ID

971

Beskrivning

Z1041: Study Drug Completion - Trastuzumab (SDCT) Combination Chemotherapy and Paclitaxel Plus Trastuzumab in Treating Women With Palpable Breast Cancer That Can Be Removed by Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=20FDDD9E-AEC2-1D91-E044-0003BA3F9857

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=20FDDD9E-AEC2-1D91-E044-0003BA3F9857

Nyckelord

Versioner (3)
  1. 2012-08-26 2012-08-26 -
  2. 2015-01-09 2015-01-09 - Martin Dugas
  3. 2015-06-27 2015-06-27 -
Uppladdad den

26 augusti 2012

DOI

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Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00513292 Treatment - Z1041: Study Drug Completion - Trastuzumab (SDCT) - 2533011v1.0

Engelsk

No Instruction available.

1 Formulär  
  1. StudyEvent: Z1041: Study Drug Completion - Trastuzumab (SDCT)
    1. No Instruction available.
Header Module
Beskrivning

Header Module

Visit
Beskrivning

AmericanCollegeofSurgeonsOncologyGroupVisitPeriodAmericanCollegeofSurgeonsOncologyGroupVisitPeriodType

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ObjectClass
C19712
UMLS 2011AA ObjectClass
C1515944
NCI Thesaurus ObjectClass
C25716
UMLS 2011AA ObjectClass
C0545082
Date
Beskrivning

PatientNotScheduleVisitDate

Datatyp

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property
C25211
UMLS 2011AA Property
C0086960
NCI Thesaurus Property
C25716
UMLS 2011AA Property
C0545082
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Patient ID (Pt. ID issued during registration or previously issued Patient ID)
Beskrivning

PatientCoordinatingIdentifierNumber

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25462
UMLS 2011AA Property
C0700114
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Patient Initials (F M L)
Beskrivning

PatientInitialsName

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Institution No.
Beskrivning

InstitutionIdentifierNumber

Datatyp

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
Institution Name
Beskrivning

InstitutionName

Datatyp

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
Assessment Date
Beskrivning

LesionAssessmentDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ValueDomain
C25367
Unnamed 2
Beskrivning

Unnamed 2

This form was completed based on information from
Beskrivning

FormCompleteSource

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C40988
UMLS 2011AA ObjectClass
C1516308
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus ValueDomain
C25683
UMLS 2011AA ValueDomain
C0449416
Date of First dose for this reporting period
Beskrivning

TreatmentFirstDoseBeginDate

Datatyp

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
Date of Last dose for this reporting period
Beskrivning

TreatmentLastDoseEndDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
Number of weeks Trastuzumab given (this period)
Beskrivning

TrastuzumabAgentAdministrationWeekCount

Datatyp

double

Alias
NCI Thesaurus ObjectClass
C1647
UMLS 2011AA ObjectClass
C0338204
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ValueDomain
C29844
UMLS 2011AA ValueDomain
C0439230
Were there any dose modifications or additions/omissions to protocol treatment?
Beskrivning

DoseModificationInd

Datatyp

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 Reason
Beskrivning

DoseModificationReason

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus Property
C25572
Other, specify
Beskrivning

TreatmentModifiedDoseSpecify

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
NCI Thesaurus Property
C25573
Did the patient receive RT during this reporting period
Beskrivning

RTReportingReceivedInd-2

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Did the patient receive any hormone therapy during this reporting period?
Beskrivning

HormoneTherapyReportPeriodAdministeredInd-3

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Completed by
Beskrivning

ResponsiblePersonName

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Date Form Completed
Beskrivning

FormCompleteDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C40988
UMLS 2011AA ObjectClass
C1516308
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus ValueDomain
C25367
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Similar models

No Instruction available.

1 Formulär
  1. StudyEvent: Z1041: Study Drug Completion - Trastuzumab (SDCT)
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Header Module
Item
Visit
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C19712 (NCI Thesaurus ObjectClass)
C1515944 (UMLS 2011AA ObjectClass)
C25716 (NCI Thesaurus ObjectClass)
C0545082 (UMLS 2011AA ObjectClass)
CL.1
Code List
Visit
CL Item
C8d21 (C8D21)
CL Item
Mo6fu (Mo6FU)
CL Item
Mo9fu (Mo9FU)
CL Item
Unscheduled (Unscheduled)
PatientNotScheduleVisitDate
Item
Date
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25211 (NCI Thesaurus Property)
C0086960 (UMLS 2011AA Property)
C25716 (NCI Thesaurus Property)
C0545082 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
PatientCoordinatingIdentifierNumber
Item
Patient ID (Pt. ID issued during registration or previously issued Patient ID)
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25462 (NCI Thesaurus Property)
C0700114 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientInitialsName
Item
Patient Initials (F M L)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (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)
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)
LesionAssessmentDate
Item
Assessment Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
Item Group
Unnamed 2
Item
This form was completed based on information from
text
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25683 (NCI Thesaurus ValueDomain)
C0449416 (UMLS 2011AA ValueDomain)
CL.2
Code List
This form was completed based on information from
CL Item
Adjuvant Period (Adjuvant period)
CL Item
Neoadjuvant Period (Neoadjuvant period)
TreatmentFirstDoseBeginDate
Item
Date of First dose for this reporting period
date
C15368 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
TreatmentLastDoseEndDate
Item
Date of Last dose for this reporting period
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
TrastuzumabAgentAdministrationWeekCount
Item
Number of weeks Trastuzumab given (this period)
double
C1647 (NCI Thesaurus ObjectClass)
C0338204 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C29844 (NCI Thesaurus ValueDomain)
C0439230 (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
Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, planned)
CL Item
Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Dose Modification Reason
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
CL.4
Code List
Dose Modification Reason
CL Item
Pulmonary Toxicity (Pulmonary toxicity)
CL Item
Cns Toxicity (CNS toxicity)
CL Item
Cardiotoxicity (Cardiotoxicity)
C27994 (NCI Thesaurus)
C0876994 (UMLS 2011AA)
CL Item
Hematologic Toxicity (Hematologic toxicity)
CL Item
Gi Toxicity (GI toxicity)
CL Item
Infection/fever (Infection/fever)
CL Item
Hepatic Dysfunction (Hepatic dysfunction)
CL Item
Weight Change >= 4.5 Kg (Weight Change >= 4.5 kg)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
TreatmentModifiedDoseSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25573 (NCI Thesaurus Property)
Item
Did the patient receive RT during this reporting period
text
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.5
Code List
Did the patient receive RT during this reporting period
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
Item
Did the patient receive any hormone therapy during this reporting period?
text
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.6
Code List
Did the patient receive any hormone therapy during this reporting period?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
ResponsiblePersonName
Item
Completed by
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
FormCompleteDate
Item
Date Form Completed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
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