ID

1038

Beschrijving

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

Trefwoorden

Versies (2)
  1. 26-08-12 26-08-12 -
  2. 09-01-15 09-01-15 - Martin Dugas
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26 augustus 2012

DOI

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

Engels

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 Formulieren  
Ccrr Module For Clinical Form (form 24-b)
Beschrijving

Ccrr Module For Clinical Form (form 24-b)

Patient ID No. (Study No.)
Beschrijving

PatientStudyID,CoordinatingGroup

Datatype

text

Patient Initials (f m fl sl)
Beschrijving

PatientInitialsName

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Patient's Date of Birth (day)
Beschrijving

PatientBirthDate

Datatype

date

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

ParticipatingCenter/Affiliate

Datatype

text

Center Code
Beschrijving

ParticipatingGroupCode

Datatype

text

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

Initial Data

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

Race(Non-NorthAmerican)

Datatype

text

Other, specify (race) (specify)
Beschrijving

RaceOther,specify

Datatype

text

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

PatientRace

Datatype

text

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

PatientEthnicGroupCategory

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16564
UMLS 2011AA Property
C0015031
Weight (kg)
Beschrijving

PatientWeight

Datatype

double

Height (cm)
Beschrijving

PatientHeight

Datatype

double

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

PatientPremenopausalAssessmentType

Datatype

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
C15491
UMLS 2011AA Property
C0279752
Estradiol value used to determine eligibility (pmol/L)
Beschrijving

Estradiolpmol/L

Datatype

text

Date blood drawn for this estradiol level
Beschrijving

Dateblooddrawnforthisestradiollevel

Datatype

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
C37984
UMLS 2011AA Property
C0022877
Institutional lower limit for premenopausal (pmol/L)
Beschrijving

Institutionallowerlimitforpremenopausal

Datatype

text

Institutional upper limit for postmenopausal (pmol/L)
Beschrijving

Institutionalupperlimitforpostmenopausal

Datatype

text

Age at menarche
Beschrijving

PatientMenarcheAgeYear

Datatype

double

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C29848
UMLS 2011AA ValueDomain
C0439234
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
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)
Beschrijving

Dateofstartofthethreerecentmenstrualcyclespriortorandomization,mostrecentfirst

Datatype

text

Menstruation (select one)
Beschrijving

Menstruation

Datatype

text

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

HysterectomyPerformedInd-3

Datatype

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
Beschrijving

Yes,specifyreason(s)performed(hysterectomy)

Datatype

text

History of diabetes?
Beschrijving

Historyofdiabetes?

Datatype

text

Has patient ever been pregnant, regardless of outcome?
Beschrijving

Haspatienteverbeenpregnant,regardlessofoutcome?

Datatype

text

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

Totalnumberofpregnancies

Datatype

text

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

Numberofsuccessfulpregnancieswhichresultedinatleast1livebirth

Datatype

text

Number of early completions
Beschrijving

Numberofearlycompletions

Datatype

text

Year of first pregnancy
Beschrijving

Yearoffirstpregnancy

Datatype

text

Year of most recent pregnancy
Beschrijving

Yearofmostrecentpregnancy

Datatype

text

Was patient pregnant at diagnosis?
Beschrijving

PatientDiagnosisPregnancyInd-2

Datatype

text

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
C15220
UMLS 2011AA Property
C0011900
Primary Disease
Beschrijving

Primary Disease

Tumor Laterality
Beschrijving

PrimaryTumorLateralityType

Datatype

text

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

RightBreastPrimaryNeoplasmSite

Datatype

text

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

LeftBreastPrimaryNeoplasmSite

Datatype

text

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

PrimaryDiseaseSiteSpecify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus ObjectClass
C25251
UMLS 2011AA ObjectClass
C0205225
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
Other specify
Beschrijving

PrimaryDiseaseSiteSpecify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus ObjectClass
C25251
UMLS 2011AA ObjectClass
C0205225
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
Required Clinical Investigations
Beschrijving

Required Clinical Investigations

Chest X-ray or chest CT
Beschrijving

ChestX-rayResultIBCSGType

Datatype

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
C17261
Results
Beschrijving

ChestX-rayresultsdescription

Datatype

text

Right mammogram (PA and lateral views)
Beschrijving

Ipsilateralmammogram

Datatype

text

Results
Beschrijving

Ipsilateralmammogramresultsdescription

Datatype

text

Left mammogram (PA and lateral views)
Beschrijving

Contralateralmammogram

Datatype

text

Alias
NCI Thesaurus ValueDomain
C20178
UMLS 2011AA ValueDomain
C0024671
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Results
Beschrijving

Contralateralmammogramresultsdescription

Datatype

text

Bone Scan
Beschrijving

BoneScan

Datatype

text

Results
Beschrijving

Ifabnormal,bonescanresultsdescription

Datatype

text

Additional test(s) to rule out bone metastasis
Beschrijving

Ifabnormal,additionaltest(s)toruleoutbonemetastasis.

Datatype

text

Bone densitometry
Beschrijving

DualX-rayAbsorptiometryAssessmentPerformedStatus

Datatype

text

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

DualX-rayAbsorptiometryAssessmentPerformedDate

Datatype

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
C48789
UMLS 2011AA ObjectClass
C1510486
SGOT (AST)
Beschrijving

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultStatus

Datatype

text

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

Lab,Hepatic,SGOT

Datatype

double

SGPT (ALT)
Beschrijving

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultStatus

Datatype

text

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

Lab,Hepatic,SGPT

Datatype

double

Alkaline Phosphatase
Beschrijving

LaboratoryProcedureAlkalinePhosphataseResultStatus

Datatype

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
C16276
UMLS 2011AA Property
C0002059
Alkaline Phosphatase
Beschrijving

Lab,Hepatic,AlkalinePhosphatase

Datatype

double

Bilirubin
Beschrijving

TotalBilirubinHepaticLabStatus

Datatype

text

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

Lab,Hepatic,Bilirubin

Datatype

double

Peripheral WBC Count x 10^9/l
Beschrijving

PeripheralWBCCount

Datatype

text

Peripheral WBC Count
Beschrijving

Lab,Hematology,WBC

Datatype

double

Peripheral Platelet Count x 10^9/l
Beschrijving

PeripheralPlateletCount

Datatype

text

Peripheral Platelet Count
Beschrijving

Lab,Hematology,Platelets

Datatype

double

Hemoglobin g/l
Beschrijving

Hemoglobin

Datatype

text

Hemoglobin
Beschrijving

Lab,Hematology,Hemoglobin

Datatype

double

Performance status at randomization (Karnofsky 90-100)
Beschrijving

PerformanceStatus

Datatype

text

Family History
Beschrijving

Family History

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

Anyknownfemalebloodrelative(s)diagnosedwithbreastcancerorovariancancer?

Datatype

text

Relative (unnamed)
Beschrijving

Relative(unnamed)

Datatype

text

Diagnosed with breast cancer
Beschrijving

Diagnosedwithbreastcancer

Datatype

text

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

Diagnosedwithovariancancer

Datatype

text

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

Agediagnosed

Datatype

text

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

Agediagnosed

Datatype

text

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

PatientRelativeDescriptionTotalNumber

Datatype

double

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

Numberwithbreastcancer

Datatype

text

Number with ovarian cancer
Beschrijving

Numberwithovariancancer

Datatype

text

Youngest age diagnosed
Beschrijving

Youngestagediagnosed

Datatype

text

Youngest age diagnosed
Beschrijving

Youngestagediagnosed

Datatype

text

Any known male blood relatives diagnosed with breast cancer?
Beschrijving

Anyknownmalebloodrelativesdiagnosedwithbreastcancer?

Datatype

text

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

Specifyfamilyrelationship.

Datatype

text

Investigator Signature (/Designee)
Beschrijving

InvestigatorSignatureText

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Date
Beschrijving

InvestigatorSignatureDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
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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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Ccrr Module For Clinical Form (form 24-b)
PatientStudyID,CoordinatingGroup
Item
Patient ID No. (Study No.)
text
PatientInitialsName
Item
Patient Initials (f m fl sl)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA 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)
C0683312 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16564 (NCI Thesaurus Property)
C0015031 (UMLS 2011AA 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)
double
PatientHeight
Item
Height (cm)
double
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)
C0279752 (UMLS 2011AA Property)
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)
C0022877 (UMLS 2011AA Property)
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
double
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C29848 (NCI Thesaurus ValueDomain)
C0439234 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
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
Item
History of diabetes?
text
CL.7
Code List
History of diabetes?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Has patient ever been pregnant, regardless of outcome?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.8
Code List
Has patient ever been pregnant, regardless of outcome?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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
Item
Was patient pregnant at diagnosis?
text
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)
C0011900 (UMLS 2011AA Property)
CL.9
Code List
Was patient pregnant at diagnosis?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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)
C0205225 (UMLS 2011AA ObjectClass)
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)
C0006141 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus Property)
C0027651 (UMLS 2011AA Property)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25251 (NCI Thesaurus Property)
C0205225 (UMLS 2011AA Property)
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)
C0006141 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25251 (NCI Thesaurus Property)
C0205225 (UMLS 2011AA Property)
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)
PrimaryDiseaseSiteSpecify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
PrimaryDiseaseSiteSpecify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
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)
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)
C0449438 (UMLS 2011AA ValueDomain)
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)
C1510486 (UMLS 2011AA ObjectClass)
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)
C1510486 (UMLS 2011AA ObjectClass)
Item
SGOT (AST)
text
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
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)
C0205307 (UMLS 2011AA)
CL Item
Abnormal (Abnormal)
C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)
C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)
Lab,Hepatic,SGOT
Item
SGOT
double
Item
SGPT (ALT)
text
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25293 (NCI Thesaurus Property)
C0376147 (UMLS 2011AA Property)
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)
C0205307 (UMLS 2011AA)
CL Item
Abnormal (Abnormal)
C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)
C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)
Lab,Hepatic,SGPT
Item
SGPT
double
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)
C0002059 (UMLS 2011AA Property)
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)
C0205307 (UMLS 2011AA)
CL Item
Abnormal (Abnormal)
C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)
C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)
Lab,Hepatic,AlkalinePhosphatase
Item
Alkaline Phosphatase
double
Item
Bilirubin
text
C25304 (NCI Thesaurus ObjectClass)
C0439810 (UMLS 2011AA ObjectClass)
C305 (NCI Thesaurus ObjectClass)
C0005437 (UMLS 2011AA ObjectClass)
C13308 (NCI Thesaurus Property)
C0205054 (UMLS 2011AA Property)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
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)
C0205307 (UMLS 2011AA)
CL Item
Abnormal (Abnormal)
C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)
C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)
Lab,Hepatic,Bilirubin
Item
Bilirubin
double
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
double
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
double
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
double
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))
Item
Diagnosed with breast cancer
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.28
Code List
Diagnosed with breast cancer
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Diagnosed with ovarian cancer
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.29
Code List
Diagnosed with ovarian cancer
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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)
double
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C21480 (NCI Thesaurus Property)
C0080103 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
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
Item
Any known male blood relatives diagnosed with breast cancer?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.30
Code List
Any known male blood relatives diagnosed with breast cancer?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Specifyfamilyrelationship.
Item
Specify family relationship.
text
InvestigatorSignatureText
Item
Investigator Signature (/Designee)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignatureDate
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
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