ID

9034

Description

Follow-up Form (Form 24-E) 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=B0FA982B-ACAA-0AC1-E034-0003BA12F5E7

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B0FA982B-ACAA-0AC1-E034-0003BA12F5E7

Mots-clés

  1. 27/08/2012 27/08/2012 -
  2. 09/01/2015 09/01/2015 - Martin Dugas
Téléchargé le

9 janvier 2015

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT00659373 Treatment - Follow-up Form (Form 24-E) - 2072392v3.0

SINCE SUBMISSION OF LAST FOLLOW-UP FORM

  1. StudyEvent: Follow-up Form (Form 24-E)
    1. SINCE SUBMISSION OF LAST FOLLOW-UP FORM
Ccrr Module For Follow-up Form (form 24-e)
Description

Ccrr Module For Follow-up Form (form 24-e)

Patient ID No. (Study No.)
Description

PatientStudyID,CoordinatingGroup

Type de données

text

Patient Initials (f m fl sl)
Description

Patient Initials

Type de données

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

Type de données

date

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

ParticipatingCenter/Affiliate

Type de données

text

Center Code (Ver.#1)
Description

ParticipatingGroupCode

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
Reporting Period Start Date (if this is the first follow-up period enter date of randomization)
Description

IntervalReportFromDate

Type de données

date

Reporting Period End Date
Description

IntervalReportToDate

Type de données

date

Documentation of hospital or clinic visit
Description

PatientContactMethodType

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
NCI Thesaurus ObjectClass-2
C25461
UMLS 2011AA ObjectClass-2
C0337611
Other, specify
Description

PatientContactMethodSpecify

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
NCI Thesaurus ObjectClass-2
C25461
UMLS 2011AA ObjectClass-2
C0337611
Patient's Vital Status (select one)
Description

Patient'sVitalStatus

Type de données

text

Date of death (day month year)
Description

DeathDocumentedDate

Type de données

date

Primary cause of death
Description

BreastCancerPatientDeathReason

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C28554
UMLS 2011AA Property
C0011065
NCI Metathesaurus ObjectClass
C0006142
Other cause, specify
Description

BreastCancerPatientDeathSpecify

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C28554
UMLS 2011AA Property
C0011065
NCI Metathesaurus ObjectClass
C0006142
Autopsy
Description

AutopsyInd

Type de données

boolean

Bone densitometry
Description

DualX-rayAbsorptiometryAssessmentPerformedStatus

Type de données

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

Type de données

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
Performance status at date of this examination or contact
Description

PerformanceStatus

Type de données

text

Weight (if measured in clinic)
Description

PatientWeight

Type de données

float

Menstrual status during 3 months prior to follow-up visit (select one)
Description

Menstrualstatusduring3monthspriortofollow-upvisit

Type de données

text

Was patient pregnant at any time during this follow-up period? If more than one pregnancy, indicate most recent episode. (If pregnant during protocol treatment, complete Form 24-EIU for each pregnancy.)
Description

Waspatientpregnantatanytimeduringthisfollow-upperiod?

Type de données

text

Did the patient have gynecologic surgery, procedures and/or diagnostic imaging (excluding PAP smear?)
Description

Didthepatienthavegynecologicsurgery,proceduresand/ordiagnosticimaging?

Type de données

text

Has the patient attempted to become pregnant during this follow-up period
Description

PatientAttemptPregnancyInd-2

Type de données

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
C39769
UMLS 2011AA Property-2
C1516084
Method
Description

PatientAttemptPregnancyType

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25742
UMLS 2011AA Property
C0032961
NCI Thesaurus Property-2
C39769
UMLS 2011AA Property-2
C1516084
Has the patient had any clinically significant cardiovascular and/or cerebrovascular events after protocol treatment ended (Report on Form 24-AE if during protocol treatment or up to 12 months after protocol treatment has ended.)
Description

Hasthepatienthadanyclinicallysignificantcardiovascularand/orcerebrovasculareventsafterprotocoltreatmentended?

Type de données

boolean

Specify event
Description

Off-TreatmentCardiovascularCerebrovascularEventSpecify

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Specify date
Description

AdverseEventOnsetDate

Type de données

date

Alias
NCI Thesaurus Property
C25164
UMLS 2011AA Property
C0011008
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property-2
C25279
UMLS 2011AA Property-2
C0332162
Specify date
Description

AdverseEventOnsetDate

Type de données

date

Alias
NCI Thesaurus Property
C25164
UMLS 2011AA Property
C0011008
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property-2
C25279
UMLS 2011AA Property-2
C0332162
Did the patient have any bone fractures after protocol treatment ended? (Report on Form 24-AE if during protocol treatment or up to 12 months after protocol treatment has ended.)
Description

Hasthepatientexperiencedabonefracturesincesubmissionoflastfollow-upform?

Type de données

boolean

Has patient experienced any other severe (> grade 3) adverse event(s), (not reported in Q13-16) after protocol treatment ended? (Report on Form 24-AE during protocol treatment or up to 12 months after protocol treatment has ended.)
Description

LateAdverseEventInd

Type de données

boolean

Describe
Description

BrieflydescribetheAE

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Was event related to protocol treatment
Description

AdverseEventProtocolTherapyAttributionScale

Type de données

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C15368
NCI Thesaurus Property-2
C28041
UMLS 2011AA Property
C1517586
NCI Thesaurus Property-3
C15206
UMLS 2011AA Property-2
C0008972
NCI Thesaurus Property-4
C25358
UMLS 2011AA Property-3
C0596130
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
Was event related to protocol treatment
Description

AdverseEventProtocolTherapyAttributionScale

Type de données

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C15368
NCI Thesaurus Property-2
C28041
UMLS 2011AA Property
C1517586
NCI Thesaurus Property-3
C15206
UMLS 2011AA Property-2
C0008972
NCI Thesaurus Property-4
C25358
UMLS 2011AA Property-3
C0596130
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
Was event related to protocol treatment
Description

AdverseEventProtocolTherapyAttributionScale

Type de données

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C15368
NCI Thesaurus Property-2
C28041
UMLS 2011AA Property
C1517586
NCI Thesaurus Property-3
C15206
UMLS 2011AA Property-2
C0008972
NCI Thesaurus Property-4
C25358
UMLS 2011AA Property-3
C0596130
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
Has the patient been diagnosed with in situ breast cancer, right side, since the submission of the last Follow-up Form (select one)
Description

HasthepatientbeendiagnosedwithipsilateralinsitubreastcancersincethesubmissionofthelastFollow-upForm?

Type de données

text

Has the patient been diagnosed with in situ breast cancer, left side, since the submission of the last Follow-up Form
Description

HasthepatientbeendiagnosedwithcontralateralinsitubreastcancersincethesubmissionofthelastFollow-upForm?

Type de données

text

Specify treatment
Description

BreastTherapyMethodName

Type de données

text

Alias
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Specify treatment
Description

BreastTherapyMethodName

Type de données

text

Alias
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Has the patient been diagnosed with in situ cervical cancer since the submission of the last Follow-up Form?
Description

HasthepatientbeendiagnosedwithinsitucervicalcancersincethesubmissionofthelastFollow-upForm?

Type de données

boolean

Has the patient been diagnosed with basal cell or squamous cell carcinoma of the skin since the submission of the last Follow-up Form?
Description

HasthepatientbeendiagnosedwithbasalcellorsquamouscellcarcinomaoftheskinsincethesubmissionofthelastFollow-upForm?

Type de données

boolean

Date of Initial Pathologic Diagnosis (day month year)
Description

InitialDiagnosisDate

Type de données

date

Date of Initial Pathologic Diagnosis (day month year)
Description

InitialDiagnosisDate

Type de données

date

Date of Initial Pathologic Diagnosis (day month year)
Description

InitialDiagnosisDate

Type de données

date

Date of Initial Pathologic Diagnosis (day month year)
Description

InitialDiagnosisDate

Type de données

date

Has patient had a suspicious or proven second primary since submission of last Follow-up Form
Description

SecondPrimaryNeoplasmDiagnosisInd-2

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C25251
UMLS 2011AA ObjectClass-2
C0205225
NCI Thesaurus ObjectClass-3
C25666
UMLS 2011AA ObjectClass-3
C0205436
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Specify site below
Description

SecondPrimaryNeoplasmDiagnosisType

Type de données

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C25251
UMLS 2011AA ObjectClass-2
C0205225
NCI Thesaurus ObjectClass-3
C25666
UMLS 2011AA ObjectClass-3
C0205436
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Other, specify type and site
Description

SecondPrimaryNeoplasmDiagnosisSpecify

Type de données

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C25251
UMLS 2011AA ObjectClass-2
C0205225
NCI Thesaurus ObjectClass-3
C25666
UMLS 2011AA ObjectClass-3
C0205436
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Other, specify type and site
Description

SecondPrimaryNeoplasmDiagnosisSpecify

Type de données

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C25251
UMLS 2011AA ObjectClass-2
C0205225
NCI Thesaurus ObjectClass-3
C25666
UMLS 2011AA ObjectClass-3
C0205436
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Date suspected
Description

Datesuspected

Type de données

text

Date suspected
Description

Datesuspected

Type de données

text

Date proven
Description

Dateproven

Type de données

text

Date proven
Description

Dateproven

Type de données

text

Specify treatment for first 2nd primary
Description

SecondPrimaryNeoplasmTherapySpecify

Type de données

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C25251
UMLS 2011AA ObjectClass-2
C0205225
NCI Thesaurus ObjectClass-3
C25666
UMLS 2011AA ObjectClass-3
C0205436
NCI Thesaurus Property
C15368
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Has patient had a suspicious or proven recurrence/metastasis or contralateral invasive breast cancer since submission of last Follow-up Form?
Description

Haspatienthadasuspiciousorprovenrecurrence/metastasisorcontralateralinvasivebreastcancersincesubmissionoflastFollow-upForm?

Type de données

boolean

Site
Description

BreastCancerRecurrenceAnatomicSite

Type de données

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus Property
C38155
UMLS 2011AA Property
C0277556
NCI Thesaurus ObjectClass
C4872
UMLS 2011AA ObjectClass
C0678222
Specify
Description

BreastCarcinomaRecurrentDiseaseSpecify

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C38155
UMLS 2011AA Property
C0277556
NCI Thesaurus ObjectClass
C4872
UMLS 2011AA ObjectClass
C0678222
Investigation
Description

Evaluation method

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2911685
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C16847
Other, specify
Description

AssessmentDiagnosticMethodSpecify

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
NCI Thesaurus Property-2
C25482
UMLS 2011AA Property-2
C0348026
Date 1st Performed
Description

PatientFirstAssessmentDate

Type de données

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C25509
UMLS 2011AA Property-2
C1279901
Date Repeated
Description

PatientRepeatAssessmentDate

Type de données

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C47886
UMLS 2011AA Property-2
C0205341
Are there additional sites
Description

BreastCarcinomaRecurrentDiseaseInd-2

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C38155
UMLS 2011AA Property
C0277556
NCI Thesaurus ObjectClass
C4872
UMLS 2011AA ObjectClass
C0678222
Surgery
Description

SurgicalProcedureBreastNeoplasmPerformedInd-2

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus Property-2
C2910
UMLS 2011AA Property-2
C0042875
Specify procedure
Description

ProtocolSurgeryType

Type de données

text

Surgery Date (D M Y)
Description

SurgeryDate

Type de données

date

Radiation Therapy
Description

RTInd

Type de données

boolean

Specify dose
Description

RTTotalDoseperField

Type de données

float

Specify field
Description

RTSite

Type de données

text

Chemotherapy
Description

Chemotherapy

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ValueDomain-2
C25180
UMLS 2011AA ValueDomain-2
C1522602
Specify drug
Description

AgentName

Type de données

text

Endocrine therapy
Description

HormonalTherapyInd

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Specify
Description

Specifyendocrinetherapy

Type de données

text

Other
Description

OtherTherapyInd

Type de données

boolean

Specify
Description

OtherTherapyType

Type de données

text

Date started
Description

Datestarted

Type de données

date

Date started
Description

Datestarted

Type de données

date

Date started
Description

Datestarted

Type de données

date

Date started
Description

Datestarted

Type de données

date

Investigator Signature (/Designee)
Description

InvestigatorSignature

Type de données

text

Alias
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Date (day month year)
Description

InvestigatorSignatureDate

Type de données

date

Similar models

SINCE SUBMISSION OF LAST FOLLOW-UP FORM

  1. StudyEvent: Follow-up Form (Form 24-E)
    1. SINCE SUBMISSION OF LAST FOLLOW-UP FORM
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Ccrr Module For Follow-up Form (form 24-e)
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 (Ver.#1)
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
IntervalReportFromDate
Item
Reporting Period Start Date (if this is the first follow-up period enter date of randomization)
date
IntervalReportToDate
Item
Reporting Period End Date
date
Item
Documentation of hospital or clinic visit
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C25461 (NCI Thesaurus ObjectClass-2)
C0337611 (UMLS 2011AA ObjectClass-2)
Code List
Documentation of hospital or clinic visit
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Patient Seen (Patient seen)
CL Item
Phone Contact To Patient (Phone contact to patient)
PatientContactMethodSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C25461 (NCI Thesaurus ObjectClass-2)
C0337611 (UMLS 2011AA ObjectClass-2)
Item
Patient's Vital Status (select one)
text
Code List
Patient's Vital Status (select one)
CL Item
Alive (Alive)
CL Item
Dead (Dead)
DeathDocumentedDate
Item
Date of death (day month year)
date
Item
Primary cause of death
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)
C0006142 (NCI Metathesaurus ObjectClass)
Code List
Primary cause of death
CL Item
Accident (Accident)
CL Item
Cerebrovascular Accident (Cerebrovascular accident)
C3390 (NCI Thesaurus)
C0038454 (UMLS 2011AA)
CL Item
Congestive Heart Failure (Congestive heart failure)
CL Item
Myocardial Infarction (Myocardial infarction)
C27996 (NCI Thesaurus)
C0027051 (UMLS 2011AA)
CL Item
New Primary Diagnosis (New primary diagnosis)
CL Item
Other Cause (Other cause)
CL Item
Progression Of Underlying Breast Cancer (Progression of underlying breast cancer)
CL Item
Sepsis / Infection (Sepsis / infection)
CL Item
Suicide (Suicide)
C3394 (NCI Thesaurus)
C0038661 (UMLS 2011AA)
CL Item
Thromboembolic Event (Thromboembolic event)
BreastCancerPatientDeathSpecify
Item
Other cause, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)
C0006142 (NCI Metathesaurus ObjectClass)
AutopsyInd
Item
Autopsy
boolean
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)
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
Performance status at date of this examination or contact
text
Code List
Performance status at date of this examination or contact
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)
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
3 (Capable of limited selfcare, confined to bed or chair more than 50% of waking hours)
CL Item
4 (Completely disabled)
PatientWeight
Item
Weight (if measured in clinic)
float
Item
Menstrual status during 3 months prior to follow-up visit (select one)
text
Code List
Menstrual status during 3 months prior to follow-up visit (select one)
CL Item
Occasionally Irregular Or Lengthened Interval, But Continuing Menstrual Cycles (Irregular)
CL Item
Normal (Normal)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
CL Item
Persistent Amenorrhea (Persistent amenorrhea)
Item
Was patient pregnant at any time during this follow-up period? If more than one pregnancy, indicate most recent episode. (If pregnant during protocol treatment, complete Form 24-EIU for each pregnancy.)
text
Code List
Was patient pregnant at any time during this follow-up period? If more than one pregnancy, indicate most recent episode. (If pregnant during protocol treatment, complete Form 24-EIU for each pregnancy.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Currently Pregnant (Yes, currently pregnant)
CL Item
Full Term Live Birth (Full term live birth)
CL Item
Preterm Live Birth (Preterm live birth)
CL Item
Stillbirth (Stillbirth)
CL Item
Neonatal Death (Neonatal death)
CL Item
Miscarriage / Spontaneous Abortion (Miscarriage / spontaneous abortion)
CL Item
Induced / Elective Abortion (Induced / elective abortion)
Item
Did the patient have gynecologic surgery, procedures and/or diagnostic imaging (excluding PAP smear?)
text
Code List
Did the patient have gynecologic surgery, procedures and/or diagnostic imaging (excluding PAP smear?)
CL Item
No (No.)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
PatientAttemptPregnancyInd-2
Item
Has the patient attempted to become pregnant during this follow-up period
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)
C39769 (NCI Thesaurus Property-2)
C1516084 (UMLS 2011AA Property-2)
Item
Method
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
C39769 (NCI Thesaurus Property-2)
C1516084 (UMLS 2011AA Property-2)
Code List
Method
CL Item
Assisted (Assisted)
CL Item
Natural (Natural)
Hasthepatienthadanyclinicallysignificantcardiovascularand/orcerebrovasculareventsafterprotocoltreatmentended?
Item
Has the patient had any clinically significant cardiovascular and/or cerebrovascular events after protocol treatment ended (Report on Form 24-AE if during protocol treatment or up to 12 months after protocol treatment has ended.)
boolean
Off-TreatmentCardiovascularCerebrovascularEventSpecify
Item
Specify event
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
AdverseEventOnsetDate
Item
Specify date
date
C25164 (NCI Thesaurus Property)
C0011008 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25279 (NCI Thesaurus Property-2)
C0332162 (UMLS 2011AA Property-2)
AdverseEventOnsetDate
Item
Specify date
date
C25164 (NCI Thesaurus Property)
C0011008 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25279 (NCI Thesaurus Property-2)
C0332162 (UMLS 2011AA Property-2)
Hasthepatientexperiencedabonefracturesincesubmissionoflastfollow-upform?
Item
Did the patient have any bone fractures after protocol treatment ended? (Report on Form 24-AE if during protocol treatment or up to 12 months after protocol treatment has ended.)
boolean
LateAdverseEventInd
Item
Has patient experienced any other severe (> grade 3) adverse event(s), (not reported in Q13-16) after protocol treatment ended? (Report on Form 24-AE during protocol treatment or up to 12 months after protocol treatment has ended.)
boolean
BrieflydescribetheAE
Item
Describe
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
Item
Was event related to protocol treatment
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C28041 (NCI Thesaurus Property-2)
C1517586 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-2)
C25358 (NCI Thesaurus Property-4)
C0596130 (UMLS 2011AA Property-3)
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
Code List
Was event related to protocol treatment
CL Item
Definite (Definite)
CL209464 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
Item
Was event related to protocol treatment
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C28041 (NCI Thesaurus Property-2)
C1517586 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-2)
C25358 (NCI Thesaurus Property-4)
C0596130 (UMLS 2011AA Property-3)
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
Code List
Was event related to protocol treatment
CL Item
Definite (Definite)
CL209464 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
Item
Was event related to protocol treatment
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C28041 (NCI Thesaurus Property-2)
C1517586 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-2)
C25358 (NCI Thesaurus Property-4)
C0596130 (UMLS 2011AA Property-3)
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
Code List
Was event related to protocol treatment
CL Item
Definite (Definite)
CL209464 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
Item
Has the patient been diagnosed with in situ breast cancer, right side, since the submission of the last Follow-up Form (select one)
text
Code List
Has the patient been diagnosed with in situ breast cancer, right side, since the submission of the last Follow-up Form (select one)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Ductal Carcinoma In Situ (Yes, ductal carcinoma in situ)
CL Item
Yes, Lobular Carcinoma In Situ (Yes, lobular carcinoma in situ)
CL Item
Yes, Both Ductal And Lobular Carcinoma In Situ (Yes, both ductal and lobular carcinoma in situ)
Item
Has the patient been diagnosed with in situ breast cancer, left side, since the submission of the last Follow-up Form
text
Code List
Has the patient been diagnosed with in situ breast cancer, left side, since the submission of the last Follow-up Form
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Both Ductal & Lobular Carcinoma In Situ (Yes, both ductal & lobular carcinoma in situ)
CL Item
Yes, Ductal Carcinoma In Situ (Yes, ductal carcinoma in situ)
CL Item
Yes, Lobular Carcinoma In Situ (Yes, lobular carcinoma in situ)
BreastTherapyMethodName
Item
Specify treatment
text
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
BreastTherapyMethodName
Item
Specify treatment
text
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
HasthepatientbeendiagnosedwithinsitucervicalcancersincethesubmissionofthelastFollow-upForm?
Item
Has the patient been diagnosed with in situ cervical cancer since the submission of the last Follow-up Form?
boolean
HasthepatientbeendiagnosedwithbasalcellorsquamouscellcarcinomaoftheskinsincethesubmissionofthelastFollow-upForm?
Item
Has the patient been diagnosed with basal cell or squamous cell carcinoma of the skin since the submission of the last Follow-up Form?
boolean
InitialDiagnosisDate
Item
Date of Initial Pathologic Diagnosis (day month year)
date
InitialDiagnosisDate
Item
Date of Initial Pathologic Diagnosis (day month year)
date
InitialDiagnosisDate
Item
Date of Initial Pathologic Diagnosis (day month year)
date
InitialDiagnosisDate
Item
Date of Initial Pathologic Diagnosis (day month year)
date
SecondPrimaryNeoplasmDiagnosisInd-2
Item
Has patient had a suspicious or proven second primary since submission of last Follow-up Form
boolean
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C25666 (NCI Thesaurus ObjectClass-3)
C0205436 (UMLS 2011AA ObjectClass-3)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Specify site below
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C25666 (NCI Thesaurus ObjectClass-3)
C0205436 (UMLS 2011AA ObjectClass-3)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Specify site below
CL Item
Endometrial Cancer (Endometrial cancer)
CL Item
Mixed Mullerian Tumor (Mixed Mullerian tumor)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Uterine Sarcoma (Uterine sarcoma)
SecondPrimaryNeoplasmDiagnosisSpecify
Item
Other, specify type and site
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C25666 (NCI Thesaurus ObjectClass-3)
C0205436 (UMLS 2011AA ObjectClass-3)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
SecondPrimaryNeoplasmDiagnosisSpecify
Item
Other, specify type and site
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C25666 (NCI Thesaurus ObjectClass-3)
C0205436 (UMLS 2011AA ObjectClass-3)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Datesuspected
Item
Date suspected
text
Datesuspected
Item
Date suspected
text
Dateproven
Item
Date proven
text
Dateproven
Item
Date proven
text
SecondPrimaryNeoplasmTherapySpecify
Item
Specify treatment for first 2nd primary
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C25666 (NCI Thesaurus ObjectClass-3)
C0205436 (UMLS 2011AA ObjectClass-3)
C15368 (NCI Thesaurus Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Haspatienthadasuspiciousorprovenrecurrence/metastasisorcontralateralinvasivebreastcancersincesubmissionoflastFollow-upForm?
Item
Has patient had a suspicious or proven recurrence/metastasis or contralateral invasive breast cancer since submission of last Follow-up Form?
boolean
Item
Site
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
Code List
Site
CL Item
Breast Scar / Skin (Breast scar / skin)
CL Item
Breast Tissue (Breast tissue)
CL Item
Chest Wall (Chest wall)
CL Item
Chest Wall / Outside Breast (Chest wall / outside breast)
CL Item
Contra Breast (Contra breast)
CL Item
Ipsi Axilla (Ipsi axilla)
CL Item
Ipsi Axillary Nodes (Ipsi axillary nodes)
CL Item
Ipsi Infraclavicular Nodes (Ipsi infraclavicular nodes)
CL Item
Ipsi Internal Mammary Nodes (Ipsi internal mammary nodes)
CL Item
Ipsi Supraclavicular Nodes (Ipsi supraclavicular nodes)
CL Item
Scar (Scar)
CL Item
Specify Site (Specify site)
BreastCarcinomaRecurrentDiseaseSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
Item
Investigation
text
C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
Code List
Investigation
CL Item
Bone Scan (Bone scan)
C17646 (NCI Thesaurus)
C0203668 (UMLS 2011AA)
CL Item
Ct Scan (CT scan)
CL Item
Cytology (Cytology)
C16491 (NCI Thesaurus)
C0010819 (UMLS 2011AA)
CL Item
Histology (Histology)
C16681 (NCI Thesaurus)
C0019638 (UMLS 2011AA)
CL Item
Mri (MRI (NMR))
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Pet Scan (PET scan)
CL Item
Ultrasound (Ultrasound)
C64384 (NCI Thesaurus)
C1456803 (UMLS 2011AA)
CL Item
X-ray (X-ray)
AssessmentDiagnosticMethodSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C25482 (NCI Thesaurus Property-2)
C0348026 (UMLS 2011AA Property-2)
PatientFirstAssessmentDate
Item
Date 1st Performed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
PatientRepeatAssessmentDate
Item
Date Repeated
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C47886 (NCI Thesaurus Property-2)
C0205341 (UMLS 2011AA Property-2)
BreastCarcinomaRecurrentDiseaseInd-2
Item
Are there additional sites
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
SurgicalProcedureBreastNeoplasmPerformedInd-2
Item
Surgery
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C2910 (NCI Thesaurus Property-2)
C0042875 (UMLS 2011AA Property-2)
ProtocolSurgeryType
Item
Specify procedure
text
SurgeryDate
Item
Surgery Date (D M Y)
date
RTInd
Item
Radiation Therapy
boolean
RTTotalDoseperField
Item
Specify dose
float
RTSite
Item
Specify field
text
Chemotherapy
Item
Chemotherapy
boolean
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25180 (NCI Thesaurus ValueDomain-2)
C1522602 (UMLS 2011AA ValueDomain-2)
AgentName
Item
Specify drug
text
HormonalTherapyInd
Item
Endocrine therapy
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Specifyendocrinetherapy
Item
Specify
text
OtherTherapyInd
Item
Other
boolean
OtherTherapyType
Item
Specify
text
Datestarted
Item
Date started
date
Datestarted
Item
Date started
date
Datestarted
Item
Date started
date
Datestarted
Item
Date started
date
InvestigatorSignature
Item
Investigator Signature (/Designee)
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignatureDate
Item
Date (day month year)
date

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