ID

1169

Beschrijving

NSABP B-45 Worksheet for Cardiac Safety Monitoring Report Form Studying Biological Markers of Fatigue in Women With Residual Invasive Breast Cancer Enrolled on Clinical Trial NSABP-B-45 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=64AFECAB-BEAA-0357-E040-BB89AD431986

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=64AFECAB-BEAA-0357-E040-BB89AD431986

Trefwoorden

Versies (2)
  1. 27-08-12 27-08-12 -
  2. 09-01-15 09-01-15 - Martin Dugas
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27 augustus 2012

DOI

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Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00914043 On-Study - NSABP B-45 Worksheet for Cardiac Safety Monitoring Report Form - 2847086v1.0

Engels

This paper worksheet may be completed to facilitate the entry of the required Cardiac Safety Monitoring information in NSABP Coordinator Online. Partially completed worksheets may be saved in Coordinator Online. DO NOT SUBMIT THIS WORKSHEET VIA FAX OR MAIL

1 Formulieren  
Unnamed1
Beschrijving

Unnamed1

Patient Initials (Last First Middle)
Beschrijving

PatientInitialsName

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
NSABP Patient ID
Beschrijving

PatientNationalSurgicalAdjuvantBreastProjectIdentifierNumber

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C15818
UMLS 2011AA Property
C1513905
Report Period
Beschrijving

Report Period

Time point (for this report)
Beschrijving

AssessmentPeriodType

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
Did the patient receive any systemic anticancer treatment for documented invasive breast cancer recurrence or second primary cancer prior to this Time Point
Beschrijving

PriorSystemicTherapyInvasiveBreastCarcinomaSecondaryMalignantNeoplasmAdministeredInd-2

Datatype

text

Alias
NCI Thesaurus ObjectClass
C15698
UMLS 2011AA ObjectClass
C1515119
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus Property
C4968
UMLS 2011AA Property
C0751623
NCI Thesaurus Property
C9245
UMLS 2011AA Property
C0853879
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Section A: Lvef Assessment
Beschrijving

Section A: Lvef Assessment

Reason LVEF was Assessed at Other Time Point (If Time Point is Other mark one)
Beschrijving

LeftVentricularEjectionFractionOtherTimepointAssessmentReason

Datatype

text

Alias
NCI Thesaurus ObjectClass
C37946
UMLS 2011AA ObjectClass
C2700377
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property
C68568
UMLS 2011AA Property
C2348792
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Other, specify
Beschrijving

LeftVentricularEjectionFractionOtherTimepointAssessmentSpecify

Datatype

text

Alias
NCI Thesaurus ObjectClass
C37946
UMLS 2011AA ObjectClass
C2700377
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property
C68568
UMLS 2011AA Property
C2348792
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Was LVEF assessment performed at this time point (If Time Point is not Other)
Beschrijving

LeftVentricularEjectionFractionAssessmentInd-2

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C37946
UMLS 2011AA ObjectClass
C2700377
LVEF (%)
Beschrijving

HeartLVEFTestPercentageValue

Datatype

double

Maateenheden
  • %
Alias
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property
C37946
UMLS 2011AA Property
C2700377
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
%
Date of LVEF (MM DD YYYY)
Beschrijving

HeartLVEFTestDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property
C37946
UMLS 2011AA Property
C2700377
Assessment Type
Beschrijving

AssessmentMethodType

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
Section B: Ecg With Qtc Assessment
Beschrijving

Section B: Ecg With Qtc Assessment

Has the patient had an EKG (this time point Note: not required 9 months after randomization)
Beschrijving

ElectrocardiographyDiagnosticProcedureAssessmentInd-2

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C38053
UMLS 2011AA ObjectClass
C1623258
NCI Thesaurus ObjectClass
C18020
UMLS 2011AA ObjectClass
C0430022
Was QTc assessed
Beschrijving

ElectrocardiographyDiagnosticProcedureQTcIntervalAssessmentInd-2

Datatype

text

Alias
NCI Thesaurus ObjectClass
C38053
UMLS 2011AA ObjectClass
C1623258
NCI Thesaurus ObjectClass
C18020
UMLS 2011AA ObjectClass
C0430022
NCI Thesaurus Property
C25367
NCI Metathesaurus Property
C0489625
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
QTc Interval
Beschrijving

ElectrocardiographyDiagnosticProcedureQTcIntervalAssessmentValue

Datatype

double

Maateenheden
  • seconds
Alias
NCI Thesaurus ObjectClass
C38053
UMLS 2011AA ObjectClass
C1623258
NCI Thesaurus ObjectClass
C18020
UMLS 2011AA ObjectClass
C0430022
NCI Thesaurus Property
C25367
NCI Metathesaurus Property
C0489625
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
seconds
Date of EKG (MM DD YYYY)
Beschrijving

DiagnosticElectrocardiogramPerformedDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C25482
UMLS 2011AA ObjectClass
C0348026
NCI Metathesaurus ObjectClass
C0013798
Section C: Cardiac Events
Beschrijving

Section C: Cardiac Events

Did the patient experience any of the following cardiac events at the specified time point (mark all that apply)
Beschrijving

CardiacDiseaseAssessmentType

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C13306
UMLS 2011AA ObjectClass
C1522601
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
Date of Symptom/Event Assessment (if applicable Month Day Year)
Beschrijving

AdverseEventAssessmentDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
Date of Definite or Probable Cardiac Death (if applicable Month Day Year)
Beschrijving

PatientHeartDiseasesDeathDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C28554
UMLS 2011AA Property
C0011065
NCI Thesaurus Property
C12727
UMLS 2011AA Property
C0018787
NCI Thesaurus Property
C2991
UMLS 2011AA Property
C0012634
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Footer
Beschrijving

Footer

Comments (optional)
Beschrijving

ResearchCommentsText

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411
Person Completing Form
Beschrijving

ResponsiblePersonName

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Date Form Completed (MM DD YYYY)
Beschrijving

FormCompleteDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C40988
UMLS 2011AA ObjectClass
C1516308
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus ValueDomain
C25367
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Similar models

This paper worksheet may be completed to facilitate the entry of the required Cardiac Safety Monitoring information in NSABP Coordinator Online. Partially completed worksheets may be saved in Coordinator Online. DO NOT SUBMIT THIS WORKSHEET VIA FAX OR MAIL

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Unnamed1
PatientInitialsName
Item
Patient Initials (Last First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
PatientNationalSurgicalAdjuvantBreastProjectIdentifierNumber
Item
NSABP Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C15818 (NCI Thesaurus Property)
C1513905 (UMLS 2011AA Property)
Item Group
Report Period
Item
Time point (for this report)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
CL.1
Code List
Time point (for this report)
CL Item
3 Months After Randomization (3 months after randomization)
CL Item
6 Months After Randomization (6 months after randomization)
CL Item
9 Months After Randomization (9 months after randomization)
CL Item
12 Months After Randomization (12 months after randomization)
CL Item
Other Specify (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Item
Did the patient receive any systemic anticancer treatment for documented invasive breast cancer recurrence or second primary cancer prior to this Time Point
text
C15698 (NCI Thesaurus ObjectClass)
C1515119 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C4968 (NCI Thesaurus Property)
C0751623 (UMLS 2011AA Property)
C9245 (NCI Thesaurus Property)
C0853879 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.2
Code List
Did the patient receive any systemic anticancer treatment for documented invasive breast cancer recurrence or second primary cancer prior to this Time Point
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Section A: Lvef Assessment
Item
Reason LVEF was Assessed at Other Time Point (If Time Point is Other mark one)
text
C37946 (NCI Thesaurus ObjectClass)
C2700377 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C68568 (NCI Thesaurus Property)
C2348792 (UMLS 2011AA Property)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
CL.3
Code List
Reason LVEF was Assessed at Other Time Point (If Time Point is Other mark one)
CL Item
Evaluation Of Symptoms (Evaluation of Symptoms)
CL Item
Follow-up Of Previous Assessment (Follow-up of Previous Assessment)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
LeftVentricularEjectionFractionOtherTimepointAssessmentSpecify
Item
Other, specify
text
C37946 (NCI Thesaurus ObjectClass)
C2700377 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C68568 (NCI Thesaurus Property)
C2348792 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Was LVEF assessment performed at this time point (If Time Point is not Other)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C37946 (NCI Thesaurus ObjectClass)
C2700377 (UMLS 2011AA ObjectClass)
CL.4
Code List
Was LVEF assessment performed at this time point (If Time Point is not Other)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
HeartLVEFTestPercentageValue
Item
LVEF (%)
double
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property)
C2700377 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
HeartLVEFTestDate
Item
Date of LVEF (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property)
C2700377 (UMLS 2011AA Property)
Item
Assessment Type
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
CL.5
Code List
Assessment Type
CL Item
2-d Echocardiogram (2-D Echocardiogram)
CL Item
Muga Scan (MUGA scan)
Item Group
Section B: Ecg With Qtc Assessment
Item
Has the patient had an EKG (this time point Note: not required 9 months after randomization)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C38053 (NCI Thesaurus ObjectClass)
C1623258 (UMLS 2011AA ObjectClass)
C18020 (NCI Thesaurus ObjectClass)
C0430022 (UMLS 2011AA ObjectClass)
CL.6
Code List
Has the patient had an EKG (this time point Note: not required 9 months after randomization)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Was QTc assessed
text
C38053 (NCI Thesaurus ObjectClass)
C1623258 (UMLS 2011AA ObjectClass)
C18020 (NCI Thesaurus ObjectClass)
C0430022 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus Property)
C0489625 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.7
Code List
Was QTc assessed
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
ElectrocardiographyDiagnosticProcedureQTcIntervalAssessmentValue
Item
QTc Interval
double
C38053 (NCI Thesaurus ObjectClass)
C1623258 (UMLS 2011AA ObjectClass)
C18020 (NCI Thesaurus ObjectClass)
C0430022 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus Property)
C0489625 (NCI Metathesaurus Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
DiagnosticElectrocardiogramPerformedDate
Item
Date of EKG (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25482 (NCI Thesaurus ObjectClass)
C0348026 (UMLS 2011AA ObjectClass)
C0013798 (NCI Metathesaurus ObjectClass)
Item Group
Section C: Cardiac Events
Item
Did the patient experience any of the following cardiac events at the specified time point (mark all that apply)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C13306 (NCI Thesaurus ObjectClass)
C1522601 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
CL.8
Code List
Did the patient experience any of the following cardiac events at the specified time point (mark all that apply)
CL Item
Definite Cardiac Death (Definite cardiac death)
CL Item
Probable Cardiac Death (Probable cardiac death)
CL Item
Signs Or Symptoms Of Chf With Documented Decrease In Lvef To < 50 % (Signs or symptoms of CHF with documented decrease in LVEF to < 50 %)
AdverseEventAssessmentDate
Item
Date of Symptom/Event Assessment (if applicable Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
PatientHeartDiseasesDeathDate
Item
Date of Definite or Probable Cardiac Death (if applicable Month Day Year)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)
C12727 (NCI Thesaurus Property)
C0018787 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Footer
ResearchCommentsText
Item
Comments (optional)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
ResponsiblePersonName
Item
Person Completing Form
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
FormCompleteDate
Item
Date Form Completed (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
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