ID

7819

Description

BIG 2-06 / NCCTG N063D / EGF106708 - Administration of Study Drug Paclitaxel 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=310FD8B6-7A8E-517A-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=310FD8B6-7A8E-517A-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 Paclitaxel - 2640557v1.0

English

No Instruction available.

1 forms  
  1. StudyEvent: BIG 2-06 / NCCTG N063D / EGF106708 - Administration of Study Drug Paclitaxel
    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 Agent Administered
Description

Agent Administered Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0450442
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C1521801
NCI Thesaurus Property
C25382
UMLS CUI-3
C0011008
Dose
Description

Medication Dose

Data type

float

Alias
NCI Thesaurus ValueDomain
C25488
UMLS CUI-1
C3174092
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain-2
C1708
NCI Thesaurus Property
C25382
Total Dose
Description

Cumulative Dose Agent

Data type

float

Alias
NCI Thesaurus ObjectClass
C1708
UMLS CUI-1
C2986497
NCI Thesaurus ObjectClass-2
C25470
UMLS CUI-2
C1521826
NCI Thesaurus Property
C25304
NCI Thesaurus Property-2
C25256
NCI Thesaurus ValueDomain
C25304
NCI Thesaurus ValueDomain-2
C25488
Was treatment delayed
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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Similar models

No Instruction available.

1 forms
  1. StudyEvent: BIG 2-06 / NCCTG N063D / EGF106708 - Administration of Study Drug Paclitaxel
    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 Administered Date
Item
Date Agent Administered
date
C25164 (NCI Thesaurus ValueDomain)
C0450442 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C1521801 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)
C0011008 (UMLS CUI-3)
Medication Dose
Item
Dose
float
C25488 (NCI Thesaurus ValueDomain)
C3174092 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)
Cumulative Dose Agent
Item
Total Dose
float
C1708 (NCI Thesaurus ObjectClass)
C2986497 (UMLS CUI-1)
C25470 (NCI Thesaurus ObjectClass-2)
C1521826 (UMLS CUI-2)
C25304 (NCI Thesaurus Property)
C25256 (NCI Thesaurus Property-2)
C25304 (NCI Thesaurus ValueDomain)
C25488 (NCI Thesaurus ValueDomain-2)
TreatmentInterruptionInd-2
Item
Was treatment delayed
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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