ID

1836

Descripción

RTOG-0421 AE: Adverse Event Evaluation Form Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=EB6FBB34-B48C-4885-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=EB6FBB34-B48C-4885-E034-0003BA3F9857

Palabras clave

Versiones (4)
  1. 19/9/12 19/9/12 -
  2. 9/1/15 9/1/15 - Martin Dugas
  3. 9/1/15 9/1/15 - Martin Dugas
  4. 8/7/15 8/7/15 -
Subido en

19 de septiembre de 2012

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0 Legacy
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Head and Neck Cancer NCT00113399 Toxicity - RTOG-0421 AE: Adverse Event Evaluation Form - 2299378v3.0

Inglés

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

1 formularios  
Unnamed Module 1
Descripción

Unnamed Module 1

RTOG Study
Descripción

ProtocolRTOGIdentifierNumber

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C19778
UMLS 2011AA Property
C1514695
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Case #
Descripción

RadiationTherapyOncologyGroupPatientCaseIdentifierNumber

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass
C19778
UMLS 2011AA ObjectClass
C1514695
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C49152
UMLS 2011AA Property
C1706256
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
Institution
Descripción

InstitutionName

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus ValueDomain
C21541
UMLS 2011AA ValueDomain
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Institution No.
Descripción

InstitutionIdentifierNumber

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Participant's Initials
Descripción

PatientInitialsName

Tipo de datos

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
Participant's I.D. No.
Descripción

PatientRadiationTherapyOncologyGroupIdentifierNumber

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C19778
UMLS 2011AA Property
C1514695
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
AMENDED DATA
Descripción

DataAmendedInd-3

Tipo de datos

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
Report All Continuing Or New Adverse Events
Descripción

Report All Continuing Or New Adverse Events

Date of assessment
Descripción

AssessmentPerformedDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
Due date of corresponding form
Descripción

AssociatedFormSubmissionDate

Tipo de datos

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
C25281
UMLS 2011AA ObjectClass
C0332281
Type of corresponding form (INSTRUCTIONS: the CTC AE Version 3.0 is used to score all adverse events)
Descripción

AssociatedFormSubmissionType

Tipo de datos

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
C25281
UMLS 2011AA ObjectClass
C0332281
MedDRA CODE ADVERSE EVENT BASED ON CTCAE TERM
Descripción

MedDRACode

Tipo de datos

double

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

CommonToxicityCriteriaAdverseEventTermType

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
CTCAE GRADE
Descripción

CommonToxicityCriteriaAdverseEventGrade

Tipo de datos

double

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
CTCAE BEGIN DATE
Descripción

CTCAdverseEventReportBeginDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
CTCAE ATTRIBUTION CODE (Attribution to Protocol Treatment See protocol sections 6 & 7 for definition of "protocol treatment")
Descripción

CTCAdverseEventAttributionScale

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
Serious Adverse Event Report Submitted
Descripción

SeriousAdverseEventReportInd-3

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus ObjectClass
C54035
UMLS 2011AA ObjectClass
C0205404
Other CTCAE Term
Descripción

CTCAdverseEventTermSpecify

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
AE Description
Descripción

Grade3AdverseEventDescriptionText

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Person completing form
Descripción

ResponsiblePersonName

Tipo de datos

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
Form completion date
Descripción

FormCompletionDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
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Similar models

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

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Unnamed Module 1
ProtocolRTOGIdentifierNumber
Item
RTOG Study
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C19778 (NCI Thesaurus Property)
C1514695 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
RadiationTherapyOncologyGroupPatientCaseIdentifierNumber
Item
Case #
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19778 (NCI Thesaurus ObjectClass)
C1514695 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C49152 (NCI Thesaurus Property)
C1706256 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
InstitutionName
Item
Institution
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
InstitutionIdentifierNumber
Item
Institution No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientInitialsName
Item
Participant's 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)
PatientRadiationTherapyOncologyGroupIdentifierNumber
Item
Participant's I.D. No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19778 (NCI Thesaurus Property)
C1514695 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Item
AMENDED DATA
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
AMENDED DATA
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Report All Continuing Or New Adverse Events
AssessmentPerformedDate
Item
Date of assessment
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA 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)
C0332281 (UMLS 2011AA ObjectClass)
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)
C0332281 (UMLS 2011AA ObjectClass)
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
double
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)
CommonToxicityCriteriaAdverseEventTermType
Item
CTCAE TERM
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
Item
CTCAE GRADE
double
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.3
Code List
CTCAE GRADE
CL Item
Death Related To Adverse Event (5)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)
CL Item
Mild Adverse Event (1)
C41338 (NCI Thesaurus)
C1513302 (UMLS 2011AA)
CL Item
Moderate Adverse Event (2)
C41339 (NCI Thesaurus)
C1513374 (UMLS 2011AA)
CL Item
Life-threatening Or Disabling Adverse Event (4)
CL Item
Severe Adverse Event (3)
C41340 (NCI Thesaurus)
C1519275 (UMLS 2011AA)
CTCAdverseEventReportBeginDate
Item
CTCAE BEGIN DATE
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
Item
CTCAE ATTRIBUTION CODE (Attribution to Protocol Treatment See protocol sections 6 & 7 for definition of "protocol treatment")
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
CL.4
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)
C1512699 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C54035 (NCI Thesaurus ObjectClass)
C0205404 (UMLS 2011AA ObjectClass)
CL.5
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)
CTCAdverseEventTermSpecify
Item
Other CTCAE Term
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
Grade3AdverseEventDescriptionText
Item
AE Description
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
ResponsiblePersonName
Item
Person completing form
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)
FormCompletionDate
Item
Form completion date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
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