ID

10087

Description

NSABP Protocol B-40 - Adverse Event Form 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 NCT00408408 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1ABDA8E9-5BF6-6122-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1ABDA8E9-5BF6-6122-E044-0003BA3F9857

Keywords

Versions (3)
  1. 8/26/12 8/26/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
  3. 3/24/15 3/24/15 - Martin Dugas
Uploaded on

March 24, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00408408 Toxicity

English

This paper worksheet may be completed to faciliate 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.

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
Institution/Affiliate
Description

Institution Name

Data type

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
Description

Person Completing Form Last Name

Data type

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
Description

Person Completing Form First Name

Data type

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
Description

Person Completing Form Phone

Data type

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
Description

Data amended

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
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
Reporting Period
Description

Reporting Period

Alias
UMLS CUI-1
C2347804
Treatment group
Description

ProtocolTreatmentArmName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus Property
C32141
NCI Thesaurus ObjectClass
C15368
UMLS CUI-1
C1522541
Preoperative Chemotherapy Cycles
Description

Preoperative Chemotherapy Cycles

Data type

integer

Alias
NCI Thesaurus ObjectClass
C15632
NCI Thesaurus Property
C54732
NCI Thesaurus Property-2
C25472
NCI Thesaurus ValueDomain
C25463
UMLS CUI-1
C0392920
UMLS CUI-2
C0445204
UMLS CUI-3
C1511572
UMLS CUI-4
C0750480
Postoperative Bevacizumab Doses
Description

BevacizumabChemotherapyPostoperativeAdministeredCount

Data type

float

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C2039
UMLS 2011AA ObjectClass-2
C0796392
NCI Thesaurus Property
C28006
UMLS 2011AA Property
C0032790
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Reporting Period Start Date
Description

Reporting Period Start Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25616
UMLS CUI-1
C2361257
NCI Thesaurus Property-2
C25651
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
Reporting Period End Date
Description

Reporting Period End Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2361259
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25651
No. of bevacizumab doses given this report period (If non given doses = 0)
Description

No. of bevacizumab doses given this report period (If non given doses = 0)

Data type

integer

Alias
NCI Thesaurus ObjectClass
C2039
NCI Thesaurus ValueDomain
C25463
NCI Thesaurus ObjectClass-2
C1708
NCI Thesaurus Property
C25382
UMLS CUI-1
C0796392
UMLS CUI-2
C0750480
Did the patient require red blood cell (RBC) tranfusion
Description

ErythrocyteTransfusionAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C12521
UMLS 2011AA ObjectClass
C0014792
NCI Thesaurus ObjectClass-2
C15408
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Did the patient require platelet transfusion
Description

PlateletTransfusionRequirementInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15366
UMLS 2011AA ObjectClass
C0086818
NCI Thesaurus Property
C38015
Was the patient hospitalized for 24 hours or more?
Description

PatientHospitalizationInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25179
UMLS 2011AA Property
C0019993
Adverse Event
Description

Adverse Event

Alias
UMLS CUI-1
C0877248
Adverse Event
Description

CommonTerminologyCriteriaforAdverseEventsVersion4.0LowLevelTermName

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
NCI Thesaurus Property
C49704
NCI Thesaurus Property-2
C45559
NCI Thesaurus ValueDomain
C45255
NCI Thesaurus ValueDomain-2
C49704
NCI Thesaurus ValueDomain-3
C42614
NCI Thesaurus ValueDomain-4
C45559
NCI Thesaurus ValueDomain-5
C25714
UMLS CUI-1
C1516728
UMLS CUI-2
C2699044
Grade
Description

AdverseEventSeverityGrade

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
NCI Thesaurus Property
C48309
NCI Thesaurus Property-2
C49705
NCI Thesaurus Property-3
C25676
NCI Thesaurus ValueDomain
C41331
NCI Thesaurus ValueDomain-2
C48309
NCI Thesaurus ValueDomain-3
C25676
UMLS CUI-1
C2985921
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Similar models

This paper worksheet may be completed to faciliate 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.

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)
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)
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)
Item Group
Reporting Period
C2347804 (UMLS CUI-1)
Item
Treatment group
text
C25191 (NCI Thesaurus ValueDomain)
C32141 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C1522541 (UMLS CUI-1)
CL.2
Code List
Treatment group
CL Item
Docetaxel Followed By Doxorubicin And Cyclophosphamide (Docetaxel - AC)
CL Item
Docetaxel And Capecitabine Followed By Doxorubicin And Cyclophosphamide (Docetaxel/Capecitabine - AC)
CL Item
Docetaxel And Gemcitabine Followed By Doxorubicin And Cyclophosphamide (Docetaxel/Gemcitabine - AC)
CL Item
Docetaxel And Bevacizumab Followed By Doxorubicin, Cyclophosphamide And Bevacizumab (Docetaxel + Bevacizumab - AC + Bevacizumab)
CL Item
Docetaxel, Capecitabine And Bevacizumab Followed By Doxorubicin, Cyclophosphamide And Bevacizumab (Docetaxel/Capecitabine + Bevacizumab- AC + Bevacizumab)
CL Item
Docetaxel, Gemcitabine And Bevacizumab Followed By Doxorubicin, Cyclophosphamide And Bevacizumab (Docetaxel/Gemcitabine + Bevacizumab - AC + Bevacizumab)
ChemotherapyPreoperativeCycleCount
Item
Preoperative Chemotherapy Cycles
integer
C15632 (NCI Thesaurus ObjectClass)
C54732 (NCI Thesaurus Property)
C25472 (NCI Thesaurus Property-2)
C25463 (NCI Thesaurus ValueDomain)
C0392920 (UMLS CUI-1)
C0445204 (UMLS CUI-2)
C1511572 (UMLS CUI-3)
C0750480 (UMLS CUI-4)
BevacizumabChemotherapyPostoperativeAdministeredCount
Item
Postoperative Bevacizumab Doses
float
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C2039 (NCI Thesaurus ObjectClass-2)
C0796392 (UMLS 2011AA ObjectClass-2)
C28006 (NCI Thesaurus Property)
C0032790 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
Reporting Period Start Date
Item
Reporting Period Start Date
date
C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C2361257 (UMLS CUI-1)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Reporting Period End Date
Item
Reporting Period End Date
date
C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
BevacizumabAgentAdministeredCount
Item
No. of bevacizumab doses given this report period (If non given doses = 0)
integer
C2039 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C0796392 (UMLS CUI-1)
C0750480 (UMLS CUI-2)
ErythrocyteTransfusionAdministeredInd-2
Item
Did the patient require red blood cell (RBC) tranfusion
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C12521 (NCI Thesaurus ObjectClass)
C0014792 (UMLS 2011AA ObjectClass)
C15408 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
PlateletTransfusionRequirementInd-3
Item
Did the patient require platelet transfusion
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15366 (NCI Thesaurus ObjectClass)
C0086818 (UMLS 2011AA ObjectClass)
C38015 (NCI Thesaurus Property)
PatientHospitalizationInd-2
Item
Was the patient hospitalized for 24 hours or more?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25179 (NCI Thesaurus Property)
C0019993 (UMLS 2011AA Property)
Item Group
Adverse Event
C0877248 (UMLS CUI-1)
CTC Adverse Event Reported Term
Item
Adverse Event
text
C41331 (NCI Thesaurus ObjectClass)
C49704 (NCI Thesaurus Property)
C45559 (NCI Thesaurus Property-2)
C45255 (NCI Thesaurus ValueDomain)
C49704 (NCI Thesaurus ValueDomain-2)
C42614 (NCI Thesaurus ValueDomain-3)
C45559 (NCI Thesaurus ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)
C1516728 (UMLS CUI-1)
C2699044 (UMLS CUI-2)
Item
Grade
text
C41331 (NCI Thesaurus ObjectClass)
C48309 (NCI Thesaurus Property)
C49705 (NCI Thesaurus Property-2)
C25676 (NCI Thesaurus Property-3)
C41331 (NCI Thesaurus ValueDomain)
C48309 (NCI Thesaurus ValueDomain-2)
C25676 (NCI Thesaurus ValueDomain-3)
C2985921 (UMLS CUI-1)
CL.10
Code List
Grade
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)
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