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  1. StudyEvent: NSABP Protocol B-40 - Tumor Response Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Patient Initials
Item
Patient Initials (Last First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Patient ID NSABP
Item
NSABP Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1513905 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C15818 (NCI Thesaurus Property-2)
Item
Reason Form Submitted
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25695 (NCI Thesaurus ObjectClass-2)
C1515023 (UMLS 2011AA ObjectClass-2)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
Reason Form Submitted
CL Item
Required Assessment At The End Of The Docetaxel Regimen (Required assessment at the end of the docetaxel regimen)
CL Item
Required Assessment At The End Of The Ac Cycles (Required assessment at the end of the AC cycles)
CL Item
Discretionary Assessment Which Identified Protocol-defined Progressive Disease (Discretionary assessment which identified protocol-defined Progressive Disease)
Item Group
Form completed by
CombinedInstitutionName
Item
Institution/Affiliate
text
ResponsiblePersonLastName
Item
Person Completing Form, Last Name
text
ResponsiblePersonFirstName
Item
Person Completing Form, First Name
text
ResponsiblePersonPhoneNumber
Item
Person Completing Form, Phone
text
DataAmendedInd-3
Item
Are data amended
boolean
TargetLesionDimensionInd-2
Item
Were the target lesions measured on this evaluation
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25702 (NCI Thesaurus ObjectClass-2)
C1521840 (UMLS 2011AA ObjectClass-2)
C25483 (NCI Thesaurus Property)
C0439534 (UMLS 2011AA Property)
LesionAssessmentDate
Item
Date of Evaluation
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 of Target lesion (s)
text
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C25702 (NCI Thesaurus ObjectClass-2)
C1521840 (UMLS 2011AA ObjectClass-2)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
Code List
Response status of Target lesion (s)
CL Item
Complete Response (Complete Response)
CL Item
Partial Response (Partial Response)
CL Item
Incomplete Response Or Stable Disease (Incomplete Response or Stable Disease)
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)
Item
Target Lesion Site
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25702 (NCI Thesaurus Property-2)
C1521840 (UMLS 2011AA Property-2)
Code List
Target Lesion Site
CL Item
Breast (Breast)
C12971 (NCI Thesaurus)
C0006141 (UMLS 2011AA)
CL Item
Axilla (Axilla)
C12674 (NCI Thesaurus)
C0004454 (UMLS 2011AA)
Longest Diameter of Lesion
Item
Longest Diameter of Lesion (s)
float
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS CUI-1)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS CUI-2)
C25558 (NCI Thesaurus Property-2)
C1522425 (UMLS CUI-3)
C25209 (NCI Thesaurus ValueDomain)
C25285 (NCI Thesaurus ValueDomain-2)
LongestLesionSumDiameterMeasurement
Item
Sum of longest diameters of all target lesions (cm)
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)
C25697 (NCI Thesaurus Property-2)
C1515051 (UMLS 2011AA Property-2)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
LesionLowestSumLongestDiameterMeasurement
Item
Smallest Sum of Longest Diameters of all Target Lesions
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)
C25697 (NCI Thesaurus Property-3)
C1515051 (UMLS 2011AA Property-3)
C43517 (NCI Thesaurus Property-4)
C1708760 (UMLS 2011AA Property-4)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25285 (NCI Thesaurus ValueDomain-2)
C1301886 (UMLS 2011AA ValueDomain-2)
LesionLowestSumLongestDiameterDate
Item
Date Smallest Sum Observed
date
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)
C25697 (NCI Thesaurus Property-3)
C1515051 (UMLS 2011AA Property-3)
C43517 (NCI Thesaurus Property-4)
C1708760 (UMLS 2011AA Property-4)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
NontargetLesionBaselinePresentInd-2
Item
Were nontarget lesions identified on the baseline evaluation
boolean
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25592 (NCI Thesaurus ObjectClass-2)
C1518389 (UMLS 2011AA ObjectClass-2)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25213 (NCI Thesaurus Property-2)
C1442488 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
NontargetLesionFollow-upAssessmentInd-2
Item
Were the nontarget lesions assessed on this evaluation
boolean
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25592 (NCI Thesaurus ObjectClass-2)
C1518389 (UMLS 2011AA ObjectClass-2)
C25367 (NCI Thesaurus Property)
C16033 (NCI Thesaurus Property-2)
C1522577 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Response Status of NONTARGET Lesions
text
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25592 (NCI Thesaurus ObjectClass-2)
C1518389 (UMLS 2011AA ObjectClass-2)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
Code List
Response Status of NONTARGET Lesions
CL Item
Complete Response (Complete Response)
CL Item
Incomplete Response/sd (Incomplete Response/SD)
CL Item
Progressive Disease (Progressive Disease)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
NewLesionAppearanceInd-2
Item
Was the appearance of any new lesions documented
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)
Item
New Lesion Site
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C25341 (NCI Thesaurus Property-2)
C0450429 (UMLS 2011AA Property-2)
Code List
New Lesion Site
CL Item
Breast (Breast)
C12971 (NCI Thesaurus)
C0006141 (UMLS 2011AA)
CL Item
Axilla (Axilla)
C12674 (NCI Thesaurus)
C0004454 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C17649 (NCI Thesaurus-3)
C0205394 (UMLS 2011AA-4)
LesionNewLocationSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C25341 (NCI Thesaurus Property-2)
C0450429 (UMLS 2011AA Property-2)
DiseaseOtherIndicationProgressionInd-2
Item
Was there any other manifestation of disease progression (other than progression of target lesions, progression of nontarget lesions, or the appearance of a new lesion)
boolean
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25331 (NCI Thesaurus Property-2)
C41184 (NCI Thesaurus Property-3)
C0392360 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
DiseaseOtherIndicationProgressionSpecify
Item
Specify (If yes)
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25331 (NCI Thesaurus Property-2)
C41184 (NCI Thesaurus Property-3)
C0392360 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

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