North Central Cancer Treatment Group Notification Form NCT00377156

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

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.

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)
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)
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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