ID

11057

Descrição

NSABP Protocol B-40 - Treatment Form for Bevacizumab NCT00408408 A Randomized Phase III Trial of Neoadjuvant Therapy in Patients With Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel When Administered Before AC With or Without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pCR With Each of the Regimens Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1B7D839C-1CA0-14D8-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1B7D839C-1CA0-14D8-E044-0003BA3F9857

Palavras-chave

Versões (3)
  1. 26/08/2012 26/08/2012 -
  2. 09/01/2015 09/01/2015 - Martin Dugas
  3. 16/06/2015 16/06/2015 -
Transferido a

16 de junho de 2015

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy
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NSABP Protocol B-40 - Treatment Form for Bevacizumab NCT00408408

Inglês

For treatment groups 1B, 2B, and 3B only. This form must be submitted for both the preoperative and postoperative time points.

1 Formulários  
Header
Descrição

Header

Patient Initials (Last First Middle)
Descrição

Patient Initials

Tipo de dados

text

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

Patient ID NSABP

Tipo de dados

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
Institution/Affiliate
Descrição

Institution Name

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Person Completing Form, Last Name
Descrição

Person Completing Form Last Name

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass-2
C25657
UMLS CUI-2
C1301584
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25551
NCI Thesaurus ValueDomain
C25191
Person Completing Form, First Name
Descrição

Person Completing Form First Name

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass-2
C25657
UMLS CUI-2
C1443235
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25509
NCI Thesaurus ValueDomain
C25191
Person Completing Form, Phone
Descrição

Person Completing Form Phone

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25190
UMLS CUI-2
C1515258
NCI Thesaurus ObjectClass-2
C25657
NCI Thesaurus Property
C25395
Are data amended
Descrição

Data amended

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
BEVACIZUMAB TREATMENT
Descrição

BEVACIZUMAB TREATMENT

Time point
Descrição

AssessmentPeriodType

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
Total No. of Doses
Descrição

Number of Doses, Total

Tipo de dados

float

Alias
NCI Thesaurus Property
C25304
UMLS CUI-1
C0178602
NCI Thesaurus ValueDomain
C25463
UMLS CUI-2
C0750480
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property-2
C25256
Agent Start Date
Descrição

Agent Start Date

Tipo de dados

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
Agent End Date
Descrição

Agent End Date

Tipo de dados

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C0806020
NCI Thesaurus Property
C25275
Reason Treatment Ended (Bevacizumabor Never Started)
Descrição

NationalSurgicalAdjuvantBreastandBowelProjectTreatmentNotAdministeredReason

Tipo de dados

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 (if applicable)
Descrição

NationalSurgicalAdjuvantBreastandBowelProjectTherapyNotAdministeredSpecify

Tipo de dados

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
Ii. Infections
Descrição

Ii. Infections

Adverse Event
Descrição

CommonTerminologyCriteriaforAdverseEventsVersion4.0LowLevelTermName

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C49704
UMLS 2011AA Property
C1516728
NCI Thesaurus Property-2
C45559
UMLS 2011AA Property-2
C1705313
NCI Thesaurus ValueDomain
C45255
UMLS 2011AA ValueDomain
C1708523
NCI Thesaurus ValueDomain-2
C49704
UMLS 2011AA ValueDomain-2
C1516728
NCI Thesaurus ValueDomain-3
C42614
UMLS 2011AA ValueDomain-3
C0027365
NCI Thesaurus ValueDomain-4
C45559
UMLS 2011AA ValueDomain-4
C1705313
NCI Thesaurus ValueDomain-5
C25714
UMLS 2011AA ValueDomain-5
C0333052
Grade
Descrição

AdverseEventSeverityGrade

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C48309
UMLS 2011AA Property
C0441800
NCI Thesaurus Property-2
C49705
UMLS 2011AA Property-2
C1710065
NCI Thesaurus Property-3
C25676
UMLS 2011AA Property-3
C0439793
NCI Thesaurus ValueDomain
C41331
UMLS 2011AA ValueDomain
C0877248
NCI Thesaurus ValueDomain-2
C48309
UMLS 2011AA ValueDomain-2
C0441800
NCI Thesaurus ValueDomain-3
C25676
UMLS 2011AA ValueDomain-3
C0439793
Comments
Descrição

Comments

Comments
Descrição

Research Comments

Tipo de dados

text

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

Person Completing Form

Tipo de dados

text

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

Date Form Completed

Tipo de dados

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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Similar models

For treatment groups 1B, 2B, and 3B only. This form must be submitted for both the preoperative and postoperative time points.

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Person Completing Form Last Name
Item
Person Completing Form, Last Name
text
C25190 (NCI Thesaurus ObjectClass)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass-2)
C1301584 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25191 (NCI Thesaurus ValueDomain)
Person Completing Form First Name
Item
Person Completing Form, First Name
text
C25190 (NCI Thesaurus ObjectClass)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass-2)
C1443235 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C25191 (NCI Thesaurus ValueDomain)
Person Completing Form Phone
Item
Person Completing Form, Phone
text
C25337 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C1515258 (UMLS CUI-2)
C25657 (NCI Thesaurus ObjectClass-2)
C25395 (NCI Thesaurus Property)
Data amended
Item
Are data amended
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
BEVACIZUMAB TREATMENT
Item
Time point
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
CL.2
Code List
Time point
CL Item
Preoperative Bevacizumab (Preoperative Bevacizumab)
CL Item
Postoperative Bevacizumab (Postoperative Bevacizumab)
Number of Doses, Total
Item
Total No. of Doses
float
C25304 (NCI Thesaurus Property)
C0178602 (UMLS CUI-1)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS CUI-2)
C1708 (NCI Thesaurus ObjectClass)
C25256 (NCI Thesaurus Property-2)
Agent Start Date
Item
Agent Start Date
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)
Agent End Date
Item
Agent End Date
date
C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C0806020 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)
Item
Reason Treatment Ended (Bevacizumabor Never Started)
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)
CL.3
Code List
Reason Treatment Ended (Bevacizumabor Never Started)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Adverse Event/side Effects/complications (Adverse event/side effects/complications)
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
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
NationalSurgicalAdjuvantBreastandBowelProjectTherapyNotAdministeredSpecify
Item
Other, specify (if applicable)
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)
CommonTerminologyCriteriaforAdverseEventsVersion4.0LowLevelTermName
Item
Adverse Event
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C49704 (NCI Thesaurus Property)
C1516728 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property-2)
C1705313 (UMLS 2011AA Property-2)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain-2)
C1516728 (UMLS 2011AA ValueDomain-2)
C42614 (NCI Thesaurus ValueDomain-3)
C0027365 (UMLS 2011AA ValueDomain-3)
C45559 (NCI Thesaurus ValueDomain-4)
C1705313 (UMLS 2011AA ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)
C0333052 (UMLS 2011AA ValueDomain-5)
Item
Grade
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C48309 (NCI Thesaurus Property)
C0441800 (UMLS 2011AA Property)
C49705 (NCI Thesaurus Property-2)
C1710065 (UMLS 2011AA Property-2)
C25676 (NCI Thesaurus Property-3)
C0439793 (UMLS 2011AA Property-3)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C48309 (NCI Thesaurus ValueDomain-2)
C0441800 (UMLS 2011AA ValueDomain-2)
C25676 (NCI Thesaurus ValueDomain-3)
C0439793 (UMLS 2011AA ValueDomain-3)
CL.4
Code List
Grade
CL Item
Mild Adverse Event (1)
C84263 (NCI Thesaurus)
C1513302 (UMLS 2011AA)
CL Item
Moderate Adverse Event (2)
C84264 (NCI Thesaurus)
C1513374 (UMLS 2011AA)
CL Item
Severe Adverse Event (3)
C84265 (NCI Thesaurus)
C2919019 (UMLS 2011AA)
CL Item
Life Threatening Adverse Event (4)
C84266 (NCI Thesaurus)
C1517874 (UMLS 2011AA)
CL Item
Death Related To Adverse Event (5)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)
Item Group
Comments
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)
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