ID
6537
Beschreibung
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 NCT01275677 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=95D01C7E-6AB6-38AE-E040-BB89AD4351B3
Link
Stichworte
Versionen (2)
- 26.08.12 26.08.12 -
- 08.01.15 08.01.15 - Martin Dugas
Hochgeladen am
8. Januar 2015
DOI
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Lizenz
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
Beschreibung
Treatment Status Of Patient At Onset Of Cardiac Event
Beschreibung
Treatment Status
Datentyp
text
Alias
- NCI Thesaurus ObjectClass
- C15368
- NCI Thesaurus ValueDomain
- C25688
- UMLS CUI-1
- C0749659
- NCI Thesaurus Property
- C25365
Beschreibung
PriorCardiovascularDisorderRecurrentDiseaseTherapyInd-2
Datentyp
boolean
Alias
- NCI Thesaurus ObjectClass
- C25629
- UMLS 2011AA ObjectClass
- C0332152
- NCI Thesaurus ObjectClass-2
- C2931
- UMLS 2011AA ObjectClass-2
- C0007222
- NCI Thesaurus Property
- C38155
- UMLS 2011AA Property
- C0277556
- NCI Thesaurus Property-2
- C15368
- NCI Thesaurus ValueDomain
- C38147
- UMLS 2011AA ValueDomain
- C1512698
Beschreibung
CardiacDiseaseAssessmentType
Datentyp
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-2
- C2991
- UMLS 2011AA ObjectClass-2
- C0012634
Beschreibung
Section 1 - Symptoms Suggestive Of Congestive Heart Failure, Even If Chf Was Not Subsequently Confirmed
Beschreibung
AdverseEventSymptomBeginDate
Datentyp
date
Alias
- NCI Thesaurus ValueDomain
- C25164
- UMLS 2011AA ValueDomain
- C0011008
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus ValueDomain-2
- C25431
- UMLS 2011AA ValueDomain-2
- C0439659
- NCI Thesaurus Property
- C4876
- UMLS 2011AA Property
- C1457887
Beschreibung
ConfirmatoryAssessmentMethodType
Datentyp
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-2
- C25458
- UMLS 2011AA ObjectClass-2
- C0750484
Beschreibung
CardiacPerformanceStatusAssessmentMostRecentDate
Datentyp
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-2
- C25577
- UMLS 2011AA ValueDomain-2
- C1513491
Beschreibung
ConcomitantDiseasePersonalMedicalHistoryType
Datentyp
text
Alias
- NCI Thesaurus ValueDomain
- C25284
- UMLS 2011AA ValueDomain
- C0332307
- NCI Thesaurus ObjectClass
- C2991
- UMLS 2011AA ObjectClass
- C0012634
- NCI Thesaurus ObjectClass-2
- C25730
- UMLS 2011AA ObjectClass-2
- C0521115
- NCI Thesaurus Property
- C18772
- UMLS 2011AA Property
- C0262926
Beschreibung
CardiacDiseaseAssessmentSpecify
Datentyp
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-2
- C2991
- UMLS 2011AA ObjectClass-2
- C0012634
Beschreibung
Section 2 - Definite Or Probable Cardiac Death
Beschreibung
PatientHeartDiseasesandDisordersDeathType
Datentyp
text
Alias
- NCI Thesaurus ObjectClass
- C16960
- UMLS 2011AA ObjectClass
- C0030705
- NCI Thesaurus Property
- C28554
- UMLS 2011AA Property
- C0011065
- NCI Thesaurus Property-2
- C12727
- UMLS 2011AA Property-2
- C0018787
- NCI Thesaurus Property-3
- C2991
- UMLS 2011AA Property-3
- C0012634
- NCI Thesaurus ValueDomain
- C25284
- UMLS 2011AA ValueDomain
- C0332307
Beschreibung
Footer
Beschreibung
Research Comments
Datentyp
text
Alias
- NCI Thesaurus ValueDomain
- C25704
- UMLS CUI-1
- C0947611
- NCI Thesaurus ObjectClass
- C15319
- NCI Thesaurus Property
- C25393
Beschreibung
Person Completing Form
Datentyp
text
Alias
- NCI Thesaurus ValueDomain
- C25191
- UMLS CUI-1
- C1550483
- NCI Thesaurus ObjectClass
- C25657
- NCI Thesaurus Property
- C25364
Beschreibung
Date Form Completed
Datentyp
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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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
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)
C25688 (NCI Thesaurus ValueDomain)
C0749659 (UMLS CUI-1)
C25365 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA ObjectClass)
C2931 (NCI Thesaurus ObjectClass-2)
C0007222 (UMLS 2011AA ObjectClass-2)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C15368 (NCI Thesaurus Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C13306 (NCI Thesaurus ObjectClass)
C1522601 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
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-2)
C0750484 (UMLS 2011AA ObjectClass-2)
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-2)
C1513491 (UMLS 2011AA ValueDomain-2)
C0332307 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
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-2)
C0012634 (UMLS 2011AA ObjectClass-2)
C0030705 (UMLS 2011AA ObjectClass)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)
C12727 (NCI Thesaurus Property-2)
C0018787 (UMLS 2011AA Property-2)
C2991 (NCI Thesaurus Property-3)
C0012634 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
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)