ID

3004

Descripción

BIG 2-06 / NCCTG N063D / EGF106708 - Months 15, 21, 30, 42, and 54 ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=31CACBF0-6868-37A9-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=31CACBF0-6868-37A9-E044-0003BA3F9857

Palabras clave

Versiones (4)
  1. 19/9/12 19/9/12 -
  2. 8/8/14 8/8/14 - Martin Dugas
  3. 9/1/15 9/1/15 - Martin Dugas
  4. 7/8/15 7/8/15 - Martin Dugas
Subido en

19 de septiembre de 2012

DOI

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Licencia

Creative Commons BY-NC 3.0 Legacy
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Neoplasms, Breast NCT00490139 On-Study - BIG 2-06 / NCCTG N063D / EGF106708 - Months 15, 21, 30, 42, and 54 - 2645769v1.0

Inglés

No Instruction available.

1 formularios  
  1. StudyEvent: BIG 2-06 / NCCTG N063D / EGF106708 - Months 15, 21, 30, 42, and 54
    1. No Instruction available.
Header Module
Descripción

Header Module

Centre No.
Descripción

InstitutionIdentifierNumber

Tipo de datos

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
Subject No.
Descripción

PatientCoordinatingIdentifierNumber

Tipo de datos

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 Status
Descripción

Patient Status

Date of Physical Exam
Descripción

PatientPhysicalExaminationDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
Not done
Descripción

AssessmentMethodText

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
Are there any changes since the previous assessment
Descripción

PatientModifiedAssessmentInd-2

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25367
NCI Thesaurus Property
C25573
Are there any changes since the previous assessment
Descripción

PatientModifiedAssessmentType

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25367
NCI Thesaurus Property
C25573
Date of Last Contact
Descripción

LastContactDate

Tipo de datos

date

Alias
NCI Thesaurus Property
C25164
UMLS 2011AA Property
C0011008
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C47954
UMLS 2011AA ObjectClass
C1705415
NCI Thesaurus ObjectClass
C25551
UMLS 2011AA ObjectClass
C1517741
Weight (kg)
Descripción

PatientWeightMeasurement

Tipo de datos

double

Unidades de medida
  • 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
ECOG Performance Status
Descripción

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Tipo de datos

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
Blood Pressure, Systolic
Descripción

BloodSystolicPressureMeasurement

Tipo de datos

double

Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus ObjectClass
C25298
UMLS 2011AA ObjectClass
C0871470
Blood pressure, Diastolic
Descripción

DiastolicBloodPressureEvaluationMeasurement

Tipo de datos

double

Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus ObjectClass
C25299
UMLS 2011AA ObjectClass
C0428883
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Similar models

No Instruction available.

1 formularios
  1. StudyEvent: BIG 2-06 / NCCTG N063D / EGF106708 - Months 15, 21, 30, 42, and 54
    1. No Instruction available.
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Header Module
InstitutionIdentifierNumber
Item
Centre 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)
PatientCoordinatingIdentifierNumber
Item
Subject No.
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)
Item Group
Patient Status
PatientPhysicalExaminationDate
Item
Date of Physical Exam
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
AssessmentMethodText
Item
Not done
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
Item
Are there any changes since the previous assessment
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus Property)
C25573 (NCI Thesaurus Property)
CL.1
Code List
Are there any changes since the previous assessment
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Are there any changes since the previous assessment
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus Property)
C25573 (NCI Thesaurus Property)
CL.2
Code List
Are there any changes since the previous assessment
CL Item
Recurrence Of Disease (Recurrence of disease)
CL Item
Second Primary Malignancy Or Contralateral Breast Cancer (Second primary malignancy or contralateral breast cancer)
CL Item
Significant Cardiac Disease (Significant cardiac disease)
CL Item
Adverse Event (Adverse Event)
C41331 (NCI Thesaurus)
C0877248 (UMLS 2011AA)
CL Item
Death (Death)
C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)
CL Item
Lost To Follow-up (Lost To Follow-up)
CL310949 (NCI Metathesaurus)
CL Item
Patient Withdrew Study Consent (Patient withdrew study consent)
LastContactDate
Item
Date of Last Contact
date
C25164 (NCI Thesaurus Property)
C0011008 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C47954 (NCI Thesaurus ObjectClass)
C1705415 (UMLS 2011AA ObjectClass)
C25551 (NCI Thesaurus ObjectClass)
C1517741 (UMLS 2011AA ObjectClass)
PatientWeightMeasurement
Item
Weight (kg)
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)
Item
ECOG 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.3
Code List
ECOG 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)
CL Item
Dead (5)
BloodSystolicPressureMeasurement
Item
Blood Pressure, Systolic
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25298 (NCI Thesaurus ObjectClass)
C0871470 (UMLS 2011AA ObjectClass)
DiastolicBloodPressureEvaluationMeasurement
Item
Blood pressure, Diastolic
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25299 (NCI Thesaurus ObjectClass)
C0428883 (UMLS 2011AA ObjectClass)
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