ID
1077
Descrição
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
Palavras-chave
Versões (2)
- 26/08/2012 26/08/2012 -
- 08/01/2015 08/01/2015 - Martin Dugas
Transferido a
26 de agosto de 2012
DOI
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Licença
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
Descrição
Treatment Status Of Patient At Onset Of Cardiac Event
Descrição
TreatmentStatusType
Tipo de dados
text
Alias
- NCI Thesaurus ObjectClass
- C15368
- NCI Thesaurus ValueDomain
- C25688
- UMLS 2011AA ValueDomain
- C0449438
- NCI Thesaurus Property
- C25365
- UMLS 2011AA Property
- C0678257
Descrição
PriorCardiovascularDisorderRecurrentDiseaseTherapyInd-2
Tipo de dados
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
Descrição
CardiacDiseaseAssessmentType
Tipo de dados
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
Descrição
Section 1 - Symptoms Suggestive Of Congestive Heart Failure, Even If Chf Was Not Subsequently Confirmed
Descrição
AdverseEventSymptomBeginDate
Tipo de dados
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
Descrição
ConfirmatoryAssessmentMethodType
Tipo de dados
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
Descrição
CardiacPerformanceStatusAssessmentMostRecentDate
Tipo de dados
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
Descrição
ConcomitantDiseasePersonalMedicalHistoryType
Tipo de dados
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
Descrição
CardiacDiseaseAssessmentSpecify
Tipo de dados
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
Descrição
Section 2 - Definite Or Probable Cardiac Death
Descrição
PatientHeartDiseasesandDisordersDeathType
Tipo de dados
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
Descrição
Footer
Descrição
ResearchCommentsText
Tipo de dados
text
Alias
- NCI Thesaurus ValueDomain
- C25704
- UMLS 2011AA ValueDomain
- C1527021
- NCI Thesaurus ObjectClass
- C15319
- NCI Thesaurus Property
- C25393
- UMLS 2011AA Property
- C0282411
Descrição
ResponsiblePersonName
Tipo de dados
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
Descrição
FormCompleteDate
Tipo de dados
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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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)