ID

8544

Beschrijving

AMC Clinical Trials - Kaposi's Sarcoma Evaluation and Clinical Benefits Form - RKS04 Valproic Acid in Treating Patients With Kaposi's Sarcoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DB5869F0-3E8A-0820-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DB5869F0-3E8A-0820-E034-0003BA12F5E7

Trefwoorden

  1. 19-09-12 19-09-12 -
  2. 09-01-15 09-01-15 - Martin Dugas
  3. 27-06-15 27-06-15 -
Geüploaded op

9 januari 2015

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy

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NCT00075777 Lab - AMC Clinical Trials - Kaposi's Sarcoma Evaluation and Clinical Benefits Form - RKS04 - 2281756v3.0

No Instruction available.

  1. StudyEvent: AMC Clinical Trials - Kaposi's Sarcoma Evaluation and Clinical Benefits Form - RKS04
    1. No Instruction available.
Unnamed 1
Beschrijving

Unnamed 1

Patient Initials
Beschrijving

Patient Initials

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Study #
Beschrijving

Protocol ID Coordinating Group

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1711341
NCI Thesaurus Property
C25462
NCI Thesaurus Property-2
C25364
Site #
Beschrijving

NCIInstitutionIdentifierCode

Datatype

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
ID #
Beschrijving

Patient Study ID

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25462
NCI Thesaurus Property-2
C25364
Cycle #
Beschrijving

Cycle Number Chemotherapeutics

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2045829
NCI Thesaurus Property
C25471
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25379
Comments
Beschrijving

Research Comments

Datatype

text

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

Research Comments

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Date of Procedure
Beschrijving

LesionAssessmentDate

Datatype

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
Date of Procedure
Beschrijving

LesionAssessmentDate

Datatype

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
Date of Procedure
Beschrijving

LesionAssessmentDate

Datatype

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
Date of Procedure
Beschrijving

LesionAssessmentDate

Datatype

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
Number of lesions
Beschrijving

LesionCount

Datatype

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
Specify Site
Beschrijving

Lesion Site, Primary

Datatype

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS CUI-1
C0449695
NCI Thesaurus ObjectClass
C3824
NCI Thesaurus Property
C25341
Specify Site
Beschrijving

Lesion Site, Primary

Datatype

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS CUI-1
C0449695
NCI Thesaurus ObjectClass
C3824
NCI Thesaurus Property
C25341
Date of relapse
Beschrijving

DiseaseRecurrentDiseaseCancerProgressionDiagnosisDate

Datatype

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
Which Kaposi's Sarcoma evaluation does this represent?
Beschrijving

WhichKaposi'sSarcomaevaluationdoesthisrepresent?

Datatype

text

Patient Symptoms of Oral Cavity Lesions
Beschrijving

PatientSymptomsofOralCavityLesions

Datatype

text

Other related symptoms (e.g., swallowing, eating, speaking)
Beschrijving

Otherrelatedsymptoms(e.g.,swallowing,eating,speaking)

Datatype

text

GI symptoms
Beschrijving

GIsymptoms

Datatype

text

Other related symptoms (e.g., swallowing, eating, speaking)
Beschrijving

Otherrelatedsymptoms(e.g.,swallowing,eating,speaking)

Datatype

text

Patient symptoms
Beschrijving

Patientsymptoms

Datatype

text

Other related symptoms (e.g., swallowing, eating, speaking)
Beschrijving

Otherrelatedsymptoms(e.g.,swallowing,eating,speaking)

Datatype

text

Is the patient experiencing tumor-related pain?
Beschrijving

Isthepatientexperiencingtumor-relatedpain?

Datatype

boolean

Is the patient on analgesics?
Beschrijving

Isthepatientonanalgesics?

Datatype

text

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

Whatwastheaveragepainexperiencedbythepatientoverthelast24hours?

Datatype

text

Pain
Beschrijving

Pain

Datatype

text

Anatomic Site of Worst Pain
Beschrijving

AnatomicSiteofWorstPain

Datatype

text

Patient Symptoms of Edema
Beschrijving

PatientSymptomsofEdema

Datatype

text

Patient Symptoms of Periorbital Edema
Beschrijving

PatientSymptomsofPeriorbitalEdema

Datatype

text

Patient symptoms of scrotal/genital swelling
Beschrijving

Patientsymptomsofscrotal/genitalswelling

Datatype

text

Patient symptoms of foot KS
Beschrijving

PatientsymptomsoffootKS

Datatype

text

At entry, does the patient have >= 50 lesions?
Beschrijving

Atentry,doesthepatienthave>=50lesions?

Datatype

boolean

Representative Area
Beschrijving

RepresentativeArea

Datatype

text

Total Number Raised Lesions
Beschrijving

TotalNumberRaisedLesions

Datatype

text

Total Number Flat Lesions
Beschrijving

TotalNumberFlatLesions

Datatype

text

Total Number New Lesions
Beschrijving

TotalNumberNewLesions

Datatype

text

Evaluation of Cutaneous Lesions
Beschrijving

EvaluationofCutaneousLesions

Datatype

text

Character of cutaneous lesions
Beschrijving

Characterofcutaneouslesions

Datatype

text

Site Code
Beschrijving

SiteCode

Datatype

text

Specify
Beschrijving

Specify

Datatype

text

Perpendicular Diameters
Beschrijving

PerpendicularDiameters

Datatype

text

Product of Diameters
Beschrijving

ProductofDiameters

Datatype

text

Photos Taken?
Beschrijving

PhotosTaken?

Datatype

boolean

Sum of Products
Beschrijving

SumofProducts

Datatype

text

Evaluation of Marker Lesions
Beschrijving

EvaluationofMarkerLesions

Datatype

text

Foot KS
Beschrijving

FootKS

Datatype

text

Compared to previous evaluation
Beschrijving

Comparedtopreviousevaluation

Datatype

text

Photos Taken?
Beschrijving

PhotosTaken?

Datatype

boolean

If Photos taken, Date?
Beschrijving

IfPhotostaken,Date?

Datatype

text

Physical findings
Beschrijving

Physicalfindings

Datatype

text

Are there any oral cavity lesions present at this evaluation?
Beschrijving

Arethereanyoralcavitylesionspresentatthisevaluation?

Datatype

text

Number of raised lesions
Beschrijving

Numberofraisedlesions

Datatype

text

Number of flat lesions
Beschrijving

Numberofflatlesions

Datatype

text

Are there lesions which are not countable or measurable?
Beschrijving

Aretherelesionswhicharenotcountableormeasurable?

Datatype

boolean

Are oral symptoms related to Kaposi's Sarcoma?
Beschrijving

AreoralsymptomsrelatedtoKaposi'sSarcoma?

Datatype

text

If not, explain
Beschrijving

Ifnot,explain

Datatype

text

Oral Site
Beschrijving

OralSite

Datatype

text

Kaposi's Sarcoma Present?
Beschrijving

Kaposi'sSarcomaPresent?

Datatype

boolean

Photos Taken?
Beschrijving

PhotosTaken?

Datatype

boolean

If Photos taken, Date?
Beschrijving

IfPhotostaken,Date?

Datatype

text

Oral cavity evaluation
Beschrijving

Oralcavityevaluation

Datatype

text

Are there any GI lesions present at this evaluation?
Beschrijving

ArethereanyGIlesionspresentatthisevaluation?

Datatype

text

Are the GI symptoms related to Kaposi's Sarcoma?
Beschrijving

AretheGIsymptomsrelatedtoKaposi'sSarcoma?

Datatype

boolean

If not, explain
Beschrijving

Ifnot,explain

Datatype

text

Documentation
Beschrijving

Documentation

Datatype

text

Findings
Beschrijving

Findings

Datatype

text

Are there any pulmonary KS lesions present at this evaluation?
Beschrijving

ArethereanypulmonaryKSlesionspresentatthisevaluation?

Datatype

text

If YES, indicate if the lesions are measurable or evaluable
Beschrijving

IfYES,indicateifthelesionsaremeasurableorevaluable

Datatype

text

Are the pulmonary symptoms related to Kaposi's Sarcoma?
Beschrijving

ArethepulmonarysymptomsrelatedtoKaposi'sSarcoma?

Datatype

boolean

If not, explain
Beschrijving

Ifnot,explain

Datatype

text

Documentation
Beschrijving

Documentation

Datatype

text

Pleural Effusion?
Beschrijving

PleuralEffusion?

Datatype

boolean

Number of new lesions
Beschrijving

Numberofnewlesions

Datatype

text

Measurements
Beschrijving

Measurements

Datatype

text

Bronchoscopy Date
Beschrijving

BronchoscopyDate

Datatype

text

Findings
Beschrijving

Findings

Datatype

text

Other Tests
Beschrijving

OtherTests

Datatype

text

Findings
Beschrijving

Findings

Datatype

text

Is there any tumor-associated edema at this evaluation?
Beschrijving

Isthereanytumor-associatededemaatthisevaluation?

Datatype

boolean

Edema Site
Beschrijving

EdemaSite

Datatype

text

If Other, Specify
Beschrijving

IfOther,Specify

Datatype

text

Edema Present?
Beschrijving

EdemaPresent?

Datatype

boolean

Compared to Previous Evaluation
Beschrijving

ComparedtoPreviousEvaluation

Datatype

text

Tumor associated edema
Beschrijving

Tumorassociatededema

Datatype

text

Edema
Beschrijving

Edema

Datatype

text

Specific Location
Beschrijving

SpecificLocation

Datatype

text

Limb Girth
Beschrijving

LimbGirth

Datatype

text

Other Findings
Beschrijving

OtherFindings

Datatype

text

Photos Taken?
Beschrijving

PhotosTaken?

Datatype

boolean

If Photos taken, Date?
Beschrijving

IfPhotostaken,Date?

Datatype

text

Physical findings
Beschrijving

Physicalfindings

Datatype

text

Photos Taken?
Beschrijving

PhotosTaken?

Datatype

boolean

If Photos taken, Date?
Beschrijving

IfPhotostaken,Date?

Datatype

text

Physical findings
Beschrijving

Physicalfindings

Datatype

text

Has a visceral disease evaluation been done since the last KS evaluation?
Beschrijving

HasavisceraldiseaseevaluationbeendonesincethelastKSevaluation?

Datatype

boolean

Site Code
Beschrijving

SiteCode

Datatype

text

KS Invol
Beschrijving

KSInvol

Datatype

text

Visc Eval
Beschrijving

ViscEval

Datatype

text

Proced
Beschrijving

Proced

Datatype

text

Specify Procedure
Beschrijving

SpecifyProcedure

Datatype

text

Interventions for Oral Cavity Lesions
Beschrijving

InterventionsforOralCavityLesions

Datatype

text

Others, specify
Beschrijving

Others,specify

Datatype

text

Interventions for GI Lesions
Beschrijving

InterventionsforGILesions

Datatype

text

Others, specify
Beschrijving

Others,specify

Datatype

text

Interventions for Pulmonary Lesion
Beschrijving

InterventionsforPulmonaryLesion

Datatype

text

Others, specify
Beschrijving

Others,specify

Datatype

text

Interventions for Extremity Edema
Beschrijving

InterventionsforExtremityEdema

Datatype

text

Others, specify
Beschrijving

Others,specify

Datatype

text

Interventions for Periorbital Edema:
Beschrijving

InterventionsforPeriorbitalEdema:

Datatype

text

Others, specify
Beschrijving

Others,specify

Datatype

text

Interventions for Scrotal/Genital Swelling
Beschrijving

InterventionsforScrotal/GenitalSwelling

Datatype

text

Others, specify
Beschrijving

Others,specify

Datatype

text

Interventions for Foot KS
Beschrijving

InterventionsforFootKS

Datatype

text

Others, specify
Beschrijving

Others,specify

Datatype

text

Best overall response attained since Entry/Baseline
Beschrijving

BestoverallresponseattainedsinceEntry/Baseline

Datatype

text

What is the present status of the best response?
Beschrijving

Whatisthepresentstatusofthebestresponse?

Datatype

text

Unnamed 6
Beschrijving

Unnamed6

Datatype

text

Date of Onset
Beschrijving

DateofOnset

Datatype

text

Similar models

No Instruction available.

  1. StudyEvent: AMC Clinical Trials - Kaposi's Sarcoma Evaluation and Clinical Benefits Form - RKS04
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Unnamed 1
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Protocol ID Coordinating Group
Item
Study #
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1711341 (UMLS CUI-2)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
NCIInstitutionIdentifierCode
Item
Site #
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)
Patient Study ID
Item
ID #
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Cycle Number Chemotherapeutics
Item
Cycle #
text
C25337 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25471 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus 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)
LesionAssessmentDate
Item
Date of Procedure
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
Date of Procedure
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
Date of Procedure
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
Date of Procedure
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)
LesionCount
Item
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)
Lesion Site, Primary
Item
Specify Site
text
C13717 (NCI Thesaurus ValueDomain)
C0449695 (UMLS CUI-1)
C3824 (NCI Thesaurus ObjectClass)
C25341 (NCI Thesaurus Property)
Lesion Site, Primary
Item
Specify Site
text
C13717 (NCI Thesaurus ValueDomain)
C0449695 (UMLS CUI-1)
C3824 (NCI Thesaurus ObjectClass)
C25341 (NCI Thesaurus Property)
DiseaseRecurrentDiseaseCancerProgressionDiagnosisDate
Item
Date of relapse
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)
Item
Which Kaposi's Sarcoma evaluation does this represent?
text
Code List
Which Kaposi's Sarcoma evaluation does this represent?
CL Item
Entry/Baseline (Entry/Baseline)
CL Item
On Treatment (On Treatment)
CL Item
Post Therapy Evaluation (Post Therapy Evaluation)
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
Oral cavity symptoms interfering with functions sometimes, or occasional bleeding. Still able to take adequate nutrition. (Oral cavity symptoms interfering with functions sometimes, or occasional bleeding. Still able to take adequate nutrition.)
CL Item
Oral cavity symptoms interfering with function most/all of the time, or recurrent bleeding, or requires alteration of food choices, or restriction of food intake (Oral cavity symptoms interfering with function most/all of the time, or recurrent bleeding, or requires alteration of food choices, or restriction of food intake)
Otherrelatedsymptoms(e.g.,swallowing,eating,speaking)
Item
Other related symptoms (e.g., swallowing, eating, speaking)
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, or unable to maintain adequate food intake with involuntary weight loss of > 5% from baseline (Gross bleeding requiring transfusions, evidence of obstruction, or unable to maintain adequate food intake with involuntary weight loss of > 5% from baseline)
Otherrelatedsymptoms(e.g.,swallowing,eating,speaking)
Item
Other related symptoms (e.g., swallowing, eating, speaking)
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 O or hemoptysis (Symptoms at rest, requiring O or hemoptysis)
CL Item
Severely limited activities, +/- gross hemoptysis (Severely limited activities, +/- gross hemoptysis)
Otherrelatedsymptoms(e.g.,swallowing,eating,speaking)
Item
Other related symptoms (e.g., swallowing, eating, speaking)
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 more than normal activities (e.g., run, dance, hike.) (Lesions present but no symptoms. Able to perform more than normal activities (e.g., run, dance, hike.))
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)
Atentry,doesthepatienthave>=50lesions?
Item
At entry, does the patient have >= 50 lesions?
boolean
RepresentativeArea
Item
Representative Area
text
TotalNumberRaisedLesions
Item
Total Number Raised Lesions
text
TotalNumberFlatLesions
Item
Total Number Flat Lesions
text
TotalNumberNewLesions
Item
Total Number New Lesions
text
Item
Evaluation of Cutaneous Lesions
text
Code List
Evaluation of Cutaneous Lesions
CL Item
Complete Resolution (Complete Resolution)
CL Item
>= 50% decrease in the number of lesions since baseline (>= 50% decrease in the number of lesions since baseline)
CL Item
>= 25% increase in the number of lesions since baseline or since best response (>= 25% increase in the number of lesions since baseline or since best response)
CL Item
None of the above (None of the above)
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 lesions since baseline or since best response (>= 25% increase in the number of lesions since baseline or since best response)
CL Item
None of the above (None of the above)
Item
Site Code
text
Code List
Site Code
CL Item
Total body (<50 lesions) (Total body (<50 lesions))
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
PerpendicularDiameters
Item
Perpendicular Diameters
text
ProductofDiameters
Item
Product of Diameters
text
PhotosTaken?
Item
Photos Taken?
boolean
SumofProducts
Item
Sum of Products
text
Item
Evaluation of Marker Lesions
text
Code List
Evaluation of Marker Lesions
CL Item
Complete Resolution (Complete Resolution)
CL Item
>= 50% decrease in the sum of the product of the diameters of all marker lesions since baseline (>= 50% decrease in the sum of the product of the diameters of all marker lesions since baseline)
CL Item
>= 25% increase in the sum of the products of the diameters of all marker lesions since baseline, or since best response (>= 25% increase in the sum of the products of the diameters of all marker lesions since baseline, or since best response)
CL Item
None of the above (None of the above)
Item
Foot KS
text
Code List
Foot KS
CL Item
Present (Present)
CL Item
Absent (Absent)
Item
Compared to previous evaluation
text
Code List
Compared to previous evaluation
CL Item
Better (Better)
CL Item
Same (Same)
CL Item
Worse (Worse)
PhotosTaken?
Item
Photos Taken?
boolean
IfPhotostaken,Date?
Item
If Photos taken, Date?
text
Physicalfindings
Item
Physical findings
text
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
Numberofflatlesions
Item
Number of flat lesions
text
Aretherelesionswhicharenotcountableormeasurable?
Item
Are there lesions which are not countable or measurable?
boolean
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)
Ifnot,explain
Item
If not, explain
text
Item
Oral Site
text
Code List
Oral Site
CL Item
Gingiva / Gums (Gingiva / Gums)
CL Item
Hard Palate (Hard Palate)
CL Item
Soft Palate (Soft Palate)
CL Item
Buccal Mucosa (Buccal Mucosa)
CL Item
Tongue (Tongue)
CL Item
Floor of Mouth (Floor of Mouth)
CL Item
Tonsils (Tonsils)
CL Item
Uvula (Uvula)
CL Item
Posterior Pharnyx (Posterior Pharnyx)
Kaposi'sSarcomaPresent?
Item
Kaposi's Sarcoma Present?
boolean
PhotosTaken?
Item
Photos Taken?
boolean
IfPhotostaken,Date?
Item
If Photos taken, Date?
text
Item
Oral cavity evaluation
text
Code List
Oral cavity evaluation
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)
Item
Are there any GI lesions present at this evaluation?
text
Code List
Are there any GI lesions present at this evaluation?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not Evaluated (Not Evaluated)
AretheGIsymptomsrelatedtoKaposi'sSarcoma?
Item
Are the GI symptoms related to Kaposi's Sarcoma?
boolean
Ifnot,explain
Item
If not, explain
text
Item
Documentation
text
Code List
Documentation
CL Item
Radiology (Radiology)
CL Item
Endoscopy (Endoscopy)
Findings
Item
Findings
text
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
If YES, indicate if the lesions are measurable or evaluable
text
Code List
If YES, indicate if the lesions are measurable or evaluable
CL Item
Measurable (Measurable)
CL Item
Evaluable (Evaluable)
ArethepulmonarysymptomsrelatedtoKaposi'sSarcoma?
Item
Are the pulmonary symptoms related to Kaposi's Sarcoma?
boolean
Ifnot,explain
Item
If not, explain
text
Item
Documentation
text
Code List
Documentation
CL Item
CXR (CXR)
CL Item
CT Scan (CT Scan)
PleuralEffusion?
Item
Pleural Effusion?
boolean
Numberofnewlesions
Item
Number of new lesions
text
Measurements
Item
Measurements
text
BronchoscopyDate
Item
Bronchoscopy Date
text
Findings
Item
Findings
text
OtherTests
Item
Other Tests
text
Findings
Item
Findings
text
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)
IfOther,Specify
Item
If Other, Specify
text
EdemaPresent?
Item
Edema Present?
boolean
Item
Compared to Previous Evaluation
text
Code List
Compared to Previous Evaluation
CL Item
Better (Better)
CL Item
Same (Same)
CL Item
Worse (Worse)
Item
Tumor associated edema
text
Code List
Tumor associated edema
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
Edema
text
Code List
Edema
CL Item
Present (Present)
CL Item
Absent (Absent)
SpecificLocation
Item
Specific Location
text
LimbGirth
Item
Limb Girth
text
OtherFindings
Item
Other Findings
text
PhotosTaken?
Item
Photos Taken?
boolean
IfPhotostaken,Date?
Item
If Photos taken, Date?
text
Physicalfindings
Item
Physical findings
text
PhotosTaken?
Item
Photos Taken?
boolean
IfPhotostaken,Date?
Item
If Photos taken, Date?
text
Physicalfindings
Item
Physical findings
text
HasavisceraldiseaseevaluationbeendonesincethelastKSevaluation?
Item
Has a visceral disease evaluation been done since the last KS evaluation?
boolean
SiteCode
Item
Site Code
text
Item
KS Invol
text
Code List
KS Invol
CL Item
Present (Present)
CL Item
Absent (Absent)
Item
Visc Eval
text
Code List
Visc Eval
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 disease (Evidence of a new site of visceral disease)
CL Item
No change (No change)
CL Item
Not applicable, Entry/Baseline evaluation (Not applicable, Entry/Baseline evaluation)
Item
Proced
text
Code List
Proced
CL Item
Upper endoscopy (Upper endoscopy)
CL Item
Colonoscopy (Colonoscopy)
CL Item
Sigmoldoscopy (Sigmoldoscopy)
CL Item
Chest X-ray (Chest X-ray)
CL Item
Bronchoscopy (Bronchoscopy)
CL Item
Other (Other)
SpecifyProcedure
Item
Specify Procedure
text
Item
Interventions for Oral Cavity Lesions
text
Code List
Interventions for Oral Cavity Lesions
CL Item
None (None)
CL Item
Local anesthetic/analgesic (Local anesthetic/analgesic)
CL Item
Local intervention to KS lesions (Local intervention to KS lesions)
CL Item
Others (Others)
Others,specify
Item
Others, specify
text
Item
Interventions for GI Lesions
text
Code List
Interventions for GI Lesions
CL Item
None (None)
CL Item
Antiemetics (Antiemetics)
CL Item
Blood transfusions (due to GI bleeding) (Blood transfusions (due to GI bleeding))
CL Item
Others (Others)
Others,specify
Item
Others, specify
text
Item
Interventions for Pulmonary Lesion
text
Code List
Interventions for Pulmonary Lesion
CL Item
None (None)
CL Item
Oxygen (Oxygen)
CL Item
Bronchodilators (Bronchodilators)
CL Item
Cough suppressant (Cough suppressant)
CL Item
Steroids (Steroids)
CL Item
Others (Others)
Others,specify
Item
Others, specify
text
Item
Interventions for Extremity Edema
text
Code List
Interventions for Extremity Edema
CL Item
None (None)
CL Item
Diuretics (Diuretics)
CL Item
Others (Others)
Others,specify
Item
Others, specify
text
Item
Interventions for Periorbital Edema:
text
Code List
Interventions for Periorbital Edema:
CL Item
None (None)
CL Item
Analgesics (Analgesics)
CL Item
Local Therapy (Local Therapy)
CL Item
Others (Others)
Others,specify
Item
Others, specify
text
Item
Interventions for Scrotal/Genital Swelling
text
Code List
Interventions for Scrotal/Genital Swelling
CL Item
None (None)
CL Item
Analgesics (Analgesics)
CL Item
Others (Others)
Others,specify
Item
Others, specify
text
Item
Interventions for Foot KS
text
Code List
Interventions for Foot KS
CL Item
None (None)
CL Item
Analgesics (Analgesics)
CL Item
Uses cane, wheelchair (Uses cane, wheelchair)
CL Item
Others (Others)
Others,specify
Item
Others, specify
text
Item
Best overall response attained since Entry/Baseline
text
Code List
Best overall response attained since Entry/Baseline
CL Item
Complete (Complete)
CL Item
Clinical complete response (Clinical complete response)
CL Item
Partial Response (Partial Response)
CL Item
Stable (since baseline) (Stable (since baseline))
CL Item
Progression (no prior response) (Progression (no prior response))
CL Item
Unevaluable (Unevaluable)
CL Item
Unknown (Unknown)
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)
Item
Unnamed 6
text
Code List
Unnamed 6
CL Item
Complete response (Complete response)
CL Item
Clinical complete response (Clinical complete response)
CL Item
Partial response (Partial response)
CL Item
Progression with no prior response (Progression with no prior response)
DateofOnset
Item
Date of Onset
text

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