

Data type

boolean

Others
Description

Others

Data type

boolean

Specify
Description

Specify

Data type

text

Overall Assessment
Description

Overall Assessment

Best overall response attained since Entry/Baseline
Description

TumorResponseCDUSType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
Date of Relapse or progression
Description

DiseaseRecurrentDiseaseCancerProgressionDiagnosisDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C38155
UMLS 2011AA Property
C0277556
NCI Thesaurus Property-2
C15220
UMLS 2011AA Property-2
C0011900
NCI Thesaurus Property-3
C19987
UMLS 2011AA Property-3
C0242656
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
During this reporting period, did a complete response occur
Description

CompleteResponseConfirmedInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25755
UMLS 2011AA ObjectClass
C0871261
NCI Thesaurus ObjectClass-2
C25250
UMLS 2011AA ObjectClass-2
C0205197
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Specify date of onset
Description

Complete Response First Observed Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C25755
UMLS CUI-1
C0677874
NCI Thesaurus ObjectClass-2
C25250
UMLS CUI-2
C1115465
NCI Thesaurus Property
C25509
NCI Thesaurus Property-2
C25599
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
During this reporting period, did a partial response occur
Description

PartialResponseConfirmedInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25755
UMLS 2011AA ObjectClass
C0871261
NCI Thesaurus ObjectClass-2
C25378
UMLS 2011AA ObjectClass-2
C0728938
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ValueDomain-2
C25755
UMLS 2011AA ValueDomain-2
C0871261
Specify date of onset
Description

Partial Response First Observed Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C25755
UMLS CUI-1
C1521726
NCI Thesaurus ObjectClass-2
C25378
UMLS CUI-2
C1115465
NCI Thesaurus Property
C25509
NCI Thesaurus Property-2
C25599
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
During this reporting period, did progression with no response occur
Description

DiseaseNewProgressionInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25586
UMLS 2011AA Property
C0205314
NCI Thesaurus Property-2
C25331
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
Specify date of onset
Description

ProgressionFirstObservedDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C25599
UMLS 2011AA Property-2
C1441672
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Signature
Description

Responsible Person Signature

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus ObjectClass-2
C25657
NCI Thesaurus Property
C25678
Date
Description

ResponsiblePersonSignatureDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass-2
C25657
UMLS 2011AA ObjectClass-2
C1273518
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
What is the present status of the best response
Description

Whatisthepresentstatusofthebestresponse

Data type

text

During this reporting period, did a clinical complete response occur
Description

Duringthisreportingperiod,didaclinicalcompleteresponseoccur

Data type

boolean

Specify date of onset
Description

Specifydateofonset

Data type

text

Similar models

No Instruction available.

  1. StudyEvent: KS Evaluation and Clinical Benefit Form: RK1
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient demographics
NCIInstitutionIdentifierCode
Item
Center
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C19202 (NCI Thesaurus ObjectClass-2)
C1513882 (UMLS 2011AA ObjectClass-2)
Study Number Participating Group
Item
Protocol
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)
Patient Study ID
Item
Participant ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Visit number
Item
Visit Number
float
C25337 (NCI Thesaurus ValueDomain)
C1549755 (UMLS CUI-1)
C16696 (NCI Thesaurus ObjectClass)
C25385 (NCI Thesaurus Property)
LesionAssessmentDate
Item
Assessment date
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)
Item
Time period
text
C25284 (NCI Thesaurus ValueDomain)
C2347804 (UMLS CUI-1)
C25214 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus ObjectClass-2)
Code List
Time period
CL Item
Baseline (Entry/Baseline)
C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)
CL Item
On treatment (On treatment)
CL Item
End Of Treatment (Post therapy evaluation)
Item Group
History And Symptoms
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Item
Are there any GI lesions present at this evaluation
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C13359 (NCI Thesaurus ObjectClass)
C0521362 (UMLS 2011AA ObjectClass)
C4876 (NCI Thesaurus ObjectClass-2)
C1457887 (UMLS 2011AA ObjectClass-2)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)
Code List
Are there any GI lesions present at this evaluation
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Not evaluated)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
ChronicDiseasePulmonaryInd-3
Item
Does the patient have other related pulmonary symptoms
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C14141 (NCI Thesaurus ObjectClass-2)
C0205191 (UMLS 2011AA ObjectClass-2)
CL317978 (NCI Metathesaurus Property)
Item
Patient symptoms of oral cavity lesions
text
Code List
Patient symptoms of oral cavity lesions
CL Item
No symptoms (No symptoms)
CL Item
Oral cavity symptoms not interfering with function (Oral cavity symptoms not interfering with function)
CL Item
Symptoms interfering w/functions sometimes, or occasional bleeding; can take adequate nutrition (Symptoms interfering w/functions sometimes, or occasional bleeding; can take adequate nutrition)
CL Item
Oral cavity symptoms interfering w/function most/all of the time, or recurrent bleeding (Oral cavity symptoms interfering w/function most/all of the time, or recurrent bleeding)
Doesthepatienthaveotherrelatedoralcavitysymptoms
Item
Does the patient have other related oral cavity symptoms
boolean
Specify
Item
Specify
text
Item
GI Symptoms
text
Code List
GI Symptoms
CL Item
No symptoms (No symptoms)
CL Item
Minimal GI symptoms (Minimal GI symptoms)
CL Item
Gross bleeding, or frequent GI symptoms (Gross bleeding, or frequent GI symptoms)
CL Item
Gross bleeding requiring transfusions, evidence of obstruction, unable to maintain adequate intake (Gross bleeding requiring transfusions, evidence of obstruction, unable to maintain adequate intake)
Specify
Item
Specify
text
Item
Patient symptoms
text
Code List
Patient symptoms
CL Item
No symptoms (No symptoms)
CL Item
Symptoms on exertion (Symptoms on exertion)
CL Item
Symptoms on normal activity (Symptoms on normal activity)
CL Item
Symptoms at rest, requiring oxygen or hemoptysis (Symptoms at rest, requiring oxygen or hemoptysis)
CL Item
Severely limited activities, +/- hemoptysis (Severely limited activities, +/- hemoptysis)
Specify
Item
Specify
text
Isthepatientexperiencingtumor-relatedpain
Item
Is the patient experiencing tumor-related pain
boolean
Item
Is the patient on analgesics
text
Code List
Is the patient on analgesics
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown (Unknown)
Item
What was the average pain experienced by the patient over the last 24 hours
text
Code List
What was the average pain experienced by the patient over the last 24 hours
CL Item
No pain (No pain)
CL Item
Mild pain (Mild pain)
CL Item
Discomforting pain (Discomforting pain)
CL Item
Distressing pain (Distressing pain)
CL Item
Horrible pain (Horrible pain)
CL Item
Excruciating pain (Excruciating pain)
Item
Pain
text
Code List
Pain
CL Item
Present (Present)
CL Item
Absent (Absent)
AnatomicSiteofWorstPain
Item
Anatomic Site of Worst Pain
text
Item
Patient symptoms of edema
text
Code List
Patient symptoms of edema
CL Item
No edema, no symptoms (No edema, no symptoms)
CL Item
Completely resolves with limb elevation and rings/shoes fit without difficulty (Completely resolves with limb elevation and rings/shoes fit without difficulty)
CL Item
Does not completely resolve with limb elevation or rings/shoes do not fit normally (Does not completely resolve with limb elevation or rings/shoes do not fit normally)
CL Item
No improvement with limb elevation or interferes with normal function (No improvement with limb elevation or interferes with normal function)
CL Item
Significantly reduced function (Significantly reduced function)
Item
Patient symptoms of periorbital edema
text
Code List
Patient symptoms of periorbital edema
CL Item
No periorbital edema (No periorbital edema)
CL Item
Swelling of the eyes noted occasionally or improves over the day (Swelling of the eyes noted occasionally or improves over the day)
CL Item
Swelling of the eyes noted at all times but does not interfere with eyesight or function (Swelling of the eyes noted at all times but does not interfere with eyesight or function)
CL Item
Swelling of eyes noted at all times and interferes with eyesight or function sometimes (Swelling of eyes noted at all times and interferes with eyesight or function sometimes)
CL Item
Swelling of eyes noted at all times and interferes with eyesight or function at all times (Swelling of eyes noted at all times and interferes with eyesight or function at all times)
Item
Patient symptoms of scrotal/genital swelling
text
Code List
Patient symptoms of scrotal/genital swelling
CL Item
No scrotal/genital edema (No scrotal/genital edema)
CL Item
Swelling of the scrotum noted occasionally (Swelling of the scrotum noted occasionally)
CL Item
Swelling of the scrotum noted at all times but no symptoms (Swelling of the scrotum noted at all times but no symptoms)
CL Item
Swelling interferes with urination, sexual function, withdrawing foreskin sometimes (Swelling interferes with urination, sexual function, withdrawing foreskin sometimes)
CL Item
Swelling interferes with urination, sexual function, withdrawing foreskin all the time (Swelling interferes with urination, sexual function, withdrawing foreskin all the time)
Item
Patient symptoms of foot KS
text
Code List
Patient symptoms of foot KS
CL Item
Lesions present but no symptoms. Able to perform normal activities (Lesions present but no symptoms. Able to perform normal activities)
CL Item
Active but cannot perform more than normal activities (Active but cannot perform more than normal activities)
CL Item
Normal activities mildly limited because of foot KS (Normal activities mildly limited because of foot KS)
CL Item
Moderate impairment of activity because of foot KS (Moderate impairment of activity because of foot KS)
CL Item
Severe impairment of activity due to foot KS (Severe impairment of activity due to foot KS)
Item Group
Evaluation Of Cutaneous Lesions
Item
Representative Area
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
Code List
Representative Area
CL Item
Total body (Total body)
CL Item
Head (Head)
CL Item
Neck (Neck)
CL Item
Chest (Chest)
CL Item
Abdomen (Abdomen)
CL Item
Back (Back)
CL Item
Right arm (Right arm)
CL Item
Left arm (Left arm)
CL Item
Right leg (Right leg)
CL Item
Left leg (Left leg)
CL Item
Right hand (Right hand)
CL Item
Left hand (Left hand)
CL Item
Right foot (Right foot)
CL Item
Left foot (Left foot)
CL Item
Genital (Genital)
LesionCount
Item
Specify number of lesions
float
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
Atentry,doesthepatienthave>=50lesions
Item
At entry, does the patient have >=50 lesions
boolean
TotalNumberRaisedLesions
Item
Total Number Raised Lesions
text
TotalNumberFlatLesions
Item
Total Number Flat Lesions
text
TotalNumberNewLesions
Item
Total Number New Lesions
text
Item
Character of cutaneous Lesions
text
Code List
Character of cutaneous Lesions
CL Item
Since baseline, >=50% of raised have become flat (Since baseline, >=50% of raised have become flat)
CL Item
>=25% increase in the number of raised lesions since baseline or since best response (>=25% increase in the number of raised lesions since baseline or since best response)
CL Item
None of the above (None of the above)
Item Group
Evaluation Of Marker Lesions
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
LesionCount
Item
Specify number of lesions
float
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
Item
Site Code
text
Code List
Site Code
CL Item
Total body (Total body)
CL Item
Head (Head)
CL Item
Neck (Neck)
CL Item
Chest (Chest)
CL Item
Abdomen (Abdomen)
CL Item
Back (Back)
CL Item
Right arm (Right arm)
CL Item
Left arm (Left arm)
CL Item
Right leg (Right leg)
CL Item
Left leg (Left leg)
CL Item
Right hand (Right hand)
CL Item
Left hand (Left hand)
CL Item
Right foot (Right foot)
CL Item
Left foot (Left foot)
CL Item
Genital (Genital)
Specify
Item
Specify
text
Item Group
Evaluation Of Foot Ks
Item
Compared to previous evaluation
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
Code List
Compared to previous evaluation
CL Item
Improvement (Better)
CL Item
No Change (Same)
CL Item
Worsening (Worse)
Assessment Date
Item
Date of Evaluation
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
Item
Foot KS
text
Code List
Foot KS
CL Item
Present (Present)
CL Item
Absent (Absent)
Photostaken
Item
Photos taken
boolean
Physicalfindings
Item
Physical findings
boolean
Specify
Item
Specify
text
Item Group
Evaluation Of Oral Cavity
Assessment Date
Item
Date of Evaluation
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
FlatLesionQuantityNumber
Item
Number of flat lesions
float
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C0205324 (NCI Metathesaurus ObjectClass)
Non-Measurable Disease
Item
Are there lesions which are not countable or measurable
boolean
C38148 (NCI Thesaurus ValueDomain)
C1334988 (UMLS CUI-1)
C25626 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C25589 (NCI Thesaurus ObjectClass-2)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
LesionAssessmentDate
Item
Assessment date
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)
LesionAssessmentDate
Item
Assessment date
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)
Item
Are there any GI lesions present at this evaluation
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C13359 (NCI Thesaurus ObjectClass)
C0521362 (UMLS 2011AA ObjectClass)
C4876 (NCI Thesaurus ObjectClass-2)
C1457887 (UMLS 2011AA ObjectClass-2)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)
Code List
Are there any GI lesions present at this evaluation
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Not evaluated)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
LesionCount
Item
Specify number of lesions
float
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
Item
Sites
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12418 (NCI Thesaurus ObjectClass-2)
C0460004 (UMLS 2011AA ObjectClass-2)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25251 (NCI Thesaurus Property-2)
C0205225 (UMLS 2011AA Property-2)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
Code List
Sites
CL Item
Upper Gingiva (Gingiva/gums)
CL Item
Hard Palate (Hard palate)
C12230 (NCI Thesaurus)
C0226901 (UMLS 2011AA)
CL Item
Soft Palate (Soft palate)
C12231 (NCI Thesaurus)
C0030219 (UMLS 2011AA)
CL Item
Buccal Mucosa (Buccal mucosa)
C12505 (NCI Thesaurus)
C1578559 (UMLS 2011AA)
CL Item
Oral Tongue (Tongue)
CL Item
Floor Of Mouth (Floor of mouth)
C0026638 (NCI Metathesaurus)
CL Item
Tonsils (Tonsils)
CL Item
Uvula (Uvula)
CL Item
Posterior Pharyngeal Wall (Posterior pharynx)
Item
Evaluation method
text
C25284 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
C2911685 (UMLS CUI-1)
Code List
Evaluation method
CL Item
Chest X-ray (CXR)
CL Item
Ct Scan (CT scan)
Item
Evaluation method
text
C25284 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
C2911685 (UMLS CUI-1)
Code List
Evaluation method
CL Item
Chest X-ray (CXR)
CL Item
Ct Scan (CT scan)
Pleural Effusion
Item
Pleural effusion
boolean
C38148 (NCI Thesaurus ValueDomain)
C0032227 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass)
C3003 (NCI Thesaurus Property)
C25223 (NCI Thesaurus Property-2)
Item
Are there any oral cavity lesions present at this evaluation
text
Code List
Are there any oral cavity lesions present at this evaluation
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not evaluated (Not evaluated)
Numberofraisedlesions
Item
Number of raised lesions
text
Item
Are oral symptoms related to Kaposi's Sarcoma
text
Code List
Are oral symptoms related to Kaposi's Sarcoma
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
No symptoms (No symptoms)
Explain
Item
Explain
text
Kaposi'sSarcomaPresent
Item
Kaposi's Sarcoma Present
boolean
Photostaken
Item
Photos taken
boolean
Item
Oral lesions
text
Code List
Oral lesions
CL Item
A resolution of all oral lesions since baseline (A resolution of all oral lesions since baseline)
CL Item
An improvement of oral lesions since baseline (An improvement of oral lesions since baseline)
CL Item
A worsening of oral lesions since baseline or best response (A worsening of oral lesions since baseline or best response)
CL Item
New oral lesions (New oral lesions)
CL Item
None of the above (None of the above)
ArethereanyGIsymptomsrelatedtoKaposi'sSarcoma
Item
Are there any GI symptoms related to Kaposi's Sarcoma
boolean
Explain
Item
Explain
text
Performed
Item
Performed
boolean
Item
Are there any pulmonary KS lesions present at this evaluation
text
Code List
Are there any pulmonary KS lesions present at this evaluation
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not evaluated (Not evaluated)
Item
Indicate if the lesions are measurable or evaluable
text
Code List
Indicate if the lesions are measurable or evaluable
CL Item
Measurable (Measurable)
CL Item
Evaluable (Evaluable)
CL Item
Both measurable and evaluable (Both measurable and evaluable)
ArethereanypulmonarysymptomsrelatedtoKaposi'sSarcoma
Item
Are there any pulmonary symptoms related to Kaposi's Sarcoma
boolean
Explain
Item
Explain
text
Performed
Item
Performed
boolean
Numberofnewlesions
Item
Number of new lesions
text
Item Group
Lesions Measurements
Lesion Site, Primary
Item
Site of Lesion
text
C13717 (NCI Thesaurus ValueDomain)
C0449695 (UMLS CUI-1)
C3824 (NCI Thesaurus ObjectClass)
C25341 (NCI Thesaurus Property)
TumorLargestDimensionMeasurement
Item
Dimension 1
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25550 (NCI Thesaurus Property)
C0443228 (UMLS 2011AA Property)
C25483 (NCI Thesaurus Property-2)
C0439534 (UMLS 2011AA Property-2)
TumorSecondDimensionMeasurement
Item
Dimension 2
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25666 (NCI Thesaurus Property)
C0205436 (UMLS 2011AA Property)
C25483 (NCI Thesaurus Property-2)
C0439534 (UMLS 2011AA Property-2)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
BronchoscopyPerformedDate
Item
Bronchoscopy date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16366 (NCI Thesaurus ObjectClass)
C0006290 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
BronchoscopyPerformed
Item
Bronchoscopy Performed
boolean
Anyothertestspeformed
Item
Any other tests peformed
boolean
Othertests
Item
Other tests
text
Item Group
Edema Evaluation
Item
Compared to previous evaluation
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
Code List
Compared to previous evaluation
CL Item
Improvement (Better)
CL Item
No Change (Same)
CL Item
Worsening (Worse)
Isthereanytumor-associatededemaatthisevaluation
Item
Is there any tumor-associated edema at this evaluation
boolean
Item
Edema Site
text
Code List
Edema Site
CL Item
Periorbital (Periorbital)
CL Item
Genital (Genital)
CL Item
Right arm (Right arm)
CL Item
Left arm (Left arm)
CL Item
Right leg (Right leg)
CL Item
Left leg (Left leg)
CL Item
Right hand (Right hand)
CL Item
Left hand (Left hand)
CL Item
Right foot (Right foot)
CL Item
Left foot (Left foot)
CL Item
Other (Other)
Other,specify
Item
Other, specify
text
Edemapresent
Item
Edema present
boolean
Item
Edema Evaluation
text
Code List
Edema Evaluation
CL Item
A resolution of all tumor-associated edema since baseline (A resolution of all tumor-associated edema since baseline)
CL Item
An improvement of tumor-associated edema since baseline (An improvement of tumor-associated edema since baseline)
CL Item
A worsening of tumor-associated edema since baseline or best response (A worsening of tumor-associated edema since baseline or best response)
CL Item
New tumor-associated edema (New tumor-associated edema)
CL Item
No Change (No Change)
Item Group
Evaluation Of Extremity Edema
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Item
Status of edema
text
Code List
Status of edema
CL Item
Present (Present)
CL Item
Absent (Absent)
Specificlocation
Item
Specific location
text
LimbGirth
Item
Limb Girth
text
Item Group
Evaluation Of Periorbital Edema
Assessment Date
Item
Date of Evaluation
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
Photostaken
Item
Photos taken
boolean
Physicalfindings
Item
Physical findings
boolean
Specify
Item
Specify
text
Item Group
Evaluation Of Scrotal/genital Swelling
Photostaken
Item
Photos taken
boolean
Date
Item
Date
text
Physicalfindings
Item
Physical findings
boolean
Specify
Item
Specify
text
Item Group
Evaluation Of Visceral Disease
Documented clinical assessment for this cancer
Item
Has a visceral disease evaluation been done since the last KS evaluation
boolean
C38148 (NCI Thesaurus ValueDomain)
C1522577 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C0006826 (UMLS CUI-2)
C9305 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property-2)
Assessment Date
Item
Date of Evaluation
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Item
Procedure
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25218 (NCI Thesaurus ObjectClass)
C1948041 (UMLS 2011AA ObjectClass)
C71104 (NCI Thesaurus ObjectClass-2)
C0008976 (UMLS 2011AA ObjectClass-2)
C42614 (NCI Thesaurus Property)
C0027365 (UMLS 2011AA Property)
Code List
Procedure
CL Item
Upper endoscopy (Upper endoscopy)
CL Item
Colonoscopy (Colonoscopy)
C16450 (NCI Thesaurus)
C0009378 (UMLS 2011AA)
CL Item
Sigmoidoscopy (Sigmoidoscopy)
CL Item
Chest X-ray (Chest X-ray)
CL Item
Bronchoscopy (Bronchoscopy)
C16366 (NCI Thesaurus)
C0006290 (UMLS 2011AA)
CL Item
Other (Other)
Evaluation method, specify
Item
Specify Procedure
text
C25685 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C16847 (NCI Thesaurus Property)
Hasanevaluationforvisceraldiseasebeendone
Item
Has an evaluation for visceral disease been done
boolean
Item
Site of Lesion
text
Code List
Site of Lesion
CL Item
Total body (Total body)
CL Item
Head (Head)
CL Item
Neck (Neck)
CL Item
Chest (Chest)
CL Item
Abdomen (Abdomen)
CL Item
Back (Back)
CL Item
Right arm (Right arm)
CL Item
Left arm (Left arm)
CL Item
Right leg (Right leg)
CL Item
Left leg (Left leg)
CL Item
Right hand (Right hand)
CL Item
Left hand (Left hand)
CL Item
Right foot (Right foot)
CL Item
Left foot (Left foot)
CL Item
Genital (Genital)
Item
KS involvement
text
Code List
KS involvement
CL Item
Present (Present)
CL Item
Absent (Absent)
Item
Visceral Evaluation
text
Code List
Visceral Evaluation
CL Item
A complete resolution of visceral disease since baseline (A complete resolution of visceral disease since baseline)
CL Item
A decrease in visceral disease since baseline (A decrease in visceral disease since baseline)
CL Item
A worsening of visceral disease since baseline, or since the best response (A worsening of visceral disease since baseline, or since the best response)
CL Item
Evidence of a new site of visceral diseases since baseline, or since the best response (Evidence of a new site of visceral diseases since baseline, or since the best response)
CL Item
No Change (No Change)
CL Item
Not applicable, Entry/Baseline evaluation (Not applicable, Entry/Baseline evaluation)
Item Group
Interventions (in Addition To Study Drug Therapy)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
AntiemeticTherapyAdministeredInd-3
Item
Antiemetics
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C267 (NCI Thesaurus ObjectClass-2)
C0003297 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
TransfusionReceivedInd
Item
Blood transfusions
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C15408 (NCI Thesaurus ObjectClass)
CorticosteroidAdministrationInd-3
Item
Steroids
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C2322 (NCI Thesaurus ObjectClass)
C0001617 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
ChronicAnalgesicsAdminInd
Item
Analgesics
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
ChronicAnalgesicsAdminInd
Item
Analgesics
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
ChronicAnalgesicsAdminInd
Item
Analgesics
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Localanesthetic/analgesic
Item
Local anesthetic/analgesic
boolean
LocalinterventionstoKSlesions
Item
Local interventions to KS lesions
boolean
Others
Item
Others
boolean
Specify
Item
Specify
text
Others
Item
Others
boolean
Specify
Item
Specify
text
Oxygen
Item
Oxygen
boolean
Bronchodilators
Item
Bronchodilators
boolean
Coughsuppressant
Item
Cough suppressant
boolean
Others
Item
Others
boolean
Specify
Item
Specify
text
Diuretics
Item
Diuretics
boolean
Others
Item
Others
boolean
Specify
Item
Specify
text
LocalTherapy
Item
Local Therapy
boolean
Others
Item
Others
boolean
Specify
Item
Specify
text
Others
Item
Others
boolean
Specify
Item
Specify
text
Usescane,wheelchair
Item
Uses cane, wheelchair
boolean
Others
Item
Others
boolean
Specify
Item
Specify
text
Item Group
Overall Assessment
Item
Best overall response attained since Entry/Baseline
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
Code List
Best overall response attained since Entry/Baseline
CL Item
Complete Response (Complete)
CL Item
Clinical complete response (Clinical complete response)
CL Item
Partial Response (Partial response)
C18212 (NCI Thesaurus)
CL Item
Stable Disease (Stable)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
CL Item
Progression (Progression)
C25331 (NCI Thesaurus)
CL Item
Not Assessed (Unevaluable)
CL Item
Other (Unknown)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
DiseaseRecurrentDiseaseCancerProgressionDiagnosisDate
Item
Date of Relapse or progression
date
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C19987 (NCI Thesaurus Property-3)
C0242656 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
CompleteResponseConfirmedInd-3
Item
During this reporting period, did a complete response occur
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus ObjectClass-2)
C0205197 (UMLS 2011AA ObjectClass-2)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Complete Response First Observed Date
Item
Specify date of onset
date
C25755 (NCI Thesaurus ObjectClass)
C0677874 (UMLS CUI-1)
C25250 (NCI Thesaurus ObjectClass-2)
C1115465 (UMLS CUI-2)
C25509 (NCI Thesaurus Property)
C25599 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
PartialResponseConfirmedInd-3
Item
During this reporting period, did a partial response occur
boolean
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25378 (NCI Thesaurus ObjectClass-2)
C0728938 (UMLS 2011AA ObjectClass-2)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ValueDomain-2)
C0871261 (UMLS 2011AA ValueDomain-2)
Partial Response First Observed Date
Item
Specify date of onset
date
C25755 (NCI Thesaurus ObjectClass)
C1521726 (UMLS CUI-1)
C25378 (NCI Thesaurus ObjectClass-2)
C1115465 (UMLS CUI-2)
C25509 (NCI Thesaurus Property)
C25599 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
DiseaseNewProgressionInd-2
Item
During this reporting period, did progression with no response occur
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C25331 (NCI Thesaurus Property-2)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
ProgressionFirstObservedDate
Item
Specify date of onset
date
C25331 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25599 (NCI Thesaurus Property-2)
C1441672 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Responsible Person Signature
Item
Signature
text
C25704 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C25657 (NCI Thesaurus ObjectClass-2)
C25678 (NCI Thesaurus Property)
ResponsiblePersonSignatureDate
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass-2)
C1273518 (UMLS 2011AA ObjectClass-2)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
Item
What is the present status of the best response
text
Code List
What is the present status of the best response
CL Item
Response continuing or first time at this response (Response continuing or first time at this response)
CL Item
Relapse occurred after a response was achieved (Relapse occurred after a response was achieved)
CL Item
No relapse observed, but patient died (No relapse observed, but patient died)
CL Item
Not Applicable (Not Applicable)
Duringthisreportingperiod,didaclinicalcompleteresponseoccur
Item
During this reporting period, did a clinical complete response occur
boolean
Specifydateofonset
Item
Specify date of onset
text

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