ID

11260

Description

North Central Cancer Treatment Group Notification Form NCT00377156 Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=10DC830B-A4D7-3095-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=10DC830B-A4D7-3095-E044-0003BA3F9857

Keywords

Versions (4)
  1. 8/26/12 8/26/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 6/27/15 6/27/15 -
Uploaded on

June 27, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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North Central Cancer Treatment Group Notification Form NCT00377156

English

Use this form to report all known information on non-AER reportable grade 4 or 5 adverse events or any hospitalization during active treatment. If AER has been submitted for this event do not submit this form.

1 forms  
Header
Description

Header

NCCTG Protocol Number
Description

Protocol ID NCCTG

Data type

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
NCCTG Patient ID
Description

PatientNorthCentralCancerTreatmentGroupIdentifierNumber

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

Patient Initials

Data type

text

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

Institution Number

Data type

text

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

Institution Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Notification Form
Description

Notification Form

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

ClinicalResearchAssociateAssessmentDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C25465
UMLS 2011AA ObjectClass
C1516627
Person Completing Form (Submitting)
Description

Person Completing Form

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Phone (#)
Description

Person Completing Form Phone

Data type

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
Cycle Number
Description

Cycle Number

Data type

integer

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2045829
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
Event => Grade 4
Description

AdverseEventLife-ThreateningDisablingDeathGradeInd-2

Data type

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
Assigned Treatment Arm
Description

Protocol Treatment Arm

Data type

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
Date of First Occurrence of Adverse Event
Description

AdverseEventFirstOccurrenceDate

Data type

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
Common Toxicity Criteria Adverse Event Term Type
Description

CTC Adverse Event Term

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C45559
CTC AE Grade
Description

CTC Adverse Event Grade

Data type

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS CUI-1
C2985911
NCI Thesaurus ValueDomain
C18000
NCI Thesaurus Property
C25365
CTC AE Attribution Code
Description

CTC Adverse Event Attribution Category

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1706735
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
Hospitalization
Description

AdverseEventRequiredHospitalizationInd-2

Data type

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)
Description

HospitalAdmissionDate

Data type

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)
Description

PatientHospitalizationReason

Data type

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
Description

PatientHospitalizationAdverseEventReasonSpecify

Data type

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
Description

PatientHospitalizationPreventiveReasonSpecify

Data type

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, specify
Description

PatientHospitalizationOtherReasonSpecify

Data type

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

Use this form to report all known information on non-AER reportable grade 4 or 5 adverse events or any hospitalization during active treatment. If AER has been submitted for this event do not submit this form.

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Protocol ID NCCTG
Item
NCCTG 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
NCCTG 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
Notification Form
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
Person Completing Form (Submitting)
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
Item
Cycle Number
integer
C25337 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
AdverseEventLife-ThreateningDisablingDeathGradeInd-2
Item
Event => Grade 4
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)
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)
AdverseEventFirstOccurrenceDate
Item
Date of First Occurrence of Adverse Event
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)
CTC Adverse Event Term
Item
Common Toxicity Criteria Adverse Event Term Type
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
CTC AE Grade
float
C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
Item
CTC AE Attribution Code
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
CL.3
Code List
CTC AE Attribution Code
CL Item
Definite (Definite)
CL209464 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
AdverseEventRequiredHospitalizationInd-2
Item
Hospitalization
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
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Prophylactic (Prophylactic)
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, 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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