ID

11589

Descrição

NCT00113386 RTOG-0412 AE: Adverse Event Evaluation Form Cisplatin and Docetaxel With or Without Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Newly Diagnosed Stage III Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=E488DFC2-2D0B-654D-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=E488DFC2-2D0B-654D-E034-0003BA3F9857

Palavras-chave

Versões (5)
  1. 19/09/2012 19/09/2012 -
  2. 09/01/2015 09/01/2015 - Martin Dugas
  3. 09/01/2015 09/01/2015 - Martin Dugas
  4. 09/01/2015 09/01/2015 - Martin Dugas
  5. 08/07/2015 08/07/2015 -
Transferido a

8 de julho de 2015

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy
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NCT00113386 RTOG-0412 AE: Adverse Event Evaluation Form

Inglês

Radiation Therapy Oncology Group Phase III Lung Pre-Op Chemotherapy vs. Pre-Op Concurrent Chemoradiation for NSCLC

1 Formulários  
RTOG clinical trial administrative data
Descrição

RTOG clinical trial administrative data

RTOG Study
Descrição

Protocol ID RTOG

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1514695
NCI Thesaurus Property
C19778
NCI Thesaurus Property-2
C25364
Case #
Descrição

Case#

Tipo de dados

text

Institution
Descrição

Institution Name

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Institution No.
Descrição

Institution Number

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
UMLS CUI-2
C0805701
NCI Thesaurus Property
C25364
Participant's 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
Participant's I.D. No.
Descrição

Patient Study ID

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25462
NCI Thesaurus Property-2
C25364
AMENDED DATA
Descrição

Data amended

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Report All Continuing Or New Adverse Events
Descrição

Report All Continuing Or New Adverse Events

Date of assessment
Descrição

Assessment Date

Tipo de dados

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985720
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C38000
Due date of corresponding form
Descrição

AssociatedFormSubmissionDate

Tipo de dados

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C19464
UMLS 2011AA ObjectClass
C0376315
NCI Thesaurus Property
C25694
UMLS 2011AA Property
C1515022
NCI Thesaurus ObjectClass-2
C25281
UMLS 2011AA ObjectClass-2
C0332281
Type of corresponding form (INSTRUCTIONS: the CTC AE Version 3.0 is used to score all adverse events)
Descrição

AssociatedFormSubmissionType

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C19464
UMLS 2011AA ObjectClass
C0376315
NCI Thesaurus Property
C25694
UMLS 2011AA Property
C1515022
NCI Thesaurus ObjectClass-2
C25281
UMLS 2011AA ObjectClass-2
C0332281
MedDRA CODE ADVERSE EVENT BASED ON CTCAE TERM
Descrição

MedDRACode

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Metathesaurus ObjectClass
CL104089
CTCAE TERM
Descrição

CTC Adverse Event Term

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C45559
CTCAE GRADE
Descrição

CTC Adverse Event Grade

Tipo de dados

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS CUI-1
C2985911
NCI Thesaurus ValueDomain
C18000
NCI Thesaurus Property
C25365
CTCAE BEGIN DATE
Descrição

Adverse Event Start Date

Tipo de dados

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2697888
NCI Thesaurus Property
C25375
NCI Thesaurus ValueDomain-2
C25431
NCI Thesaurus ObjectClass
C49704
CTCAE ATTRIBUTION CODE (Attribution to Protocol Treatment See protocol sections 6 & 7 for definition of "protocol treatment")
Descrição

CTC Adverse Event Attribution Category

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1706735
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
Serious Adverse Event Report Submitted
Descrição

SAE report

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1519255
NCI Thesaurus ObjectClass
C41331
UMLS CUI-2
C0684224
NCI Thesaurus Property
C25375
NCI Thesaurus ObjectClass-2
C54035
IF UNRELATED TO PROTOCOL TREATMENTS SPECIFY CAUSE
Descrição

Non-ProtocolAdverseEventAssessmentSpecify

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass-2
C1518384
Comments
Descrição

Research Comments

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Laboratory Procedure Date
Descrição

Laboratory Procedure Date

Date (mm/dd Year)
Descrição

Laboratory Procedure Date

Tipo de dados

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0022885
NCI Thesaurus Property
C25214
UMLS CUI-2
C0011008
NCI Thesaurus Property-2
C38000
NCI Thesaurus ObjectClass
C25294
Treatment Week
Descrição

TreatmentReportingPeriodWeekNumber

Tipo de dados

float

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25651
UMLS 2011AA Property-2
C0700287
Blood
Descrição

Blood

Hgb (gms)
Descrição

Hemoglobin

Tipo de dados

float

Alias
NCI Thesaurus Property
C16676
UMLS CUI-1
C0019046
NCI Thesaurus Property-2
C20200
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
Hct (%)
Descrição

HematologyLabHematocritCount

Tipo de dados

float

Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
WBC (x1000)
Descrição

Leukocytes (WBC)

Tipo de dados

float

Unidades de medida
  • 1000/uL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0023508
NCI Thesaurus Property
C12529
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C38024
1000/uL
Platelets (x1000)
Descrição

Platelets

Tipo de dados

float

Unidades de medida
  • 1000/uL
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0005821
NCI Thesaurus Property-2
C12520
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
1000/uL
Neutrophils/gran (%)
Descrição

Neutrophil percentage

Tipo de dados

float

Unidades de medida
  • %
Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C1171400
NCI Thesaurus Property
C12533
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C25613
NCI Thesaurus ValueDomain-2
C25712
%
ANC
Descrição

Neutrophil count

Tipo de dados

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0200633
NCI Thesaurus Property
C12533
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C25304
NCI Thesaurus ValueDomain-2
C25712
Chemistries
Descrição

Chemistries

BUN
Descrição

Blood Urea Nitrogen

Tipo de dados

float

Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0005845
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property-2
C61019
NCI Thesaurus ValueDomain
C25712
Creatinine (mg%)
Descrição

RenalCreatinineLabSpecifiedValue

Tipo de dados

float

Unidades de medida
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25225
UMLS 2011AA ObjectClass
C0022646
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus Property-2
C25294
UMLS 2011AA Property-2
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mg/dL
Calc. Creatinine Clearance
Descrição

Creatinine Clearance

Tipo de dados

float

Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0373595
NCI Thesaurus Property-2
C25747
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
Bilirubin (total mg%)
Descrição

TotalBilirubinHepaticLabUnspecifiedValue

Tipo de dados

float

Alias
NCI Thesaurus ObjectClass
C25304
UMLS 2011AA ObjectClass
C0439810
NCI Thesaurus ObjectClass-2
C305
UMLS 2011AA ObjectClass-2
C0005437
NCI Thesaurus Property
C13308
UMLS 2011AA Property
C0205054
NCI Thesaurus Property-2
C37984
UMLS 2011AA Property-2
C0022877
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
Alkaline Phosphatase
Descrição

HepaticAlkalinePhosphataseLabValue

Tipo de dados

float

Alias
NCI Thesaurus ObjectClass
C13308
UMLS 2011AA ObjectClass
C0205054
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property-2
C16276
UMLS 2011AA Property-2
C0002059
LDH
Descrição

LDH

Tipo de dados

float

Unidades de medida
  • U/L
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0202113
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus Property-2
C25184
U/L
SGOT
Descrição

HepaticSGOT(AST)LabUnspecifiedValue

Tipo de dados

float

Alias
NCI Thesaurus ObjectClass
C13308
UMLS 2011AA ObjectClass
C0205054
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property-2
C37984
UMLS 2011AA Property-2
C0022877
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
SGPT
Descrição

HepaticSGPT(ALT)LabUnspecifiedValue

Tipo de dados

float

Alias
NCI Thesaurus ObjectClass
C13308
UMLS 2011AA ObjectClass
C0205054
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus Property-2
C25293
UMLS 2011AA Property-2
C0376147
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
Uric Acid (mg%)
Descrição

LaboratoryProcedureUricAcidResultSpecifiedValue

Tipo de dados

float

Unidades de medida
  • mg/dL
Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property-2
C62652
UMLS 2011AA Property-2
C0041980
mg/dL
Albumin (gm%)
Descrição

Albumin

Tipo de dados

float

Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0201838
NCI Thesaurus Property-2
C214
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
Potassium (mg/L)
Descrição

LaboratoryProcedurePotassiumElectrolytesOutcomeSpecifiedValue

Tipo de dados

float

Unidades de medida
  • mmol/L
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C464
UMLS 2011AA Property-2
C0013832
NCI Thesaurus Property-3
C765
UMLS 2011AA Property-3
C0032821
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mmol/L
Calcium (mg/d)
Descrição

ElectrolytesCalciumLabSpecifiedValue

Tipo de dados

float

Unidades de medida
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C331
UMLS 2011AA Property
C0006675
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus Property-3
C464
UMLS 2011AA Property-3
C0013832
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mg/dL
Glucose
Descrição

LaboratoryProcedureGlucoseElectrolytesOutcomeUnspecifiedValue

Tipo de dados

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C2831
UMLS 2011AA Property-2
C0017725
NCI Thesaurus Property-3
C464
UMLS 2011AA Property-3
C0013832
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Sodium (meq/L)
Descrição

LaboratoryProcedureSodiumElectrolytesOutcomeSpecifiedValue

Tipo de dados

float

Unidades de medida
  • mmol/L
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C830
UMLS 2011AA Property-2
C0037473
NCI Thesaurus Property-3
C464
UMLS 2011AA Property-3
C0013832
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mmol/L
Total Protein
Descrição

TotalProtein

Tipo de dados

text

Other Studies
Descrição

Other Studies

Other
Descrição

LaboratoryProcedurePerformedSpecify

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Normal Range (Remarks use R1, R2, R3, etc.)
Descrição

InstitutionNormalLabValue

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C14165
UMLS 2011AA Property
C0205307
NCI Thesaurus Property-2
C37984
UMLS 2011AA Property-2
C0022877
NCI Thesaurus ValueDomain
C37984
UMLS 2011AA ValueDomain
C0022877
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
Name of person completing this form
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
Form completion date, original
Descrição

Form Completion Date

Tipo de dados

date

Alias
NCI Thesaurus ObjectClass
C19464
UMLS CUI-1
C1549507
NCI Thesaurus Property
C25250
NCI Thesaurus Property-2
C25604
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Comments
Descrição

Research Comments

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
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Similar models

Radiation Therapy Oncology Group Phase III Lung Pre-Op Chemotherapy vs. Pre-Op Concurrent Chemoradiation for NSCLC

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
RTOG clinical trial administrative data
Protocol ID RTOG
Item
RTOG Study
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1514695 (UMLS CUI-2)
C19778 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Case#
Item
Case #
text
Institution Name
Item
Institution
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Institution Number
Item
Institution No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
Patient Initials
Item
Participant's Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Patient Study ID
Item
Participant's I.D. No.
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Data amended
Item
AMENDED DATA
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Report All Continuing Or New Adverse Events
Assessment Date
Item
Date of assessment
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
AssociatedFormSubmissionDate
Item
Due date of corresponding form
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25694 (NCI Thesaurus Property)
C1515022 (UMLS 2011AA Property)
C25281 (NCI Thesaurus ObjectClass-2)
C0332281 (UMLS 2011AA ObjectClass-2)
Item
Type of corresponding form (INSTRUCTIONS: the CTC AE Version 3.0 is used to score all adverse events)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25694 (NCI Thesaurus Property)
C1515022 (UMLS 2011AA Property)
C25281 (NCI Thesaurus ObjectClass-2)
C0332281 (UMLS 2011AA ObjectClass-2)
CL.2
Code List
Type of corresponding form (INSTRUCTIONS: the CTC AE Version 3.0 is used to score all adverse events)
CL Item
Tf (TF)
CL Item
F1 (F1)
MedDRACode
Item
MedDRA CODE ADVERSE EVENT BASED ON CTCAE TERM
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)
CTC Adverse Event Term
Item
CTCAE TERM
text
C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)
CTC Adverse Event Grade
Item
CTCAE GRADE
float
C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
Adverse Event Start Date
Item
CTCAE BEGIN DATE
date
C25164 (NCI Thesaurus ValueDomain)
C2697888 (UMLS CUI-1)
C25375 (NCI Thesaurus Property)
C25431 (NCI Thesaurus ValueDomain-2)
C49704 (NCI Thesaurus ObjectClass)
Item
CTCAE ATTRIBUTION CODE (Attribution to Protocol Treatment See protocol sections 6 & 7 for definition of "protocol treatment")
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
CL.3
Code List
CTCAE ATTRIBUTION CODE (Attribution to Protocol Treatment See protocol sections 6 & 7 for definition of "protocol treatment")
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
Serious Adverse Event Report Submitted
text
C38148 (NCI Thesaurus ValueDomain)
C1519255 (UMLS CUI-1)
C41331 (NCI Thesaurus ObjectClass)
C0684224 (UMLS CUI-2)
C25375 (NCI Thesaurus Property)
C54035 (NCI Thesaurus ObjectClass-2)
CL.4
Code List
Serious Adverse Event Report Submitted
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Non-ProtocolAdverseEventAssessmentSpecify
Item
IF UNRELATED TO PROTOCOL TREATMENTS SPECIFY CAUSE
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass-2)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Item Group
Laboratory Procedure Date
Laboratory Procedure Date
Item
Date (mm/dd Year)
date
C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
TreatmentReportingPeriodWeekNumber
Item
Treatment Week
float
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
C0700287 (UMLS 2011AA Property-2)
Item Group
Blood
Hemoglobin
Item
Hgb (gms)
float
C16676 (NCI Thesaurus Property)
C0019046 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
HematologyLabHematocritCount
Item
Hct (%)
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Leukocytes (WBC)
Item
WBC (x1000)
float
C25294 (NCI Thesaurus ObjectClass)
C0023508 (UMLS CUI-1)
C12529 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
Platelets
Item
Platelets (x1000)
float
C20200 (NCI Thesaurus Property)
C0005821 (UMLS CUI-1)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Neutrophil percentage
Item
Neutrophils/gran (%)
float
C25294 (NCI Thesaurus ObjectClass)
C1171400 (UMLS CUI-1)
C12533 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25613 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Neutrophil count
Item
ANC
float
C25294 (NCI Thesaurus ObjectClass)
C0200633 (UMLS CUI-1)
C12533 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25304 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Item Group
Chemistries
Blood Urea Nitrogen
Item
BUN
float
C20200 (NCI Thesaurus Property)
C0005845 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C61019 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
RenalCreatinineLabSpecifiedValue
Item
Creatinine (mg%)
float
C25225 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Creatinine Clearance
Item
Calc. Creatinine Clearance
float
C20200 (NCI Thesaurus Property)
C0373595 (UMLS CUI-1)
C25747 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
TotalBilirubinHepaticLabUnspecifiedValue
Item
Bilirubin (total mg%)
float
C25304 (NCI Thesaurus ObjectClass)
C0439810 (UMLS 2011AA ObjectClass)
C305 (NCI Thesaurus ObjectClass-2)
C0005437 (UMLS 2011AA ObjectClass-2)
C13308 (NCI Thesaurus Property)
C0205054 (UMLS 2011AA Property)
C37984 (NCI Thesaurus Property-2)
C0022877 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
HepaticAlkalinePhosphataseLabValue
Item
Alkaline Phosphatase
float
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C16276 (NCI Thesaurus Property-2)
C0002059 (UMLS 2011AA Property-2)
LDH
Item
LDH
float
C20200 (NCI Thesaurus Property)
C0202113 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C25184 (NCI Thesaurus Property-2)
HepaticSGOT(AST)LabUnspecifiedValue
Item
SGOT
float
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C37984 (NCI Thesaurus Property-2)
C0022877 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
HepaticSGPT(ALT)LabUnspecifiedValue
Item
SGPT
float
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property-2)
C0376147 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureUricAcidResultSpecifiedValue
Item
Uric Acid (mg%)
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C62652 (NCI Thesaurus Property-2)
C0041980 (UMLS 2011AA Property-2)
Albumin
Item
Albumin (gm%)
float
C20200 (NCI Thesaurus Property)
C0201838 (UMLS CUI-1)
C214 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
LaboratoryProcedurePotassiumElectrolytesOutcomeSpecifiedValue
Item
Potassium (mg/L)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C464 (NCI Thesaurus Property-2)
C0013832 (UMLS 2011AA Property-2)
C765 (NCI Thesaurus Property-3)
C0032821 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
ElectrolytesCalciumLabSpecifiedValue
Item
Calcium (mg/d)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C331 (NCI Thesaurus Property)
C0006675 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C464 (NCI Thesaurus Property-3)
C0013832 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureGlucoseElectrolytesOutcomeUnspecifiedValue
Item
Glucose
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C2831 (NCI Thesaurus Property-2)
C0017725 (UMLS 2011AA Property-2)
C464 (NCI Thesaurus Property-3)
C0013832 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSodiumElectrolytesOutcomeSpecifiedValue
Item
Sodium (meq/L)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C830 (NCI Thesaurus Property-2)
C0037473 (UMLS 2011AA Property-2)
C464 (NCI Thesaurus Property-3)
C0013832 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
TotalProtein
Item
Total Protein
text
Item Group
Other Studies
LaboratoryProcedurePerformedSpecify
Item
Other
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
InstitutionNormalLabValue
Item
Normal Range (Remarks use R1, R2, R3, etc.)
text
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C14165 (NCI Thesaurus Property)
C0205307 (UMLS 2011AA Property)
C37984 (NCI Thesaurus Property-2)
C0022877 (UMLS 2011AA Property-2)
C37984 (NCI Thesaurus ValueDomain)
C0022877 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Person Completing Form
Item
Name of person completing this form
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Form Completion Date
Item
Form completion date, original
date
C19464 (NCI Thesaurus ObjectClass)
C1549507 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C25604 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
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