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  1. StudyEvent: Follow-Up Brain Tumor Evaluation Form
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Crf Header
Protocol ID Coordinating Group
Item
Coordinating Group Protocol No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1711341 (UMLS CUI-2)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Coordinating Group Code
Item
Coordinating Group Code
text
C25162 (NCI Thesaurus ValueDomain)
C1711341 (UMLS CUI-1)
C17005 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25462 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Protocol Title
Item
Protocol Title
text
C25191 (NCI Thesaurus ValueDomain)
C2986303 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C42774 (NCI Thesaurus Property)
Patient Study ID
Item
Patient Study ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Trial subject ID Participating Group
Item
Other Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
ParticipatingGroupIdentifierCode
Item
Participating Group Code
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C1257890 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Patient Name
Item
Patient Name (initials acceptable)
text
C25191 (NCI Thesaurus ValueDomain)
C1299487 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Item Group
Brain: Follow-up Form Administration
Reporting Period Start Date
Item
Reporting Period Start Date (MM DD YYYY)
date
C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C2361257 (UMLS CUI-1)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Reporting Period End Date
Item
Reporting Period End Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
Follow-Up Date
Item
Date of Last Clinical Assessment (MM DD YYYY)
date
C9305 (NCI Thesaurus ObjectClass)
C3694716 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C25365 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Brain: Baseline Status
Item
Was the patient NED at baseline?
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12439 (NCI Thesaurus ObjectClass-2)
C0006104 (UMLS 2011AA ObjectClass-2)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C40413 (NCI Thesaurus Property-2)
C1518340 (UMLS 2011AA Property-2)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.1
Code List
Was the patient NED at baseline?
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)
Item Group
Brain: Measurable Lesion(s) Follow-up Evaluation
Measurable Disease
Item
Is measurable disease present?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1513041 (UMLS CUI-1)
C25626 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C37894 (NCI Thesaurus ObjectClass-2)
LesionSiteNumber
Item
Lesion Number
float
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
Lesion Site, Primary
Item
Site of Lesion (New)
text
C13717 (NCI Thesaurus ValueDomain)
C0449695 (UMLS CUI-1)
C3824 (NCI Thesaurus ObjectClass)
C25341 (NCI Thesaurus Property)
LesionLongestDiameterMeasurement
Item
Longest Bidimensional Measurements of Lesions (cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25558 (NCI Thesaurus Property-2)
C1522425 (UMLS 2011AA Property-2)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
LesionLongestDimensionPerpendicularMeasurement
Item
Longest Bidimensional Measurements of Lesions (x cm)
float
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25558 (NCI Thesaurus Property-2)
C1522425 (UMLS 2011AA Property-2)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C54649 (NCI Thesaurus ValueDomain-2)
C1295725 (UMLS 2011AA ValueDomain-2)
Item
Method of Evaluation
text
C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
CL.12
Code List
Method of Evaluation
CL Item
Clinical Examination (pe) (Clinical examination)
CL Item
Ct Scan (CT Scan)
CL Item
Mri (MRI (NMR))
CL Item
Pet Scan (PET scan)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Evaluation method, specify
Item
Other Specify (If)
text
C25685 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C16847 (NCI Thesaurus Property)
LesionAssessmentDate
Item
Date of Evaluation (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain-2)
LongestLesionTransverseDiameterMeasurement
Item
Sum of Longest Transverse Diameters (of All Measureable Lesions)
float
C25558 (NCI Thesaurus ObjectClass)
C1522425 (UMLS 2011AA ObjectClass)
C3824 (NCI Thesaurus ObjectClass-2)
C0221198 (UMLS 2011AA ObjectClass-2)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C0205106 (NCI Metathesaurus Property)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
SumLesionDiameterProductMeasurement
Item
Sum of Products of Greatest Diameters (of All Measurable Lesions)
float
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25697 (NCI Thesaurus ObjectClass-2)
C1515051 (UMLS 2011AA ObjectClass-2)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C40352 (NCI Thesaurus ValueDomain-2)
C1704444 (UMLS 2011AA ValueDomain-2)
Item
Response Status at This Assessment, Imaging (mark one)
text
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C17059 (NCI Thesaurus ObjectClass)
C0034599 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.9
Code List
Response Status at This Assessment, Imaging (mark one)
CL Item
Complete Response (CR)
CL Item
Stable Disease (SD)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
CL Item
Regr (REGR)
CL Item
Progressive Disease (PD)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
CL Item
Insufficient Evaluation To Determine Response Status (Insufficient evaluation to determine response status)
Item
Response Status at This Assessment, Treating Physician (mark one)
text
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.10
Code List
Response Status at This Assessment, Treating Physician (mark one)
CL Item
Complete Response (CR)
CL Item
Stable Disease (SD)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
CL Item
Regr (REGR)
CL Item
Progressive Disease (PD)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
CL Item
Insufficient Evaluation To Determine Response Status (Insufficient evaluation to determine response status)
Item Group
Brain: Non-measureable/evaluable Lesion(s) Follow-up Evaluation
Non-Measurable Disease
Item
Is non-measurable disease present?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1334988 (UMLS CUI-1)
C25626 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C25589 (NCI Thesaurus ObjectClass-2)
LesionSiteNumber
Item
Lesion Number
float
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
Lesion Site, Primary
Item
Site of Lesion (New)
text
C13717 (NCI Thesaurus ValueDomain)
C0449695 (UMLS CUI-1)
C3824 (NCI Thesaurus ObjectClass)
C25341 (NCI Thesaurus Property)
Item
Method of Evaluation
text
C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
CL.12
Code List
Method of Evaluation
CL Item
Clinical Examination (pe) (Clinical examination)
CL Item
Ct Scan (CT Scan)
CL Item
Mri (MRI (NMR))
CL Item
Pet Scan (PET scan)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Evaluation method, specify
Item
Other Specify (If)
text
C25685 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C16847 (NCI Thesaurus Property)
Item
Follow-up Status of Lesion (s)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
CL.8
Code List
Follow-up Status of Lesion (s)
CL Item
Complete Response (CR)
CL Item
Regr (REGR)
CL Item
Stable Disease (SD)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
C18213 (NCI Thesaurus-3)
C0677946 (UMLS 2011AA-4)
CL Item
Progressive Disease (PD)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
C35571 (NCI Thesaurus-3)
C1335499 (UMLS 2011AA-4)
LesionAssessmentDate
Item
Date of Evaluation (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Response Status at This Assessment, Imaging (mark one)
text
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C17059 (NCI Thesaurus ObjectClass)
C0034599 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.9
Code List
Response Status at This Assessment, Imaging (mark one)
CL Item
Complete Response (CR)
CL Item
Stable Disease (SD)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
CL Item
Regr (REGR)
CL Item
Progressive Disease (PD)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
CL Item
Insufficient Evaluation To Determine Response Status (Insufficient evaluation to determine response status)
Item
Response Status at This Assessment, Treating Physician (mark one)
text
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.10
Code List
Response Status at This Assessment, Treating Physician (mark one)
CL Item
Complete Response (CR)
CL Item
Stable Disease (SD)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
CL Item
Regr (REGR)
CL Item
Progressive Disease (PD)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
CL Item
Insufficient Evaluation To Determine Response Status (Insufficient evaluation to determine response status)
Item Group
Brain: New Lesion(s) At Follow-up Evaluation
NewLesionAppearanceInd-2
Item
Was the appearance of any new lesions documented (since the baseline evaluation?)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25586 (NCI Thesaurus ObjectClass-2)
C0205314 (UMLS 2011AA ObjectClass-2)
C25377 (NCI Thesaurus Property)
C0700364 (UMLS 2011AA Property)
LesionSiteNumber
Item
Lesion Number
float
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
Lesion Site, Primary
Item
Site of Lesion (New)
text
C13717 (NCI Thesaurus ValueDomain)
C0449695 (UMLS CUI-1)
C3824 (NCI Thesaurus ObjectClass)
C25341 (NCI Thesaurus Property)
Item
Method of Evaluation
text
C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
CL.12
Code List
Method of Evaluation
CL Item
Clinical Examination (pe) (Clinical examination)
CL Item
Ct Scan (CT Scan)
CL Item
Mri (MRI (NMR))
CL Item
Pet Scan (PET scan)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Evaluation method, specify
Item
Other Specify (If)
text
C25685 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C16847 (NCI Thesaurus Property)
LesionAssessmentDate
Item
Date of Evaluation (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Brain: Evaluation Summary
Item
Neurologic Exam Score
text
C12439 (NCI Thesaurus ObjectClass)
C0006104 (UMLS 2011AA ObjectClass)
C25262 (NCI Thesaurus ObjectClass-2)
C0205494 (UMLS 2011AA ObjectClass-2)
C25305 (NCI Thesaurus Property)
C0582103 (UMLS 2011AA Property)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
CL.13
Code List
Neurologic Exam Score
CL Item
Better (Better)
CL Item
Same (Same)
CL Item
Worse (Worse)
C71686 (NCI Thesaurus)
C1457868 (UMLS 2011AA)
CL Item
Not Done (Not Done)
CL281691 (NCI Metathesaurus)
ResponseSymptomaticDeteriorationInd-3
Item
Is there Symptomatic Deterioration of the patient's health status requiring discontinuation of treatment?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25269 (NCI Thesaurus Property)
C0231220 (UMLS 2011AA Property)
C25751 (NCI Thesaurus Property-2)
C0868945 (UMLS 2011AA Property-2)
ResponseSymptomaticDeteriorationSpecify
Item
Yes specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25269 (NCI Thesaurus Property)
C0231220 (UMLS 2011AA Property)
C25751 (NCI Thesaurus Property-2)
C0868945 (UMLS 2011AA Property-2)
Item
Overall Response Status at This Assessment (mark one)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25605 (NCI Thesaurus ObjectClass-2)
C1561607 (UMLS 2011AA ObjectClass-2)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
CL.15
Code List
Overall Response Status at This Assessment (mark one)
CL Item
Not An Approved Recist Value (NED)
CL Item
Complete Response (CR)
CL Item
Partial Response (PR)
C18212 (NCI Thesaurus)
CL Item
Not An Approved Recist Value (REGR)
CL Item
Stable Disease (SD)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
CL Item
Progressive Disease (PD)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
CL Item
Death Prior To Completion Of Protocol Criteria (Early death)
CL Item
Insufficient Evaluation (Insufficient evaluation to determine response status)
Item Group
Comments
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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