ID

7733

Beskrivning

NSABP Protocol B-40 - Treatment Form for Docetaxel/Gemcitabine Cycles in Groups 3A and 3B 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=1AF9CE89-A16C-4210-E044-0003BA3F9857

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1AF9CE89-A16C-4210-E044-0003BA3F9857

Nyckelord

  1. 2014-12-18 2014-12-18 - Martin Dugas
  2. 2015-01-09 2015-01-09 - Martin Dugas
  3. 2015-06-16 2015-06-16 -
Uppladdad den

9 januari 2015

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT00408408 Treatment - NSABP Protocol B-40 - Treatment Form for Docetaxel/Gemcitabine Cycles in Groups 3A and 3B - 2506049v1.0

No Instruction available.

  1. StudyEvent: NSABP Protocol B-40 - Treatment Form for Docetaxel/Gemcitabine Cycles in Groups 3A and 3B
    1. No Instruction available.
Header
Beskrivning

Header

Patient Initials (Last First Middle)
Beskrivning

Patient Initials

Datatyp

text

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

Patient ID NSABP

Datatyp

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
Unnamed2
Beskrivning

Unnamed2

Institution/Affiliate
Beskrivning

CombinedInstitutionName

Datatyp

text

Treating MD Last Name
Beskrivning

TreatingPhysicianLastName

Datatyp

text

Treating MD First Name
Beskrivning

TreatingPhysicianFirstName

Datatyp

text

Treating MD Phone
Beskrivning

TreatingPhysicianPhoneNumber

Datatyp

text

Person Completing Form, Last Name
Beskrivning

ResponsiblePersonLastName

Datatyp

text

Person Completing Form, First Name
Beskrivning

ResponsiblePersonFirstName

Datatyp

text

Person Completing Form, Phone
Beskrivning

ResponsiblePersonPhoneNumber

Datatyp

text

Are data amended
Beskrivning

DataAmendedInd-3

Datatyp

boolean

Unnamed3
Beskrivning

Unnamed3

Total Number of Cycles Given (Docetaxel/Gemcitabine)
Beskrivning

TherapyCourseAdministeredCount

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
Why did treatment end or not begin (Docetaxel/Gemcitabine)
Beskrivning

NationalSurgicalAdjuvantBreastandBowelProjectTreatmentNotAdministeredReason

Datatyp

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
Beskrivning

NationalSurgicalAdjuvantBreastandBowelProjectTherapyNotAdministeredSpecify

Datatyp

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
Unnamed4
Beskrivning

Unnamed4

Cycle Number
Beskrivning

Cycle Number

Datatyp

float

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2045829
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
Cycle Start Date
Beskrivning

Chemotherapy Cycle Start Date

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1302181
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain-2
C25431
UMLS CUI-2
C3173309
NCI Thesaurus Property
C25379
Agent Name (Docetaxel, Gemcitabine Day 1, Gemcitabine Day 8)
Beskrivning

Agent

Datatyp

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
Agent Dose (per M^2 - mg/m^2 - Dose used to calculate the amount of drug to be administered. In Groups 3A and 3B, full dose of docetaxel is 75 mg/m^2. Full dose of gemcitabine is 1000 mg/m^2.)
Beskrivning

Medication Dose

Datatyp

float

Alias
NCI Thesaurus ValueDomain
C25488
UMLS CUI-1
C3174092
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain-2
C1708
NCI Thesaurus Property
C25382

Similar models

No Instruction available.

  1. StudyEvent: NSABP Protocol B-40 - Treatment Form for Docetaxel/Gemcitabine Cycles in Groups 3A and 3B
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
Unnamed2
CombinedInstitutionName
Item
Institution/Affiliate
text
TreatingPhysicianLastName
Item
Treating MD Last Name
text
TreatingPhysicianFirstName
Item
Treating MD First Name
text
TreatingPhysicianPhoneNumber
Item
Treating MD Phone
text
ResponsiblePersonLastName
Item
Person Completing Form, Last Name
text
ResponsiblePersonFirstName
Item
Person Completing Form, First Name
text
ResponsiblePersonPhoneNumber
Item
Person Completing Form, Phone
text
DataAmendedInd-3
Item
Are data amended
boolean
Item Group
Unnamed3
Item
Total Number of Cycles Given (Docetaxel/Gemcitabine)
text
C15368 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
Code List
Total Number of Cycles Given (Docetaxel/Gemcitabine)
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
1 (1)
CL Item
2 (2)
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
3 (3)
CL Item
4 (4)
Item
Why did treatment end or not begin (Docetaxel/Gemcitabine)
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
Why did treatment end or not begin (Docetaxel/Gemcitabine)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
CL Item
Adverse Event/side Effects/complications (Adverse event/side effects/complications)
CL Item
Alternative Therapy (Alternative therapy)
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
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
Unnamed4
Cycle Number
Item
Cycle Number
float
C25337 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
Chemotherapy Cycle Start Date
Item
Cycle Start Date
date
C25164 (NCI Thesaurus ValueDomain)
C1302181 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus ValueDomain-2)
C3173309 (UMLS CUI-2)
C25379 (NCI Thesaurus Property)
Agent
Item
Agent Name (Docetaxel, Gemcitabine Day 1, Gemcitabine Day 8)
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Medication Dose
Item
Agent Dose (per M^2 - mg/m^2 - Dose used to calculate the amount of drug to be administered. In Groups 3A and 3B, full dose of docetaxel is 75 mg/m^2. Full dose of gemcitabine is 1000 mg/m^2.)
float
C25488 (NCI Thesaurus ValueDomain)
C3174092 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)

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