ID

10706

Descrição

CALGB: 80405 SUPPLEMENTAL ADVERSE EVENT FORM NCT00265850 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

Palavras-chave

Versões (3)
  1. 27/08/2012 27/08/2012 -
  2. 08/01/2015 08/01/2015 - Martin Dugas
  3. 08/06/2015 08/06/2015 -
Transferido a

8 de junho de 2015

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy
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CALGB: 80405 SUPPLEMENTAL ADVERSE EVENT FORM NCT00265850

Inglês

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 Formulários  
Header
Descrição

Header

CALGB Form
Descrição

Form ID CALGB

Tipo de dados

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
Descrição

Protocol ID CALGB

Tipo de dados

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
Descrição

Trial subject ID CALGB

Tipo de dados

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
Descrição

Reporting Period Start Date

Tipo de dados

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
Descrição

Reporting Period End Date

Tipo de dados

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2361259
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25651
Are data amended
Descrição

Data amended

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Patient demographics
Descrição

Patient demographics

Patient Initials
Descrição

Patient Initials

Tipo de dados

text

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

Patient Hospital No

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C0421459
NCI Thesaurus Property
C16960
NCI Thesaurus Property-2
C25364
NCI Thesaurus ObjectClass
C16696
Institution/Affiliate
Descrição

Institution Name

Tipo de dados

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
Descrição

Participating Group

Tipo de dados

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.
Descrição

Study Number Participating Group

Tipo de dados

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
Descrição

Trial subject ID Participating Group

Tipo de dados

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
Assessment of medication
Descrição

Assessment of medication

Cycle number
Descrição

Cycle Number

Tipo de dados

integer

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2045829
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
Medications received during this reporting period (Mark one with an X)
Descrição

ReceivedMedicationReportingPeriodType

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ObjectClass-2
C25639
UMLS 2011AA ObjectClass-2
C1514756
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25651
UMLS 2011AA Property-2
C0700287
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NSAID, specify
Descrição

NonsteroidalAntiinflammatoryDrugMedicationReportingPeriodSpecify

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ObjectClass-2
C257
UMLS 2011AA ObjectClass-2
C0003211
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25651
UMLS 2011AA Property-2
C0700287
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Anti-platelet, specify
Descrição

AntiplateletMedicationReportingPeriodSpecify

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ObjectClass-2
C1327
UMLS 2011AA ObjectClass-2
C0085826
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25651
UMLS 2011AA Property-2
C0700287
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Statin, specify
Descrição

LipidLoweringMedicationReportingPeriodSpecify

Tipo de dados

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-2
C25651
UMLS 2011AA Property-2
C0700287
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
BP or cardiac medication, specify
Descrição

CardiacMedicationReportingPeriodSpecify

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C13306
UMLS 2011AA ObjectClass
C1522601
NCI Thesaurus ObjectClass-2
C459
UMLS 2011AA ObjectClass-2
C0013227
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25651
UMLS 2011AA Property-2
C0700287
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Anticoagulant, specify
Descrição

AnticoagulantMedicationReportingPeriodSpecify

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ObjectClass-2
C263
UMLS 2011AA ObjectClass-2
C0003280
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25651
UMLS 2011AA Property-2
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)
Descrição

ArterialThrombosisReportingPeriodType

Tipo de dados

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-2
C25651
UMLS 2011AA Property-2
C0700287
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Other arterial event, specify
Descrição

ArterialThrombosisReportingPeriodSpecify

Tipo de dados

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-2
C25651
UMLS 2011AA Property-2
C0700287
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Treatment for ATE (Mark one with an X)
Descrição

ArterialThrombosisTherapyType

Tipo de dados

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)
Descrição

ArterialThrombosisOutcomeType

Tipo de dados

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)
Descrição

VenousThrombosisReportingPeriodType

Tipo de dados

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-2
C25291
UMLS 2011AA ObjectClass-2
C0348013
NCI Thesaurus Property-2
C25651
UMLS 2011AA Property-2
C0700287
Other venous thrombotic event, specify
Descrição

VenousThrombosisReportingPeriodSpecify

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C26891
UMLS 2011AA ObjectClass
C0040053
NCI Thesaurus ObjectClass-2
C25291
UMLS 2011AA ObjectClass-2
C0348013
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25651
UMLS 2011AA Property-2
C0700287
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Was the patient receiving anticoagulants prior to the VTEt?
Descrição

VenousThrombosisPriorAnticoagulantInd-2

Tipo de dados

boolean

Alias
NCI Thesaurus ObjectClass
C26891
UMLS 2011AA ObjectClass
C0040053
NCI Thesaurus ObjectClass-2
C25291
UMLS 2011AA ObjectClass-2
C0348013
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C263
UMLS 2011AA Property-2
C0003280
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Yes, specify
Descrição

VenousThrombosisPriorAnticoagulantSpecify

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C26891
UMLS 2011AA ObjectClass
C0040053
NCI Thesaurus ObjectClass-2
C25291
UMLS 2011AA ObjectClass-2
C0348013
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C263
UMLS 2011AA Property-2
C0003280
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Were anticoagulants used to treate the VTE?
Descrição

VenousThrombosisAnticoagulantTreatmentInd-2

Tipo de dados

boolean

Alias
NCI Thesaurus ObjectClass
C26891
UMLS 2011AA ObjectClass
C0040053
NCI Thesaurus ObjectClass-2
C25291
UMLS 2011AA ObjectClass-2
C0348013
NCI Thesaurus Property
C15368
NCI Thesaurus Property-2
C263
UMLS 2011AA Property
C0003280
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Yes, specify
Descrição

VenousThrombosisAnticoagulantTreatmentSpecify

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C26891
UMLS 2011AA ObjectClass
C0040053
NCI Thesaurus ObjectClass-2
C25291
UMLS 2011AA ObjectClass-2
C0348013
NCI Thesaurus Property
C15368
NCI Thesaurus Property-2
C263
UMLS 2011AA Property
C0003280
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Treatment for VTE (Mark one with an X)
Descrição

VenousThrombosisTreatmentType

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C26891
UMLS 2011AA ObjectClass
C0040053
NCI Thesaurus ObjectClass-2
C25291
UMLS 2011AA ObjectClass-2
C0348013
NCI Metathesaurus Property
C0087111
Outcome of VTE (Mark one with an X)
Descrição

VenousThrombosisOutcomeType

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C26891
UMLS 2011AA ObjectClass
C0040053
NCI Thesaurus ObjectClass-2
C25291
UMLS 2011AA ObjectClass-2
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)
Descrição

CetuximabInfusionReactionReportingPeriodIndicator

Tipo de dados

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-2
C25651
UMLS 2011AA Property-2
C0700287
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Yes, specify grade (Report even on C-1399 Adverse Event Form.)
Descrição

CetuximabInfusionReactionReportingPeriodSpecify

Tipo de dados

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-2
C25651
UMLS 2011AA Property-2
C0700287
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Were steroids given pre-infusion (including as an antiemetic?)
Descrição

InfusionSteroidTherapyAdministeredInd-2

Tipo de dados

boolean

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-2
C15370
UMLS 2011AA ObjectClass-2
C0149783
Was blood drawn for infusion reaction biomarkers?
Descrição

CollectedBloodInfusionReactionBiomarkerInd-2

Tipo de dados

boolean

Alias
NCI Thesaurus ObjectClass
C12434
UMLS 2011AA ObjectClass
C0229664
NCI Thesaurus ObjectClass-2
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)
Descrição

CetuximabInfusionReactionTreatmentType

Tipo de dados

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)
Descrição

CetuximabInfusionReactionOutcomeType

Tipo de dados

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?
Descrição

CetuximabTreatmentPostInfusionReactionInd-2

Tipo de dados

boolean

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?
Descrição

AcuteInfusionReactionRetreatmentInd-2

Tipo de dados

boolean

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
Descrição

Person Completing Form

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date form completed
Descrição

Date Form Completed

Tipo de dados

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
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 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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
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
date
C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (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)
Item Group
Patient demographics
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Patient Hospital No
Item
Patient Hospital No
text
C25337 (NCI Thesaurus ValueDomain)
C0421459 (UMLS CUI-1)
C16960 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
C16696 (NCI Thesaurus ObjectClass)
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)
Item Group
Assessment of medication
Cycle Number
Item
Cycle number
integer
C25337 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus 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-2)
C1514756 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property-2)
C0700287 (UMLS 2011AA Property-2)
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-2)
C0003211 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property-2)
C0700287 (UMLS 2011AA Property-2)
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-2)
C0085826 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property-2)
C0700287 (UMLS 2011AA Property-2)
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-2)
C0700287 (UMLS 2011AA Property-2)
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-2)
C0013227 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property-2)
C0700287 (UMLS 2011AA Property-2)
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-2)
C0003280 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property-2)
C0700287 (UMLS 2011AA Property-2)
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-2)
C0700287 (UMLS 2011AA Property-2)
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-2)
C0700287 (UMLS 2011AA Property-2)
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-2)
C0348013 (UMLS 2011AA ObjectClass-2)
C25651 (NCI Thesaurus Property-2)
C0700287 (UMLS 2011AA Property-2)
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-2)
C0348013 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property-2)
C0700287 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
VenousThrombosisPriorAnticoagulantInd-2
Item
Was the patient receiving anticoagulants prior to the VTEt?
boolean
C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C25291 (NCI Thesaurus ObjectClass-2)
C0348013 (UMLS 2011AA ObjectClass-2)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C263 (NCI Thesaurus Property-2)
C0003280 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
VenousThrombosisPriorAnticoagulantSpecify
Item
Yes, specify
text
C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C25291 (NCI Thesaurus ObjectClass-2)
C0348013 (UMLS 2011AA ObjectClass-2)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C263 (NCI Thesaurus Property-2)
C0003280 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
VenousThrombosisAnticoagulantTreatmentInd-2
Item
Were anticoagulants used to treate the VTE?
boolean
C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C25291 (NCI Thesaurus ObjectClass-2)
C0348013 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus Property)
C263 (NCI Thesaurus Property-2)
C0003280 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
VenousThrombosisAnticoagulantTreatmentSpecify
Item
Yes, specify
text
C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C25291 (NCI Thesaurus ObjectClass-2)
C0348013 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus Property)
C263 (NCI Thesaurus Property-2)
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-2)
C0348013 (UMLS 2011AA ObjectClass-2)
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-2)
C0348013 (UMLS 2011AA ObjectClass-2)
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-2)
C0700287 (UMLS 2011AA Property-2)
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-2)
C0700287 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
InfusionSteroidTherapyAdministeredInd-2
Item
Were steroids given pre-infusion (including as an antiemetic?)
boolean
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-2)
C0149783 (UMLS 2011AA ObjectClass-2)
CollectedBloodInfusionReactionBiomarkerInd-2
Item
Was blood drawn for infusion reaction biomarkers?
boolean
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)
C16342 (NCI Thesaurus Property)
C0005516 (UMLS 2011AA Property)
CL049508 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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)
CetuximabTreatmentPostInfusionReactionInd-2
Item
Was the patient retreated with cetuximab after the reaction?
boolean
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)
AcuteInfusionReactionRetreatmentInd-2
Item
If Yes, did the patient experience an acute infusion reaction upon retreatment?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C14140 (NCI Thesaurus ObjectClass)
C0205178 (UMLS 2011AA ObjectClass)
CL049508 (NCI Metathesaurus ObjectClass)
C0376495 (NCI Metathesaurus Property)
Person Completing Form
Item
Completed by
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
Date form completed
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
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