ID
9067
Beschrijving
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
Trefwoorden
Versies (2)
- 27-08-12 27-08-12 -
- 09-01-15 09-01-15 - Martin Dugas
Geüploaded op
9 januari 2015
DOI
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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
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
Beschrijving
Unnamed3
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
Beschrijving
LeftVentricularEjectionFractionAssessmentInd-2
Datatype
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
Beschrijving
Unnamed5
Beschrijving
HeartLVEFTestPercentageValue
Datatype
float
Maateenheden
- %
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
Beschrijving
Assessment Date
Datatype
date
Alias
- NCI Thesaurus ValueDomain
- C25164
- UMLS CUI-1
- C2985720
- NCI Thesaurus ObjectClass
- C25367
- NCI Thesaurus ValueDomain-2
- C25367
- NCI Thesaurus Property
- C38000
Beschrijving
Evaluation method
Datatype
text
Alias
- NCI Thesaurus ValueDomain
- C25284
- UMLS CUI-1
- C2911685
- NCI Thesaurus ObjectClass
- C20989
- NCI Thesaurus Property
- C16847
Beschrijving
Footer
Beschrijving
Research Comments
Datatype
text
Alias
- NCI Thesaurus ValueDomain
- C25704
- UMLS CUI-1
- C0947611
- NCI Thesaurus ObjectClass
- C15319
- NCI Thesaurus Property
- C25393
Beschrijving
Person Completing Form
Datatype
text
Alias
- NCI Thesaurus ValueDomain
- C25191
- UMLS CUI-1
- C1550483
- NCI Thesaurus ObjectClass
- C25657
- NCI Thesaurus Property
- C25364
Beschrijving
Date Form Completed
Datatype
date
Alias
- NCI Thesaurus ValueDomain
- C25164
- UMLS CUI-1
- C1115437
- NCI Thesaurus ObjectClass
- C40988
- NCI Thesaurus Property
- C25250
- NCI Thesaurus ValueDomain-2
- 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
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1513905 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C15818 (NCI Thesaurus Property-2)
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)
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)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)