ID

9067

Description

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

Link

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

Keywords

Versions (2)
  1. 8/27/12 8/27/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

January 9, 2015

DOI

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License

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

English

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 forms  
Header
Description

Header

Patient Initials (Last First Middle)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
NSABP Patient ID
Description

Patient ID NSABP

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1513905
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C15818
Unnamed3
Description

Unnamed3

Time point of this assessment (for LVEF Assessment)
Description

AssessmentPeriodType

Data type

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
Description

LeftVentricularEjectionFractionAssessmentInd-2

Data type

boolean

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
Description

Unnamed5

LVEF (%)
Description

HeartLVEFTestPercentageValue

Data type

float

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property-2
C37946
UMLS 2011AA Property-2
C2700377
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
%
Date of Assessment (Month Day Year)
Description

Assessment Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985720
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C38000
Assessment Type
Description

Evaluation method

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2911685
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C16847
Footer
Description

Footer

Comments (optional)
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Person Completing Form
Description

Person Completing Form

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date Form Completed
Description

Date Form Completed

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Patient Initials
Item
Patient Initials (Last First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Patient ID NSABP
Item
NSABP Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1513905 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C15818 (NCI Thesaurus Property-2)
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)
LeftVentricularEjectionFractionAssessmentInd-2
Item
Was LVEF assessment performed at this time point
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C37946 (NCI Thesaurus ObjectClass)
C2700377 (UMLS 2011AA ObjectClass)
Item Group
Unnamed5
HeartLVEFTestPercentageValue
Item
LVEF (%)
float
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property-2)
C2700377 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Assessment Date
Item
Date of Assessment (Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
Item
Assessment Type
text
C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
CL.3
Code List
Assessment Type
CL Item
Muga Scan (MUGA scan)
CL Item
2-d Echocardiogram (2-D Echocardiogram)
Item Group
Footer
Research Comments
Item
Comments (optional)
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Person Completing Form
Item
Person Completing Form
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
Date Form Completed
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
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