ID
1161
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
Keywords
Versions (2)
- 8/27/12 8/27/12 -
- 1/9/15 1/9/15 - Martin Dugas
Uploaded on
August 27, 2012
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0 Legacy
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Breast Cancer NCT01275677 Follow-Up - NSABP-B-47 Left Ventricular Assessment Report Form (Form LVA) - 3161750v1.0
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
Description
Unnamed3
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
Description
LeftVentricularEjectionFractionAssessmentInd-2
Data type
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
Description
Unnamed5
Description
HeartLVEFTestPercentageValue
Data type
double
Measurement units
- %
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
Description
AssessmentPerformedDate
Data type
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
Description
AssessmentMethodType
Data type
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
Description
Footer
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
Description
ResponsiblePersonName
Data type
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
Description
FormCompleteDate
Data type
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
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
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
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)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C37946 (NCI Thesaurus ObjectClass)
C2700377 (UMLS 2011AA ObjectClass)
C1705108 (UMLS 2011AA)
C1298908 (UMLS 2011AA)
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)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C0011008 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)