ID

7849

Description

NSABP B-45 Worksheet for Reporting Initiation of Sunitinib/Placebo Studying Biological Markers of Fatigue in Women With Residual Invasive Breast Cancer Enrolled on Clinical Trial NSABP-B-45 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=61A68212-D8B0-0740-E040-BB89AD431DF9

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=61A68212-D8B0-0740-E040-BB89AD431DF9

Keywords

  1. 8/27/12 8/27/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

January 9, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT00914043 Treatment - NSABP B-45 Worksheet for Reporting Initiation of Sunitinib/Placebo - 2830516v1.0

This paper worksheet may be completed to facilitate the entry of the information in NSABP Coordinator Online. Partially completed forms may be saved in Coordinator Online. DO NOT SUBMIT THIS WORKSHEET VIA FAX OR MAIL. For all patients, information on initiation of Sunitinib/Placebo must be reported within 4 weeks following randomization

Header Module
Description

Header Module

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
All Patients
Description

All Patients

Did the patient begin Sunitinib/Placebo
Description

AgentPlaceboSunitinibMalateAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C753
UMLS 2011AA Property
C0032042
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus Property-3
C26673
UMLS 2011AA Property-3
C1698963
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Agent Start Date (Sunitinib/Placebo Month Day Year)
Description

Agent Start Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1521826
NCI Thesaurus ValueDomain-2
C25431
UMLS CUI-2
C0808070
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property
C25275
Reason Treatment did not begin (Sunitinib/Placebo)
Description

NationalSurgicalAdjuvantBreastandBowelProjectTreatmentNotAdministeredReason

Data type

text

Alias
NCI Thesaurus ObjectClass
C15818
UMLS 2011AA ObjectClass
C1513905
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Other, specify
Description

NationalSurgicalAdjuvantBreastandBowelProjectTherapyNotAdministeredSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C15818
UMLS 2011AA ObjectClass
C1513905
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Footer Module
Description

Footer Module

Comments (optional)
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 (MM DD YYYY)
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

Similar models

This paper worksheet may be completed to facilitate the entry of the information in NSABP Coordinator Online. Partially completed forms may be saved in Coordinator Online. DO NOT SUBMIT THIS WORKSHEET VIA FAX OR MAIL. For all patients, information on initiation of Sunitinib/Placebo must be reported within 4 weeks following randomization

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
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
All Patients
AgentPlaceboSunitinibMalateAdministeredInd-2
Item
Did the patient begin Sunitinib/Placebo
boolean
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C753 (NCI Thesaurus Property)
C0032042 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C26673 (NCI Thesaurus Property-3)
C1698963 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Agent Start Date
Item
Agent Start Date (Sunitinib/Placebo Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C25431 (NCI Thesaurus ValueDomain-2)
C0808070 (UMLS CUI-2)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
Item
Reason Treatment did not begin (Sunitinib/Placebo)
text
C15818 (NCI Thesaurus ObjectClass)
C1513905 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
Code List
Reason Treatment did not begin (Sunitinib/Placebo)
CL Item
Patient Withdrawal Or Refusal (Patient withdrawal or refusal)
CL Item
New Lesion (including Second Primary Cancer) Or Other Sign Of Progression (New lesion (including second primary cancer) or other sign of progression)
CL Item
Death (Death)
C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
NationalSurgicalAdjuvantBreastandBowelProjectTherapyNotAdministeredSpecify
Item
Other, specify
text
C15818 (NCI Thesaurus ObjectClass)
C1513905 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item Group
Footer Module
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 (MM DD YYYY)
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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