ID

10800

Descripción

North Central Cancer Treatment Group N0577 Notification Form NCT00887146 Radiation Therapy or Radiation Therapy and Temozolomide or Temozolomide Alone in Treating Patients With Newly Diagnosed Anaplastic Glioma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4C07CD25-652F-2417-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4C07CD25-652F-2417-E044-0003BA3F9857

Palabras clave

Versiones (3)
  1. 26/8/12 26/8/12 -
  2. 8/1/15 8/1/15 - Martin Dugas
  3. 8/6/15 8/6/15 -
Subido en

8 de junio de 2015

DOI

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Licencia

Creative Commons BY-NC 3.0 Legacy
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North Central Cancer Treatment Group N0577 Notification Form NCT00887146

Inglés

Grade 4 or 5 Non-AER Reportable Events/Hospitalization NCCTG Members Only

1 formularios  
  1. StudyEvent: North Central Cancer Treatment Group N0577 Notification Form
    1. Grade 4 or 5 Non-AER Reportable Events/Hospitalization NCCTG Members Only
Header
Descripción

Header

Protocol Number
Descripción

Protocol ID NCCTG

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1518419
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25581
Patient ID
Descripción

PatientNorthCentralCancerTreatmentGroupIdentifierNumber

Tipo de datos

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-2
C25581
UMLS 2011AA Property-2
C1518419
Patient Initials (L F M)
Descripción

Patient Initials

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Institution Number
Descripción

Institution Number

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
UMLS CUI-2
C0805701
NCI Thesaurus Property
C25364
Institution
Descripción

Institution Name

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Patient status assessment
Descripción

Patient status assessment

Date membership CRA aware of event(s) (mm/dd/yyyy)
Descripción

ClinicalResearchAssociateAssessmentDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C25465
UMLS 2011AA ObjectClass
C1516627
Name of person completing form
Descripción

Person Completing Form

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Phone
Descripción

Person Completing Form Phone

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25190
UMLS CUI-2
C1515258
NCI Thesaurus ObjectClass-2
C25657
NCI Thesaurus Property
C25395
Current Cycle Number
Descripción

Cycle Number Chemotherapeutics

Tipo de datos

integer

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2045829
NCI Thesaurus Property
C25471
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25379
Assigned Treatment Arm
Descripción

Protocol Treatment Arm

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C42651
UMLS CUI-1
C1522541
NCI Thesaurus Property
C32141
NCI Thesaurus Property-2
C25426
NCI Thesaurus ValueDomain
C25704
Event => Grade 4 (check one)
Descripción

AdverseEventLife-ThreateningDisablingDeathGradeInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C48275
UMLS 2011AA Property
C1705232
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property-2
C41337
UMLS 2011AA Property-2
C1517874
NCI Thesaurus Property-3
C48309
UMLS 2011AA Property-3
C0441800
Date of First Occurrence of Adverse Event (mm/dd/yyyy)
Descripción

AdverseEventFirstOccurrenceDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C25275
UMLS 2011AA Property-2
C2745955
CTC Adverse Event Term (only one event per line)
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
CTC Adverse Event Grade
Descripción

CommonToxicityCriteriaAdverseEventGrade

Tipo de datos

float

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
In your opinion, is this related to the study medication
Descripción

HospitalizationAdverseEventClinicalStudyAgentAttributionInd-3

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass-2
C25179
UMLS 2011AA ObjectClass-2
C0019993
NCI Thesaurus Property
C1708
UMLS 2011AA Property
C0450442
NCI Thesaurus Property-2
C15206
UMLS 2011AA Property-2
C0008972
NCI Thesaurus Property-3
C25358
UMLS 2011AA Property-3
C0596130
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Hospitalization (check one)
Descripción

AdverseEventRequiredHospitalizationInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25652
UMLS 2011AA Property
C1514873
NCI Thesaurus Property-2
C25179
UMLS 2011AA Property-2
C0019993
Hospital Admission Date (mm/dd/yyyy)
Descripción

HospitalAdmissionDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16696
UMLS 2011AA ObjectClass
C0019994
NCI Thesaurus Property
C25385
UMLS 2011AA Property
C0809949
Reason for Hospitalization (s)
Descripción

PatientHospitalizationReason

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25179
UMLS 2011AA Property
C0019993
Adverse event, specify type and grade
Descripción

PatientHospitalizationAdverseEventReasonSpecify

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C25179
UMLS 2011AA ObjectClass-2
C0019993
NCI Thesaurus Property
C25638
UMLS 2011AA Property
C0392360
NCI Thesaurus Property-2
C41331
UMLS 2011AA Property-2
C0877248
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Prophylactic, specify
Descripción

PatientHospitalizationPreventiveReasonSpecify

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C25179
UMLS 2011AA ObjectClass-2
C0019993
NCI Thesaurus Property
C25638
UMLS 2011AA Property
C0392360
NCI Thesaurus Property-2
C28005
UMLS 2011AA Property-2
C1456501
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Other reason, specify
Descripción

PatientHospitalizationOtherReasonSpecify

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C25179
UMLS 2011AA ObjectClass-2
C0019993
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C25638
UMLS 2011AA Property-2
C0392360
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
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Similar models

Grade 4 or 5 Non-AER Reportable Events/Hospitalization NCCTG Members Only

1 formularios
  1. StudyEvent: North Central Cancer Treatment Group N0577 Notification Form
    1. Grade 4 or 5 Non-AER Reportable Events/Hospitalization NCCTG Members Only
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Header
Protocol ID NCCTG
Item
Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1518419 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25581 (NCI Thesaurus Property-2)
PatientNorthCentralCancerTreatmentGroupIdentifierNumber
Item
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)
C25581 (NCI Thesaurus Property-2)
C1518419 (UMLS 2011AA Property-2)
Patient Initials
Item
Patient Initials (L F M)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Institution Number
Item
Institution Number
text
C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
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)
Item Group
Patient status assessment
ClinicalResearchAssociateAssessmentDate
Item
Date membership CRA aware of event(s) (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25465 (NCI Thesaurus ObjectClass)
C1516627 (UMLS 2011AA ObjectClass)
Person Completing Form
Item
Name of person completing form
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Person Completing Form Phone
Item
Phone
text
C25337 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C1515258 (UMLS CUI-2)
C25657 (NCI Thesaurus ObjectClass-2)
C25395 (NCI Thesaurus Property)
Cycle Number Chemotherapeutics
Item
Current Cycle Number
integer
C25337 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25471 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property-2)
Protocol Treatment Arm
Item
Assigned Treatment Arm
text
C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass-2)
C1522541 (UMLS CUI-1)
C32141 (NCI Thesaurus Property)
C25426 (NCI Thesaurus Property-2)
C25704 (NCI Thesaurus ValueDomain)
AdverseEventLife-ThreateningDisablingDeathGradeInd-2
Item
Event => Grade 4 (check one)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C48275 (NCI Thesaurus Property)
C1705232 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C41337 (NCI Thesaurus Property-2)
C1517874 (UMLS 2011AA Property-2)
C48309 (NCI Thesaurus Property-3)
C0441800 (UMLS 2011AA Property-3)
AdverseEventFirstOccurrenceDate
Item
Date of First Occurrence of Adverse Event (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
CommonToxicityCriteriaAdverseEventTermType
Item
CTC Adverse Event Term (only one event per line)
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)
CommonToxicityCriteriaAdverseEventGrade
Item
CTC Adverse Event Grade
float
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item
In your opinion, is this related to the study medication
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25179 (NCI Thesaurus ObjectClass-2)
C0019993 (UMLS 2011AA ObjectClass-2)
C1708 (NCI Thesaurus Property)
C0450442 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property-2)
C0008972 (UMLS 2011AA Property-2)
C25358 (NCI Thesaurus Property-3)
C0596130 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.3
Code List
In your opinion, is this related to the study medication
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
AdverseEventRequiredHospitalizationInd-2
Item
Hospitalization (check one)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25652 (NCI Thesaurus Property)
C1514873 (UMLS 2011AA Property)
C25179 (NCI Thesaurus Property-2)
C0019993 (UMLS 2011AA Property-2)
HospitalAdmissionDate
Item
Hospital Admission Date (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16696 (NCI Thesaurus ObjectClass)
C0019994 (UMLS 2011AA ObjectClass)
C25385 (NCI Thesaurus Property)
C0809949 (UMLS 2011AA Property)
Item
Reason for Hospitalization (s)
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25179 (NCI Thesaurus Property)
C0019993 (UMLS 2011AA Property)
CL.5
Code List
Reason for Hospitalization (s)
CL Item
Adverse Event (adverse event)
C41331 (NCI Thesaurus)
C0877248 (UMLS 2011AA)
CL Item
Prophylactic (Prophylactic)
CL Item
Other Reason (Other reason)
PatientHospitalizationAdverseEventReasonSpecify
Item
Adverse event, specify type and grade
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25179 (NCI Thesaurus ObjectClass-2)
C0019993 (UMLS 2011AA ObjectClass-2)
C25638 (NCI Thesaurus Property)
C0392360 (UMLS 2011AA Property)
C41331 (NCI Thesaurus Property-2)
C0877248 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
PatientHospitalizationPreventiveReasonSpecify
Item
Prophylactic, specify
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25179 (NCI Thesaurus ObjectClass-2)
C0019993 (UMLS 2011AA ObjectClass-2)
C25638 (NCI Thesaurus Property)
C0392360 (UMLS 2011AA Property)
C28005 (NCI Thesaurus Property-2)
C1456501 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
PatientHospitalizationOtherReasonSpecify
Item
Other reason, specify
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25179 (NCI Thesaurus ObjectClass-2)
C0019993 (UMLS 2011AA ObjectClass-2)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25638 (NCI Thesaurus Property-2)
C0392360 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
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