ID

3298

Description

BIG 2-06 / NCCTG N063D / EGF106708 - Treatment Completion 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=314FE254-F5BC-36C0-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=314FE254-F5BC-36C0-E044-0003BA3F9857

Keywords

Versions (2)
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

September 19, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Neoplasms, Breast NCT00490139 Follow-Up - BIG 2-06 / NCCTG N063D / EGF106708 - Treatment Completion - 2644342v1.0

English

No Instruction available.

1 forms  
  1. StudyEvent: BIG 2-06 / NCCTG N063D / EGF106708 - Treatment Completion
    1. No Instruction available.
Header Module
Description

Header Module

Centre No.
Description

InstitutionIdentifierNumber

Data type

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.
Description

PatientCoordinatingIdentifierNumber

Data type

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
Treatment Completion
Description

Treatment Completion

Did the patient complete Lapatinib as per protocol
Description

LapatinibTherapyCompleteIndicator

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus ObjectClass
C26653
UMLS 2011AA ObjectClass
C1173538
NCI Thesaurus ObjectClass
C15368
Did the patient complete Trastuzumab as per protocol
Description

TrastuzumabTherapyCompleteIndicator

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus ObjectClass
C1647
UMLS 2011AA ObjectClass
C0338204
NCI Thesaurus ObjectClass
C15368
Did the patient complete Paclitaxel as per protocol
Description

PaclitaxelTherapyCompleteIndicator

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus ObjectClass
C1411
UMLS 2011AA ObjectClass
C0144576
NCI Thesaurus ObjectClass
C15368
Reasons for treatment discontinuation
Description

TherapyDiscontinueReason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
Date of last contact within treatment period
Description

PatientLastClinicalStudyPeriodContactDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25461
UMLS 2011AA Property
C0337611
NCI Thesaurus Property
C15206
UMLS 2011AA Property
C0008972
NCI Thesaurus Property
C25551
UMLS 2011AA Property
C1517741
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Additional Comments And Investigator's Signature
Description

Additional Comments And Investigator's Signature

CRF page number
Description

CaseReportFormSubmissionPageNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C40988
UMLS 2011AA ObjectClass
C1516308
NCI Thesaurus Property
C25694
UMLS 2011AA Property
C1515022
Comments
Description

ResearchCommentsText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411
Investigator Signature
Description

InvestigatorSignatureText

Data type

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
Date
Description

InvestigatorSignatureDate

Data type

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
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Similar models

No Instruction available.

1 forms
  1. StudyEvent: BIG 2-06 / NCCTG N063D / EGF106708 - Treatment Completion
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Treatment Completion
Item
Did the patient complete Lapatinib as per protocol
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C26653 (NCI Thesaurus ObjectClass)
C1173538 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
CL.1
Code List
Did the patient complete Lapatinib as per protocol
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
Item
Did the patient complete Trastuzumab as per protocol
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C1647 (NCI Thesaurus ObjectClass)
C0338204 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
CL.2
Code List
Did the patient complete Trastuzumab as per protocol
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
Item
Did the patient complete Paclitaxel as per protocol
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C1411 (NCI Thesaurus ObjectClass)
C0144576 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
CL.3
Code List
Did the patient complete Paclitaxel as per protocol
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
Item
Reasons for treatment discontinuation
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
CL.4
Code List
Reasons for treatment discontinuation
CL Item
Adverse Event (Adverse Event)
C41331 (NCI Thesaurus)
C0877248 (UMLS 2011AA)
CL Item
Protocol Violation (Protocol violation)
C48251 (NCI Thesaurus)
C1709750 (UMLS 2011AA)
CL Item
Subject Decided To Withdraw From Investigational Product But Is Continuing To Be Followed Per Protocol (Subject decided to withdraw from investigational product but is continuing to be followed per protocol)
CL Item
Subject Decided To Withdraw From The Study (Subject decided to withdraw from the study)
CL Item
Recurrence Of Disease Or Second Primary Malignancy Or Contralateral Breast Cancer (Recurrence of disease or second primary malignancy or contralateral breast cancer)
CL Item
Death (Death)
C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)
CL Item
Lost To Follow-up: C48227 (Lost to follow-up)
C48227 (NCI Thesaurus)
C1302313 (UMLS 2011AA)
PatientLastClinicalStudyPeriodContactDate
Item
Date of last contact within treatment period
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25461 (NCI Thesaurus Property)
C0337611 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property)
C0008972 (UMLS 2011AA Property)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Additional Comments And Investigator's Signature
CaseReportFormSubmissionPageNumber
Item
CRF page number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25694 (NCI Thesaurus Property)
C1515022 (UMLS 2011AA Property)
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
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)
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)
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