ID

6537

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 NCT01275677 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=95D01C7E-6AB6-38AE-E040-BB89AD4351B3

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=95D01C7E-6AB6-38AE-E040-BB89AD4351B3

Keywords

Versions (2)
  1. 8/26/12 8/26/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
Uploaded on

January 8, 2015

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.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

No comments

In order to download data models you must be logged in. Please log in or register for free.

Breast Cancer NCT01275677 On-Study - NSABP-B-47 Cardiac Report Form (Form CR) - 3162764v1.0

English

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

1 forms  
Header
Description

Header

Patient Initials (Last First Middle)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
NSABP Patient ID
Description

Patient ID NSABP

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1513905
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C15818
Treatment Status Of Patient At Onset Of Cardiac Event
Description

Treatment Status Of Patient At Onset Of Cardiac Event

Treatment Status (Mark the item that corresponds to the patient's treatment status at the time of the cardiac event)
Description

Treatment Status

Data type

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain
C25688
UMLS CUI-1
C0749659
NCI Thesaurus Property
C25365
Was therapy for recurrence or second primary cancer initiated before the onset of this cardiac event
Description

PriorCardiovascularDisorderRecurrentDiseaseTherapyInd-2

Data type

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
Did the patient experience any of the following cardiac events at the specified time point (Mark all that apply to this report.)
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-2
C2991
UMLS 2011AA ObjectClass-2
C0012634
Section 1 - Symptoms Suggestive Of Congestive Heart Failure, Even If Chf Was Not Subsequently Confirmed
Description

Section 1 - Symptoms Suggestive Of Congestive Heart Failure, Even If Chf Was Not Subsequently Confirmed

Date of Onset of Symptoms (Month Day Year)
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-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
NCI Thesaurus Property
C4876
UMLS 2011AA Property
C1457887
Type of Confirmatory Assessment
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-2
C25458
UMLS 2011AA ObjectClass-2
C0750484
Date of Confirmatory Assessment (The report for the confirmatory MUGA scan and/or echocardiogram must be submitted along with any other pertinent documentation e.g., chest x-ray report, cardiology consult note, medical oncologist's progress note, discharge summary. Enter Form LVA online for each confirmatory MUGA scan or echocardiogram.)
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-2
C25577
UMLS 2011AA ValueDomain-2
C1513491
Diagnosis (Group 2B only - If the diagnosis of CHF is confirmed during AC, the initiation of trastuzumab is prohibited Protocol Section 9.6.1)
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-2
C25730
UMLS 2011AA ObjectClass-2
C0521115
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
Specify
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-2
C2991
UMLS 2011AA ObjectClass-2
C0012634
Section 2 - Definite Or Probable Cardiac Death
Description

Section 2 - Definite Or Probable Cardiac Death

Nature of 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-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
Footer
Description

Footer

Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Person Completing Form
Description

Person Completing Form

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date Form Completed
Description

Date Form Completed

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
C25367
Back to the top of the page

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Patient Initials
Item
Patient Initials (Last First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Patient ID NSABP
Item
NSABP Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1513905 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C15818 (NCI Thesaurus Property-2)
Item Group
Treatment Status Of Patient At Onset Of Cardiac Event
Item
Treatment Status (Mark the item that corresponds to the patient's treatment status at the time of the cardiac event)
text
C15368 (NCI Thesaurus ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0749659 (UMLS CUI-1)
C25365 (NCI Thesaurus Property)
CL.1
Code List
Treatment Status (Mark the item that corresponds to the patient's treatment status at the time of the cardiac event)
CL Item
During Chemotherapy (During chemotherapy)
CL Item
Post-chemotherapy Trastuzumab (Post-chemotherapy trastuzumab)
CL Item
After Study Therapy Has Ended (After study therapy has ended)
PriorCardiovascularDisorderRecurrentDiseaseTherapyInd-2
Item
Was therapy for recurrence or second primary cancer initiated before the onset of this cardiac event
boolean
C25629 (NCI Thesaurus ObjectClass)
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)
Item
Did the patient experience any of the following cardiac events at the specified time point (Mark all that apply to this report.)
text
C25284 (NCI Thesaurus 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)
CL.3
Code List
Did the patient experience any of the following cardiac events at the specified time point (Mark all that apply to this report.)
CL Item
Symptoms Suggestive Of Chf (Symptoms suggestive of CHF)
CL Item
Definite Or Probable Cardiac Death (Definite or probable cardiac death)
Item Group
Section 1 - Symptoms Suggestive Of Congestive Heart Failure, Even If Chf Was Not Subsequently Confirmed
AdverseEventSymptomBeginDate
Item
Date of Onset of Symptoms (Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
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)
Item
Type of Confirmatory Assessment
text
C25284 (NCI Thesaurus ValueDomain)
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)
CL.4
Code List
Type of Confirmatory Assessment
CL Item
2-d Echocardiogram (2-D Echocardiogram)
CL Item
Muga Scan (MUGA scan)
CardiacPerformanceStatusAssessmentMostRecentDate
Item
Date of Confirmatory Assessment (The report for the confirmatory MUGA scan and/or echocardiogram must be submitted along with any other pertinent documentation e.g., chest x-ray report, cardiology consult note, medical oncologist's progress note, discharge summary. Enter Form LVA online for each confirmatory MUGA scan or echocardiogram.)
date
C13306 (NCI Thesaurus 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-2)
C1513491 (UMLS 2011AA ValueDomain-2)
Item
Diagnosis (Group 2B only - If the diagnosis of CHF is confirmed during AC, the initiation of trastuzumab is prohibited Protocol Section 9.6.1)
text
C25284 (NCI Thesaurus ValueDomain)
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)
CL.5
Code List
Diagnosis (Group 2B only - If the diagnosis of CHF is confirmed during AC, the initiation of trastuzumab is prohibited Protocol Section 9.6.1)
CL Item
Congestive Heart Failure Confirmed (Congestive heart failure confirmed)
CL Item
Congestive Heart Failure Not Confirmed (Congestive heart failure not confirmed)
CardiacDiseaseAssessmentSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
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)
Item Group
Section 2 - Definite Or Probable Cardiac Death
Item
Nature of Cardiac Death
text
C16960 (NCI Thesaurus ObjectClass)
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)
CL.6
Code List
Nature of Cardiac Death
CL Item
Definite Cardiac (Definite cardiac)
CL Item
Probable Cardiac (Probable cardiac)
Item Group
Footer
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Person Completing Form
Item
Person Completing Form
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
Date Form Completed
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial