ID

9427

Descripción

FORM 5S - SHORT FOLLOW-UP REPORT 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=ABE490D9-DEFA-56EC-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=ABE490D9-DEFA-56EC-E034-0003BA12F5E7

Palabras clave

Versiones (3)
  1. 26/8/12 26/8/12 -
  2. 9/1/15 9/1/15 - Martin Dugas
  3. 5/7/15 5/7/15 -
Subido en

9 de enero de 2015

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00090974 Follow-Up - FORM 5S - SHORT FOLLOW-UP REPORT - 2060886v3.0

Inglés

Canadian Centres: When completed please mail to:National Cancer Institute of Canada, Clinical Trials Group, Queen's University, 82-84 Barrie Street, Kingston, Ontario, K7L 3N6

1 formularios  
Patient Information
Descripción

Patient Information

Patient Study ID, Coordinating Group
Descripción

PatientStudyID,CoordinatingGroup

Tipo de datos

text

Patient Initials (first - middle - last)
Descripción

Patient Initials

Tipo de datos

text

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

PatientMedicalRecordNumber

Tipo de datos

text

Investigator Name
Descripción

InvestigatorName

Tipo de datos

text

Institution Name
Descripción

InstitutionName

Tipo de datos

text

Registered Investigator (NCI Investigator #)
Descripción

RegisteredInvestigator

Tipo de datos

text

Month Of Report
Descripción

Month Of Report

Month of report (circle one)
Descripción

VisitReportMonthCount

Tipo de datos

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)
Descripción

VisitReportMonthSpecify

Tipo de datos

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
Date of last clinical assessment (yyyy mmm dd)
Descripción

CancerFollow-upStatusDate

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Disease Status
Descripción

Disease Status

Status of most recent clinical assessment
Descripción

CancerFollow-upStatus,Recent

Tipo de datos

text

Other Malignancies Or Myelodysplastic Syndrome
Descripción

Other Malignancies Or Myelodysplastic Syndrome

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

NewPrimaryCancerInd

Tipo de datos

boolean

Date of diagnosis (yyyy mmm dd)
Descripción

NewPrimaryCancerDate

Tipo de datos

date

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

MalignancyType

Tipo de datos

text

Site(s) of New Primary
Descripción

NewPrimarySite

Tipo de datos

text

Describe (new primary cancer or MDS)
Descripción

NewPrimaryDiagnosis

Tipo de datos

text

Investigations
Descripción

Investigations

Imaging site
Descripción

DiagnosticImagingAnatomicSite

Tipo de datos

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
Descripción

MethodofEvaluation

Tipo de datos

text

Date of Evaluation (yyyy-mmm-dd)
Descripción

AssessmentDate

Tipo de datos

date

Header
Descripción

Header

Patient Study ID, Coordinating Group
Descripción

PatientStudyID,CoordinatingGroup

Tipo de datos

text

Patient Initials (first - middle - last)
Descripción

Patient Initials

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Toxicity Evaluation
Descripción

Toxicity Evaluation

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

NEWORCONTINUINGTOXICITY(>SeverityGrade3)SINCETHELASTREPORT?

Tipo de datos

boolean

COMMENTS
Descripción

Comments

Tipo de datos

text

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

CTCAdverseEventTerm

Tipo de datos

text

CTC Adverse Event Term, Other (specify)
Descripción

CTCAdverseEventTerm,Other

Tipo de datos

text

CTC Adverse Event Term, Other (specify)
Descripción

CTCAdverseEventTerm,Other

Tipo de datos

text

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

CTCAdverseEventCategory

Tipo de datos

text

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

CTCAdverseEventGrade

Tipo de datos

text

CTC Adverse Event Attribution Code
Descripción

CTCAdverseEventAttributionCode

Tipo de datos

text

Unnamed2
Descripción

Unnamed2

Patient Study ID, Coordinating Group
Descripción

PatientStudyID,CoordinatingGroup

Tipo de datos

text

Patient Initials (first - middle - last)
Descripción

Patient Initials

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Treatment Given Since Last Report To Ncic Ctg
Descripción

Treatment Given Since Last Report To Ncic Ctg

Raloxifene Therapy
Descripción

Non-ProtocolRaloxifeneTherapy

Tipo de datos

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
Bisphosphonate Therapy
Descripción

Non-ProtocolTherapeuticProcedureBiphosphonateAdministeredInd-3

Tipo de datos

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
Name
Descripción

Non-ProtocolTherapeuticProcedureBiphosphonateAdministeredText

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C443
UMLS 2011AA Property
C0012544
NCI Thesaurus ObjectClass
C49236
UMLS 2011AA ObjectClass
C0087111
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass-2
C1518384
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
Lipid-lowering Therapy
Descripción

Non-ProtocolLipidLoweringTherapy

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Name
Descripción

Non-ProtocolLipidLoweringTherapyText

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Is the patient receiving any non-protocol cancer therapy not previously reported? (Cancer Therapy)
Descripción

Non-ProtocolTherapyInd

Tipo de datos

boolean

Name of non-protocol cancer therapy
Descripción

Non-protocolTherapyAdministeredText

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Adverse Events
Descripción

Adverse Events

Has the patient experienced a bone fracture since last report?
Descripción

FractureBoneNotReportAssessmentSite

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C12366
UMLS 2011AA ObjectClass
C0262950
NCI Thesaurus ObjectClass-2
C3046
UMLS 2011AA ObjectClass-2
C0016658
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C25594
UMLS 2011AA Property-2
C1518422
NCI Thesaurus Property-3
C25375
UMLS 2011AA Property-3
C0684224
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
Bone Fracture Site, Spinal (Check)
Descripción

BoneFractureSite,Spinal

Tipo de datos

text

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

BoneFractureSite,Wrist

Tipo de datos

text

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

BoneFractureSite,Pelvis

Tipo de datos

text

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

BoneFractureSite,Hip

Tipo de datos

text

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

BoneFractureSite,Femur

Tipo de datos

text

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

BoneFractureSite,Tibia

Tipo de datos

text

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

BoneFractureSite,Ankle

Tipo de datos

text

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

BoneFractureSite,Other(specify)

Tipo de datos

text

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

indicatesite(bonefracturesite)

Tipo de datos

text

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

BoneFractureDate

Tipo de datos

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 last report?
Descripción

Hasthepatienthadanewdiagnosisofosteoporosissincesubmissionoflastfollow-upform?

Tipo de datos

boolean

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

DiseaseOsteoporosisDiagnosisDate

Tipo de datos

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?
Descripción

Hasthepatientsufferedcardiovasculardiseasesincesubmissionoflastfollow-upform?

Tipo de datos

text

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.)
Descripción

CardiovascularEvent,Myocardialinfarction

Tipo de datos

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.)
Descripción

CardiovascularEvent,Stroke/transientischemicattack(TIA)

Tipo de datos

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.)
Descripción

CardiovascularEvent,On-goingangina(nosurgicalintervention)

Tipo de datos

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.)
Descripción

HeartPatientAnginaPercutaneousTransluminalCoronaryAngioplastyPersonalMedicalHistoryInd-3

Tipo de datos

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.)
Descripción

CardiovascularEvent,Thromboembolicevent

Tipo de datos

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.)
Descripción

CardiovascularEvent,Other(specify)

Tipo de datos

text

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

pleasedescribeevent(cardiovascularevent)

Tipo de datos

text

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

DateofMostRecentEpisode

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Unnamed3
Descripción

Unnamed3

Patient Study ID, Coordinating Group
Descripción

PatientStudyID,CoordinatingGroup

Tipo de datos

text

Patient Initials (first - middle - last)
Descripción

Patient Initials

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Comments
Descripción

Comments

COMMENTS
Descripción

Comments

Tipo de datos

text

Supporting Documentation
Descripción

Supporting Documentation

Investigator Signature
Descripción

Investigator Signature

Investigator Signature
Descripción

InvestigatorSignature

Tipo de datos

text

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

PersonCompletingForm,LastName

Tipo de datos

text

Person Completing Form, First Name
Descripción

PersonCompletingForm,FirstName

Tipo de datos

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)
Descripción

FormCompletionDate,Original

Tipo de datos

date

Ccrr Module For Form 5s - Short Follow-up Report
Descripción

Ccrr Module For Form 5s - Short Follow-up Report

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Similar models

Canadian Centres: When completed please mail to:National Cancer Institute of Canada, Clinical Trials Group, Queen's University, 82-84 Barrie Street, Kingston, Ontario, K7L 3N6

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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)
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)
CL Item
12 (12)
CL Item
24 (24)
CL Item
36 (36)
CL Item
48 (48)
CL Item
60 (60)
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)
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)
Item Group
Disease Status
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
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 or MDS)
text
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.4
Code List
Imaging site
CL Item
Chest (Chest)
C25389 (NCI Thesaurus)
C0817096 (UMLS 2011AA)
Item
Method of Evaluation
text
CL.5
Code List
Method of Evaluation
CL Item
Bilateral Mammogram (Bilateral Mammogram)
AssessmentDate
Item
Date of Evaluation (yyyy-mmm-dd)
date
Item Group
Header
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)
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
Comments
Item
COMMENTS
text
Item
CTC Adverse Event Term (Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
text
CL.7
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
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.8
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.9
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)
Item Group
Unnamed2
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)
Item Group
Treatment Given Since Last Report To Ncic Ctg
Non-ProtocolRaloxifeneTherapy
Item
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
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-ProtocolTherapeuticProcedureBiphosphonateAdministeredText
Item
Name
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C443 (NCI Thesaurus Property)
C0012544 (UMLS 2011AA Property)
C49236 (NCI Thesaurus ObjectClass)
C0087111 (UMLS 2011AA ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
Non-ProtocolLipidLoweringTherapy
Item
Lipid-lowering Therapy
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Non-ProtocolLipidLoweringTherapyText
Item
Name
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
Non-ProtocolTherapyInd
Item
Is the patient receiving any non-protocol cancer therapy not previously reported? (Cancer Therapy)
boolean
Non-protocolTherapyAdministeredText
Item
Name of non-protocol cancer therapy
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item Group
Adverse Events
FractureBoneNotReportAssessmentSite
Item
Has the patient experienced a bone fracture since last report?
boolean
C12366 (NCI Thesaurus ObjectClass)
C0262950 (UMLS 2011AA ObjectClass)
C3046 (NCI Thesaurus ObjectClass-2)
C0016658 (UMLS 2011AA ObjectClass-2)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25594 (NCI Thesaurus Property-2)
C1518422 (UMLS 2011AA Property-2)
C25375 (NCI Thesaurus Property-3)
C0684224 (UMLS 2011AA Property-3)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
Item
Bone Fracture Site, Spinal (Check)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.15
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.16
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.17
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.18
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.19
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.20
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.21
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.22
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 last report?
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?
text
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.24
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.25
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.26
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.27
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.28
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.29
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
Unnamed3
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)
Item Group
Comments
Comments
Item
COMMENTS
text
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 5s - Short Follow-up Report
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