ID

3043

Description

AMC-063 Physical Exam Form (RK2) Bortezomib in Treating Patients With Relapsed or Refractory AIDS-Related Kaposi Sarcoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8163A333-BC0C-35E0-E040-BB89AD435080

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8163A333-BC0C-35E0-E040-BB89AD435080

Keywords

  1. 9/19/12 9/19/12 -
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September 19, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Sarcoma NCT01016730 On-Study - AMC-063 Physical Exam Form (RK2) - 3020992v1.0

This form represents the aggregate of initial and follow-up evaluation screens. Five questions are merged as a result: At entry, does the participant have >=50 lesions (2646194); Total Number New Lesions (2646313); Number of cutaneous lesions (2646435); Character of cutaneous lesions (2646439); and, Number of Marker Lesions (2646443)

Header Module
Description

Header Module

Visit number
Description

HospitalAdmissionOrdinalNumber

Data type

double

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16696
UMLS 2011AA ObjectClass
C0019994
NCI Thesaurus Property
C25385
UMLS 2011AA Property
C0809949
Unnamed2
Description

Unnamed2

At entry, does the participant have >=50 lesions
Description

KaposiSarcomaMalignantNeoplasmCutaneousAssessmentInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass
C9087
UMLS 2011AA ObjectClass
C0036220
NCI Thesaurus Property
C25367
NCI Thesaurus Property
C13316
UMLS 2011AA Property
C0221912
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Representative Area
Description

KaposiSarcomaMalignantNeoplasmCutaneousAnatomicSite

Data type

text

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass
C9087
UMLS 2011AA ObjectClass
C0036220
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property
C13316
UMLS 2011AA Property
C0221912
NCI Thesaurus Property
C25421
UMLS 2011AA Property
C0002808
NCI Thesaurus ValueDomain
C37901
UMLS 2011AA ValueDomain
C0205145
Total Number Raised Lesions
Description

KaposiSarcomaMalignantNeoplasmElevatedCount

Data type

double

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass
C9087
UMLS 2011AA ObjectClass
C0036220
NCI Thesaurus Property
C25493
UMLS 2011AA Property
C0205250
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Total Number Flat Lesions
Description

KaposiSarcomaMalignantNeoplasmFlatCount

Data type

double

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass
C9087
UMLS 2011AA ObjectClass
C0036220
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
NCI Metathesaurus Property
C0205324
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Total Number New Lesions
Description

KaposiSarcomaMalignantNeoplasmNewCount

Data type

double

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass
C9087
UMLS 2011AA ObjectClass
C0036220
NCI Thesaurus Property
C25586
UMLS 2011AA Property
C0205314
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Number of cutaneous lesions
Description

KaposiSarcomaNumberMalignantNeoplasmCutaneousAssessmentStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C25337
UMLS 2011AA ObjectClass
C0237753
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass
C9087
UMLS 2011AA ObjectClass
C0036220
NCI Thesaurus Property
C25367
NCI Thesaurus Property
C13316
UMLS 2011AA Property
C0221912
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Character of cutaneous lesions (since baseline or best response)
Description

KaposiSarcomaMalignantNeoplasmCutaneousAssessmentStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass
C9087
UMLS 2011AA ObjectClass
C0036220
NCI Thesaurus Property
C25367
NCI Thesaurus Property
C13316
UMLS 2011AA Property
C0221912
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Unnamed3
Description

Unnamed3

Representative Area
Description

KaposiSarcomaMalignantNeoplasmDiseaseMarkerAnatomicSite

Data type

text

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass
C9087
UMLS 2011AA ObjectClass
C0036220
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property
C18329
UMLS 2011AA Property
C1511983
NCI Thesaurus Property
C25421
UMLS 2011AA Property
C0002808
NCI Thesaurus ValueDomain
C37901
UMLS 2011AA ValueDomain
C0205145
Specify
Description

KaposiSarcomaMalignantNeoplasmDiseaseMarkerAnatomicLocationSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass
C9087
UMLS 2011AA ObjectClass
C0036220
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property
C18329
UMLS 2011AA Property
C1511983
NCI Thesaurus Property
C25421
UMLS 2011AA Property
C0002808
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Dimension 1 (cm)
Description

TumorLargestDimensionMeasurement

Data type

double

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
C25483
UMLS 2011AA Property
C0439534
cm
Dimension 2 (cm)
Description

TumorSecondDimensionMeasurement

Data type

double

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
C25483
UMLS 2011AA Property
C0439534
cm
Product of Diameters
Description

MalignantNeoplasmProductDimensionMeasurement

Data type

double

Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C25483
UMLS 2011AA Property
C0439534
NCI Thesaurus Property
C40352
UMLS 2011AA Property
C1704444
Photos Taken
Description

PatientPhotographMalignantNeoplasmAssessmentInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25367
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property
C86035
UMLS 2011AA Property
C0441468
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Sum of Products of Greatest Diameters
Description

SumLesionDiameterProductMeasurement

Data type

double

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass
C25697
UMLS 2011AA ObjectClass
C1515051
NCI Thesaurus Property
C25285
UMLS 2011AA Property
C1301886
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ValueDomain
C40352
UMLS 2011AA ValueDomain
C1704444
Evaluation of Marker Lesions
Description

KaposiSarcomaMalignantNeoplasmDiseaseMarkerAssessmentStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass
C9087
UMLS 2011AA ObjectClass
C0036220
NCI Thesaurus Property
C25367
NCI Thesaurus Property
C18329
UMLS 2011AA Property
C1511983
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Footer Module
Description

Footer Module

Comments
Description

ResearchCommentsText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411

Similar models

This form represents the aggregate of initial and follow-up evaluation screens. Five questions are merged as a result: At entry, does the participant have >=50 lesions (2646194); Total Number New Lesions (2646313); Number of cutaneous lesions (2646435); Character of cutaneous lesions (2646439); and, Number of Marker Lesions (2646443)

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
HospitalAdmissionOrdinalNumber
Item
Visit number
double
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16696 (NCI Thesaurus ObjectClass)
C0019994 (UMLS 2011AA ObjectClass)
C25385 (NCI Thesaurus Property)
C0809949 (UMLS 2011AA Property)
Item
At entry, does the participant have >=50 lesions
text
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C9087 (NCI Thesaurus ObjectClass)
C0036220 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus Property)
C13316 (NCI Thesaurus Property)
C0221912 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
At entry, does the participant have >=50 lesions
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Representative Area
text
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C9087 (NCI Thesaurus ObjectClass)
C0036220 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C13316 (NCI Thesaurus Property)
C0221912 (UMLS 2011AA Property)
C25421 (NCI Thesaurus Property)
C0002808 (UMLS 2011AA Property)
C37901 (NCI Thesaurus ValueDomain)
C0205145 (UMLS 2011AA ValueDomain)
Code List
Representative Area
CL Item
Abdomen (Abdomen)
C12664 (NCI Thesaurus)
C0230168 (UMLS 2011AA)
CL Item
Back (Back)
C13062 (NCI Thesaurus)
C0205095 (UMLS 2011AA)
CL Item
Chest (Chest)
C25389 (NCI Thesaurus)
C0817096 (UMLS 2011AA)
CL Item
Genital Area (Genital)
CL Item
Head (Head)
C12419 (NCI Thesaurus)
C0018670 (UMLS 2011AA)
CL Item
Left Arm (Left arm)
CL Item
Left Foot (Left foot)
CL Item
Left Hand (Left hand)
CL Item
Left Leg (Left leg)
CL Item
Neck (Neck)
C13063 (NCI Thesaurus)
C0027530 (UMLS 2011AA)
CL Item
Right Arm (Right arm)
CL Item
Right Foot (Right foot)
CL Item
Right Hand (Right hand)
CL Item
Right Leg (Right leg)
CL Item
Total Body (Total body)
KaposiSarcomaMalignantNeoplasmElevatedCount
Item
Total Number Raised Lesions
double
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C9087 (NCI Thesaurus ObjectClass)
C0036220 (UMLS 2011AA ObjectClass)
C25493 (NCI Thesaurus Property)
C0205250 (UMLS 2011AA Property)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
KaposiSarcomaMalignantNeoplasmFlatCount
Item
Total Number Flat Lesions
double
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C9087 (NCI Thesaurus ObjectClass)
C0036220 (UMLS 2011AA ObjectClass)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C0205324 (NCI Metathesaurus Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
KaposiSarcomaMalignantNeoplasmNewCount
Item
Total Number New Lesions
double
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C9087 (NCI Thesaurus ObjectClass)
C0036220 (UMLS 2011AA ObjectClass)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
Item
Number of cutaneous lesions
text
C25337 (NCI Thesaurus ObjectClass)
C0237753 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C9087 (NCI Thesaurus ObjectClass)
C0036220 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus Property)
C13316 (NCI Thesaurus Property)
C0221912 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
Code List
Number of cutaneous lesions
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
>=50% Decrease In The Number Of Lesions Since Baseline (>=50% decrease in the number of lesions since baseline)
CL Item
Complete Resolution (Complete resolution)
CL Item
None Of The Above (None of the above)
Item
Character of cutaneous lesions (since baseline or best response)
text
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C9087 (NCI Thesaurus ObjectClass)
C0036220 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus Property)
C13316 (NCI Thesaurus Property)
C0221912 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
Code List
Character of cutaneous lesions (since baseline or best response)
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 (>=25% increase in the number of raised lesions)
CL Item
None Of The Above (None of the above)
Item Group
Unnamed3
Item
Representative Area
text
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C9087 (NCI Thesaurus ObjectClass)
C0036220 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C18329 (NCI Thesaurus Property)
C1511983 (UMLS 2011AA Property)
C25421 (NCI Thesaurus Property)
C0002808 (UMLS 2011AA Property)
C37901 (NCI Thesaurus ValueDomain)
C0205145 (UMLS 2011AA ValueDomain)
Code List
Representative Area
CL Item
Abdomen (Abdomen)
C12664 (NCI Thesaurus)
C0230168 (UMLS 2011AA)
CL Item
Back (Back)
C13062 (NCI Thesaurus)
C0205095 (UMLS 2011AA)
CL Item
Chest (Chest)
C25389 (NCI Thesaurus)
C0817096 (UMLS 2011AA)
CL Item
Genital Area (Genital)
CL Item
Head (Head)
C12419 (NCI Thesaurus)
C0018670 (UMLS 2011AA)
CL Item
Left Arm (Left arm)
CL Item
Left Foot (Left foot)
CL Item
Left Hand (Left hand)
CL Item
Left Leg (Left leg)
CL Item
Neck (Neck)
C13063 (NCI Thesaurus)
C0027530 (UMLS 2011AA)
CL Item
Right Arm (Right arm)
CL Item
Right Foot (Right foot)
CL Item
Right Hand (Right hand)
CL Item
Right Leg (Right leg)
CL Item
Total Body (Total body)
KaposiSarcomaMalignantNeoplasmDiseaseMarkerAnatomicLocationSpecify
Item
Specify
text
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C9087 (NCI Thesaurus ObjectClass)
C0036220 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C18329 (NCI Thesaurus Property)
C1511983 (UMLS 2011AA Property)
C25421 (NCI Thesaurus Property)
C0002808 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
TumorLargestDimensionMeasurement
Item
Dimension 1 (cm)
double
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)
C0439534 (UMLS 2011AA Property)
TumorSecondDimensionMeasurement
Item
Dimension 2 (cm)
double
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)
C0439534 (UMLS 2011AA Property)
MalignantNeoplasmProductDimensionMeasurement
Item
Product of Diameters
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25483 (NCI Thesaurus Property)
C0439534 (UMLS 2011AA Property)
C40352 (NCI Thesaurus Property)
C1704444 (UMLS 2011AA Property)
Item
Photos Taken
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus Property)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C86035 (NCI Thesaurus Property)
C0441468 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Photos Taken
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
SumLesionDiameterProductMeasurement
Item
Sum of Products of Greatest Diameters
double
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25697 (NCI Thesaurus ObjectClass)
C1515051 (UMLS 2011AA ObjectClass)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C40352 (NCI Thesaurus ValueDomain)
C1704444 (UMLS 2011AA ValueDomain)
Item
Evaluation of Marker Lesions
text
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C9087 (NCI Thesaurus ObjectClass)
C0036220 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus Property)
C18329 (NCI Thesaurus Property)
C1511983 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
Code List
Evaluation of Marker Lesions
CL Item
Complete Resolution (Complete resolution)
CL Item
>=50% Decrease In The Sum Of The Products Of The Diameters Of All Marker Lesions Since Baseline (>=50% decrease in the sum of the products of the diameters of all marker lesions since baseline)
CL Item
>=25% Inc In Sum Of The Products Of The Diam Of All Marker Lesions Since Baseline/best Response (>=25% inc in sum of the products of the diam of all marker lesions since baseline/best response)
CL Item
None Of The Above (None of the above)
Item Group
Footer Module
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)

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