ON-STUDY FORM (CALGB 49907)

CALGB: 49907 ON-STUDY FORM Comparison of Combination Chemotherapy Regimens in Treating Older Women Who Have Undergone Surgery for Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A50D7D2E-A557-3317-E034-080020C9C0E0

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  1. StudyEvent: CALGB: 49907 ON-STUDY FORM
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
CALGBForm
Item
CALGB Form
text
CALGBStudyNo
Item
CALGB Study No
text
CALGBPatientID
Item
CALGB Patient ID (Disease Description)
text
Item
Amended data?
text
Code List
Amended data?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Patient'sName
Item
Patient's Name
text
ParticipatingGroup
Item
Participating Group
text
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientHospitalNumber
Item
Patient Hospital Number
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
MainMemberInstitution/Adjunct
Item
Main Member Institution/Adjunct
text
ParticipatingGroupPatientNo.
Item
Participating Group Patient No.
text
Item Group
Surgical Procedures
FirstPositiveBiopsyDate
Item
First positive biopsy date (M)
date
Item
Most extensive primary surgery (mark one with an X)
text
Code List
Most extensive primary surgery (mark one with an X)
CL Item
Partial Mastectomy/lumpectomy/excisional Biopsy (Partial mastectomy/lumpectomy/excisional biopsy)
CL Item
Mastectomy, Nos (Mastectomy, NOS)
PrimarySurgeryDate
Item
Date of most extensive primary surgery (if required, used date of last re-excision)
date
Item
Sentinel node biopsy?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Code List
Sentinel node biopsy?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
SentinelNodeBiopsyDate
Item
Sentinel node biopsy date (M)
date
Item
Sentinel node biopsy results (per protocol)
text
Code List
Sentinel node biopsy results (per protocol)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
Item
Was axillary dissection performed?
text
Code List
Was axillary dissection performed?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
AxillaryDissectionDate
Item
Date of axillary dissection (M)
date
Totalnumberoflymphnodesexamined
Item
Total number of lymph nodes examined (if sentinel node biopsy and axillary node dissection were performed, enter the total number of nodes examined)
double
Item Group
Laboratory
GRANULOCYTES
Item
Granulocytes
text
Totalbilirubin
Item
Total bilirubin (mg/dl)
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
Lab,Renal,Creatinine
Item
Creatinine (mg/dl)
double
Plateletcount
Item
Platelet count
double
Bilirubinupperlimitofinstitutionallaboratorynormal
Item
Bilirubin upper limit of institutional laboratory normal (mg/dl)
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
Calculatedcreatinineclearance
Item
Calculated creatinine clearance (mL/min)
double
%LVEF
Item
% LVEF
text
%LowerlimitofinstitutionalnormalLVEF
Item
% Lower limit of institutional normal LVEF
double
Item Group
Pathology
C0030664 (UMLS CUI-1)
Item
Tumor laterality (mark one with an X)
text
Code List
Tumor laterality (mark one with an X)
CL Item
Left (Left)
C25229 (NCI Thesaurus)
C0205091 (UMLS 2011AA)
CL Item
Right (Right)
C25228 (NCI Thesaurus)
C0205090 (UMLS 2011AA)
CL Item
Bilateral (Bilateral)
Item
Receptor status, ER (If measured in fmols/mg cytosol protein >=10 is positive. If other measures are used apply institutional standards; borderline results should be reported as positive)
text
Code List
Receptor status, ER (If measured in fmols/mg cytosol protein >=10 is positive. If other measures are used apply institutional standards; borderline results should be reported as positive)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
Item
Receptor status, PgR
text
Code List
Receptor status, PgR
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
PathologicPrimaryTumorSize
Item
Pathologic primary tumor size (cm)
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
Item
Histologic grade (combined histologic grade is used according to SRE/Elston classification)
text
Code List
Histologic grade (combined histologic grade is used according to SRE/Elston classification)
CL Item
Well Differentiated (Low)
C14171 (NCI Thesaurus)
C0205615 (UMLS 2011AA)
CL Item
Moderately Differentiated (Intermediate)
C14162 (NCI Thesaurus)
C0205616 (UMLS 2011AA)
CL Item
Poorly Differentiated (High)
C14167 (NCI Thesaurus)
C0205617 (UMLS 2011AA)
Totalnumberofpositivelymphnodes
Item
Total number of positive lymph nodes (If sentinel node biopsy and axillary node dissection were performed, enter the sum of positive nodes)
double
T(TNMclassification)
Item
T (TNM classification)
double
N(TNMclassification)
Item
N (TNM classification)
double
M(TNMclassification)
Item
M (TNM classification) (Prior Systemic Therapy)
double
Item
Prior breast cancer prevention therapy?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Code List
Prior breast cancer prevention therapy?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
If Yes, what type (prior breast cancer prevention therapy) (mark all that apply with an X)
text
Code List
If Yes, what type (prior breast cancer prevention therapy) (mark all that apply with an X)
CL Item
Tamoxifen (Tamoxifen)
C855 (NCI Thesaurus)
C0039286 (UMLS 2011AA)
CL Item
Raloxifene (Raloxifene)
C1518 (NCI Thesaurus)
C0244404 (UMLS 2011AA)
CL Item
Other, Specify (Other, specify)
Other,specify(priorbreastcancertherapy)
Item
Other, specify (prior breast cancer therapy)
text
CompletedBy
Item
Completed By (Print or Type Name)
text
DateCompleted
Item
Date Completed
date

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