ID

1161

Descrizione

NSABP-B-47 Left Ventricular Assessment Report Form (Form LVA) A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women With Node- Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=955926C1-ED44-2CC7-E040-BB89AD436024

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=955926C1-ED44-2CC7-E040-BB89AD436024

Keywords

versioni (2)
  1. 27/08/12 27/08/12 -
  2. 09/01/15 09/01/15 - Martin Dugas
Caricato su

27 agosto 2012

DOI

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Licenza

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT01275677 Follow-Up - NSABP-B-47 Left Ventricular Assessment Report Form (Form LVA) - 3161750v1.0

Inglese

This paper worksheet may be completed to facilitate the entry of LVEF information in NSABP Coordinator Online. Partially completed online forms may be saved in Coordinator Online. DO NOT SUBMIT THIS WORKSHEET VIA FAX OR MAIL. Submission of Form LVA with the echocardiogram or MUGA scan report is required within 21 days after all LVEF assessments. Submission of Form LVA is required for the groups listed below for time points A, B, C, D, and E even if LVEF was not assessed. All LVEF assessments should be performed by the same method (either 2-D echocardiogram or MUGA scan) that was performed at baseline. If trastuzumab is discontinued for any reason, protocol-mandated LVEF assessments should continue to be obtained. (Exception: LVEF assessments are not required after documented invasive breast cancer recurrence, invasive contralateral breast cancer, or second non-breast primary cancer excluding squamous or basal cell skin cancers or new in situ carcinomas of any site.) During therapy and until 30 days after the last dose of study therapy (either as part of required AdEERS reports or as part of routine AE reporting), >= grade 2 decreases in LVEF must also be reported as an AE. (see "Ejection Fraction Decreased" in the Investigations section of the CTCAE v4.0). Refer to Tables 17 and 28 in the protocol for information regarding repeat LVEF assessments

1 moduli  
Unnamed1
Descrizione

Unnamed1

Patient Initials (Last First Middle)
Descrizione

PatientInitialsName

Tipo di dati

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
Descrizione

PatientNationalSurgicalAdjuvantBreastProjectIdentifierNumber

Tipo di dati

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
Unnamed3
Descrizione

Unnamed3

Time point of this assessment (for LVEF Assessment)
Descrizione

AssessmentPeriodType

Tipo di dati

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
Was LVEF assessment performed at this time point
Descrizione

LeftVentricularEjectionFractionAssessmentInd-2

Tipo di dati

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
Unnamed5
Descrizione

Unnamed5

LVEF (%)
Descrizione

HeartLVEFTestPercentageValue

Tipo di dati

double

Unità di misura
  • %
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 Assessment (Month Day Year)
Descrizione

AssessmentPerformedDate

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
Assessment Type
Descrizione

AssessmentMethodType

Tipo di dati

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
Footer
Descrizione

Footer

Comments (optional)
Descrizione

ResearchCommentsText

Tipo di dati

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
Descrizione

ResponsiblePersonName

Tipo di dati

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
Descrizione

FormCompleteDate

Tipo di dati

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 LVEF information in NSABP Coordinator Online. Partially completed online forms may be saved in Coordinator Online. DO NOT SUBMIT THIS WORKSHEET VIA FAX OR MAIL. Submission of Form LVA with the echocardiogram or MUGA scan report is required within 21 days after all LVEF assessments. Submission of Form LVA is required for the groups listed below for time points A, B, C, D, and E even if LVEF was not assessed. All LVEF assessments should be performed by the same method (either 2-D echocardiogram or MUGA scan) that was performed at baseline. If trastuzumab is discontinued for any reason, protocol-mandated LVEF assessments should continue to be obtained. (Exception: LVEF assessments are not required after documented invasive breast cancer recurrence, invasive contralateral breast cancer, or second non-breast primary cancer excluding squamous or basal cell skin cancers or new in situ carcinomas of any site.) During therapy and until 30 days after the last dose of study therapy (either as part of required AdEERS reports or as part of routine AE reporting), >= grade 2 decreases in LVEF must also be reported as an AE. (see "Ejection Fraction Decreased" in the Investigations section of the CTCAE v4.0). Refer to Tables 17 and 28 in the protocol for information regarding repeat LVEF assessments

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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
Time point of this assessment (for LVEF Assessment)
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 of this assessment (for LVEF Assessment)
CL Item
A (A)
CL Item
A-r (A-R)
CL Item
B (B)
CL Item
B-r (B-R)
CL Item
C (C)
CL Item
C-r (C-R)
CL Item
D (D)
CL Item
D-r (D-R)
CL Item
E (E)
CL Item
F (F)
CL Item
G (G)
Item
Was LVEF assessment performed at this time point
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.2
Code List
Was LVEF assessment performed at this time point
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item Group
Unnamed5
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)
AssessmentPerformedDate
Item
Date of Assessment (Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (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.3
Code List
Assessment Type
CL Item
Muga Scan (MUGA scan)
CL Item
2-d Echocardiogram (2-D Echocardiogram)
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
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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