ID

1427

Description

CALGB: 80405 SUPPLEMENTAL ADVERSE EVENT FORM Cetuximab and/or Bevacizumab Combined With Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F39D4556-5D0B-6221-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F39D4556-5D0B-6221-E034-0003BA3F9857

Keywords

Versions (3)
  1. 8/27/12 8/27/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
  3. 6/8/15 6/8/15 -
Uploaded on

August 27, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Colorectal Cancer NCT00265850 Toxicity - CALGB: 80405 SUPPLEMENTAL ADVERSE EVENT FORM - 2308251v3.0

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.

1 forms  
Unnamed1
Description

Unnamed1

CALGB Form
Description

CALGBFormIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C19464
UMLS 2011AA ObjectClass
C0376315
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C25442
UMLS 2011AA ObjectClass
C1516238
CALGB Study No
Description

ProtocolCALGBIdentifierNumber

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
C25442
UMLS 2011AA Property
C1516238
CALGB Patient ID
Description

PatientCALGBIdentifierNumber

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
C25442
UMLS 2011AA Property
C1516238
Reporting period start date
Description

TreatmentReportingPeriodBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
Reporting period end date
Description

TreatmentReportingPeriodEndDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
Are data amended
Description

DataAmendedInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Unnamed2
Description

Unnamed2

Patient Initials
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
Patient Hospital No
Description

HospitalPatientIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C16960
UMLS 2011AA Property
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C16696
UMLS 2011AA ObjectClass
C0019994
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
Participating Group
Description

ParticipatingGroupName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25608
UMLS 2011AA ObjectClass
C0679823
NCI Thesaurus ObjectClass
C17005
UMLS 2011AA ObjectClass
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Participating Group Study No.
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
Unnamed 3
Description

Unnamed 3

Cycle number
Description

TherapyCourseNumber

Data type

double

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
Medications received during this reporting period (Mark one with an X)
Description

ReceivedMedicationReportingPeriodType

Data type

text

Alias
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ObjectClass
C25639
UMLS 2011AA ObjectClass
C1514756
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NSAID, specify
Description

NonsteroidalAntiinflammatoryDrugMedicationReportingPeriodSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ObjectClass
C257
UMLS 2011AA ObjectClass
C0003211
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Anti-platelet, specify
Description

AntiplateletMedicationReportingPeriodSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ObjectClass
C1327
UMLS 2011AA ObjectClass
C0085826
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Statin, specify
Description

LipidLoweringMedicationReportingPeriodSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Metathesaurus ObjectClass
CL264271
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
BP or cardiac medication, specify
Description

CardiacMedicationReportingPeriodSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C13306
UMLS 2011AA ObjectClass
C1522601
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Anticoagulant, specify
Description

AnticoagulantMedicationReportingPeriodSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ObjectClass
C263
UMLS 2011AA ObjectClass
C0003280
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Which of the following arterial thrombotic events (ATEs) occurred during this reporting period? (Mark one with an X)
Description

ArterialThrombosisReportingPeriodType

Data type

text

Alias
NCI Thesaurus ObjectClass
C26891
UMLS 2011AA ObjectClass
C0040053
NCI Metathesaurus ObjectClass
C0221464
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Other arterial event, specify
Description

ArterialThrombosisReportingPeriodSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C26891
UMLS 2011AA ObjectClass
C0040053
NCI Metathesaurus ObjectClass
C0221464
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Treatment for ATE (Mark one with an X)
Description

ArterialThrombosisTherapyType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C26891
UMLS 2011AA ObjectClass
C0040053
NCI Thesaurus Property
C15368
NCI Metathesaurus ObjectClass
C0221464
Outcome of ATE (Mark one with an X)
Description

ArterialThrombosisOutcomeType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C26891
UMLS 2011AA ObjectClass
C0040053
NCI Metathesaurus ObjectClass
C0221464
NCI Metathesaurus Property
CL158230
Which of the following venous thrombotic events (VTEs) occurred during this reporting period? (Mark one with an X)
Description

VenousThrombosisReportingPeriodType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ObjectClass
C26891
UMLS 2011AA ObjectClass
C0040053
NCI Thesaurus ObjectClass
C25291
UMLS 2011AA ObjectClass
C0348013
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
Other venous thrombotic event, specify
Description

VenousThrombosisReportingPeriodSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C26891
UMLS 2011AA ObjectClass
C0040053
NCI Thesaurus ObjectClass
C25291
UMLS 2011AA ObjectClass
C0348013
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Was the patient receiving anticoagulants prior to the VTEt?
Description

VenousThrombosisPriorAnticoagulantInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C26891
UMLS 2011AA ObjectClass
C0040053
NCI Thesaurus ObjectClass
C25291
UMLS 2011AA ObjectClass
C0348013
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C263
UMLS 2011AA Property
C0003280
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Yes, specify
Description

VenousThrombosisPriorAnticoagulantSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C26891
UMLS 2011AA ObjectClass
C0040053
NCI Thesaurus ObjectClass
C25291
UMLS 2011AA ObjectClass
C0348013
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C263
UMLS 2011AA Property
C0003280
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Were anticoagulants used to treate the VTE?
Description

VenousThrombosisAnticoagulantTreatmentInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C26891
UMLS 2011AA ObjectClass
C0040053
NCI Thesaurus ObjectClass
C25291
UMLS 2011AA ObjectClass
C0348013
NCI Thesaurus Property
C15368
NCI Thesaurus Property
C263
UMLS 2011AA Property
C0003280
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Yes, specify
Description

VenousThrombosisAnticoagulantTreatmentSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C26891
UMLS 2011AA ObjectClass
C0040053
NCI Thesaurus ObjectClass
C25291
UMLS 2011AA ObjectClass
C0348013
NCI Thesaurus Property
C15368
NCI Thesaurus Property
C263
UMLS 2011AA Property
C0003280
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Treatment for VTE (Mark one with an X)
Description

VenousThrombosisTreatmentType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C26891
UMLS 2011AA ObjectClass
C0040053
NCI Thesaurus ObjectClass
C25291
UMLS 2011AA ObjectClass
C0348013
NCI Metathesaurus Property
C0087111
Outcome of VTE (Mark one with an X)
Description

VenousThrombosisOutcomeType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C26891
UMLS 2011AA ObjectClass
C0040053
NCI Thesaurus ObjectClass
C25291
UMLS 2011AA ObjectClass
C0348013
NCI Metathesaurus Property
CL158230
Did the patient experience an infusion reaction to cetuximab during the reporting period? (refer to CTCAE v. 3 Cytokine release syndrome/acute infusion reaction)
Description

CetuximabInfusionReactionReportingPeriodIndicator

Data type

text

Alias
NCI Thesaurus ObjectClass
C1723
UMLS 2011AA ObjectClass
C0879636
NCI Metathesaurus ObjectClass
CL049508
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Yes, specify grade (Report even on C-1399 Adverse Event Form.)
Description

CetuximabInfusionReactionReportingPeriodSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C1723
UMLS 2011AA ObjectClass
C0879636
NCI Metathesaurus ObjectClass
CL049508
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Were steroids given pre-infusion (including as an antiemetic?)
Description

InfusionSteroidTherapyAdministeredInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15388
UMLS 2011AA ObjectClass
C0574032
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ObjectClass
C15370
UMLS 2011AA ObjectClass
C0149783
Was blood drawn for infusion reaction biomarkers?
Description

CollectedBloodInfusionReactionBiomarkerInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C12434
UMLS 2011AA ObjectClass
C0229664
NCI Thesaurus ObjectClass
C25452
NCI Thesaurus Property
C16342
UMLS 2011AA Property
C0005516
NCI Metathesaurus Property
CL049508
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Treatment (Mark one with an X)
Description

CetuximabInfusionReactionTreatmentType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C1723
UMLS 2011AA ObjectClass
C0879636
NCI Metathesaurus Property
C0087111
NCI Metathesaurus ObjectClass
CL049508
Outcome (Mark one with an X)
Description

CetuximabInfusionReactionOutcomeType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C1723
UMLS 2011AA ObjectClass
C0879636
NCI Metathesaurus ObjectClass
CL049508
NCI Metathesaurus Property
CL158230
Was the patient retreated with cetuximab after the reaction?
Description

CetuximabTreatmentPostInfusionReactionInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C1723
UMLS 2011AA ObjectClass
C0879636
NCI Metathesaurus ObjectClass
C0087111
NCI Thesaurus Property
C38008
UMLS 2011AA Property
C0687676
NCI Metathesaurus Property
CL049508
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
If Yes, did the patient experience an acute infusion reaction upon retreatment?
Description

AcuteInfusionReactionRetreatmentInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C14140
UMLS 2011AA ObjectClass
C0205178
NCI Metathesaurus ObjectClass
CL049508
NCI Metathesaurus Property
C0376495
Completed by
Description

ResponsiblePersonName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Date form completed
Description

FormCompleteDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C40988
UMLS 2011AA ObjectClass
C1516308
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus ValueDomain
C25367
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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.

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Unnamed1
CALGBFormIdentifierNumber
Item
CALGB Form
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus ObjectClass)
C1516238 (UMLS 2011AA ObjectClass)
ProtocolCALGBIdentifierNumber
Item
CALGB Study No
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)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)
PatientCALGBIdentifierNumber
Item
CALGB 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)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)
TreatmentReportingPeriodBeginDate
Item
Reporting period start date
date
C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
TreatmentReportingPeriodEndDate
Item
Reporting period end date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
Item
Are data amended
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
CL.1
Code List
Are data amended
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Unnamed2
PatientInitialsName
Item
Patient Initials
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)
HospitalPatientIdentifierNumber
Item
Patient Hospital No
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C16696 (NCI Thesaurus ObjectClass)
C0019994 (UMLS 2011AA ObjectClass)
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)
ParticipatingGroupName
Item
Participating Group
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
ProtocolParticipatingIdentifierNumber
Item
Participating Group Study No.
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)
Item Group
Unnamed 3
TherapyCourseNumber
Item
Cycle number
double
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
Item
Medications received during this reporting period (Mark one with an X)
text
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus ObjectClass)
C1514756 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.2
Code List
Medications received during this reporting period (Mark one with an X)
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Aspirin (Aspirin)
CL Item
Nsaid (NSAID)
CL Item
Anti-platelet (Anti-platelet)
CL Item
Statin (Statin)
CL Item
Bp Or Cardiac Medication (BP or cardiac medication)
CL Item
Anticoagulant (Anticoagulant)
NonsteroidalAntiinflammatoryDrugMedicationReportingPeriodSpecify
Item
NSAID, specify
text
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C257 (NCI Thesaurus ObjectClass)
C0003211 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
AntiplateletMedicationReportingPeriodSpecify
Item
Anti-platelet, specify
text
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C1327 (NCI Thesaurus ObjectClass)
C0085826 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
LipidLoweringMedicationReportingPeriodSpecify
Item
Statin, specify
text
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
CL264271 (NCI Metathesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
CardiacMedicationReportingPeriodSpecify
Item
BP or cardiac medication, specify
text
C13306 (NCI Thesaurus ObjectClass)
C1522601 (UMLS 2011AA ObjectClass)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
AnticoagulantMedicationReportingPeriodSpecify
Item
Anticoagulant, specify
text
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C263 (NCI Thesaurus ObjectClass)
C0003280 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Which of the following arterial thrombotic events (ATEs) occurred during this reporting period? (Mark one with an X)
text
C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C0221464 (NCI Metathesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.3
Code List
Which of the following arterial thrombotic events (ATEs) occurred during this reporting period? (Mark one with an X)
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Myocardial Infarction (Myocardial infarction)
C27996 (NCI Thesaurus)
C0027051 (UMLS 2011AA)
CL Item
Angina (Angina)
C51221 (NCI Thesaurus)
C0002962 (UMLS 2011AA)
CL Item
Cva - Thrombotic (CVA - thrombotic)
CL Item
Cva - Hemorrhagic (CVA - hemorrhagic)
CL Item
Transient Ischemic Attack (Transient ischemic attack)
CL Item
Other Arterial Event (Other arterial event)
ArterialThrombosisReportingPeriodSpecify
Item
Other arterial event, specify
text
C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C0221464 (NCI Metathesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Treatment for ATE (Mark one with an X)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C0221464 (NCI Metathesaurus ObjectClass)
CL.4
Code List
Treatment for ATE (Mark one with an X)
CL Item
Outpatient Management Only (Outpatient management only)
CL Item
Emergency Room (Emergency room)
CL Item
Hospitalization (Hospitalization)
Item
Outcome of ATE (Mark one with an X)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C0221464 (NCI Metathesaurus ObjectClass)
CL158230 (NCI Metathesaurus Property)
CL.5
Code List
Outcome of ATE (Mark one with an X)
CL Item
Resolved (Resolved)
C49498 (NCI Thesaurus)
C1709863 (UMLS 2011AA)
CL Item
Not Resolved (Not resolved)
CL Item
Resulted In Death (Resulted in death)
Item
Which of the following venous thrombotic events (VTEs) occurred during this reporting period? (Mark one with an X)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C25291 (NCI Thesaurus ObjectClass)
C0348013 (UMLS 2011AA ObjectClass)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
CL.6
Code List
Which of the following venous thrombotic events (VTEs) occurred during this reporting period? (Mark one with an X)
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Catheter Related (Catheter related)
CL Item
Dvt (DVT)
CL Item
Pulmonary Embolism (Pulmonary embolism)
CL Item
Other Venous Thrombotic Event (Other venous thrombotic event)
VenousThrombosisReportingPeriodSpecify
Item
Other venous thrombotic event, specify
text
C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C25291 (NCI Thesaurus ObjectClass)
C0348013 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Was the patient receiving anticoagulants prior to the VTEt?
text
C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C25291 (NCI Thesaurus ObjectClass)
C0348013 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C263 (NCI Thesaurus Property)
C0003280 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.7
Code List
Was the patient receiving anticoagulants prior to the VTEt?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
VenousThrombosisPriorAnticoagulantSpecify
Item
Yes, specify
text
C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C25291 (NCI Thesaurus ObjectClass)
C0348013 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C263 (NCI Thesaurus Property)
C0003280 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Were anticoagulants used to treate the VTE?
text
C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C25291 (NCI Thesaurus ObjectClass)
C0348013 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C263 (NCI Thesaurus Property)
C0003280 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.8
Code List
Were anticoagulants used to treate the VTE?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
VenousThrombosisAnticoagulantTreatmentSpecify
Item
Yes, specify
text
C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C25291 (NCI Thesaurus ObjectClass)
C0348013 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C263 (NCI Thesaurus Property)
C0003280 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Treatment for VTE (Mark one with an X)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C25291 (NCI Thesaurus ObjectClass)
C0348013 (UMLS 2011AA ObjectClass)
C0087111 (NCI Metathesaurus Property)
CL.9
Code List
Treatment for VTE (Mark one with an X)
CL Item
Outpatient Management Only (Outpatient management only)
CL Item
Emergency Room (Emergency room)
CL Item
Hospitalization (Hospitalization)
Item
Outcome of VTE (Mark one with an X)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C25291 (NCI Thesaurus ObjectClass)
C0348013 (UMLS 2011AA ObjectClass)
CL158230 (NCI Metathesaurus Property)
CL.10
Code List
Outcome of VTE (Mark one with an X)
CL Item
Resolved (Resolved)
C49498 (NCI Thesaurus)
C1709863 (UMLS 2011AA)
CL Item
Not Resolved (Not resolved)
CL Item
Resulted In Death (Resulted in death)
Item
Did the patient experience an infusion reaction to cetuximab during the reporting period? (refer to CTCAE v. 3 Cytokine release syndrome/acute infusion reaction)
text
C1723 (NCI Thesaurus ObjectClass)
C0879636 (UMLS 2011AA ObjectClass)
CL049508 (NCI Metathesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.11
Code List
Did the patient experience an infusion reaction to cetuximab during the reporting period? (refer to CTCAE v. 3 Cytokine release syndrome/acute infusion reaction)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Patient Did Not Receive Cetuximab (Patient did not receive cetuximab)
CetuximabInfusionReactionReportingPeriodSpecify
Item
Yes, specify grade (Report even on C-1399 Adverse Event Form.)
text
C1723 (NCI Thesaurus ObjectClass)
C0879636 (UMLS 2011AA ObjectClass)
CL049508 (NCI Metathesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Were steroids given pre-infusion (including as an antiemetic?)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15388 (NCI Thesaurus ObjectClass)
C0574032 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C15370 (NCI Thesaurus ObjectClass)
C0149783 (UMLS 2011AA ObjectClass)
CL.12
Code List
Were steroids given pre-infusion (including as an antiemetic?)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Was blood drawn for infusion reaction biomarkers?
text
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus ObjectClass)
C16342 (NCI Thesaurus Property)
C0005516 (UMLS 2011AA Property)
CL049508 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.13
Code List
Was blood drawn for infusion reaction biomarkers?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Treatment (Mark one with an X)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C1723 (NCI Thesaurus ObjectClass)
C0879636 (UMLS 2011AA ObjectClass)
C0087111 (NCI Metathesaurus Property)
CL049508 (NCI Metathesaurus ObjectClass)
CL.14
Code List
Treatment (Mark one with an X)
CL Item
Outpatient Management Only (Outpatient management only)
CL Item
Emergency Room (Emergency room)
CL Item
Hospitalization (Hospitalization)
Item
Outcome (Mark one with an X)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C1723 (NCI Thesaurus ObjectClass)
C0879636 (UMLS 2011AA ObjectClass)
CL049508 (NCI Metathesaurus ObjectClass)
CL158230 (NCI Metathesaurus Property)
CL.15
Code List
Outcome (Mark one with an X)
CL Item
Resolved (Resolved)
C49498 (NCI Thesaurus)
C1709863 (UMLS 2011AA)
CL Item
Not Resolved (Not resolved)
CL Item
Resulted In Death (Resulted in death)
Item
Was the patient retreated with cetuximab after the reaction?
text
C1723 (NCI Thesaurus ObjectClass)
C0879636 (UMLS 2011AA ObjectClass)
C0087111 (NCI Metathesaurus ObjectClass)
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
CL049508 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.16
Code List
Was the patient retreated with cetuximab after the reaction?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
If Yes, did the patient experience an acute infusion reaction upon retreatment?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C14140 (NCI Thesaurus ObjectClass)
C0205178 (UMLS 2011AA ObjectClass)
CL049508 (NCI Metathesaurus ObjectClass)
C0376495 (NCI Metathesaurus Property)
CL.17
Code List
If Yes, did the patient experience an acute infusion reaction upon retreatment?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
ResponsiblePersonName
Item
Completed by
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
FormCompleteDate
Item
Date form completed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
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