ID

6211

Description

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

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A50D7D2E-A557-3317-E034-080020C9C0E0

Keywords

Versions (1)
  1. 12/18/14 12/18/14 - Martin Dugas
Uploaded on

December 18, 2014

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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ON-STUDY FORM (CALGB 49907)

English

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1 forms  
  1. StudyEvent: CALGB: 49907 ON-STUDY FORM
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Header
Description

Header

Alias
UMLS CUI-1
C1320722
CALGB Form
Description

CALGBForm

Data type

text

CALGB Study No
Description

CALGBStudyNo

Data type

text

CALGB Patient ID (Disease Description)
Description

CALGBPatientID

Data type

text

Amended data?
Description

Amendeddata?

Data type

text

Patient's Name
Description

Patient'sName

Data type

text

Participating Group
Description

ParticipatingGroup

Data type

text

Alias
NCI Thesaurus ObjectClass
C17005
UMLS 2011AA ObjectClass
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Patient Hospital Number
Description

PatientHospitalNumber

Data type

text

Participating Group Protocol No.
Description

ParticipatingGroupProtocolNo.

Data type

text

Main Member Institution/Adjunct
Description

MainMemberInstitution/Adjunct

Data type

text

Participating Group Patient No.
Description

ParticipatingGroupPatientNo.

Data type

text

Surgical Procedures
Description

Surgical Procedures

First positive biopsy date (M)
Description

FirstPositiveBiopsyDate

Data type

date

Most extensive primary surgery (mark one with an X)
Description

PrimarySurgeryType

Data type

text

Date of most extensive primary surgery (if required, used date of last re-excision)
Description

PrimarySurgeryDate

Data type

date

Sentinel node biopsy?
Description

Sentinelnodebiopsy?

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Sentinel node biopsy date (M)
Description

SentinelNodeBiopsyDate

Data type

date

Sentinel node biopsy results (per protocol)
Description

SentinelNodeBiopsyResults

Data type

text

Was axillary dissection performed?
Description

AxillaryDissectionInd

Data type

text

Date of axillary dissection (M)
Description

AxillaryDissectionDate

Data type

date

Total number of lymph nodes examined (if sentinel node biopsy and axillary node dissection were performed, enter the total number of nodes examined)
Description

Totalnumberoflymphnodesexamined

Data type

double

Laboratory
Description

Laboratory

Granulocytes
Description

GRANULOCYTES

Data type

text

Total bilirubin (mg/dl)
Description

Totalbilirubin

Data type

double

Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
Creatinine (mg/dl)
Description

Lab,Renal,Creatinine

Data type

double

Platelet count
Description

Plateletcount

Data type

double

Bilirubin upper limit of institutional laboratory normal (mg/dl)
Description

Bilirubinupperlimitofinstitutionallaboratorynormal

Data type

double

Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
Calculated creatinine clearance (mL/min)
Description

Calculatedcreatinineclearance

Data type

double

% LVEF
Description

%LVEF

Data type

text

% Lower limit of institutional normal LVEF
Description

%LowerlimitofinstitutionalnormalLVEF

Data type

double

Pathology
Description

Pathology

Alias
UMLS CUI-1
C0030664
Tumor laterality (mark one with an X)
Description

PrimaryTumorLaterality

Data type

text

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)
Description

ERStatus

Data type

text

Receptor status, PgR
Description

PgRStatus

Data type

text

Pathologic primary tumor size (cm)
Description

PathologicPrimaryTumorSize

Data type

double

Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
Histologic grade (combined histologic grade is used according to SRE/Elston classification)
Description

HistologicGrade

Data type

text

Total number of positive lymph nodes (If sentinel node biopsy and axillary node dissection were performed, enter the sum of positive nodes)
Description

Totalnumberofpositivelymphnodes

Data type

double

T (TNM classification)
Description

T(TNMclassification)

Data type

double

N (TNM classification)
Description

N(TNMclassification)

Data type

double

M (TNM classification) (Prior Systemic Therapy)
Description

M(TNMclassification)

Data type

double

Prior breast cancer prevention therapy?
Description

Priorbreastcancerpreventiontherapy?

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
If Yes, what type (prior breast cancer prevention therapy) (mark all that apply with an X)
Description

IfYes,whattype(priorbreastcancerpreventiontherapy)

Data type

text

Other, specify (prior breast cancer therapy)
Description

Other,specify(priorbreastcancertherapy)

Data type

text

Completed By (Print or Type Name)
Description

CompletedBy

Data type

text

Date Completed
Description

DateCompleted

Data type

date

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1 forms
  1. StudyEvent: CALGB: 49907 ON-STUDY FORM
    1. Continue on next page
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
CL.1
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
CL.2
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)
CL.3
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
CL.4
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
CL.5
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
CL.6
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
CL.7
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
CL.8
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
CL.9
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)
CL.10
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
CL.11
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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