ID

3176

Description

AMC-063 Overall Assessment Form (RK6) 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=82179F3F-7A58-1C3D-E040-BB89AD43134F

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=82179F3F-7A58-1C3D-E040-BB89AD43134F

Keywords

Versions (1)
  1. 9/19/12 9/19/12 -
Uploaded on

September 19, 2012

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Creative Commons BY-NC 3.0 Legacy
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Sarcoma NCT01016730 Response - AMC-063 Overall Assessment Form (RK6) - 3028267v1.0

English

THIS FORM IS NOT SUBMITTED AT VISIT 0 Refer to protocol for complete description of response categories

1 forms  
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
Unnamed1
Description

Unnamed1

Best Response (since Entry/Baseline)
Description

KaposiSarcomaBestResponseType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
NCI Thesaurus ObjectClass
C9087
UMLS 2011AA ObjectClass
C0036220
NCI Thesaurus Property
C25432
UMLS 2011AA Property
C1522427
What is the present status of the best response
Description

KaposiSarcomaBestResponseStatus

Data type

text

Alias
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
NCI Thesaurus ObjectClass
C9087
UMLS 2011AA ObjectClass
C0036220
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
NCI Thesaurus Property
C25432
UMLS 2011AA Property
C1522427
Date of Relapse or Progression (if applicable mm/dd/yyyy)
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
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus Property
C19987
UMLS 2011AA Property
C0242656
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Unnamed2
Description

Unnamed2

Is complete response observed (During this reporting period)
Description

CompleteResponseObservedInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25755
UMLS 2011AA ObjectClass
C0871261
NCI Thesaurus ObjectClass
C25250
UMLS 2011AA ObjectClass
C0205197
NCI Thesaurus Property
C25599
UMLS 2011AA Property
C1441672
Complete Response Observed Date (mm/dd/yyyy)
Description

CompleteResponseObservedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25755
UMLS 2011AA ObjectClass
C0871261
NCI Thesaurus ObjectClass
C25250
UMLS 2011AA ObjectClass
C0205197
NCI Thesaurus Property
C25599
UMLS 2011AA Property
C1441672
Is Clinical Complete Response observed (During this reporting period)
Description

ClinicalCompleteResponseObservedInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C25755
UMLS 2011AA ObjectClass
C0871261
NCI Thesaurus ObjectClass
C25250
UMLS 2011AA ObjectClass
C0205197
NCI Metathesaurus ObjectClass
CL035092
NCI Thesaurus Property
C25599
UMLS 2011AA Property
C1441672
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Clinical Complete Response observed date (mm/dd/yyyy)
Description

ClinicalCompleteResponseObservedDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25755
UMLS 2011AA ObjectClass
C0871261
NCI Thesaurus ObjectClass
C25250
UMLS 2011AA ObjectClass
C0205197
NCI Metathesaurus ObjectClass
CL035092
NCI Thesaurus Property
C25599
UMLS 2011AA Property
C1441672
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Is partial response observed (During this reporting period)
Description

PartialResponseFirstObservedInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C25755
UMLS 2011AA ObjectClass
C0871261
NCI Thesaurus ObjectClass
C25378
UMLS 2011AA ObjectClass
C0728938
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property
C25599
UMLS 2011AA Property
C1441672
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Partial Response Observed Date (mm/dd/yyyy)
Description

PartialResponseFirstObservedDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25755
UMLS 2011AA ObjectClass
C0871261
NCI Thesaurus ObjectClass
C25378
UMLS 2011AA ObjectClass
C0728938
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property
C25599
UMLS 2011AA Property
C1441672
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
Is progression observed (During this reporting period)
Description

DiseaseProgressionInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25331
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
Progressive Disease Observed Date (mm/dd/yyyy)
Description

ProgressionObservedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus Property
C25599
UMLS 2011AA Property
C1441672
Accelerated Disease
Description

Accelerated Disease

Acceleration in disease progression
Description

DiseaseAcceleratedProgressionInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25331
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C83495
UMLS 2011AA Property
C0151685
Is accelerated progression confirmed (by the investigator)
Description

AcceleratedProgressionConfirmedInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ObjectClass
C83495
UMLS 2011AA ObjectClass
C0151685
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
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Similar models

THIS FORM IS NOT SUBMITTED AT VISIT 0 Refer to protocol for complete description of response categories

1 forms
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 Group
Unnamed1
Item
Best Response (since Entry/Baseline)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C9087 (NCI Thesaurus ObjectClass)
C0036220 (UMLS 2011AA ObjectClass)
C25432 (NCI Thesaurus Property)
C1522427 (UMLS 2011AA Property)
CL.1
Code List
Best Response (since Entry/Baseline)
CL Item
Complete Response (Complete response)
CL Item
Clinical Complete Response (Clinical complete response)
CL Item
Partial Response (Partial response)
C18212 (NCI Thesaurus)
C18212 (NCI Thesaurus)
CL Item
Stable Disease (Stable disease)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
CL Item
Progressive Disease (Progressive disease)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
CL Item
Unevaluable (Unevaluable)
C62222 (NCI Thesaurus)
C1883425 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
What is the present status of the best response
text
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C9087 (NCI Thesaurus ObjectClass)
C0036220 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25432 (NCI Thesaurus Property)
C1522427 (UMLS 2011AA Property)
CL.2
Code List
What is the present status of the best response
CL Item
No Relapse Observed, But Patent Died (No relapse observed, but patent died)
CL Item
Not Applicable (Not applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
CL Item
Relapse Occurred After A Response Was Achieved (Relapse occurred after a response was achieved)
CL Item
Response Continuing Or First Time At This Response (Response continuing or first time at this response)
DiseaseRecurrentDiseaseCancerProgressionDiagnosisDate
Item
Date of Relapse or Progression (if applicable mm/dd/yyyy)
date
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C19987 (NCI Thesaurus Property)
C0242656 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Unnamed2
Item
Is complete response observed (During this reporting period)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus ObjectClass)
C0205197 (UMLS 2011AA ObjectClass)
C25599 (NCI Thesaurus Property)
C1441672 (UMLS 2011AA Property)
CL.3
Code List
Is complete response observed (During this reporting period)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CompleteResponseObservedDate
Item
Complete Response Observed Date (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus ObjectClass)
C0205197 (UMLS 2011AA ObjectClass)
C25599 (NCI Thesaurus Property)
C1441672 (UMLS 2011AA Property)
Item
Is Clinical Complete Response observed (During this reporting period)
text
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus ObjectClass)
C0205197 (UMLS 2011AA ObjectClass)
CL035092 (NCI Metathesaurus ObjectClass)
C25599 (NCI Thesaurus Property)
C1441672 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.4
Code List
Is Clinical Complete Response observed (During this reporting period)
CL Item
No (NO)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (YES)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
ClinicalCompleteResponseObservedDate
Item
Clinical Complete Response observed date (mm/dd/yyyy)
date
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus ObjectClass)
C0205197 (UMLS 2011AA ObjectClass)
CL035092 (NCI Metathesaurus ObjectClass)
C25599 (NCI Thesaurus Property)
C1441672 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Is partial response observed (During this reporting period)
text
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25378 (NCI Thesaurus ObjectClass)
C0728938 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25599 (NCI Thesaurus Property)
C1441672 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.5
Code List
Is partial response observed (During this reporting period)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
PartialResponseFirstObservedDate
Item
Partial Response Observed Date (mm/dd/yyyy)
date
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25378 (NCI Thesaurus ObjectClass)
C0728938 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25599 (NCI Thesaurus Property)
C1441672 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
Item
Is progression observed (During this reporting period)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
CL.6
Code List
Is progression observed (During this reporting period)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
ProgressionObservedDate
Item
Progressive Disease Observed Date (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C25331 (NCI Thesaurus ObjectClass)
C25599 (NCI Thesaurus Property)
C1441672 (UMLS 2011AA Property)
Item Group
Accelerated Disease
Item
Acceleration in disease progression
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C83495 (NCI Thesaurus Property)
C0151685 (UMLS 2011AA Property)
CL.7
Code List
Acceleration in disease progression
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Is accelerated progression confirmed (by the investigator)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C25331 (NCI Thesaurus ObjectClass)
C83495 (NCI Thesaurus ObjectClass)
C0151685 (UMLS 2011AA ObjectClass)
CL.8
Code List
Is accelerated progression confirmed (by the investigator)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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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