ID

994

Beschrijving

Chemotherapy-docetaxel/capecitabine arm Genetic Testing or Clinical Assessment in Determining the Need for Chemotherapy in Women With Breast Cancer That Involves No More Than 3 Lymph Nodes Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=196E5474-4AF3-680E-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=196E5474-4AF3-680E-E044-0003BA3F9857

Trefwoorden

Versies (3)
  1. 26-08-12 26-08-12 -
  2. 05-01-15 05-01-15 - Martin Dugas
  3. 29-07-15 29-07-15 - Martin Dugas
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26 augustus 2012

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00433589 Treatment - Chemotherapy-docetaxel/capecitabine arm - 2499349v1.0

Engels

No Instruction available.

1 Formulieren  
  1. StudyEvent: Chemotherapy-docetaxel/capecitabine arm
    1. No Instruction available.
Header
Beschrijving

Header

Patient Birth Date
Beschrijving

PatientBirthDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C25155
UMLS 2011AA Property
C0005615
Patient Hospital Number
Beschrijving

HospitalPatientIdentifierNumber

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C16960
UMLS 2011AA Property
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C16696
UMLS 2011AA ObjectClass
C0019994
Institution Name
Beschrijving

InstitutionName

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus ValueDomain
C21541
UMLS 2011AA ValueDomain
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Institution No.
Beschrijving

InstitutionIdentifierNumber

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Physician of Record
Beschrijving

RegisteredInvestigatorName

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
NCI Thesaurus ObjectClass
C25644
Chemotherapy - Anthracycline Arm
Beschrijving

Chemotherapy - Anthracycline Arm

Date Chemotherapy Began
Beschrijving

ChemotherapyAdministeredBeginDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Cycle Number
Beschrijving

TherapyCourseNumber

Datatype

double

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
Weight
Beschrijving

PatientWeightMeasurement

Datatype

double

Maateenheden
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25208
UMLS 2011AA Property
C0043100
Kg
Body Surface Area
Beschrijving

PatientBodySurfaceAreaMeasurement

Datatype

double

Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25157
UMLS 2011AA Property
C0005902
Performance Status
Beschrijving

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain
C25491
UMLS 2011AA ValueDomain
C1512162
NCI Thesaurus ObjectClass
C20641
UMLS 2011AA ObjectClass
C1518965
Cycle Delayed?
Beschrijving

TreatmentDelayedCycleInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25477
NCI Thesaurus Property
C25472
UMLS 2011AA Property
C1511572
NCI Thesaurus ObjectClass
C15368
Total Daily Dose of Agent (or Drug)
Beschrijving

DailyAgentTotalDose

Datatype

double

Alias
NCI Thesaurus ObjectClass
C25473
UMLS 2011AA ObjectClass
C0332173
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25304
UMLS 2011AA Property
C0439810
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ValueDomain
C1708
UMLS 2011AA ValueDomain
C0450442
Were there any dose modifications or additions/omissions to protocol treatment?
Beschrijving

DoseModificationInd

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C25256
UMLS 2011AA ObjectClass
C1265611
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain
C25572
Dose modification
Beschrijving

DoseModificationStatus

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
NCI Thesaurus Property
C25572
Was treatment modified?
Beschrijving

TreatmentModifiedInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25572
Reason for therapy modification
Beschrijving

DoseModificationReason

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus Property
C25572
Reason for therapy modification
Beschrijving

DoseModificationReason

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus Property
C25572
For Capecitabine
Beschrijving

For Capecitabine

Number of Doses Missed
Beschrijving

MissedDoseCount

Datatype

text

Alias
NCI Thesaurus Property
C54031
UMLS 2011AA Property
C1705492
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Metathesaurus ValueDomain
CL052797
Comments
Beschrijving

Comments

Date
Beschrijving

InvestigatorSignatureDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Investigator Signature
Beschrijving

InvestigatorSignatureText

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
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Similar models

No Instruction available.

1 Formulieren
  1. StudyEvent: Chemotherapy-docetaxel/capecitabine arm
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Header
PatientBirthDate
Item
Patient Birth Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C25155 (NCI Thesaurus Property)
C0005615 (UMLS 2011AA Property)
HospitalPatientIdentifierNumber
Item
Patient Hospital Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C16696 (NCI Thesaurus ObjectClass)
C0019994 (UMLS 2011AA ObjectClass)
InstitutionName
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
InstitutionIdentifierNumber
Item
Institution No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
RegisteredInvestigatorName
Item
Physician of Record
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
C25644 (NCI Thesaurus ObjectClass)
Item Group
Chemotherapy - Anthracycline Arm
ChemotherapyAdministeredBeginDate
Item
Date Chemotherapy Began
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
TherapyCourseNumber
Item
Cycle Number
double
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
PatientWeightMeasurement
Item
Weight
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25208 (NCI Thesaurus Property)
C0043100 (UMLS 2011AA Property)
PatientBodySurfaceAreaMeasurement
Item
Body Surface Area
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS 2011AA Property)
Item
Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain)
C1512162 (UMLS 2011AA ValueDomain)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
CL.1
Code List
Performance Status
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
Item
Cycle Delayed?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25477 (NCI Thesaurus Property)
C25472 (NCI Thesaurus Property)
C1511572 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
CL.2
Code List
Cycle Delayed?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
DailyAgentTotalDose
Item
Total Daily Dose of Agent (or Drug)
double
C25473 (NCI Thesaurus ObjectClass)
C0332173 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25304 (NCI Thesaurus Property)
C0439810 (UMLS 2011AA Property)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
Item
Were there any dose modifications or additions/omissions to protocol treatment?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25256 (NCI Thesaurus ObjectClass)
C1265611 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain)
CL.3
Code List
Were there any dose modifications or additions/omissions to protocol treatment?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Both Planned And Unplanned (Yes, both planned and unplanned)
Item
Dose modification
text
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25572 (NCI Thesaurus Property)
CL.4
Code List
Dose modification
CL Item
Dose Delayed (Dose delayed)
CL Item
Dose Delayed And Reduced (Dose delayed and reduced)
CL Item
Dose Escalated (Dose escalated)
CL Item
Dose Held (Dose held)
CL Item
Dose Reduced (Dose reduced)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
CL Item
Drug Discontinued (Drug discontinued)
CL Item
No Dose Modification (No dose modification)
Item
Was treatment modified?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
CL.6
Code List
Was treatment modified?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Reason for therapy modification
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
CL.7
Code List
Reason for therapy modification
CL Item
Hematologic Toxicity (Hematologic toxicity)
Item
Reason for therapy modification
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
CL.7
Code List
Reason for therapy modification
CL Item
Hematologic Toxicity (Hematologic toxicity)
Item Group
For Capecitabine
MissedDoseCount
Item
Number of Doses Missed
text
C54031 (NCI Thesaurus Property)
C1705492 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
CL052797 (NCI Metathesaurus ValueDomain)
Item Group
Comments
InvestigatorSignatureDate
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignatureText
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
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