ID

7866

Description

BIG 2-06 / NCCTG N063D / EGF106708 - Administration of Study Drug Lapatinib 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=31D240FB-CF19-6486-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=31D240FB-CF19-6486-E044-0003BA3F9857

Keywords

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

January 9, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Neoplasms, Breast DRKS00003651 NCT00490139 Treatment - BIG 2-06 / NCCTG N063D / EGF106708 - Administration of Study Drug Lapatinib - 2646027v1.0

English

No Instruction available.

1 forms  
  1. StudyEvent: BIG 2-06 / NCCTG N063D / EGF106708 - Administration of Study Drug Lapatinib
    1. No Instruction available.
Header Module
Description

Header Module

Centre No.
Description

Institution Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
UMLS CUI-2
C0805701
NCI Thesaurus Property
C25364
Subject No.
Description

Patient Study ID

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25462
NCI Thesaurus Property-2
C25364
Administration Of Paclitaxel Concomitantly With Biological Therapy (design 2)
Description

Administration Of Paclitaxel Concomitantly With Biological Therapy (design 2)

Date Started
Description

Agent Start Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1521826
NCI Thesaurus ValueDomain-2
C25431
UMLS CUI-2
C0808070
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property
C25275
Date Stopped
Description

Agent End Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C0806020
NCI Thesaurus Property
C25275
Total Daily Dose of Agent (or Drug) (mg)
Description

Concomitant Medication Daily Dose

Data type

float

Alias
NCI Thesaurus ObjectClass
C25473
UMLS CUI-1
C2826638
NCI Thesaurus ObjectClass-2
C1708
NCI Thesaurus Property
C25304
NCI Thesaurus Property-2
C25256
NCI Thesaurus ValueDomain
C25488
NCI Thesaurus ValueDomain-2
C1708
Was treatment interrupted
Description

TreatmentInterruptionInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25542
UMLS 2011AA Property
C1512900
Specify code
Description

TreatmentInterruptionType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25542
UMLS 2011AA Property
C1512900
Specify
Description

TreatmentInterruptionSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25542
UMLS 2011AA Property
C1512900
Was dose reduced
Description

AgentReducedQuantityInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25640
UMLS 2011AA Property
C0392756
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property-2
C25256
UMLS 2011AA Property-2
C1265611
Specify code
Description

AgentReducedDoseType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25640
UMLS 2011AA Property
C0392756
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property-2
C25256
UMLS 2011AA Property-2
C1265611
Specify
Description

AgentReducedQuantitySpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C25640
UMLS 2011AA Property
C0392756
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property-2
C25256
UMLS 2011AA Property-2
C1265611
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No Instruction available.

1 forms
  1. StudyEvent: BIG 2-06 / NCCTG N063D / EGF106708 - Administration of Study Drug Lapatinib
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
Institution Number
Item
Centre No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
Patient Study ID
Item
Subject No.
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Item Group
Administration Of Paclitaxel Concomitantly With Biological Therapy (design 2)
Agent Start Date
Item
Date Started
date
C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C25431 (NCI Thesaurus ValueDomain-2)
C0808070 (UMLS CUI-2)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
Agent End Date
Item
Date Stopped
date
C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C0806020 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)
Concomitant Medication Daily Dose
Item
Total Daily Dose of Agent (or Drug) (mg)
float
C25473 (NCI Thesaurus ObjectClass)
C2826638 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass-2)
C25304 (NCI Thesaurus Property)
C25256 (NCI Thesaurus Property-2)
C25488 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus ValueDomain-2)
TreatmentInterruptionInd-2
Item
Was treatment interrupted
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25542 (NCI Thesaurus Property)
C1512900 (UMLS 2011AA Property)
Item
Specify code
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25542 (NCI Thesaurus Property)
C1512900 (UMLS 2011AA Property)
CL.2
Code List
Specify code
CL Item
Hematologic Adverse Event (Hematologic adverse event)
CL Item
Cardiac Adverse Event (Cardiac adverse event)
CL Item
Adverse Event Other Than Hematologic Or Cardiac (Adverse event other than hematologic or cardiac)
CL Item
Dosing Error (Dosing error)
CL Item
Subject Non-compliance (Subject non-compliance)
CL Item
Administrative Reasons (Administrative reasons)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C17649 (NCI Thesaurus-3)
C0205394 (UMLS 2011AA-4)
TreatmentInterruptionSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25542 (NCI Thesaurus Property)
C1512900 (UMLS 2011AA Property)
AgentReducedQuantityInd-2
Item
Was dose reduced
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25640 (NCI Thesaurus Property)
C0392756 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25256 (NCI Thesaurus Property-2)
C1265611 (UMLS 2011AA Property-2)
Item
Specify code
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25640 (NCI Thesaurus Property)
C0392756 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25256 (NCI Thesaurus Property-2)
C1265611 (UMLS 2011AA Property-2)
CL.4
Code List
Specify code
CL Item
Hematologic Adverse Event (Hematologic adverse event)
CL Item
Cardiac Adverse Event (Cardiac adverse event)
CL Item
Adverse Event Other Than Hematologic Or Cardiac (Adverse event other than hematologic or cardiac)
CL Item
Dosing Error (Dosing error)
CL Item
Subject Non-compliance (Subject non-compliance)
CL Item
Administrative Reasons (Administrative reasons)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
AgentReducedQuantitySpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25640 (NCI Thesaurus Property)
C0392756 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25256 (NCI Thesaurus Property-2)
C1265611 (UMLS 2011AA Property-2)
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