ID

9087

Beschreibung

NSABP-B-47 Cardiac Report Follow-Up Form (Form CR-F) 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-6A9D-38AE-E040-BB89AD4351B3

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=95D01C7E-6A9D-38AE-E040-BB89AD4351B3

Stichworte

Versionen (2)
  1. 27.08.12 27.08.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
Hochgeladen am

9. Januar 2015

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT01275677 Follow-Up - NSABP-B-47 Cardiac Report Follow-Up Form (Form CR-F) - 3162754v1.0

Englisch

This paper worksheet may be completed to facilitate the entry of the information in NSABP Coordinator Online. Partially completed worksheets may be saved in Coordinator Online. DO NOT SUBMIT THIS WORKSHEET VIA FAX OR MAIL. Following receipt of a Cardiac Report form (Form CR), the documentation will be reviewed to determine if routine submission of a Cardiac Report Follow-up form (Form CR-F) will be required. The decision will be conveyed to the institution's Program Coordinator. If cardiac follow-up is required, Form CR-F must be submitted for 2 years, approximately every 6 months following the date of confirmatory LVEF reported on Form CR. (Submission of Form CR-F should be timed to coincide with submission of the B-47 Follow-up form (Form F).)

1 Formulare  
Header
Beschreibung

Header

Patient Initials (Last First Middle)
Beschreibung

Patient Initials

Datentyp

text

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

Patient ID NSABP

Datentyp

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
Reporting Period
Beschreibung

Reporting Period

Reporting Period
Beschreibung

Clinical Trial Period

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2347804
NCI Thesaurus ObjectClass
C25214
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass-2
C25651
Reporting Period End Date (Month Day Year)
Beschreibung

Reporting Period End Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2361259
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25651
Cardiac Information
Beschreibung

Cardiac Information

Has the patient had symptoms of CHF since the previous report (Previous report will be Form CR if this is the first CR-F form submitted.)
Beschreibung

SymptomaticCongestiveHeartFailurePresentInd-3

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C3080
UMLS 2011AA ObjectClass
C0018802
NCI Thesaurus ObjectClass-2
C25269
UMLS 2011AA ObjectClass-2
C0231220
How would you classify the symptoms of congestive heart failure (If yes)
Beschreibung

CongestiveHeartFailureAdverseEventSymptomType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass-2
C3080
UMLS 2011AA ObjectClass-2
C0018802
NCI Thesaurus Property
C4876
UMLS 2011AA Property
C1457887
Has the patient had one or more LVEF assessments since the previous report (Form LVA should be submitted any time through 10 years following randomization when a non-protocol specified LVEF assessment has been performed because the patient has signs or symptoms of CHF see Protocol Section 5.3. Please submit all LVEF assessments since the previous report)
Beschreibung

LeftVentricularEjectionFractionAssessmentInd-2

Datentyp

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
Has the patient received medications for heart failure and/or hypertension since the previous report
Beschreibung

HeartMedicationAdministrationInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus ObjectClass-2
C459
UMLS 2011AA ObjectClass-2
C0013227
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
Medications (Mark all that apply)
Beschreibung

CardiovascularAgentPriorYearReceivedType

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C2079
UMLS 2011AA ObjectClass
C0007209
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C29848
UMLS 2011AA Property-2
C0439234
NCI Thesaurus Property-3
C25639
UMLS 2011AA Property-3
C1514756
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Other, specify
Beschreibung

CardiacMedicationReportingPeriodSpecify

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C13306
UMLS 2011AA ObjectClass
C1522601
NCI Thesaurus ObjectClass-2
C459
UMLS 2011AA ObjectClass-2
C0013227
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25651
UMLS 2011AA Property-2
C0700287
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Medication Reason (Mark all reasons that apply)
Beschreibung

PatientMedicalConditionCurrentType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25261
UMLS 2011AA Property
C0205476
NCI Thesaurus Property-2
C25457
UMLS 2011AA Property-2
C0348080
Footer
Beschreibung

Footer

Comments (optional)
Beschreibung

Research Comments

Datentyp

text

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

Person Completing Form

Datentyp

text

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

This paper worksheet may be completed to facilitate the entry of the information in NSABP Coordinator Online. Partially completed worksheets may be saved in Coordinator Online. DO NOT SUBMIT THIS WORKSHEET VIA FAX OR MAIL. Following receipt of a Cardiac Report form (Form CR), the documentation will be reviewed to determine if routine submission of a Cardiac Report Follow-up form (Form CR-F) will be required. The decision will be conveyed to the institution's Program Coordinator. If cardiac follow-up is required, Form CR-F must be submitted for 2 years, approximately every 6 months following the date of confirmatory LVEF reported on Form CR. (Submission of Form CR-F should be timed to coincide with submission of the B-47 Follow-up form (Form F).)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
Reporting Period
Item
Reporting Period
text
C25284 (NCI Thesaurus ValueDomain)
C2347804 (UMLS CUI-1)
C25214 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus ObjectClass-2)
CL.1
Code List
Reporting Period
CL Item
First Cardiac Follow-up (First cardiac follow-up)
CL Item
Second Cardiac Follow-up (Second cardiac follow-up)
CL Item
Third Cardiac Follow-up (Third cardiac follow-up)
CL Item
Fourth Cardiac Follow-up (Fourth cardiac follow-up)
Reporting Period End Date
Item
Reporting Period End Date (Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
Item Group
Cardiac Information
SymptomaticCongestiveHeartFailurePresentInd-3
Item
Has the patient had symptoms of CHF since the previous report (Previous report will be Form CR if this is the first CR-F form submitted.)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C3080 (NCI Thesaurus ObjectClass)
C0018802 (UMLS 2011AA ObjectClass)
C25269 (NCI Thesaurus ObjectClass-2)
C0231220 (UMLS 2011AA ObjectClass-2)
Item
How would you classify the symptoms of congestive heart failure (If yes)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C3080 (NCI Thesaurus ObjectClass-2)
C0018802 (UMLS 2011AA ObjectClass-2)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)
CL.3
Code List
How would you classify the symptoms of congestive heart failure (If yes)
CL Item
Ordinary Physical Activity Does Not Cause Undue Fatigue, Palpitation, Dyspnea Or Anginal Pain (Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea or anginal pain)
CL Item
Asymptomatic At Rest, But Ordinary Physical Activity Results In Fatigue, Palpitation, Dyspnea Or Anginal Pain (Asymptomatic at rest, but ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain)
CL Item
Asymptomatic At Rest, But Less Than Ordinary Physical Activity Results In Fatigue, Palpitation, Dyspnea Or Anginal Pain (Asymptomatic at rest, but less than ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain)
CL Item
Symptomatic At Rest, Or Any Physical Activity Results In Fatigue, Palpitation, Dyspnea Or Anginal Pain (Symptomatic at rest, or any physical activity results in fatigue, palpitation, dyspnea or anginal pain)
LeftVentricularEjectionFractionAssessmentInd-2
Item
Has the patient had one or more LVEF assessments since the previous report (Form LVA should be submitted any time through 10 years following randomization when a non-protocol specified LVEF assessment has been performed because the patient has signs or symptoms of CHF see Protocol Section 5.3. Please submit all LVEF assessments since the previous report)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C37946 (NCI Thesaurus ObjectClass)
C2700377 (UMLS 2011AA ObjectClass)
HeartMedicationAdministrationInd-2
Item
Has the patient received medications for heart failure and/or hypertension since the previous report
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C459 (NCI Thesaurus ObjectClass-2)
C0013227 (UMLS 2011AA ObjectClass-2)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
Item
Medications (Mark all that apply)
text
C2079 (NCI Thesaurus ObjectClass)
C0007209 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C29848 (NCI Thesaurus Property-2)
C0439234 (UMLS 2011AA Property-2)
C25639 (NCI Thesaurus Property-3)
C1514756 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.6
Code List
Medications (Mark all that apply)
CL Item
Ace Inhibitor (ACE inhibitors)
CL Item
Alpha/beta Blocker (Alpha/beta blocker)
CL Item
Arb (ARB)
CL Item
Beta Blocker (Beta blockers)
CL Item
Cardiac Glycoside (Cardiac glycoside)
CL Item
Diuretic (Diuretics)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CardiacMedicationReportingPeriodSpecify
Item
Other, specify
text
C13306 (NCI Thesaurus ObjectClass)
C1522601 (UMLS 2011AA ObjectClass)
C459 (NCI Thesaurus ObjectClass-2)
C0013227 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property-2)
C0700287 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Medication Reason (Mark all reasons that apply)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25457 (NCI Thesaurus Property-2)
C0348080 (UMLS 2011AA Property-2)
CL.7
Code List
Medication Reason (Mark all reasons that apply)
CL Item
Heart Failure (Heart Failure)
C50577 (NCI Thesaurus)
C0018801 (UMLS 2011AA)
CL Item
Hypertension (hypertension)
C3117 (NCI Thesaurus)
C0020538 (UMLS 2011AA)
Item Group
Footer
Research Comments
Item
Comments (optional)
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)
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