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  1. StudyEvent: NSABP PROTOCOL B-36: ON-STUDY FORM
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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)
Institution Name
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Affiliate Name
Item
Affiliate Name
text
C21541 (NCI Thesaurus ObjectClass)
C1510825 (UMLS CUI-1)
C25413 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Person Completing Form
Item
Person Completing Form (Phone)
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Data amended
Item
Are data amended?
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Surgery
Item
Most Extensive Primary Surgery
text
CL.9
Code List
Most Extensive Primary Surgery
CL Item
Partial Mastectomy/lumpectomy/excisional Biopsy (Partial mastectomy/lumpectomy/excisional biopsy)
CL Item
Total Mastectomy (Total Mastectomy)
CL Item
Mastectomy, Nos (Mastectomy, NOS)
Item
Were margins histologically free of invasive tumor and DCIS? (If partial mastectomy/lumpectomy/excisional biopsy:)
text
C25508 (NCI Thesaurus ObjectClass)
C0205088 (UMLS 2011AA ObjectClass)
C25563 (NCI Thesaurus ObjectClass-2)
C0205284 (UMLS 2011AA ObjectClass-2)
C25547 (NCI Thesaurus Property)
C25527 (NCI Thesaurus Property-2)
C0205462 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.10
Code List
Were margins histologically free of invasive tumor and DCIS? (If partial mastectomy/lumpectomy/excisional biopsy:)
CL Item
Free (Free)
CL Item
Not free (Not free)
Item Group
Surgical Procedures
Item
Core Needle Biopsy (1.)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15680 (NCI Thesaurus Property)
C1318309 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
CL.2
Code List
Core Needle Biopsy (1.)
CL Item
Yes (Y)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (N)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Excisional Biopsy or Lumpectomy (2.)
text
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C15755 (NCI Thesaurus Property)
C0024885 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C15385 (NCI Thesaurus Property-3)
C0184921 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.3
Code List
Excisional Biopsy or Lumpectomy (2.)
CL Item
Y (Y)
CL Item
N (N)
Item
Resection of Lumpectomy Margins (3.)
text
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C15755 (NCI Thesaurus Property)
C0024885 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C15232 (NCI Thesaurus Property-3)
C0728940 (UMLS 2011AA Property-3)
C41227 (NCI Thesaurus Property-4)
C0229985 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.4
Code List
Resection of Lumpectomy Margins (3.)
CL Item
Y (Y)
CL Item
N (N)
Item
Total Mastectomy (4.)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25180 (NCI Thesaurus ValueDomain-2)
C1522602 (UMLS 2011AA ValueDomain-2)
CL.5
Code List
Total Mastectomy (4.)
CL Item
Y (Y)
CL Item
N (N)
Item
Sentinel Node Biopsy (5.)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
CL.6
Code List
Sentinel Node Biopsy (5.)
CL Item
Y (Y)
CL Item
N (N)
Item
Axillary Dissection or Axillary Sampling (6.)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12674 (NCI Thesaurus ObjectClass)
C0004454 (UMLS 2011AA ObjectClass)
C25662 (NCI Thesaurus Property)
C0441621 (UMLS 2011AA Property)
CL.7
Code List
Axillary Dissection or Axillary Sampling (6.)
CL Item
Y (Y)
CL Item
N (N)
SurgicalProcedurePerformedDate
Item
DATE OF PROCEDURE (Month, Day, Year)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
SpecimenAccessionNumber
Item
ACCESSION NUMBER (Pathology Specimen Number)
float
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25402 (NCI Thesaurus Property)
C1510755 (UMLS 2011AA Property)
Item Group
Patient status
Item
Menopausal Status (per protocol criteria)
text
CL.8
Code List
Menopausal Status (per protocol criteria)
CL Item
Premenopausal (Premenopausal)
CL Item
Postmenopausal (Postmenopausal)
Date Form Completed
Item
Date Baseline QOL Completed by Patient (0=not applicable)
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
Medication Start Date
Item
Date Celecoxib/Placebo Began (0=not begun)
date
C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C25431 (NCI Thesaurus ValueDomain-2)
C0808070 (UMLS CUI-2)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
Agent
Item
Agent
text
C25364 (NCI Thesaurus Property)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
C1521826 (UMLS CUI-1)
Item Group
Disease Description
Item
Tumor Laterality
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C25185 (NCI Thesaurus Property)
C0332304 (UMLS 2011AA Property)
CL.11
Code List
Tumor Laterality
CL Item
Left (Left breast)
C25229 (NCI Thesaurus)
C0205091 (UMLS 2011AA)
CL Item
Right (Right breast)
C25228 (NCI Thesaurus)
C0205090 (UMLS 2011AA)
Item
ER (Receptor Status)
text
C3262 (NCI Thesaurus ValueDomain)
C0027651 (UMLS 2011AA ValueDomain)
C17069 (NCI Thesaurus ObjectClass)
C0034804 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain-2)
C0449438 (UMLS 2011AA ValueDomain-2)
C25554 (NCI Thesaurus Property)
C0441889 (UMLS 2011AA Property)
CL.12
Code List
ER (Receptor Status)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
PgR (Receptor Status)
text
CL.13
Code List
PgR (Receptor Status)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
PathologicTumorPrimarySizeMeasurement
Item
Pathologic Primary Tumor Size (cm)
float
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25610 (NCI Thesaurus ObjectClass-2)
C1521733 (UMLS 2011AA ObjectClass-2)
C25251 (NCI Thesaurus Property)
C0205225 (UMLS 2011AA Property)
C25681 (NCI Thesaurus Property-2)
C0456389 (UMLS 2011AA Property-2)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
Item
Histologic Grade (Use combined histologic grade SBR/Elston classification)
text
CL.14
Code List
Histologic Grade (Use combined histologic grade SBR/Elston classification)
CL Item
Low Grade (Low)
C14161 (NCI Thesaurus)
C1282907 (UMLS 2011AA)
CL Item
Intermediate (Intermediate)
CL Item
High Grade (High)
C14158 (NCI Thesaurus)
C0205082 (UMLS 2011AA)
Item Group
Ccrr Module For Nsabp Protocol B-36: On-study Form
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