ID

6514

Description

CALGB 40601 TREATMENT FORM Paclitaxel and Trastuzumab With or Without Lapatinib in Treating Patients With Stage II or Stage III Breast Cancer That Can Be Removed by Surgery NCT00770809 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3A0519D7-D7F7-3073-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3A0519D7-D7F7-3073-E044-0003BA3F9857

Keywords

Versions (2)
  1. 8/26/12 8/26/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
Uploaded on

January 8, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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TREATMENT FORM Breast Cancer (NCT00770809)

English

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice.

1 forms  
Header
Description

Header

CALGB Form
Description

Form ID CALGB

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3262252
NCI Thesaurus ObjectClass
C19464
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass-2
C25442
CALGB Study No
Description

Protocol ID CALGB

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
CALGB Patient ID
Description

Trial subject ID CALGB

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
Reporting Period Start Date (MM DD YYYY)
Description

Reporting Period Start Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25616
UMLS CUI-1
C2361257
NCI Thesaurus Property-2
C25651
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
Reporting Period End Date (MM DD YYYY)
Description

Reporting Period End Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2361259
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25651
Patient Initials (Last, First Middle)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Patient Hospital No.
Description

Medical Record Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301894
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25198
Institution/Affiliate
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Participating Group
Description

Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2347449
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass-2
C17005
NCI Thesaurus Property
C25364
Participating Group Study No.
Description

Study Number Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Participating Group Patient ID
Description

Trial subject ID Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Are data amended
Description

Data amended

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Completed by (Last name, First name)
Description

Person Completing Form

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date form completed (MM DD YYYY)
Description

Date Form Completed

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
C25367
Bevacizumab/placebo
Description

Bevacizumab/placebo

Assigned Treatment Arm
Description

Protocol Treatment Arm

Data type

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C42651
UMLS CUI-1
C1522541
NCI Thesaurus Property
C32141
NCI Thesaurus Property-2
C25426
NCI Thesaurus ValueDomain
C25284
On Treatment Report Period
Description

Cycle number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2045829
NCI Thesaurus Property
C25214
NCI Thesaurus Property-2
C25616
NCI Thesaurus ObjectClass
C15368
Bevacizumab/placebo
Description

Bevacizumab/placebo

Agent
Description

Agent

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
Prescribed dose (mg/kg)
Description

Agent dose prescribed

Data type

float

Alias
NCI Thesaurus ObjectClass
C28180
UMLS CUI-1
C0678766
NCI Thesaurus ObjectClass-2
C1708
UMLS CUI-2
C0278329
NCI Thesaurus Property
C25256
NCI Thesaurus ValueDomain
C25488
NCI Thesaurus ValueDomain-2
C1708
Total actual dose of agent/drugs (for this period mg/kg)
Description

TotalAgentActualCourseDose

Data type

float

Alias
NCI Thesaurus ObjectClass
C25304
UMLS 2011AA ObjectClass
C0439810
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus Property-2
C25274
UMLS 2011AA Property-2
C0237400
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ValueDomain-2
C25274
UMLS 2011AA ValueDomain-2
C0237400
Were there any delays in dose administration
Description

DoseDelayedInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25477
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
Days Treatment Was Interrupted
Description

TreatmentInterruptionDayDuration

Data type

float

Alias
NCI Thesaurus ValueDomain
C25301
UMLS 2011AA ValueDomain
C0439228
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain-2
C25330
UMLS 2011AA ValueDomain-2
C0449238
NCI Thesaurus Property
C25542
UMLS 2011AA Property
C1512900
Reason dose was delayed
Description

Reason for treatment delay, specify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C1298642
NCI Thesaurus Property
C25477
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property-2
C25409
Was treatment discontinued during this period?
Description

Drug treatment discontinued during chemotherapy cycle

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25471
UMLS CUI-1
C0558681
NCI Thesaurus Property-2
C25472
UMLS CUI-2
C0347984
NCI Thesaurus Property-3
C25484
UMLS CUI-3
C1302181
NCI Thesaurus ValueDomain
C38147
Date treatment was discontinued (MM DD YYYY)
Description

TherapyDiscontinueDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
Bevacizumab/placebo
Description

Bevacizumab/placebo

Agent
Description

Agent

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
Prescribed dose (mg/kg)
Description

Agent dose prescribed

Data type

float

Alias
NCI Thesaurus ObjectClass
C28180
UMLS CUI-1
C0678766
NCI Thesaurus ObjectClass-2
C1708
UMLS CUI-2
C0278329
NCI Thesaurus Property
C25256
NCI Thesaurus ValueDomain
C25488
NCI Thesaurus ValueDomain-2
C1708
Total actual dose of agent/drugs (for this period mg/kg)
Description

TotalAgentActualCourseDose

Data type

float

Alias
NCI Thesaurus ObjectClass
C25304
UMLS 2011AA ObjectClass
C0439810
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus Property-2
C25274
UMLS 2011AA Property-2
C0237400
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ValueDomain-2
C25274
UMLS 2011AA ValueDomain-2
C0237400
Were there any delays in dose administration
Description

DoseDelayedInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25477
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
Days Treatment Was Interrupted
Description

TreatmentInterruptionDayDuration

Data type

float

Alias
NCI Thesaurus ValueDomain
C25301
UMLS 2011AA ValueDomain
C0439228
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain-2
C25330
UMLS 2011AA ValueDomain-2
C0449238
NCI Thesaurus Property
C25542
UMLS 2011AA Property
C1512900
Reason dose was delayed
Description

Reason for treatment delay, specify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C1298642
NCI Thesaurus Property
C25477
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property-2
C25409
Was treatment discontinued during this period?
Description

Drug treatment discontinued during chemotherapy cycle

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25471
UMLS CUI-1
C0558681
NCI Thesaurus Property-2
C25472
UMLS CUI-2
C0347984
NCI Thesaurus Property-3
C25484
UMLS CUI-3
C1302181
NCI Thesaurus ValueDomain
C38147
Specify (Yes)
Description

TreatmentCurrentCycleDiscontinuedSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus Property-2
C25472
UMLS 2011AA Property-2
C1511572
NCI Thesaurus Property-3
C25484
UMLS 2011AA Property-3
C1444662
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Date treatment was discontinued (MM DD YYYY)
Description

TherapyDiscontinueDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
Bevacizumab/placebo
Description

Bevacizumab/placebo

Agent
Description

Agent

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
Dose used
Description

PillDosageFormAdministeredAmount

Data type

text

Alias
NCI Thesaurus ObjectClass
C25394
UMLS 2011AA ObjectClass
C0994475
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25417
Total actual dose of agent/drugs (for this period mg/kg)
Description

TotalAgentActualCourseDose

Data type

float

Alias
NCI Thesaurus ObjectClass
C25304
UMLS 2011AA ObjectClass
C0439810
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus Property-2
C25274
UMLS 2011AA Property-2
C0237400
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ValueDomain-2
C25274
UMLS 2011AA ValueDomain-2
C0237400
Were there any delays in dose administration
Description

DoseDelayedInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25477
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
Days Treatment Was Interrupted
Description

TreatmentInterruptionDayDuration

Data type

float

Alias
NCI Thesaurus ValueDomain
C25301
UMLS 2011AA ValueDomain
C0439228
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain-2
C25330
UMLS 2011AA ValueDomain-2
C0449238
NCI Thesaurus Property
C25542
UMLS 2011AA Property
C1512900
Reason dose was delayed
Description

Reason for treatment delay, specify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C1298642
NCI Thesaurus Property
C25477
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property-2
C25409
Was treatment discontinued during this period?
Description

Drug treatment discontinued during chemotherapy cycle

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25471
UMLS CUI-1
C0558681
NCI Thesaurus Property-2
C25472
UMLS CUI-2
C0347984
NCI Thesaurus Property-3
C25484
UMLS CUI-3
C1302181
NCI Thesaurus ValueDomain
C38147
Date treatment was discontinued (MM DD YYYY)
Description

TherapyDiscontinueDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
Muga Results
Description

Muga Results

Time point (Mark one with an X.)
Description

AssessmentPeriodType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
Other specify
Description

AssessmentPeriodSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
LVEF (%)
Description

HeartLVEFTestPercentageValue

Data type

float

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property-2
C37946
UMLS 2011AA Property-2
C2700377
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
%
LVEF Institutional Lower Limit of Normal (%)
Description

HeartLVEFTestPercentageLowerLimitofNormalValue

Data type

float

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property-2
C37946
UMLS 2011AA Property-2
C2700377
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
NCI Thesaurus ValueDomain-3
C25555
UMLS 2011AA ValueDomain-3
C1518030
%
Has the patient experienced a drop of at least 15 percentage points in the current LVEF compared with the baseline value
Description

HeartLeftVentricularEjectionFractionReducedFunctionIndicator

Data type

text

Alias
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus Property
C25640
UMLS 2011AA Property
C0392756
NCI Thesaurus Property-2
C25518
UMLS 2011AA Property-2
C0542341
NCI Thesaurus Property-3
C37946
UMLS 2011AA Property-3
C2700377
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
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INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice.

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Form ID CALGB
Item
CALGB Form
text
C25337 (NCI Thesaurus ValueDomain)
C3262252 (UMLS CUI-1)
C19464 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus ObjectClass-2)
Protocol ID CALGB
Item
CALGB Study No
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Trial subject ID CALGB
Item
CALGB Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Reporting Period Start Date
Item
Reporting Period Start Date (MM DD YYYY)
date
C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C2361257 (UMLS CUI-1)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Reporting Period End Date
Item
Reporting Period End Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
Patient Initials
Item
Patient Initials (Last, First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Medical Record Number
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Participating Group
Item
Participating Group
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Data amended
Item
Are data amended
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Person Completing Form
Item
Completed by (Last name, First name)
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
Date form completed (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Bevacizumab/placebo
Item
Assigned Treatment Arm
text
C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass-2)
C1522541 (UMLS CUI-1)
C32141 (NCI Thesaurus Property)
C25426 (NCI Thesaurus Property-2)
C25284 (NCI Thesaurus ValueDomain)
CL.2
Code List
Assigned Treatment Arm
CL Item
Arm 1 (Arm 1)
CL Item
Arm 2 (Arm 2)
CL Item
Arm 3 (Arm 3)
Item
On Treatment Report Period
text
C25284 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25616 (NCI Thesaurus Property-2)
C15368 (NCI Thesaurus ObjectClass)
CL.3
Code List
On Treatment Report Period
CL Item
Weeks 1-4 (Weeks 1-4)
CL Item
Weeks 13-16 (Weeks 13-16)
CL Item
Weeks 5-8 (Weeks 5-8)
CL Item
Weeks 9-12 (Weeks 9-12)
Item Group
Bevacizumab/placebo
Agent
Item
Agent
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Agent dose prescribed
Item
Prescribed dose (mg/kg)
float
C28180 (NCI Thesaurus ObjectClass)
C0678766 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass-2)
C0278329 (UMLS CUI-2)
C25256 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus ValueDomain-2)
TotalAgentActualCourseDose
Item
Total actual dose of agent/drugs (for this period mg/kg)
float
C25304 (NCI Thesaurus ObjectClass)
C0439810 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25274 (NCI Thesaurus Property-2)
C0237400 (UMLS 2011AA Property-2)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C25274 (NCI Thesaurus ValueDomain-2)
C0237400 (UMLS 2011AA ValueDomain-2)
DoseDelayedInd-3
Item
Were there any delays in dose administration
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25477 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
TreatmentInterruptionDayDuration
Item
Days Treatment Was Interrupted
float
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25330 (NCI Thesaurus ValueDomain-2)
C0449238 (UMLS 2011AA ValueDomain-2)
C25542 (NCI Thesaurus Property)
C1512900 (UMLS 2011AA Property)
Reason for treatment delay, specify
Item
Reason dose was delayed
text
C25704 (NCI Thesaurus ValueDomain)
C1298642 (UMLS CUI-1)
C25477 (NCI Thesaurus Property)
C1708 (NCI Thesaurus ObjectClass)
C25409 (NCI Thesaurus Property-2)
Drug treatment discontinued during chemotherapy cycle
Item
Was treatment discontinued during this period?
boolean
C15368 (NCI Thesaurus ObjectClass)
C25471 (NCI Thesaurus Property)
C0558681 (UMLS CUI-1)
C25472 (NCI Thesaurus Property-2)
C0347984 (UMLS CUI-2)
C25484 (NCI Thesaurus Property-3)
C1302181 (UMLS CUI-3)
C38147 (NCI Thesaurus ValueDomain)
TherapyDiscontinueDate
Item
Date treatment was discontinued (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
Item Group
Bevacizumab/placebo
Agent
Item
Agent
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Agent dose prescribed
Item
Prescribed dose (mg/kg)
float
C28180 (NCI Thesaurus ObjectClass)
C0678766 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass-2)
C0278329 (UMLS CUI-2)
C25256 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus ValueDomain-2)
TotalAgentActualCourseDose
Item
Total actual dose of agent/drugs (for this period mg/kg)
float
C25304 (NCI Thesaurus ObjectClass)
C0439810 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25274 (NCI Thesaurus Property-2)
C0237400 (UMLS 2011AA Property-2)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C25274 (NCI Thesaurus ValueDomain-2)
C0237400 (UMLS 2011AA ValueDomain-2)
DoseDelayedInd-3
Item
Were there any delays in dose administration
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25477 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
TreatmentInterruptionDayDuration
Item
Days Treatment Was Interrupted
float
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25330 (NCI Thesaurus ValueDomain-2)
C0449238 (UMLS 2011AA ValueDomain-2)
C25542 (NCI Thesaurus Property)
C1512900 (UMLS 2011AA Property)
Reason for treatment delay, specify
Item
Reason dose was delayed
text
C25704 (NCI Thesaurus ValueDomain)
C1298642 (UMLS CUI-1)
C25477 (NCI Thesaurus Property)
C1708 (NCI Thesaurus ObjectClass)
C25409 (NCI Thesaurus Property-2)
Drug treatment discontinued during chemotherapy cycle
Item
Was treatment discontinued during this period?
boolean
C15368 (NCI Thesaurus ObjectClass)
C25471 (NCI Thesaurus Property)
C0558681 (UMLS CUI-1)
C25472 (NCI Thesaurus Property-2)
C0347984 (UMLS CUI-2)
C25484 (NCI Thesaurus Property-3)
C1302181 (UMLS CUI-3)
C38147 (NCI Thesaurus ValueDomain)
TreatmentCurrentCycleDiscontinuedSpecify
Item
Specify (Yes)
text
C15368 (NCI Thesaurus ObjectClass)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C25472 (NCI Thesaurus Property-2)
C1511572 (UMLS 2011AA Property-2)
C25484 (NCI Thesaurus Property-3)
C1444662 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
TherapyDiscontinueDate
Item
Date treatment was discontinued (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
Item Group
Bevacizumab/placebo
Agent
Item
Agent
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
PillDosageFormAdministeredAmount
Item
Dose used
text
C25394 (NCI Thesaurus ObjectClass)
C0994475 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25417 (NCI Thesaurus ValueDomain)
TotalAgentActualCourseDose
Item
Total actual dose of agent/drugs (for this period mg/kg)
float
C25304 (NCI Thesaurus ObjectClass)
C0439810 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25274 (NCI Thesaurus Property-2)
C0237400 (UMLS 2011AA Property-2)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C25274 (NCI Thesaurus ValueDomain-2)
C0237400 (UMLS 2011AA ValueDomain-2)
DoseDelayedInd-3
Item
Were there any delays in dose administration
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25477 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
TreatmentInterruptionDayDuration
Item
Days Treatment Was Interrupted
float
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25330 (NCI Thesaurus ValueDomain-2)
C0449238 (UMLS 2011AA ValueDomain-2)
C25542 (NCI Thesaurus Property)
C1512900 (UMLS 2011AA Property)
Reason for treatment delay, specify
Item
Reason dose was delayed
text
C25704 (NCI Thesaurus ValueDomain)
C1298642 (UMLS CUI-1)
C25477 (NCI Thesaurus Property)
C1708 (NCI Thesaurus ObjectClass)
C25409 (NCI Thesaurus Property-2)
Drug treatment discontinued during chemotherapy cycle
Item
Was treatment discontinued during this period?
boolean
C15368 (NCI Thesaurus ObjectClass)
C25471 (NCI Thesaurus Property)
C0558681 (UMLS CUI-1)
C25472 (NCI Thesaurus Property-2)
C0347984 (UMLS CUI-2)
C25484 (NCI Thesaurus Property-3)
C1302181 (UMLS CUI-3)
C38147 (NCI Thesaurus ValueDomain)
TherapyDiscontinueDate
Item
Date treatment was discontinued (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
Item Group
Muga Results
Item
Time point (Mark one with an X.)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
CL.10
Code List
Time point (Mark one with an X.)
CL Item
Baseline (baseline)
C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)
CL Item
Week 8 (Week 8)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
AssessmentPeriodSpecify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
HeartLVEFTestPercentageValue
Item
LVEF (%)
float
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property-2)
C2700377 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
HeartLVEFTestPercentageLowerLimitofNormalValue
Item
LVEF Institutional Lower Limit of Normal (%)
float
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property-2)
C2700377 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)
C1518030 (UMLS 2011AA ValueDomain-3)
Item
Has the patient experienced a drop of at least 15 percentage points in the current LVEF compared with the baseline value
text
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25640 (NCI Thesaurus Property)
C0392756 (UMLS 2011AA Property)
C25518 (NCI Thesaurus Property-2)
C0542341 (UMLS 2011AA Property-2)
C37946 (NCI Thesaurus Property-3)
C2700377 (UMLS 2011AA Property-3)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.11
Code List
Has the patient experienced a drop of at least 15 percentage points in the current LVEF compared with the baseline value
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Not Available (NA)
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