ID
1077
Description
NSABP-B-47 Cardiac Report Form (Form CR) 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=95D01C7E-6AB6-38AE-E040-BB89AD4351B3
Link
Keywords
Versions (2)
- 8/26/12 8/26/12 -
- 1/8/15 1/8/15 - Martin Dugas
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August 26, 2012
DOI
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License
Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT01275677 On-Study - NSABP-B-47 Cardiac Report Form (Form CR) - 3162764v1.0
This paper worksheet may be completed to facilitate the entry of the report in NSABP Coordinator Online. Partially completed online forms may be saved in Coordinator Online. DO NOT SUBMIT THIS WORKSHEET VIA FAX OR MAIL. Submit the report as soon as possible within 21 days of learning of the event. Submit the required information online whenever any of the following cardiac events occurs in any protocol patient: Signs or symptoms of CHF (i.e., >= grade 2 heart failure or grade >= 3 left ventricular systolic dysfunction) Definite cardiac death defined as any grade 5 AE included in the Cardiac Disorders section of CTCAE v4.0 Sudden death NOS as defined in the General Disorders section of the CTCAE v4.0 >= grade 3 acute coronary syndrome >= grade 3 myocardial infarction
Description
Treatment Status Of Patient At Onset Of Cardiac Event
Description
TreatmentStatusType
Data type
text
Alias
- NCI Thesaurus ObjectClass
- C15368
- NCI Thesaurus ValueDomain
- C25688
- UMLS 2011AA ValueDomain
- C0449438
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Description
PriorCardiovascularDisorderRecurrentDiseaseTherapyInd-2
Data type
text
Alias
- NCI Thesaurus ObjectClass
- C25629
- UMLS 2011AA ObjectClass
- C0332152
- NCI Thesaurus ObjectClass
- C2931
- UMLS 2011AA ObjectClass
- C0007222
- NCI Thesaurus Property
- C38155
- UMLS 2011AA Property
- C0277556
- NCI Thesaurus Property
- C15368
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Description
CardiacDiseaseAssessmentType
Data type
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
Description
Section 1 - Symptoms Suggestive Of Congestive Heart Failure, Even If Chf Was Not Subsequently Confirmed
Description
AdverseEventSymptomBeginDate
Data type
date
Alias
- NCI Thesaurus ValueDomain
- C25164
- UMLS 2011AA ValueDomain
- C0011008
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus ValueDomain
- C25431
- UMLS 2011AA ValueDomain
- C0439659
- NCI Thesaurus Property
- C4876
- UMLS 2011AA Property
- C1457887
Description
ConfirmatoryAssessmentMethodType
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
- NCI Thesaurus ObjectClass
- C25458
- UMLS 2011AA ObjectClass
- C0750484
Description
CardiacPerformanceStatusAssessmentMostRecentDate
Data type
date
Alias
- NCI Thesaurus ObjectClass
- C13306
- UMLS 2011AA ObjectClass
- C1522601
- NCI Metathesaurus ObjectClass
- CL092952
- NCI Thesaurus Property
- C20989
- UMLS 2011AA Property
- C0031809
- NCI Thesaurus ValueDomain
- C25164
- UMLS 2011AA ValueDomain
- C0011008
- NCI Thesaurus ValueDomain
- C25577
- UMLS 2011AA ValueDomain
- C1513491
Description
ConcomitantDiseasePersonalMedicalHistoryType
Data type
text
Alias
- NCI Thesaurus ValueDomain
- C25284
- UMLS 2011AA ValueDomain
- C0332307
- NCI Thesaurus ObjectClass
- C2991
- UMLS 2011AA ObjectClass
- C0012634
- NCI Thesaurus ObjectClass
- C25730
- UMLS 2011AA ObjectClass
- C0521115
- NCI Thesaurus Property
- C18772
- UMLS 2011AA Property
- C0262926
Description
CardiacDiseaseAssessmentSpecify
Data type
text
Alias
- NCI Thesaurus ValueDomain
- C25685
- UMLS 2011AA ValueDomain
- C1521902
- NCI Thesaurus Property
- C20989
- UMLS 2011AA Property
- C0031809
- NCI Thesaurus ObjectClass
- C13306
- UMLS 2011AA ObjectClass
- C1522601
- NCI Thesaurus ObjectClass
- C2991
- UMLS 2011AA ObjectClass
- C0012634
Description
Section 2 - Definite Or Probable Cardiac Death
Description
PatientHeartDiseasesandDisordersDeathType
Data type
text
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
- C25284
- UMLS 2011AA ValueDomain
- C0332307
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 the report in NSABP Coordinator Online. Partially completed online forms may be saved in Coordinator Online. DO NOT SUBMIT THIS WORKSHEET VIA FAX OR MAIL. Submit the report as soon as possible within 21 days of learning of the event. Submit the required information online whenever any of the following cardiac events occurs in any protocol patient: Signs or symptoms of CHF (i.e., >= grade 2 heart failure or grade >= 3 left ventricular systolic dysfunction) Definite cardiac death defined as any grade 5 AE included in the Cardiac Disorders section of CTCAE v4.0 Sudden death NOS as defined in the General Disorders section of the CTCAE v4.0 >= grade 3 acute coronary syndrome >= grade 3 myocardial infarction
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)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C0332152 (UMLS 2011AA ObjectClass)
C2931 (NCI Thesaurus ObjectClass)
C0007222 (UMLS 2011AA ObjectClass)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C15368 (NCI Thesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C1705108 (UMLS 2011AA)
C1298908 (UMLS 2011AA)
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)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C25458 (NCI Thesaurus ObjectClass)
C0750484 (UMLS 2011AA ObjectClass)
C1522601 (UMLS 2011AA ObjectClass)
CL092952 (NCI Metathesaurus ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25577 (NCI Thesaurus ValueDomain)
C1513491 (UMLS 2011AA ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass)
C0521115 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C1521902 (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)
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)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
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)