ID

8943

Description

Clinical Form (Form 24-B) Brain Function in Premenopausal Women Receiving Tamoxifen With or Without Ovarian Function Suppression for Early-Stage Breast Cancer on Clinical Trial IBCSG-2402 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B121C37B-513A-4BC8-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B121C37B-513A-4BC8-E034-0003BA12F5E7

Keywords

Versions (2)
  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

January 9, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00659373 On-Study - Clinical Form (Form 24-B) - 2074000v3.0

English

Clinical Form (Form 24-B) Instructions: This form should reflect the status of the patient and disease at randomization. Please submit within one (1) month of randomization. Mark your selection with an ?X? in the appropriate box(es). Use minus one (-1) to indicate that an answer is unknown, unobtainable, or not done.

1 forms  
Ccrr Module For Clinical Form (form 24-b)
Description

Ccrr Module For Clinical Form (form 24-b)

Patient ID No. (Study No.)
Description

PatientStudyID,CoordinatingGroup

Data type

text

Patient Initials (f m fl sl)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Patient's Date of Birth (day)
Description

PatientBirthDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Participating Center/Affiliate
Description

ParticipatingCenter/Affiliate

Data type

text

Center Code
Description

ParticipatingGroupCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
Initial Data
Description

Initial Data

Race (Non-North American) (Non-North American Centers select one)
Description

Race(Non-NorthAmerican)

Data type

text

Other, specify (race) (specify)
Description

RaceOther,specify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Race (Ethnicity)
Description

PatientRace

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17049
UMLS 2011AA Property
C0034510
Ethnicity
Description

Ethnic Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS CUI-1
C0015031
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C16564
Weight (kg)
Description

PatientWeight

Data type

float

Height (cm)
Description

PatientHeight

Data type

float

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25347
UMLS 2011AA Property
C0489786
Premenopausal determination
Description

PatientPremenopausalAssessmentType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C15491
UMLS 2011AA Property-2
C0279752
Estradiol value used to determine eligibility (pmol/L)
Description

Estradiolpmol/L

Data type

text

Date blood drawn for this estradiol level
Description

Dateblooddrawnforthisestradiollevel

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Metathesaurus ObjectClass
C0521425
NCI Thesaurus Property
C2295
UMLS 2011AA Property
C0014912
NCI Thesaurus Property-2
C37984
UMLS 2011AA Property-2
C0022877
Institutional lower limit for premenopausal (pmol/L)
Description

Institutionallowerlimitforpremenopausal

Data type

text

Institutional upper limit for postmenopausal (pmol/L)
Description

Institutionalupperlimitforpostmenopausal

Data type

text

Age at menarche
Description

PatientMenarcheAgeYear

Data type

float

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C29848
UMLS 2011AA ValueDomain
C0439234
NCI Thesaurus ValueDomain-2
C25463
UMLS 2011AA ValueDomain-2
C0750480
NCI Thesaurus Property
C3228
UMLS 2011AA Property
C0025274
Date of start of the three recent menstrual cycles prior to randomization, most recent first (most recent)
Description

Dateofstartofthethreerecentmenstrualcyclespriortorandomization,mostrecentfirst

Data type

text

Menstruation (select one)
Description

Menstruation

Data type

text

Has the patient had a hysterectomy? (D M Y )
Description

HysterectomyPerformedInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C15256
UMLS 2011AA ObjectClass
C0020699
Specify reason(s) performed
Description

Yes,specifyreason(s)performed(hysterectomy)

Data type

text

History of diabetes?
Description

Historyofdiabetes?

Data type

boolean

Has patient ever been pregnant, regardless of outcome?
Description

Haspatienteverbeenpregnant,regardlessofoutcome?

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Total number of pregnancies
Description

Totalnumberofpregnancies

Data type

text

Number of successful pregnancies which resulted in at least 1 live birth
Description

Numberofsuccessfulpregnancieswhichresultedinatleast1livebirth

Data type

text

Number of early completions
Description

Numberofearlycompletions

Data type

text

Year of first pregnancy
Description

Yearoffirstpregnancy

Data type

text

Year of most recent pregnancy
Description

Yearofmostrecentpregnancy

Data type

text

Was patient pregnant at diagnosis?
Description

PatientDiagnosisPregnancyInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25742
UMLS 2011AA Property
C0032961
NCI Thesaurus Property-2
C15220
UMLS 2011AA Property-2
C0011900
Primary Disease
Description

Primary Disease

Tumor Laterality
Description

PrimaryTumorLateralityType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C25251
UMLS 2011AA ObjectClass-2
C0205225
NCI Thesaurus Property
C25185
UMLS 2011AA Property
C0332304
Predominant site of primary right breast/side
Description

RightBreastPrimaryNeoplasmSite

Data type

text

Alias
NCI Thesaurus ObjectClass
C25228
UMLS 2011AA ObjectClass
C0205090
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus Property
C3262
UMLS 2011AA Property
C0027651
NCI Thesaurus Property-2
C25341
UMLS 2011AA Property-2
C0450429
NCI Thesaurus Property-3
C25251
UMLS 2011AA Property-3
C0205225
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
Predominant site of primary left breast/side
Description

LeftBreastPrimaryNeoplasmSite

Data type

text

Alias
NCI Thesaurus ObjectClass
C25229
UMLS 2011AA ObjectClass
C0205091
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property-2
C25251
UMLS 2011AA Property-2
C0205225
NCI Metathesaurus Property
CL053268
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
Other specify
Description

Primary Disease Site

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C0449695
NCI Thesaurus Property
C25341
NCI Thesaurus ObjectClass
C25251
NCI Thesaurus ObjectClass-2
C2991
Other specify
Description

Primary Disease Site

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C0449695
NCI Thesaurus Property
C25341
NCI Thesaurus ObjectClass
C25251
NCI Thesaurus ObjectClass-2
C2991
Required Clinical Investigations
Description

Required Clinical Investigations

Chest X-ray or chest CT
Description

ChestX-rayResultIBCSGType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C25389
UMLS 2011AA ObjectClass
C0817096
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass-2
C17261
Results
Description

ChestX-rayresultsdescription

Data type

text

Right mammogram (PA and lateral views)
Description

Ipsilateralmammogram

Data type

text

Results
Description

Ipsilateralmammogramresultsdescription

Data type

text

Left mammogram (PA and lateral views)
Description

Contralateralmammogram

Data type

text

Alias
NCI Thesaurus ValueDomain
C20178
UMLS 2011AA ValueDomain
C0024671
NCI Thesaurus ValueDomain-2
C25688
UMLS 2011AA ValueDomain-2
C0449438
Results
Description

Contralateralmammogramresultsdescription

Data type

text

Bone Scan
Description

BoneScan

Data type

text

Results
Description

Ifabnormal,bonescanresultsdescription

Data type

text

Additional test(s) to rule out bone metastasis
Description

Ifabnormal,additionaltest(s)toruleoutbonemetastasis.

Data type

text

Bone densitometry
Description

DualX-rayAbsorptiometryAssessmentPerformedStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass-2
C48789
UMLS 2011AA ObjectClass-2
C1510486
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Date performed
Description

DualX-rayAbsorptiometryAssessmentPerformedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass-2
C48789
UMLS 2011AA ObjectClass-2
C1510486
SGOT (AST)
Description

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultStatus

Data type

text

Alias
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
SGOT
Description

Lab,Hepatic,SGOT

Data type

float

SGPT (ALT)
Description

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultStatus

Data type

text

Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C25293
UMLS 2011AA Property-2
C0376147
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
SGPT
Description

Lab,Hepatic,SGPT

Data type

float

Alkaline Phosphatase
Description

LaboratoryProcedureAlkalinePhosphataseResultStatus

Data type

text

Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
NCI Thesaurus Property-2
C16276
UMLS 2011AA Property-2
C0002059
Alkaline Phosphatase
Description

Lab,Hepatic,AlkalinePhosphatase

Data type

float

Bilirubin
Description

TotalBilirubinHepaticLabStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C25304
UMLS 2011AA ObjectClass
C0439810
NCI Thesaurus ObjectClass-2
C305
UMLS 2011AA ObjectClass-2
C0005437
NCI Thesaurus Property
C13308
UMLS 2011AA Property
C0205054
NCI Thesaurus Property-2
C37984
UMLS 2011AA Property-2
C0022877
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Bilirubin
Description

Lab,Hepatic,Bilirubin

Data type

float

Peripheral WBC Count x 10^9/l
Description

PeripheralWBCCount

Data type

text

Peripheral WBC Count
Description

Lab,Hematology,WBC

Data type

float

Peripheral Platelet Count x 10^9/l
Description

PeripheralPlateletCount

Data type

text

Peripheral Platelet Count
Description

Lab,Hematology,Platelets

Data type

float

Hemoglobin g/l
Description

Hemoglobin

Data type

text

Hemoglobin
Description

Lab,Hematology,Hemoglobin

Data type

float

Performance status at randomization (Karnofsky 90-100)
Description

PerformanceStatus

Data type

text

Family History
Description

Family History

Any known female blood relative(s) diagnosed with breast cancer or ovarian cancer?
Description

Anyknownfemalebloodrelative(s)diagnosedwithbreastcancerorovariancancer?

Data type

text

Relative (unnamed)
Description

Relative(unnamed)

Data type

text

Diagnosed with breast cancer
Description

Diagnosedwithbreastcancer

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Diagnosed with ovarian cancer
Description

Diagnosedwithovariancancer

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Age diagnosed
Description

Agediagnosed

Data type

text

Alias
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ObjectClass
C25150
UMLS 2011AA ObjectClass
C0001779
Age diagnosed
Description

Agediagnosed

Data type

text

Alias
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ObjectClass
C25150
UMLS 2011AA ObjectClass
C0001779
Total number (of relatives)
Description

PatientRelativeDescriptionTotalNumber

Data type

float

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C21480
UMLS 2011AA Property
C0080103
NCI Thesaurus Property-2
C25365
UMLS 2011AA Property-2
C0678257
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ValueDomain-2
C25304
UMLS 2011AA ValueDomain-2
C0439810
Number with breast cancer
Description

Numberwithbreastcancer

Data type

text

Number with ovarian cancer
Description

Numberwithovariancancer

Data type

text

Youngest age diagnosed
Description

Youngestagediagnosed

Data type

text

Youngest age diagnosed
Description

Youngestagediagnosed

Data type

text

Any known male blood relatives diagnosed with breast cancer?
Description

Anyknownmalebloodrelativesdiagnosedwithbreastcancer?

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Specify family relationship.
Description

Specifyfamilyrelationship.

Data type

text

Investigator Signature (/Designee)
Description

Investigator Signature

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
NCI Thesaurus ObjectClass
C17089
Date
Description

Investigator Signature Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
UMLS CUI-2
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C17089
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Similar models

Clinical Form (Form 24-B) Instructions: This form should reflect the status of the patient and disease at randomization. Please submit within one (1) month of randomization. Mark your selection with an ?X? in the appropriate box(es). Use minus one (-1) to indicate that an answer is unknown, unobtainable, or not done.

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Ccrr Module For Clinical Form (form 24-b)
PatientStudyID,CoordinatingGroup
Item
Patient ID No. (Study No.)
text
Patient Initials
Item
Patient Initials (f m fl sl)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
PatientBirthDate
Item
Patient's Date of Birth (day)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
ParticipatingCenter/Affiliate
Item
Participating Center/Affiliate
text
ParticipatingGroupCode
Item
Center Code
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
Item Group
Initial Data
Item
Race (Non-North American) (Non-North American Centers select one)
text
CL.1
Code List
Race (Non-North American) (Non-North American Centers select one)
CL Item
White / Caucasian (White / Caucasian)
CL Item
Black (Black)
CL Item
Asian (Asian)
CL106519 (NCI Metathesaurus)
CL Item
Other, Specify (Other, specify)
RaceOther,specify
Item
Other, specify (race) (specify)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Race (Ethnicity)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17049 (NCI Thesaurus Property)
C0034510 (UMLS 2011AA Property)
CL.2
Code List
Race (Ethnicity)
CL Item
Native_american_cdus (American Indian or Alaska Native)
CL Item
Asian_cdus (Asian)
CL Item
Black_cdus (Black or African American)
CL Item
Pacific_islander_cdus (Native Hawaiian or other Pacific Islander)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
White_cdus (White)
Item
Ethnicity
text
C25372 (NCI Thesaurus ValueDomain)
C0015031 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C16564 (NCI Thesaurus Property)
CL.3
Code List
Ethnicity
CL Item
A Person Of Mexican, Puerto Rican, Cuban, Central Or South American Or Other Spanish Culture Or Origin, Regardless Of Race. (HISPANIC OR LATINO)
C17459 (NCI Thesaurus)
C0086409 (UMLS 2011AA)
CL Item
A Person Not Meeting The Definition For Hispanic Or Latino. (NOT HISPANIC OR LATINO)
C41222 (NCI Thesaurus)
C1518424 (UMLS 2011AA)
CL Item
Could Not Be Determined Or Unsure (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
PatientWeight
Item
Weight (kg)
float
PatientHeight
Item
Height (cm)
float
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS 2011AA Property)
Item
Premenopausal determination
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C15491 (NCI Thesaurus Property-2)
C0279752 (UMLS 2011AA Property-2)
CL.4
Code List
Premenopausal determination
CL Item
Estradiol Levels (Estradiol levels)
CL Item
Patient Did Not Receive Chemotherapy, Patient Menstruating Regularly And Has Not Had Any Hormonal Contraception Or Treatment During The 6 Months Before Randomization (Patient did NOT receive chemotherapy, patient menstruating regularly and has not had any hormonal contraception or treatment during the 6 months before randomization)
Estradiolpmol/L
Item
Estradiol value used to determine eligibility (pmol/L)
text
Dateblooddrawnforthisestradiollevel
Item
Date blood drawn for this estradiol level
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C0521425 (NCI Metathesaurus ObjectClass)
C2295 (NCI Thesaurus Property)
C0014912 (UMLS 2011AA Property)
C37984 (NCI Thesaurus Property-2)
C0022877 (UMLS 2011AA Property-2)
Institutionallowerlimitforpremenopausal
Item
Institutional lower limit for premenopausal (pmol/L)
text
Institutionalupperlimitforpostmenopausal
Item
Institutional upper limit for postmenopausal (pmol/L)
text
PatientMenarcheAgeYear
Item
Age at menarche
float
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C29848 (NCI Thesaurus ValueDomain)
C0439234 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
C3228 (NCI Thesaurus Property)
C0025274 (UMLS 2011AA Property)
Dateofstartofthethreerecentmenstrualcyclespriortorandomization,mostrecentfirst
Item
Date of start of the three recent menstrual cycles prior to randomization, most recent first (most recent)
text
Item
Menstruation (select one)
text
CL.5
Code List
Menstruation (select one)
CL Item
Normal (Normal)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
CL Item
Occasionally Irregular Or Lengthened Interval, But Continuing Menstrual Cycles (Irregular)
CL Item
Persistent Amenorrhea (Persistent amenorrhea)
Item
Has the patient had a hysterectomy? (D M Y )
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15256 (NCI Thesaurus ObjectClass)
C0020699 (UMLS 2011AA ObjectClass)
CL.6
Code List
Has the patient had a hysterectomy? (D M Y )
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes, specify reason(s) performed)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Yes,specifyreason(s)performed(hysterectomy)
Item
Specify reason(s) performed
text
Historyofdiabetes?
Item
History of diabetes?
boolean
Haspatienteverbeenpregnant,regardlessofoutcome?
Item
Has patient ever been pregnant, regardless of outcome?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Totalnumberofpregnancies
Item
Total number of pregnancies
text
Numberofsuccessfulpregnancieswhichresultedinatleast1livebirth
Item
Number of successful pregnancies which resulted in at least 1 live birth
text
Numberofearlycompletions
Item
Number of early completions
text
Yearoffirstpregnancy
Item
Year of first pregnancy
text
Yearofmostrecentpregnancy
Item
Year of most recent pregnancy
text
PatientDiagnosisPregnancyInd-2
Item
Was patient pregnant at diagnosis?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
Item Group
Primary Disease
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.10
Code List
Tumor Laterality
CL Item
Right (Right)
C25228 (NCI Thesaurus)
C0205090 (UMLS 2011AA)
CL Item
Left (Left)
C25229 (NCI Thesaurus)
C0205091 (UMLS 2011AA)
CL Item
Bilateral (Bilateral)
C13332 (NCI Thesaurus)
C0238767 (UMLS 2011AA)
Item
Predominant site of primary right breast/side
text
C25228 (NCI Thesaurus ObjectClass)
C0205090 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C3262 (NCI Thesaurus Property)
C0027651 (UMLS 2011AA Property)
C25341 (NCI Thesaurus Property-2)
C0450429 (UMLS 2011AA Property-2)
C25251 (NCI Thesaurus Property-3)
C0205225 (UMLS 2011AA Property-3)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
CL.11
Code List
Predominant site of primary right breast/side
CL Item
Lateral (Lateral)
C25230 (NCI Thesaurus)
C0205093 (UMLS 2011AA)
CL Item
Medial (Medial)
C25232 (NCI Thesaurus)
C0205098 (UMLS 2011AA)
CL Item
On The Vertical Central Line (On the vertical central line)
CL Item
Other, Specify (Other, specify)
Item
Predominant site of primary left breast/side
text
C25229 (NCI Thesaurus ObjectClass)
C0205091 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25251 (NCI Thesaurus Property-2)
C0205225 (UMLS 2011AA Property-2)
CL053268 (NCI Metathesaurus Property)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
CL.12
Code List
Predominant site of primary left breast/side
CL Item
Lateral (Lateral)
C25230 (NCI Thesaurus)
C0205093 (UMLS 2011AA)
CL Item
Medial (Medial)
C25232 (NCI Thesaurus)
C0205098 (UMLS 2011AA)
CL Item
On The Vertical Central Line (On the vertical central line)
CL Item
Other, Specify (Other, specify)
Primary Disease Site
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C0449695 (UMLS CUI-1)
C25341 (NCI Thesaurus Property)
C25251 (NCI Thesaurus ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
Primary Disease Site
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C0449695 (UMLS CUI-1)
C25341 (NCI Thesaurus Property)
C25251 (NCI Thesaurus ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
Item Group
Required Clinical Investigations
Item
Chest X-ray or chest CT
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25389 (NCI Thesaurus ObjectClass)
C0817096 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17261 (NCI Thesaurus ObjectClass-2)
CL.13
Code List
Chest X-ray or chest CT
CL Item
Abnormal (Abnormal)
C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)
CL Item
Normal (Normal)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
ChestX-rayresultsdescription
Item
Results
text
Item
Right mammogram (PA and lateral views)
text
CL.14
Code List
Right mammogram (PA and lateral views)
CL Item
Normal (Normal)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
CL Item
Abnormal (Abnormal)
C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)
Ipsilateralmammogramresultsdescription
Item
Results
text
Item
Left mammogram (PA and lateral views)
text
C20178 (NCI Thesaurus ValueDomain)
C0024671 (UMLS 2011AA ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C0449438 (UMLS 2011AA ValueDomain-2)
CL.15
Code List
Left mammogram (PA and lateral views)
CL Item
No Metastases (Normal)
CL Item
Suspicious For Metastases (Abnormal)
Contralateralmammogramresultsdescription
Item
Results
text
Item
Bone Scan
text
CL.16
Code List
Bone Scan
CL Item
Not Done (Not Done)
CL281691 (NCI Metathesaurus)
CL Item
Normal (Normal)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
CL Item
Abnormal (Abnormal)
C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)
Ifabnormal,bonescanresultsdescription
Item
Results
text
Ifabnormal,additionaltest(s)toruleoutbonemetastasis.
Item
Additional test(s) to rule out bone metastasis
text
Item
Bone densitometry
text
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C48789 (NCI Thesaurus ObjectClass-2)
C1510486 (UMLS 2011AA ObjectClass-2)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.17
Code List
Bone densitometry
CL Item
Below Normal (Below Normal)
CL Item
Normal (Normal)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
CL Item
Not Done (Not Done)
DualX-rayAbsorptiometryAssessmentPerformedDate
Item
Date performed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C48789 (NCI Thesaurus ObjectClass-2)
C1510486 (UMLS 2011AA ObjectClass-2)
Item
SGOT (AST)
text
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.18
Code List
SGOT (AST)
CL Item
Not Done (Not Done)
CL281691 (NCI Metathesaurus)
CL Item
Normal (Normal)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
C14165 (NCI Thesaurus-3)
C0205307 (UMLS 2011AA-4)
CL Item
Abnormal (Abnormal)
C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)
C25401 (NCI Thesaurus-3)
C0205161 (UMLS 2011AA-4)
Lab,Hepatic,SGOT
Item
SGOT
float
Item
SGPT (ALT)
text
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25293 (NCI Thesaurus Property-2)
C0376147 (UMLS 2011AA Property-2)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.19
Code List
SGPT (ALT)
CL Item
Not Done (Not Done)
CL281691 (NCI Metathesaurus)
CL Item
Normal (Normal)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
C14165 (NCI Thesaurus-3)
C0205307 (UMLS 2011AA-4)
CL Item
Abnormal (Abnormal)
C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)
C25401 (NCI Thesaurus-3)
C0205161 (UMLS 2011AA-4)
Lab,Hepatic,SGPT
Item
SGPT
float
Item
Alkaline Phosphatase
text
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C16276 (NCI Thesaurus Property-2)
C0002059 (UMLS 2011AA Property-2)
CL.20
Code List
Alkaline Phosphatase
CL Item
Not Done (Not Done)
CL281691 (NCI Metathesaurus)
CL Item
Normal (Normal)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
C14165 (NCI Thesaurus-3)
C0205307 (UMLS 2011AA-4)
CL Item
Abnormal (Abnormal)
C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)
C25401 (NCI Thesaurus-3)
C0205161 (UMLS 2011AA-4)
Lab,Hepatic,AlkalinePhosphatase
Item
Alkaline Phosphatase
float
Item
Bilirubin
text
C25304 (NCI Thesaurus ObjectClass)
C0439810 (UMLS 2011AA ObjectClass)
C305 (NCI Thesaurus ObjectClass-2)
C0005437 (UMLS 2011AA ObjectClass-2)
C13308 (NCI Thesaurus Property)
C0205054 (UMLS 2011AA Property)
C37984 (NCI Thesaurus Property-2)
C0022877 (UMLS 2011AA Property-2)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.21
Code List
Bilirubin
CL Item
Not Done (Not Done)
CL281691 (NCI Metathesaurus)
CL Item
Normal (Normal)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
C14165 (NCI Thesaurus-3)
C0205307 (UMLS 2011AA-4)
CL Item
Abnormal (Abnormal)
C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)
C25401 (NCI Thesaurus-3)
C0205161 (UMLS 2011AA-4)
Lab,Hepatic,Bilirubin
Item
Bilirubin
float
Item
Peripheral WBC Count x 10^9/l
text
CL.22
Code List
Peripheral WBC Count x 10^9/l
CL Item
Not Done (Not Done)
CL281691 (NCI Metathesaurus)
CL Item
Normal (Normal)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
CL Item
Abnormal (Abnormal)
C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)
Lab,Hematology,WBC
Item
Peripheral WBC Count
float
Item
Peripheral Platelet Count x 10^9/l
text
CL.23
Code List
Peripheral Platelet Count x 10^9/l
CL Item
Not Done (Not Done)
CL281691 (NCI Metathesaurus)
CL Item
Normal (Normal)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
CL Item
Abnormal (Abnormal)
C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)
Lab,Hematology,Platelets
Item
Peripheral Platelet Count
float
Item
Hemoglobin g/l
text
CL.24
Code List
Hemoglobin g/l
CL Item
Not Done (Not Done)
CL281691 (NCI Metathesaurus)
CL Item
Normal (Normal)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
CL Item
Abnormal (Abnormal)
C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)
Lab,Hematology,Hemoglobin
Item
Hemoglobin
float
Item
Performance status at randomization (Karnofsky 90-100)
text
CL.25
Code List
Performance status at randomization (Karnofsky 90-100)
CL Item
0 (Fully active, able to carry on all pre-disease performance without restriction)
C0919414 (NCI Metathesaurus)
CL Item
1 (Restricted in physically strenuous activity, but ambulatory)
CL Item
2 (Ambulatory and capable of all selfcare but unable to carry out any work activities (K 50 - 60))
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
3 (Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours (K 30 - 40))
CL Item
4 (Completely disabled)
Item Group
Family History
Item
Any known female blood relative(s) diagnosed with breast cancer or ovarian cancer?
text
CL.26
Code List
Any known female blood relative(s) diagnosed with breast cancer or ovarian cancer?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Patient Adopted (Patient adopted)
Item
Relative (unnamed)
text
CL.27
Code List
Relative (unnamed)
CL Item
Mother (Mother)
C25189 (NCI Thesaurus)
C0026591 (UMLS 2011AA)
CL Item
Maternal Grandmother (Maternal grandmother)
CL Item
Paternal Grandmother (Paternal grandmother)
CL Item
Sister(s) (Sister(s))
CL Item
Daughter(s) (Daughter(s))
CL Item
Maternal Aunt(s) (Maternal aunt(s))
CL Item
Paternal Aunt(s) (Paternal aunt(s))
Diagnosedwithbreastcancer
Item
Diagnosed with breast cancer
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Diagnosedwithovariancancer
Item
Diagnosed with ovarian cancer
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Agediagnosed
Item
Age diagnosed
text
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25150 (NCI Thesaurus ObjectClass)
C0001779 (UMLS 2011AA ObjectClass)
Agediagnosed
Item
Age diagnosed
text
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25150 (NCI Thesaurus ObjectClass)
C0001779 (UMLS 2011AA ObjectClass)
PatientRelativeDescriptionTotalNumber
Item
Total number (of relatives)
float
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C21480 (NCI Thesaurus Property)
C0080103 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25304 (NCI Thesaurus ValueDomain-2)
C0439810 (UMLS 2011AA ValueDomain-2)
Numberwithbreastcancer
Item
Number with breast cancer
text
Numberwithovariancancer
Item
Number with ovarian cancer
text
Youngestagediagnosed
Item
Youngest age diagnosed
text
Youngestagediagnosed
Item
Youngest age diagnosed
text
Anyknownmalebloodrelativesdiagnosedwithbreastcancer?
Item
Any known male blood relatives diagnosed with breast cancer?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Specifyfamilyrelationship.
Item
Specify family relationship.
text
Investigator Signature
Item
Investigator Signature (/Designee)
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
Investigator Signature Date
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)
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