ID

11491

Description

FORM 5 - SYSTEMIC THERAPY & FOLLOW-UP REPORT NCT00090974 Quality Of Life Companion Study For JMA27 (NCIC-MA.27): A Randomized Phase III Trial Of Exemestane Versus Anastrozole With Or Without Celecoxib In Postmenopausal Women With Receptor Positive Primary Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=ABF6F62D-7F89-673B-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=ABF6F62D-7F89-673B-E034-0003BA12F5E7

Keywords

Versions (3)
  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 7/5/15 7/5/15 -
Uploaded on

July 5, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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FORM 5 - SYSTEMIC THERAPY & FOLLOW-UP REPORT NCT00090974

English

To be completed on all patients at 6 and 12 months, then annually after randomization or until the patient discontinues all protocol treatment. To be submitted within 6 weeks of the date the patient was seen at the clinic. (After the patient has stopped receiving protocol treatment use Form 5S.)

1 forms  
Patient Information
Description

Patient Information

Patient Study ID, Coordinating Group
Description

PatientStudyID,CoordinatingGroup

Data type

text

Patient Initials (first - middle - last)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Patient Medical Record Number
Description

PatientMedicalRecordNumber

Data type

text

Investigator Name
Description

InvestigatorName

Data type

text

Institution Name
Description

InstitutionName

Data type

text

Registered Investigator (NCI Investigator #)
Description

RegisteredInvestigator

Data type

text

Month Of Report
Description

Month Of Report

Month of report (circle one or enter # of months from randomization)
Description

VisitReportMonthCount

Data type

text

Alias
NCI Thesaurus Property
C29846
UMLS 2011AA Property
C0439231
NCI Thesaurus ObjectClass
C25375
UMLS 2011AA ObjectClass
C0684224
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ObjectClass-2
C25716
UMLS 2011AA ObjectClass-2
C0545082
Other (month of report)
Description

VisitReportMonthSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C29846
UMLS 2011AA Property
C0439231
NCI Thesaurus ObjectClass
C25375
UMLS 2011AA ObjectClass
C0684224
NCI Thesaurus ObjectClass-2
C25716
UMLS 2011AA ObjectClass-2
C0545082
Physical Exam
Description

Physical Exam

Date of last clinical assessment (yyyy mmm dd)
Description

CancerFollow-upStatusDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Patient Weight (kg)
Description

PatientWeight

Data type

float

Status of most recent clinical assessment
Description

CancerFollow-upStatus,Recent

Data type

text

Systemic Therapy Report
Description

Systemic Therapy Report

Treatment Begin Date (yyyy mmm dd)
Description

TreatmentBeginDate

Data type

date

Were there any dose modifications or additions/omissions to protocol treatment?
Description

DoseModification(Change)

Data type

text

Explanation (Yes, planned modifications to protocol treatment)
Description

Explanation(Yes,plannedmodificationstoprotocoltreatment)

Data type

text

Explanation (Yes, unplanned modifications to protocol treatment)
Description

DoseModificationReason

Data type

text

Number of Aromatase Inhibitor pills missed or lost since last follow-up
Description

NumberofAromataseInhibitorpillsmissedorlostsincelastfollow-up

Data type

float

Number of Celecoxib/Placebo pills missed or lost since last follow-up
Description

NumberofCelecoxib/Placebopillsmissedorlostsincelastfollow-up

Data type

float

Has Aromatase Inhibitor been permanently discontinued?
Description

HasAromataseInhibitorbeenpermanentlydiscontinued?

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Celecoxib/Placebo End Date (yyyy mmm dd)
Description

AgentEndDate

Data type

date

Has Celecoxib/Placebo been permanently discontinued?
Description

HasCelecoxib/Placebobeenpermanentlydiscontinued?

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Adverse Events
Description

Adverse Events

Has the patient experienced a bone fracture since submission of last follow-up form?
Description

Hasthepatientexperiencedabonefracturesincesubmissionoflastfollow-upform?

Data type

boolean

Bone Fracture Site, Spinal (Check)
Description

BoneFractureSite,Spinal

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Bone Fracture Site, Wrist (Check)
Description

BoneFractureSite,Wrist

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Bone Fracture Site, Pelvis (Check)
Description

BoneFractureSite,Pelvis

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Bone Fracture Site, Hip (Check)
Description

BoneFractureSite,Hip

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Bone Fracture Site, Femur (Check)
Description

BoneFractureSite,Femur

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Bone Fracture Site, Tibia (Check)
Description

BoneFractureSite,Tibia

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Bone Fracture Site, Ankle (Check)
Description

BoneFractureSite,Ankle

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Bone Fracture Site, Other (specify) (Check)
Description

BoneFractureSite,Other(specify)

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
indicate site (bone fracture site)
Description

indicatesite(bonefracturesite)

Data type

text

Date of Bone Fracture (yyyy-mmm-dd)
Description

BoneFractureDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C12366
UMLS 2011AA ObjectClass
C0262950
NCI Thesaurus Property
C3046
UMLS 2011AA Property
C0016658
Has the patient had a new diagnosis of osteoporosis since submission of last follow-up form?
Description

Hasthepatienthadanewdiagnosisofosteoporosissincesubmissionoflastfollow-upform?

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Date of new diagnosis of osteoporosis (yyyy mmm dd)
Description

DiseaseOsteoporosisDiagnosisDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C3298
UMLS 2011AA Property
C0029456
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property-2
C15220
UMLS 2011AA Property-2
C0011900
Has the patient suffered cardiovascular disease since submission of last follow-up form?
Description

Hasthepatientsufferedcardiovasculardiseasesincesubmissionoflastfollow-upform?

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Cardiovascular Event, Myocardial infarction (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
Description

CardiovascularEvent,Myocardialinfarction

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Cardiovascular Event, Stroke/transient ischemic attack (TIA) (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
Description

CardiovascularEvent,Stroke/transientischemicattack(TIA)

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Cardiovascular Event, On-going angina (no surgical intervention) (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
Description

CardiovascularEvent,On-goingangina(nosurgicalintervention)

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Cardiovascular Event, Angina requiring percutaneous transluminal coronary angioplasty (PTCA) (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
Description

HeartPatientAnginaPercutaneousTransluminalCoronaryAngioplastyPersonalMedicalHistoryInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C12727
UMLS 2011AA ObjectClass-2
C0018787
NCI Thesaurus Property
C51221
UMLS 2011AA Property
C0002962
NCI Thesaurus Property-2
C38078
UMLS 2011AA Property-2
C2936173
NCI Thesaurus Property-3
C18772
UMLS 2011AA Property-3
C0262926
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Cardiovascular Event, Thromboembolic event (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
Description

CardiovascularEvent,Thromboembolicevent

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Cardiovascular Event, Other (specify) (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
Description

CardiovascularEvent,Other(specify)

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
please describe event (cardiovascular event)
Description

pleasedescribeevent(cardiovascularevent)

Data type

text

Date of Most Recent Episode (yyyy-mmm-dd)
Description

DateofMostRecentEpisode

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Other Malignancies Or Myelodysplastic Syndrome
Description

Other Malignancies Or Myelodysplastic Syndrome

Has a new primary cancer or MDS been diagnosed that has not been previously reported?
Description

NewPrimaryCancerInd

Data type

boolean

Date of diagnosis (yyyy mmm dd)
Description

NewPrimaryCancerDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Malignancy Type
Description

MalignancyType

Data type

text

Site(s) of New Primary
Description

NewPrimarySite

Data type

text

Describe (new primary cancer) (See protocol section 11.0 for details of reporting.)
Description

NewPrimaryDiagnosis

Data type

text

Hematology
Description

Hematology

Date Hematology (Blood) Sample Obtained (yyyy mmm dd)
Description

Lab,Hematology,SampleCollectionDate

Data type

date

Peripheral WBC Count (Value)
Description

Lab,Hematology,WBC

Data type

float

Lab Unit of Measure (circle unit used)
Description

Lab,UnitsofMeasure

Data type

text

Peripheral Neutrophil Count (granulocytes)
Description

Lab,Hematology,NeutrophilCount

Data type

float

Peripheral Neutrophils % (Value)
Description

Lab,Hematology,Neutrophils,CellPercentage

Data type

float

Peripheral Platelet Count (Value)
Description

Lab,Hematology,Platelets

Data type

float

Hemoglobin (Value)
Description

Lab,Hematology,Hemoglobin

Data type

float

Biochemistry
Description

Biochemistry

Specimen Collection Date -- Biochemistry (yyyy mmm dd)
Description

SpecimenCollectionDate

Data type

date

SGOT (AST) (Value)
Description

Lab,Hepatic,SGOT

Data type

float

SGOT (AST) ULN
Description

SGOTLabUpperLimitNormalValue

Data type

float

Alias
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
SGPT (ALT) (Value)
Description

Lab,Hepatic,SGPT

Data type

float

SGPT (ALT) ULN
Description

SGPTLabUpperLimitNormalValue

Data type

float

Alias
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
Alkaline Phosphatase (Value)
Description

Lab,Hepatic,AlkalinePhosphatase

Data type

float

Alkaline Phosphatase ULN
Description

Alkaline Phosphatase ULN

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0151420
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C16276
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
Creatinine (Value)
Description

Lab,Renal,Creatinine

Data type

float

Creatinine ULN
Description

Creatinine, serum ULN

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201976
NCI Thesaurus Property
C20200
UMLS CUI-2
C1519815
NCI Thesaurus Property-2
C399
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
Calcium(Ca) (Value)
Description

Calcium(Ca)

Data type

float

Calcium LLN
Description

LaboratoryProcedureCalciumElectrolytesOutcomeLowerLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C331
UMLS 2011AA Property
C0006675
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus Property-3
C464
UMLS 2011AA Property-3
C0013832
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25555
UMLS 2011AA ValueDomain-2
C1518030
Calcium ULN
Description

LaboratoryProcedureCalciumElectrolytesOutcomeUpperLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C331
UMLS 2011AA Property
C0006675
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus Property-3
C464
UMLS 2011AA Property-3
C0013832
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
Investigations
Description

Investigations

Imaging site
Description

DiagnosticImagingAnatomicSite

Data type

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus ObjectClass
C16502
UMLS 2011AA ObjectClass
C0011923
NCI Thesaurus Property-2
C25421
UMLS 2011AA Property-2
C0002808
Method of Evaluation
Description

MethodofEvaluation

Data type

text

Date of Evaluation (yyyy-mmm-dd)
Description

AssessmentDate

Data type

date

Toxicity Evaluation
Description

Toxicity Evaluation

Did the patient experience any new or continuing toxicities of protocol treatment since the last report?
Description

NEWORCONTINUINGTOXICITY(>SeverityGrade3)SINCETHELASTREPORT?

Data type

boolean

CTC Adverse Event Term (Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
Description

CTCAdverseEventTerm

Data type

text

CTC Adverse Event Term, Other (specify)
Description

CTCAdverseEventTerm,Other

Data type

text

CTC Adverse Event Category (Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
Description

CTCAdverseEventCategory

Data type

text

CTC Adverse Event Grade (Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
Description

CTCAdverseEventGrade

Data type

text

CTC Adverse Event Attribution Code
Description

CTCAdverseEventAttributionCode

Data type

text

COMMENTS
Description

Comments

Data type

text

Treatment Given Since Last Report To Ncic Ctg
Description

Treatment Given Since Last Report To Ncic Ctg

Is the patient receiving any non-protocol cancer therapy not previously reported?
Description

Non-ProtocolTherapyInd

Data type

boolean

Non-Protocol Raloxifene Therapy
Description

Non-ProtocolRaloxifeneTherapy

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C1518
UMLS 2011AA Property
C0244404
NCI Thesaurus ObjectClass
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
Non-Protocol Bisphosphonate Therapy
Description

Non-ProtocolTherapeuticProcedureBiphosphonateAdministeredInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C49236
UMLS 2011AA ObjectClass
C0087111
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass-2
C1518384
NCI Thesaurus Property
C443
UMLS 2011AA Property
C0012544
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Non-Protocol Lipid Lowering Therapy
Description

Non-ProtocolLipidLoweringTherapy

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Other Non-Protocol Therapy
Description

OtherNon-ProtocolTherapyInd

Data type

boolean

Other Non-Protocol Therapy Name
Description

OtherNon-ProtocolTherapyName

Data type

text

Comments
Description

Comments

Supporting Documentation
Description

Supporting Documentation

Investigator Signature
Description

Investigator Signature

Investigator Signature
Description

InvestigatorSignature

Data type

text

Alias
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Person Completing Form, Last Name
Description

PersonCompletingForm,LastName

Data type

text

Person Completing Form, First Name
Description

PersonCompletingForm,FirstName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Form Completion Date, Original (yyyy mmm dd)
Description

FormCompletionDate,Original

Data type

date

Ccrr Module For Form 5 - Systemic Therapy & Follow-up Report
Description

Ccrr Module For Form 5 - Systemic Therapy & Follow-up Report

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To be completed on all patients at 6 and 12 months, then annually after randomization or until the patient discontinues all protocol treatment. To be submitted within 6 weeks of the date the patient was seen at the clinic. (After the patient has stopped receiving protocol treatment use Form 5S.)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient Information
PatientStudyID,CoordinatingGroup
Item
Patient Study ID, Coordinating Group
text
Patient Initials
Item
Patient Initials (first - middle - last)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
PatientMedicalRecordNumber
Item
Patient Medical Record Number
text
InvestigatorName
Item
Investigator Name
text
InstitutionName
Item
Institution Name
text
RegisteredInvestigator
Item
Registered Investigator (NCI Investigator #)
text
Item Group
Month Of Report
Item
Month of report (circle one or enter # of months from randomization)
text
C29846 (NCI Thesaurus Property)
C0439231 (UMLS 2011AA Property)
C25375 (NCI Thesaurus ObjectClass)
C0684224 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25716 (NCI Thesaurus ObjectClass-2)
C0545082 (UMLS 2011AA ObjectClass-2)
CL.1
Code List
Month of report (circle one or enter # of months from randomization)
CL Item
6 (6)
CL Item
12 (12)
CL Item
Other Month (Other)
VisitReportMonthSpecify
Item
Other (month of report)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C29846 (NCI Thesaurus Property)
C0439231 (UMLS 2011AA Property)
C25375 (NCI Thesaurus ObjectClass)
C0684224 (UMLS 2011AA ObjectClass)
C25716 (NCI Thesaurus ObjectClass-2)
C0545082 (UMLS 2011AA ObjectClass-2)
Item Group
Physical Exam
CancerFollow-upStatusDate
Item
Date of last clinical assessment (yyyy mmm dd)
date
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
PatientWeight
Item
Patient Weight (kg)
float
Item
Status of most recent clinical assessment
text
CL.2
Code List
Status of most recent clinical assessment
CL Item
No Evidence Of Disease (No evidence of disease)
CL Item
Cancer Present (Cancer Present)
Item Group
Systemic Therapy Report
TreatmentBeginDate
Item
Treatment Begin Date (yyyy mmm dd)
date
Item
Were there any dose modifications or additions/omissions to protocol treatment?
text
CL.3
Code List
Were there any dose modifications or additions/omissions to protocol treatment?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
(i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes Planned)
CL Item
(i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes Unplanned)
Explanation(Yes,plannedmodificationstoprotocoltreatment)
Item
Explanation (Yes, planned modifications to protocol treatment)
text
DoseModificationReason
Item
Explanation (Yes, unplanned modifications to protocol treatment)
text
NumberofAromataseInhibitorpillsmissedorlostsincelastfollow-up
Item
Number of Aromatase Inhibitor pills missed or lost since last follow-up
float
NumberofCelecoxib/Placebopillsmissedorlostsincelastfollow-up
Item
Number of Celecoxib/Placebo pills missed or lost since last follow-up
float
HasAromataseInhibitorbeenpermanentlydiscontinued?
Item
Has Aromatase Inhibitor been permanently discontinued?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
AgentEndDate
Item
Celecoxib/Placebo End Date (yyyy mmm dd)
date
HasCelecoxib/Placebobeenpermanentlydiscontinued?
Item
Has Celecoxib/Placebo been permanently discontinued?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Item Group
Adverse Events
Hasthepatientexperiencedabonefracturesincesubmissionoflastfollow-upform?
Item
Has the patient experienced a bone fracture since submission of last follow-up form?
boolean
Item
Bone Fracture Site, Spinal (Check)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.7
Code List
Bone Fracture Site, Spinal (Check)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Bone Fracture Site, Wrist (Check)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.8
Code List
Bone Fracture Site, Wrist (Check)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Bone Fracture Site, Pelvis (Check)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.9
Code List
Bone Fracture Site, Pelvis (Check)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Bone Fracture Site, Hip (Check)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.10
Code List
Bone Fracture Site, Hip (Check)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Bone Fracture Site, Femur (Check)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.11
Code List
Bone Fracture Site, Femur (Check)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Bone Fracture Site, Tibia (Check)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.12
Code List
Bone Fracture Site, Tibia (Check)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Bone Fracture Site, Ankle (Check)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.13
Code List
Bone Fracture Site, Ankle (Check)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Bone Fracture Site, Other (specify) (Check)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.14
Code List
Bone Fracture Site, Other (specify) (Check)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
indicatesite(bonefracturesite)
Item
indicate site (bone fracture site)
text
BoneFractureDate
Item
Date of Bone Fracture (yyyy-mmm-dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C12366 (NCI Thesaurus ObjectClass)
C0262950 (UMLS 2011AA ObjectClass)
C3046 (NCI Thesaurus Property)
C0016658 (UMLS 2011AA Property)
Hasthepatienthadanewdiagnosisofosteoporosissincesubmissionoflastfollow-upform?
Item
Has the patient had a new diagnosis of osteoporosis since submission of last follow-up form?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
DiseaseOsteoporosisDiagnosisDate
Item
Date of new diagnosis of osteoporosis (yyyy mmm dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3298 (NCI Thesaurus Property)
C0029456 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
Hasthepatientsufferedcardiovasculardiseasesincesubmissionoflastfollow-upform?
Item
Has the patient suffered cardiovascular disease since submission of last follow-up form?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Item
Cardiovascular Event, Myocardial infarction (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.17
Code List
Cardiovascular Event, Myocardial infarction (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Cardiovascular Event, Stroke/transient ischemic attack (TIA) (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.18
Code List
Cardiovascular Event, Stroke/transient ischemic attack (TIA) (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Cardiovascular Event, On-going angina (no surgical intervention) (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.19
Code List
Cardiovascular Event, On-going angina (no surgical intervention) (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Cardiovascular Event, Angina requiring percutaneous transluminal coronary angioplasty (PTCA) (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12727 (NCI Thesaurus ObjectClass-2)
C0018787 (UMLS 2011AA ObjectClass-2)
C51221 (NCI Thesaurus Property)
C0002962 (UMLS 2011AA Property)
C38078 (NCI Thesaurus Property-2)
C2936173 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.20
Code List
Cardiovascular Event, Angina requiring percutaneous transluminal coronary angioplasty (PTCA) (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Cardiovascular Event, Thromboembolic event (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.21
Code List
Cardiovascular Event, Thromboembolic event (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Cardiovascular Event, Other (specify) (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.22
Code List
Cardiovascular Event, Other (specify) (Report only events which have occurred since last report or conditions which were present at the time of last report and have worsened since. Report non-ischemic events in the "other" category.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
pleasedescribeevent(cardiovascularevent)
Item
please describe event (cardiovascular event)
text
DateofMostRecentEpisode
Item
Date of Most Recent Episode (yyyy-mmm-dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Other Malignancies Or Myelodysplastic Syndrome
NewPrimaryCancerInd
Item
Has a new primary cancer or MDS been diagnosed that has not been previously reported?
boolean
NewPrimaryCancerDate
Item
Date of diagnosis (yyyy mmm dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
MalignancyType
Item
Malignancy Type
text
NewPrimarySite
Item
Site(s) of New Primary
text
NewPrimaryDiagnosis
Item
Describe (new primary cancer) (See protocol section 11.0 for details of reporting.)
text
Item Group
Hematology
Lab,Hematology,SampleCollectionDate
Item
Date Hematology (Blood) Sample Obtained (yyyy mmm dd)
date
Lab,Hematology,WBC
Item
Peripheral WBC Count (Value)
float
Item
Lab Unit of Measure (circle unit used)
text
CL.33
Code List
Lab Unit of Measure (circle unit used)
CL Item
Umol/l (umol/L)
CL Item
Mg/dl (mg/dL)
Lab,Hematology,NeutrophilCount
Item
Peripheral Neutrophil Count (granulocytes)
float
Lab,Hematology,Neutrophils,CellPercentage
Item
Peripheral Neutrophils % (Value)
float
Lab,Hematology,Platelets
Item
Peripheral Platelet Count (Value)
float
Lab,Hematology,Hemoglobin
Item
Hemoglobin (Value)
float
Item Group
Biochemistry
SpecimenCollectionDate
Item
Specimen Collection Date -- Biochemistry (yyyy mmm dd)
date
Lab,Hepatic,SGOT
Item
SGOT (AST) (Value)
float
SGOTLabUpperLimitNormalValue
Item
SGOT (AST) ULN
float
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
Lab,Hepatic,SGPT
Item
SGPT (ALT) (Value)
float
SGPTLabUpperLimitNormalValue
Item
SGPT (ALT) ULN
float
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
Lab,Hepatic,AlkalinePhosphatase
Item
Alkaline Phosphatase (Value)
float
Alkaline Phosphatase ULN
Item
Alkaline Phosphatase ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0151420 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C16276 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
Lab,Renal,Creatinine
Item
Creatinine (Value)
float
Creatinine, serum ULN
Item
Creatinine ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C399 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
Calcium(Ca)
Item
Calcium(Ca) (Value)
float
LaboratoryProcedureCalciumElectrolytesOutcomeLowerLimitofNormalValue
Item
Calcium LLN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C331 (NCI Thesaurus Property)
C0006675 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C464 (NCI Thesaurus Property-3)
C0013832 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureCalciumElectrolytesOutcomeUpperLimitofNormalValue
Item
Calcium ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C331 (NCI Thesaurus Property)
C0006675 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C464 (NCI Thesaurus Property-3)
C0013832 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
Item Group
Investigations
Item
Imaging site
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C25421 (NCI Thesaurus Property-2)
C0002808 (UMLS 2011AA Property-2)
CL.34
Code List
Imaging site
CL Item
Chest (CHEST)
C25389 (NCI Thesaurus)
C0817096 (UMLS 2011AA)
Item
Method of Evaluation
text
CL.35
Code List
Method of Evaluation
CL Item
Bilateral Mammogram (Bilateral Mammogram)
AssessmentDate
Item
Date of Evaluation (yyyy-mmm-dd)
date
Item Group
Toxicity Evaluation
NEWORCONTINUINGTOXICITY(>SeverityGrade3)SINCETHELASTREPORT?
Item
Did the patient experience any new or continuing toxicities of protocol treatment since the last report?
boolean
Item
CTC Adverse Event Term (Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
text
CL.37
Code List
CTC Adverse Event Term (Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
CL Item
edema (edema)
CL Item
fatigue (lethary/malaise/asthenia) (fatigue (lethary/malaise/asthenia))
CL Item
sweating (diaphoresis) (sweating (diaphoresis))
CL Item
rash/desquamation (rash/desquamation)
CL Item
hot flashes/flushes (hot flashes/flushes)
CL Item
anorexia (anorexia)
CL Item
constipation (constipation)
CL Item
diarrhea (patients without colostomy) (diarrhea (patients without colostomy))
CL Item
dyspepsia/heartburn (dyspepsia/heartburn)
CL Item
flatulence (flatulence)
CL Item
nausea (nausea)
CL Item
vomiting (vomiting)
CL Item
vaginal bleeding (vaginal bleeding)
CL Item
infection (without neutropenia) (infection (without neutropenia))
CL Item
hypercholesterolemia (hypercholesterolemia)
CL Item
dizziness/lightheadedness (dizziness/lightheadedness)
CL Item
abdominal pain or cramping (abdominal pain or cramping)
CL Item
arthralgia (joint pain) (arthralgia (joint pain))
CL Item
headache (headache)
CL Item
cough (cough)
CL Item
dyspnea (shortness of breath) (dyspnea (shortness of breath))
CL Item
other (other)
CTCAdverseEventTerm,Other
Item
CTC Adverse Event Term, Other (specify)
text
Item
CTC Adverse Event Category (Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
text
CL.38
Code List
CTC Adverse Event Category (Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
CL Item
cardiovascular (cardiovascular)
CL Item
constitutional symptoms (constitutional symptoms)
CL Item
dermatology/skin (dermatology/skin)
CL Item
endocrine (endocrine)
CL Item
gastrointestinal (gastrointestinal)
CL Item
hemorrhage (hemorrhage)
CL Item
infection (infection)
CL Item
metabolic (metabolic)
CL Item
neurology (neurology)
CL Item
pain (pain)
CL Item
pulmonary (pulmonary)
CTCAdverseEventGrade
Item
CTC Adverse Event Grade (Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
text
Item
CTC Adverse Event Attribution Code
text
CL.39
Code List
CTC Adverse Event Attribution Code
CL Item
Unrelated (unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (unlikely)
CL Item
Possibly (possible)
CL Item
Probably (probable)
CL Item
Definitely (definite)
Comments
Item
COMMENTS
text
Item Group
Treatment Given Since Last Report To Ncic Ctg
Non-ProtocolTherapyInd
Item
Is the patient receiving any non-protocol cancer therapy not previously reported?
boolean
Non-ProtocolRaloxifeneTherapy
Item
Non-Protocol Raloxifene Therapy
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C1518 (NCI Thesaurus Property)
C0244404 (UMLS 2011AA Property)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
Non-ProtocolTherapeuticProcedureBiphosphonateAdministeredInd-3
Item
Non-Protocol Bisphosphonate Therapy
boolean
C49236 (NCI Thesaurus ObjectClass)
C0087111 (UMLS 2011AA ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass-2)
C443 (NCI Thesaurus Property)
C0012544 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Non-ProtocolLipidLoweringTherapy
Item
Non-Protocol Lipid Lowering Therapy
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
OtherNon-ProtocolTherapyInd
Item
Other Non-Protocol Therapy
boolean
OtherNon-ProtocolTherapyName
Item
Other Non-Protocol Therapy Name
text
Item Group
Comments
Item Group
Supporting Documentation
Item Group
Investigator Signature
InvestigatorSignature
Item
Investigator Signature
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
PersonCompletingForm,LastName
Item
Person Completing Form, Last Name
text
PersonCompletingForm,FirstName
Item
Person Completing Form, First Name
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
FormCompletionDate,Original
Item
Form Completion Date, Original (yyyy mmm dd)
date
Item Group
Ccrr Module For Form 5 - Systemic Therapy & Follow-up Report
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