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

Clinical Trial

Treatment Form

Lymphoma, AIDS-Related

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

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

Name

Type

Description | Question | Decode (Coded Value)

Data type

Alias

Patient demographics

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)

Clinical Trial Period

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)

CL.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)

History and Symptoms

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)

GastrointestinalSymptomPresentInd-3

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)

CL.34

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)

Patientsymptomsoforalcavitylesions

Item

Patient symptoms of oral cavity lesions

text

CL.3

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

GISymptoms

Item

GI Symptoms

text

CL.5

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

Patientsymptoms

Item

Patient symptoms

text

CL.7

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

Isthepatientonanalgesics

Item

Is the patient on analgesics

text

CL.10

Code List

Is the patient on analgesics

CL Item

Yes (Yes)

CL Item

No (No)

CL Item

Unknown (Unknown)

Whatwastheaveragepainexperiencedbythepatientoverthelast24hours

Item

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

text

CL.11

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)

Pain

Item

Pain

text

CL.12

Code List

Pain

CL Item

Present (Present)

CL Item

Absent (Absent)

AnatomicSiteofWorstPain

Item

Anatomic Site of Worst Pain

text

Patientsymptomsofedema

Item

Patient symptoms of edema

text

CL.13

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)

Patientsymptomsofperiorbitaledema

Item

Patient symptoms of periorbital edema

text

CL.14

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)

Patientsymptomsofscrotal/genitalswelling

Item

Patient symptoms of scrotal/genital swelling

text

CL.15

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)

PatientsymptomsoffootKS

Item

Patient symptoms of foot KS

text

CL.16

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)

Evaluation of Cutaneous Lesions

Item Group

Evaluation Of Cutaneous Lesions

LesionSiteICD-OCode

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)

CL.18

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

CharacterofcutaneousLesions

Item

Character of cutaneous Lesions

text

CL.20

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)

Evaluation of Marker Lesions

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

SiteCode

Item

Site Code

text

CL.21

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

Evaluation of Foot KS

Item Group

Evaluation Of Foot Ks

LesionFollow-UpAssessmentType

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)

CL.49

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)

FootKS

Item

Foot KS

text

CL.23

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

Evaluation of Oral Cavity

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

LesionAssessmentDate

Item

Assessment date

date

GastrointestinalSymptomPresentInd-3

Item

Are there any GI lesions present at this evaluation

text

CL.34

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

HeadandNeckTumorPrimaryLocation

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)

CL.30

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)

Evaluation method

Item

Evaluation method

text

C25284 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
C2911685 (UMLS CUI-1)

CL.41

Code List

Evaluation method

CL Item

Chest X-ray (CXR)

CL Item

Ct Scan (CT scan)

Evaluation method

Item

Evaluation method

text

C25284 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
C2911685 (UMLS CUI-1)

CL.41

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)

Arethereanyoralcavitylesionspresentatthisevaluation

Item

Are there any oral cavity lesions present at this evaluation

text

CL.27

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

AreoralsymptomsrelatedtoKaposi'sSarcoma

Item

Are oral symptoms related to Kaposi's Sarcoma

text

CL.29

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

Orallesions

Item

Oral lesions

text

CL.33

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

ArethereanypulmonaryKSlesionspresentatthisevaluation

Item

Are there any pulmonary KS lesions present at this evaluation

text

CL.38

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)

Indicateifthelesionsaremeasurableorevaluable

Item

Indicate if the lesions are measurable or evaluable

text

CL.39

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

Lesions Measurements

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

Edema Evaluation

Item Group

Edema Evaluation

LesionFollow-UpAssessmentType

Item

Compared to previous evaluation

text

CL.49

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

EdemaSite

Item

Edema Site

text

CL.47

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

EdemaEvaluation

Item

Edema Evaluation

text

CL.50

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)

Evaluation of Extremity Edema

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)

Statusofedema

Item

Status of edema

text

CL.51

Code List

Status of edema

CL Item

Present (Present)

CL Item

Absent (Absent)

Specificlocation

Item

Specific location

text

LimbGirth

Item

Limb Girth

text

Evaluation of Periorbital Edema

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

Evaluation of Scrotal/Genital Swelling

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

Evaluation of Visceral Disease

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)

ProcedureName

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)

CL.61

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

SiteofLesion

Item

Site of Lesion

text

CL.58

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)

KSinvolvement

Item

KS involvement

text

CL.59

Code List

KS involvement

CL Item

Present (Present)

CL Item

Absent (Absent)

VisceralEvaluation

Item

Visceral Evaluation

text

CL.60

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)

Interventions (in addition to study drug therapy)

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

Overall Assessment

Item Group

Overall Assessment

TumorResponseCDUSType

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)

CL.83

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)

Whatisthepresentstatusofthebestresponse

Item

What is the present status of the best response

text

CL.84

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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Item comments for :

KS Evaluation and Clinical Benefit Form: RK1 NCT00310128

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