ID

1007

Description

E5103 Adverse Event Form (CTCAE v3) Doxorubicin, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=22B14F38-EFAA-6454-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=22B14F38-EFAA-6454-E044-0003BA3F9857

Keywords

  1. 8/26/12 8/26/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 1/9/15 1/9/15 - Martin Dugas
  5. 7/8/15 7/8/15 -
Uploaded on

August 26, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT00433511 Toxicity - E5103 Adverse Event Form (CTCAE v3) - 2544497v1.0

INSTRUCTIONS: Complete this form at the end of each cycle (1 cycle = 3 weeks), and at required follow-ups if specified by the Long-Term Follow-Up Form (to report late adverse events).

Unnamed1
Description

Unnamed1

ECOG Protocol Number
Description

ProtocolECOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25491
UMLS 2011AA Property
C1512162
ECOG Patient ID
Description

PatientECOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25491
UMLS 2011AA Property
C1512162
DCI Name
Description

CollectedDataFormName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C19464
UMLS 2011AA Property
C0376315
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus ObjectClass
C25452
Registration Step
Description

RegistrationStepNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25646
UMLS 2011AA ObjectClass
C1514821
NCI Thesaurus Property
C16154
UMLS 2011AA Property
C1704379
NCI Thesaurus ValueDomain
C16154
UMLS 2011AA ValueDomain
C1704379
Unnamed2
Description

Unnamed2

Patient Initials (Last, First)
Description

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
ECOG Protocol Number
Description

ProtocolECOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25491
UMLS 2011AA Property
C1512162
ECOG Patient ID
Description

PatientECOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25491
UMLS 2011AA Property
C1512162
Participating Group Protocol Number
Description

ProtocolParticipatingIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Participating Group Patient ID
Description

PatientParticipatingIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Institution/Affiliate
Description

CombinedInstitutionName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS 2011AA ObjectClass
C0205195
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ValueDomain
C21541
UMLS 2011AA ValueDomain
C0018704
Unnamed3
Description

Unnamed3

Please mark an 'X' if data have been amended.
Description

DataAmendedText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Date data amended (s m/d/y)
Description

DataAmendedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
NCI Thesaurus ValueDomain
C25367
Unnamed Module 4
Description

Unnamed Module 4

On Treatment Report Period (STEP 2 - ARM D ONLY)
Description

TreatmentEvaluationPeriodType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ObjectClass
C15368
On Treatment Report Period (STEP 2 - ARM D ONLY)
Description

TreatmentEvaluationPeriodType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ObjectClass
C15368
Off Treatment Reporting Period
Description

Off Treatment Reporting Period

Off Treatment Report Period
Description

PersonOff-TreatmentTimePeriodType

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25601
UMLS 2011AA Property
C1518544
NCI Thesaurus Property
C25207
UMLS 2011AA Property
C0040223
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Unnamed4
Description

Unnamed4

Were adverse events assessed during this report period (cycle)
Description

AdverseEventCurrentAssessmentInd

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
CTC Adverse Event Report Begin Date (For the dates below, record the start and end dates of the time period within current report period in which patient was assessed for adverse events.)
Description

CTCAdverseEventReportBeginDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
CTC Adverse Event Report End Date (m/d/y)
Description

CTCAdverseEventReportEndDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
Unnamed5
Description

Unnamed5

CTC Adverse Event Term
Description

CommonToxicityCriteriaAdverseEventTermType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
CTC Adverse Event Grade (v3.0)
Description

CommonToxicityCriteriaAdverseEventGrade

Data type

double

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
CTC AE Attribution Code
Description

CTCAdverseEventAttributionScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
Action taken for this AE for Chemotherapy
Description

DoseChemotherapyAdverseEventModificationStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus Property
C15632
UMLS 2011AA Property
C0392920
NCI Thesaurus Property
C41331
UMLS 2011AA Property
C0877248
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Action taken for this AE for Bevacizumab (/placebo)
Description

DoseBevacizumabAdverseEventModificationStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus Property
C2039
UMLS 2011AA Property
C0796392
NCI Thesaurus Property
C41331
UMLS 2011AA Property
C0877248
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Unnamed5
Description

Unnamed5

CTC Adverse Event Term
Description

CommonToxicityCriteriaAdverseEventTermType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
CTC Adverse Event Short Name (Specify site for each event)
Description

CommonToxicityCriteriaAdverseEventShortNameType

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Metathesaurus ValueDomain
C0332307
NCI Thesaurus Property
C25249
UMLS 2011AA Property
C1806781
CTC Select AE
Description

CTCAdverseEventSpecifiedTermType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C38024
UMLS 2011AA Property
C0205369
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
CTC Adverse Event Grade (v3.0)
Description

CommonToxicityCriteriaAdverseEventGrade

Data type

double

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
CTC AE Attribution Code
Description

CTCAdverseEventAttributionScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
Action taken for this AE for Chemotherapy
Description

DoseChemotherapyAdverseEventModificationStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus Property
C15632
UMLS 2011AA Property
C0392920
NCI Thesaurus Property
C41331
UMLS 2011AA Property
C0877248
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Action taken for this AE for Bevacizumab (/placebo)
Description

DoseBevacizumabAdverseEventModificationStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus Property
C2039
UMLS 2011AA Property
C0796392
NCI Thesaurus Property
C41331
UMLS 2011AA Property
C0877248
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Unnamed5
Description

Unnamed5

CTC Adverse Event Term
Description

CommonToxicityCriteriaAdverseEventTermType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
CTC Adverse Event Grade (v3.0)
Description

CommonToxicityCriteriaAdverseEventGrade

Data type

double

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
CTC AE Attribution Code
Description

CTCAdverseEventAttributionScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
Action taken for this AE for Chemotherapy
Description

DoseChemotherapyAdverseEventModificationStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus Property
C15632
UMLS 2011AA Property
C0392920
NCI Thesaurus Property
C41331
UMLS 2011AA Property
C0877248
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Action taken for this AE for Bevacizumab (/placebo)
Description

DoseBevacizumabAdverseEventModificationStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus Property
C2039
UMLS 2011AA Property
C0796392
NCI Thesaurus Property
C41331
UMLS 2011AA Property
C0877248
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Iii. Infections
Description

Iii. Infections

CTC Adverse Event Short Name (Specify site for each event)
Description

CommonToxicityCriteriaAdverseEventShortNameType

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Metathesaurus ValueDomain
C0332307
NCI Thesaurus Property
C25249
UMLS 2011AA Property
C1806781
CTC Select AE
Description

CTCAdverseEventSpecifiedTermType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C38024
UMLS 2011AA Property
C0205369
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
CTC Adverse Event Grade (v3.0)
Description

CommonToxicityCriteriaAdverseEventGrade

Data type

double

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
CTC AE Attribution Code
Description

CTCAdverseEventAttributionScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
Action taken for this AE for Chemotherapy
Description

DoseChemotherapyAdverseEventModificationStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus Property
C15632
UMLS 2011AA Property
C0392920
NCI Thesaurus Property
C41331
UMLS 2011AA Property
C0877248
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Action taken for this AE for Bevacizumab (/placebo)
Description

DoseBevacizumabAdverseEventModificationStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus Property
C2039
UMLS 2011AA Property
C0796392
NCI Thesaurus Property
C41331
UMLS 2011AA Property
C0877248
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Iii. Infections
Description

Iii. Infections

CTC Adverse Event Short Name (Specify site for each event)
Description

CommonToxicityCriteriaAdverseEventShortNameType

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Metathesaurus ValueDomain
C0332307
NCI Thesaurus Property
C25249
UMLS 2011AA Property
C1806781
CTC Select AE
Description

CTCAdverseEventSpecifiedTermType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C38024
UMLS 2011AA Property
C0205369
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
CTC Adverse Event Grade (v3.0)
Description

CommonToxicityCriteriaAdverseEventGrade

Data type

double

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
CTC AE Attribution Code
Description

CTCAdverseEventAttributionScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
Action taken for this AE for Chemotherapy
Description

DoseChemotherapyAdverseEventModificationStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus Property
C15632
UMLS 2011AA Property
C0392920
NCI Thesaurus Property
C41331
UMLS 2011AA Property
C0877248
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Action taken for this AE for Bevacizumab (/placebo)
Description

DoseBevacizumabAdverseEventModificationStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus Property
C2039
UMLS 2011AA Property
C0796392
NCI Thesaurus Property
C41331
UMLS 2011AA Property
C0877248
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Comments
Description

Comments

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
Investigator Signature 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

Similar models

INSTRUCTIONS: Complete this form at the end of each cycle (1 cycle = 3 weeks), and at required follow-ups if specified by the Long-Term Follow-Up Form (to report late adverse events).

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Unnamed1
ProtocolECOGIdentifierNumber
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
PatientECOGIdentifierNumber
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
CollectedDataFormName
Item
DCI Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus Property)
C0376315 (UMLS 2011AA Property)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus ObjectClass)
RegistrationStepNumber
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25646 (NCI Thesaurus ObjectClass)
C1514821 (UMLS 2011AA ObjectClass)
C16154 (NCI Thesaurus Property)
C1704379 (UMLS 2011AA Property)
C16154 (NCI Thesaurus ValueDomain)
C1704379 (UMLS 2011AA ValueDomain)
Item Group
Unnamed2
PatientInitialsName
Item
Patient Initials (Last, First)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
ProtocolECOGIdentifierNumber
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
PatientECOGIdentifierNumber
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
ProtocolParticipatingIdentifierNumber
Item
Participating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientParticipatingIdentifierNumber
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CombinedInstitutionName
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
Item Group
Unnamed3
DataAmendedText
Item
Please mark an 'X' if data have been amended.
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
DataAmendedDate
Item
Date data amended (s m/d/y)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
Item Group
Unnamed Module 4
Item
On Treatment Report Period (STEP 2 - ARM D ONLY)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
Code List
On Treatment Report Period (STEP 2 - ARM D ONLY)
CL Item
Cycle 10 Step 2 (Cycle 10 Step 2)
CL Item
Cycle 11 Step 2 (Cycle 11 Step 2)
CL Item
Cycle 12 Step 2 (Cycle 12 Step 2)
CL Item
Cycle 13-step 2 (Cycle 13-Step 2)
CL Item
Cycle 14-step 2 (Cycle 14-Step 2)
CL Item
Cycle 15 Step 2 (Cycle 15 Step 2)
CL Item
Cycle 16-step 2 (Cycle 16-Step 2)
CL Item
Cycle 17 Step 2 (Cycle 17 Step 2)
CL Item
Cycle 18-step 2 (Cycle 18-Step 2)
CL Item
Cycle 9 Step 2 (Cycle 9 Step 2)
Item
On Treatment Report Period (STEP 2 - ARM D ONLY)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
Code List
On Treatment Report Period (STEP 2 - ARM D ONLY)
CL Item
Cycle 10 Step 2 (Cycle 10 Step 2)
CL Item
Cycle 11 Step 2 (Cycle 11 Step 2)
CL Item
Cycle 12 Step 2 (Cycle 12 Step 2)
CL Item
Cycle 13-step 2 (Cycle 13-Step 2)
CL Item
Cycle 14-step 2 (Cycle 14-Step 2)
CL Item
Cycle 15 Step 2 (Cycle 15 Step 2)
CL Item
Cycle 16-step 2 (Cycle 16-Step 2)
CL Item
Cycle 17 Step 2 (Cycle 17 Step 2)
CL Item
Cycle 18-step 2 (Cycle 18-Step 2)
CL Item
Cycle 9 Step 2 (Cycle 9 Step 2)
Item Group
Off Treatment Reporting Period
Item
Off Treatment Report Period
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25601 (NCI Thesaurus Property)
C1518544 (UMLS 2011AA Property)
C25207 (NCI Thesaurus Property)
C0040223 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Off Treatment Report Period
CL Item
3 Months Post-treatment (3 Months Post-Treatment)
CL Item
6 Months Post-treatment (6 Months Post-Treatment)
CL Item
9 Months Post-treatment (9 Months Post-Treatment)
CL Item
12 Months Post-treatment (12 Months Post-Treatment)
Item Group
Unnamed4
Item
Were adverse events assessed during this report period (cycle)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
Code List
Were adverse events assessed during this report period (cycle)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, But No Reportable Adverse Events Occurred (Yes, but no reportable adverse events occurred)
CL Item
Yes, And Reportable Adverse Events Occurred (Yes, and reportable adverse events occurred)
CTCAdverseEventReportBeginDate
Item
CTC Adverse Event Report Begin Date (For the dates below, record the start and end dates of the time period within current report period in which patient was assessed for adverse events.)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
CTCAdverseEventReportEndDate
Item
CTC Adverse Event Report End Date (m/d/y)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
Item Group
Unnamed5
Item
CTC Adverse Event Term
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
Code List
CTC Adverse Event Term
CL Item
Hypersensitivity Nos (Allergic reaction/hypersensitivity (including drug fever))
CL Item
Anorexia (Anorexia)
C2875 (NCI Thesaurus)
C0003123 (UMLS 2011AA)
CL Item
Ataxia Nec (Ataxia (incoordination))
CL Item
Myocardial Ischaemia (Cardiac ischemia/infarction)
C0151744 (NCI Metathesaurus)
CL Item
Cns Necrosis/cystic Progression (CNS necrosis/cystic progression)
CL Item
Constipation (Constipation)
C37930 (NCI Thesaurus)
C0009806 (UMLS 2011AA)
CL Item
Cough (Cough)
C37935 (NCI Thesaurus)
C0010200 (UMLS 2011AA)
CL Item
Cytokine Release Syndrome/acute Infusion Reaction (Cytokine release syndrome/acute infusion reaction)
CL Item
Diarrhoea Nos (Diarrhea)
CL Item
Dizziness (exc Vertigo) (Dizziness)
CL Item
Dyspnoea Nos (Dyspnea (shortness of breath))
CL Item
Fatigue (Fatigue (asthenia, lethargy, malaise))
C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)
CL Item
Pyrexia (Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9/L))
CL Item
Alopecia (Hair loss/Alopecia (scalp or body))
C2865 (NCI Thesaurus)
CL Item
Dyspepsia (Heartburn/dyspepsia)
C26756 (NCI Thesaurus)
C0013395 (UMLS 2011AA)
CL Item
Haemorrhagic Stroke (Hemorrhage, CNS)
CL036983 (NCI Metathesaurus)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Lower GI NOS)
CL Item
Haematemesis (Hemorrhage, GI - Stomach)
C0018926 (NCI Metathesaurus)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Upper GI NOS)
CL Item
Hypertension Nos (Hypertension)
CL Item
Depression Nec (Mood alteration - depression)
CL Item
Mucositis/stomatitis (functional/symptomatic) (Mucositis/stomatitis (functional/symptomatic) - Oral cavity)
CL Item
Nausea (Nausea)
C3258 (NCI Thesaurus)
C0027497 (UMLS 2011AA)
CL Item
Chest Pain (Pain - Chest/thorax NOS)
C38665 (NCI Thesaurus)
C0008031 (UMLS 2011AA)
CL Item
Headache Nos (Pain - Head/headache)
CL Item
Arthralgia (Pain - Joint)
C0003862 (NCI Metathesaurus)
CL Item
Myalgia (Pain - Muscle)
C27009 (NCI Thesaurus)
C0231528 (UMLS 2011AA)
CL Item
Pruritus Nos (Pruritus/itching)
CL Item
Dermatitis Exfoliative Nos (Rash/desquamation)
CL Item
Rigors (Rigors/chills)
C0424790 (NCI Metathesaurus)
CL Item
Supraventricular And Nodal Arrhythmia (Supraventricular and nodal arrhythmia - Sinus arrhythmia)
CL Item
Taste Disturbance (Taste alteration (dysgeusia))
CL Item
Urticaria Nos (Urticaria (hives, welts, wheals))
CL Item
Dysphonia (Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis))
C0935979 (NCI Metathesaurus)
CL Item
Vomiting Nos (Vomiting)
CL Item
Culture Wound Negative (Wound complication, non-infectious)
CL040841 (NCI Metathesaurus)
Item
CTC Adverse Event Grade (v3.0)
double
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
CTC Adverse Event Grade (v3.0)
CL Item
Severe Adverse Event (3)
C41340 (NCI Thesaurus)
C1519275 (UMLS 2011AA)
CL Item
Life-threatening Or Disabling Adverse Event (4)
CL Item
Death Related To Adverse Event (5)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)
Item
CTC AE Attribution Code
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
Code List
CTC AE Attribution Code
CL Item
Unrelated (unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (unlikely)
CL Item
Possible (possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (probable)
C0332148 (NCI Metathesaurus)
CL Item
Definite (definite)
CL209464 (NCI Metathesaurus)
Item
Action taken for this AE for Chemotherapy
text
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus Property)
C0392920 (UMLS 2011AA Property)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C25572 (NCI Thesaurus Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
Code List
Action taken for this AE for Chemotherapy
CL Item
Dose Delayed (Dose delayed)
CL Item
Dose Delayed And Reduced (Dose delayed and reduced)
CL Item
Dose Held (Dose held)
CL Item
Dose Reduced (Dose reduced)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
CL Item
Drug Discontinued (Drug discontinued)
Item
Action taken for this AE for Bevacizumab (/placebo)
text
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C2039 (NCI Thesaurus Property)
C0796392 (UMLS 2011AA Property)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C25572 (NCI Thesaurus Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
Code List
Action taken for this AE for Bevacizumab (/placebo)
CL Item
Dose Delayed (Dose delayed)
CL Item
Dose Held (Dose held)
CL Item
Drug Discontinued (Drug discontinued)
Item
CTC Adverse Event Term
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
Code List
CTC Adverse Event Term
CL Item
Hypersensitivity Nos (Allergic reaction/hypersensitivity (including drug fever))
CL Item
Anorexia (Anorexia)
C2875 (NCI Thesaurus)
C0003123 (UMLS 2011AA)
CL Item
Ataxia Nec (Ataxia (incoordination))
CL Item
Myocardial Ischaemia (Cardiac ischemia/infarction)
C0151744 (NCI Metathesaurus)
CL Item
Cns Necrosis/cystic Progression (CNS necrosis/cystic progression)
CL Item
Constipation (Constipation)
C37930 (NCI Thesaurus)
C0009806 (UMLS 2011AA)
CL Item
Cough (Cough)
C37935 (NCI Thesaurus)
C0010200 (UMLS 2011AA)
CL Item
Cytokine Release Syndrome/acute Infusion Reaction (Cytokine release syndrome/acute infusion reaction)
CL Item
Diarrhoea Nos (Diarrhea)
CL Item
Dizziness (exc Vertigo) (Dizziness)
CL Item
Dyspnoea Nos (Dyspnea (shortness of breath))
CL Item
Fatigue (Fatigue (asthenia, lethargy, malaise))
C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)
CL Item
Pyrexia (Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9/L))
CL Item
Alopecia (Hair loss/Alopecia (scalp or body))
C2865 (NCI Thesaurus)
CL Item
Dyspepsia (Heartburn/dyspepsia)
C26756 (NCI Thesaurus)
C0013395 (UMLS 2011AA)
CL Item
Haemorrhagic Stroke (Hemorrhage, CNS)
CL036983 (NCI Metathesaurus)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Lower GI NOS)
CL Item
Haematemesis (Hemorrhage, GI - Stomach)
C0018926 (NCI Metathesaurus)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Upper GI NOS)
CL Item
Hypertension Nos (Hypertension)
CL Item
Depression Nec (Mood alteration - depression)
CL Item
Mucositis/stomatitis (functional/symptomatic) (Mucositis/stomatitis (functional/symptomatic) - Oral cavity)
CL Item
Nausea (Nausea)
C3258 (NCI Thesaurus)
C0027497 (UMLS 2011AA)
CL Item
Chest Pain (Pain - Chest/thorax NOS)
C38665 (NCI Thesaurus)
C0008031 (UMLS 2011AA)
CL Item
Headache Nos (Pain - Head/headache)
CL Item
Arthralgia (Pain - Joint)
C0003862 (NCI Metathesaurus)
CL Item
Myalgia (Pain - Muscle)
C27009 (NCI Thesaurus)
C0231528 (UMLS 2011AA)
CL Item
Pruritus Nos (Pruritus/itching)
CL Item
Dermatitis Exfoliative Nos (Rash/desquamation)
CL Item
Rigors (Rigors/chills)
C0424790 (NCI Metathesaurus)
CL Item
Supraventricular And Nodal Arrhythmia (Supraventricular and nodal arrhythmia - Sinus arrhythmia)
CL Item
Taste Disturbance (Taste alteration (dysgeusia))
CL Item
Urticaria Nos (Urticaria (hives, welts, wheals))
CL Item
Dysphonia (Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis))
C0935979 (NCI Metathesaurus)
CL Item
Vomiting Nos (Vomiting)
CL Item
Culture Wound Negative (Wound complication, non-infectious)
CL040841 (NCI Metathesaurus)
Item
CTC Adverse Event Short Name (Specify site for each event)
text
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C0332307 (NCI Metathesaurus ValueDomain)
C25249 (NCI Thesaurus Property)
C1806781 (UMLS 2011AA Property)
Code List
CTC Adverse Event Short Name (Specify site for each event)
CL Item
Febrile Neutropenia (fever Of Unknown Origin Without Clinically Or Microbiologically Documented Infection) (anc <1.0 X 10^9/l, Fever >=38.5 Degrees C) (Febrile neutropenia)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically) - Select)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC - Select)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Select)
CTCAdverseEventSpecifiedTermType
Item
CTC Select AE
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C38024 (NCI Thesaurus Property)
C0205369 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
Item
CTC Adverse Event Grade (v3.0)
double
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
CTC Adverse Event Grade (v3.0)
CL Item
Severe Adverse Event (3)
C41340 (NCI Thesaurus)
C1519275 (UMLS 2011AA)
CL Item
Life-threatening Or Disabling Adverse Event (4)
CL Item
Death Related To Adverse Event (5)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)
Item
CTC AE Attribution Code
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
Code List
CTC AE Attribution Code
CL Item
Unrelated (unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (unlikely)
CL Item
Possible (possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (probable)
C0332148 (NCI Metathesaurus)
CL Item
Definite (definite)
CL209464 (NCI Metathesaurus)
Item
Action taken for this AE for Chemotherapy
text
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus Property)
C0392920 (UMLS 2011AA Property)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C25572 (NCI Thesaurus Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
Code List
Action taken for this AE for Chemotherapy
CL Item
Dose Delayed (Dose delayed)
CL Item
Dose Delayed And Reduced (Dose delayed and reduced)
CL Item
Dose Held (Dose held)
CL Item
Dose Reduced (Dose reduced)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
CL Item
Drug Discontinued (Drug discontinued)
Item
Action taken for this AE for Bevacizumab (/placebo)
text
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C2039 (NCI Thesaurus Property)
C0796392 (UMLS 2011AA Property)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C25572 (NCI Thesaurus Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
Code List
Action taken for this AE for Bevacizumab (/placebo)
CL Item
Dose Delayed (Dose delayed)
CL Item
Dose Held (Dose held)
CL Item
Drug Discontinued (Drug discontinued)
Item Group
Unnamed5
Item
CTC Adverse Event Term
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
Code List
CTC Adverse Event Term
CL Item
Hypersensitivity Nos (Allergic reaction/hypersensitivity (including drug fever))
CL Item
Anorexia (Anorexia)
C2875 (NCI Thesaurus)
C0003123 (UMLS 2011AA)
CL Item
Ataxia Nec (Ataxia (incoordination))
CL Item
Myocardial Ischaemia (Cardiac ischemia/infarction)
C0151744 (NCI Metathesaurus)
CL Item
Cns Necrosis/cystic Progression (CNS necrosis/cystic progression)
CL Item
Constipation (Constipation)
C37930 (NCI Thesaurus)
C0009806 (UMLS 2011AA)
CL Item
Cough (Cough)
C37935 (NCI Thesaurus)
C0010200 (UMLS 2011AA)
CL Item
Cytokine Release Syndrome/acute Infusion Reaction (Cytokine release syndrome/acute infusion reaction)
CL Item
Diarrhoea Nos (Diarrhea)
CL Item
Dizziness (exc Vertigo) (Dizziness)
CL Item
Dyspnoea Nos (Dyspnea (shortness of breath))
CL Item
Fatigue (Fatigue (asthenia, lethargy, malaise))
C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)
CL Item
Pyrexia (Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9/L))
CL Item
Alopecia (Hair loss/Alopecia (scalp or body))
C2865 (NCI Thesaurus)
CL Item
Dyspepsia (Heartburn/dyspepsia)
C26756 (NCI Thesaurus)
C0013395 (UMLS 2011AA)
CL Item
Haemorrhagic Stroke (Hemorrhage, CNS)
CL036983 (NCI Metathesaurus)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Lower GI NOS)
CL Item
Haematemesis (Hemorrhage, GI - Stomach)
C0018926 (NCI Metathesaurus)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Upper GI NOS)
CL Item
Hypertension Nos (Hypertension)
CL Item
Depression Nec (Mood alteration - depression)
CL Item
Mucositis/stomatitis (functional/symptomatic) (Mucositis/stomatitis (functional/symptomatic) - Oral cavity)
CL Item
Nausea (Nausea)
C3258 (NCI Thesaurus)
C0027497 (UMLS 2011AA)
CL Item
Chest Pain (Pain - Chest/thorax NOS)
C38665 (NCI Thesaurus)
C0008031 (UMLS 2011AA)
CL Item
Headache Nos (Pain - Head/headache)
CL Item
Arthralgia (Pain - Joint)
C0003862 (NCI Metathesaurus)
CL Item
Myalgia (Pain - Muscle)
C27009 (NCI Thesaurus)
C0231528 (UMLS 2011AA)
CL Item
Pruritus Nos (Pruritus/itching)
CL Item
Dermatitis Exfoliative Nos (Rash/desquamation)
CL Item
Rigors (Rigors/chills)
C0424790 (NCI Metathesaurus)
CL Item
Supraventricular And Nodal Arrhythmia (Supraventricular and nodal arrhythmia - Sinus arrhythmia)
CL Item
Taste Disturbance (Taste alteration (dysgeusia))
CL Item
Urticaria Nos (Urticaria (hives, welts, wheals))
CL Item
Dysphonia (Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis))
C0935979 (NCI Metathesaurus)
CL Item
Vomiting Nos (Vomiting)
CL Item
Culture Wound Negative (Wound complication, non-infectious)
CL040841 (NCI Metathesaurus)
Item
CTC Adverse Event Grade (v3.0)
double
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
CTC Adverse Event Grade (v3.0)
CL Item
Severe Adverse Event (3)
C41340 (NCI Thesaurus)
C1519275 (UMLS 2011AA)
CL Item
Life-threatening Or Disabling Adverse Event (4)
CL Item
Death Related To Adverse Event (5)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)
Item
CTC AE Attribution Code
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
Code List
CTC AE Attribution Code
CL Item
Unrelated (unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (unlikely)
CL Item
Possible (possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (probable)
C0332148 (NCI Metathesaurus)
CL Item
Definite (definite)
CL209464 (NCI Metathesaurus)
Item
Action taken for this AE for Chemotherapy
text
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus Property)
C0392920 (UMLS 2011AA Property)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C25572 (NCI Thesaurus Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
Code List
Action taken for this AE for Chemotherapy
CL Item
Dose Delayed (Dose delayed)
CL Item
Dose Delayed And Reduced (Dose delayed and reduced)
CL Item
Dose Held (Dose held)
CL Item
Dose Reduced (Dose reduced)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
CL Item
Drug Discontinued (Drug discontinued)
Item
Action taken for this AE for Bevacizumab (/placebo)
text
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C2039 (NCI Thesaurus Property)
C0796392 (UMLS 2011AA Property)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C25572 (NCI Thesaurus Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
Code List
Action taken for this AE for Bevacizumab (/placebo)
CL Item
Dose Delayed (Dose delayed)
CL Item
Dose Held (Dose held)
CL Item
Drug Discontinued (Drug discontinued)
Item Group
Iii. Infections
Item
CTC Adverse Event Short Name (Specify site for each event)
text
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C0332307 (NCI Metathesaurus ValueDomain)
C25249 (NCI Thesaurus Property)
C1806781 (UMLS 2011AA Property)
Code List
CTC Adverse Event Short Name (Specify site for each event)
CL Item
Febrile Neutropenia (fever Of Unknown Origin Without Clinically Or Microbiologically Documented Infection) (anc <1.0 X 10^9/l, Fever >=38.5 Degrees C) (Febrile neutropenia)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically) - Select)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC - Select)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Select)
CTCAdverseEventSpecifiedTermType
Item
CTC Select AE
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C38024 (NCI Thesaurus Property)
C0205369 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
Item
CTC Adverse Event Grade (v3.0)
double
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
CTC Adverse Event Grade (v3.0)
CL Item
Severe Adverse Event (3)
C41340 (NCI Thesaurus)
C1519275 (UMLS 2011AA)
CL Item
Life-threatening Or Disabling Adverse Event (4)
CL Item
Death Related To Adverse Event (5)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)
Item
CTC AE Attribution Code
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
Code List
CTC AE Attribution Code
CL Item
Unrelated (unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (unlikely)
CL Item
Possible (possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (probable)
C0332148 (NCI Metathesaurus)
CL Item
Definite (definite)
CL209464 (NCI Metathesaurus)
Item
Action taken for this AE for Chemotherapy
text
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus Property)
C0392920 (UMLS 2011AA Property)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C25572 (NCI Thesaurus Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
Code List
Action taken for this AE for Chemotherapy
CL Item
Dose Delayed (Dose delayed)
CL Item
Dose Delayed And Reduced (Dose delayed and reduced)
CL Item
Dose Held (Dose held)
CL Item
Dose Reduced (Dose reduced)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
CL Item
Drug Discontinued (Drug discontinued)
Item
Action taken for this AE for Bevacizumab (/placebo)
text
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C2039 (NCI Thesaurus Property)
C0796392 (UMLS 2011AA Property)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C25572 (NCI Thesaurus Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
Code List
Action taken for this AE for Bevacizumab (/placebo)
CL Item
Dose Delayed (Dose delayed)
CL Item
Dose Held (Dose held)
CL Item
Drug Discontinued (Drug discontinued)
Item Group
Iii. Infections
Item
CTC Adverse Event Short Name (Specify site for each event)
text
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C0332307 (NCI Metathesaurus ValueDomain)
C25249 (NCI Thesaurus Property)
C1806781 (UMLS 2011AA Property)
Code List
CTC Adverse Event Short Name (Specify site for each event)
CL Item
Febrile Neutropenia (fever Of Unknown Origin Without Clinically Or Microbiologically Documented Infection) (anc <1.0 X 10^9/l, Fever >=38.5 Degrees C) (Febrile neutropenia)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically) - Select)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC - Select)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Select)
CTCAdverseEventSpecifiedTermType
Item
CTC Select AE
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C38024 (NCI Thesaurus Property)
C0205369 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
Item
CTC Adverse Event Grade (v3.0)
double
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
CTC Adverse Event Grade (v3.0)
CL Item
Severe Adverse Event (3)
C41340 (NCI Thesaurus)
C1519275 (UMLS 2011AA)
CL Item
Life-threatening Or Disabling Adverse Event (4)
CL Item
Death Related To Adverse Event (5)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)
Item
CTC AE Attribution Code
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
Code List
CTC AE Attribution Code
CL Item
Unrelated (unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (unlikely)
CL Item
Possible (possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (probable)
C0332148 (NCI Metathesaurus)
CL Item
Definite (definite)
CL209464 (NCI Metathesaurus)
Item
Action taken for this AE for Chemotherapy
text
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus Property)
C0392920 (UMLS 2011AA Property)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C25572 (NCI Thesaurus Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
Code List
Action taken for this AE for Chemotherapy
CL Item
Dose Delayed (Dose delayed)
CL Item
Dose Delayed And Reduced (Dose delayed and reduced)
CL Item
Dose Held (Dose held)
CL Item
Dose Reduced (Dose reduced)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
CL Item
Drug Discontinued (Drug discontinued)
Item
Action taken for this AE for Bevacizumab (/placebo)
text
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C2039 (NCI Thesaurus Property)
C0796392 (UMLS 2011AA Property)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C25572 (NCI Thesaurus Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
Code List
Action taken for this AE for Bevacizumab (/placebo)
CL Item
Dose Delayed (Dose delayed)
CL Item
Dose Held (Dose held)
CL Item
Drug Discontinued (Drug discontinued)
Item Group
Comments
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
Investigator Signature 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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