ID

11488

Beskrivning

FORM 6 - FINAL 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=ABE51386-B5AC-5668-E034-0003BA12F5E7

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=ABE51386-B5AC-5668-E034-0003BA12F5E7

Nyckelord

  1. 2012-08-26 2012-08-26 -
  2. 2015-01-09 2015-01-09 - Martin Dugas
  3. 2015-07-05 2015-07-05 -
Uppladdad den

5 juli 2015

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy

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FORM 6 - FINAL REPORT NCT00090974

To be submitted within 6 weeks of the patient's death.

Patient Information
Beskrivning

Patient Information

Patient Study ID, Coordinating Group
Beskrivning

PatientStudyID,CoordinatingGroup

Datatyp

text

Patient Initials (first - middle - last)
Beskrivning

Patient Initials

Datatyp

text

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

PatientMedicalRecordNumber

Datatyp

text

Investigator Name
Beskrivning

InvestigatorName

Datatyp

text

Institution Name
Beskrivning

InstitutionName

Datatyp

text

Registered Investigator (NCI Investigator #)
Beskrivning

RegisteredInvestigator

Datatyp

text

Cause Of Death
Beskrivning

Cause Of Death

Date of death (yyyy mmm dd)
Beskrivning

DeathDate/LastContactDate

Datatyp

date

Primary Cause of Death (check one)
Beskrivning

PrimaryCauseofDeath

Datatyp

text

Due to other cause, describe primary cause of death
Beskrivning

DeathReason,Specify

Datatyp

text

Autopsy
Beskrivning

Autopsy

Autopsy?
Beskrivning

AutopsyInd

Datatyp

text

Disease Status
Beskrivning

Disease Status

Status of most recent clinical assessment
Beskrivning

CancerFollow-upStatus,Recent

Datatyp

text

Other Malignancies Or Myelodysplastic Syndrome
Beskrivning

Other Malignancies Or Myelodysplastic Syndrome

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

NewPrimaryCancerInd

Datatyp

boolean

Date of diagnosis (yyyy mmm dd)
Beskrivning

NewPrimaryCancerDate

Datatyp

date

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

MalignancyType

Datatyp

text

Site(s) of New Primary
Beskrivning

NewPrimarySite

Datatyp

text

Describe (new primary cancer or MDS)
Beskrivning

NewPrimaryDiagnosis

Datatyp

text

Toxicity Evaluation
Beskrivning

Toxicity Evaluation

Did the patient experience any new or continuing toxicities since the last report?
Beskrivning

Didthepatientexperienceanyneworcontinuingtoxicitiessincethelastreport?

Datatyp

boolean

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

CTCAdverseEventTerm

Datatyp

text

CTC Adverse Event Term, Other (specify)
Beskrivning

CTCAdverseEventTerm,Other

Datatyp

text

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

CTCAdverseEventCategory

Datatyp

text

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

CTCAdverseEventGrade

Datatyp

text

CTC Adverse Event Attribution Code
Beskrivning

CTCAdverseEventAttributionCode

Datatyp

text

COMMENTS
Beskrivning

Comments

Datatyp

text

Adverse Events
Beskrivning

Adverse Events

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

Hasthepatientexperiencedabonefracturesincesubmissionoflastfollow-upform?

Datatyp

boolean

Bone Fracture Site, Spinal (Check)
Beskrivning

BoneFractureSite,Spinal

Datatyp

text

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

BoneFractureSite,Wrist

Datatyp

text

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

BoneFractureSite,Pelvis

Datatyp

text

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

BoneFractureSite,Hip

Datatyp

text

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

BoneFractureSite,Femur

Datatyp

text

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

BoneFractureSite,Tibia

Datatyp

text

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

BoneFractureSite,Ankle

Datatyp

text

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

BoneFractureSite,Other(specify)

Datatyp

text

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

indicatesite(bonefracturesite)

Datatyp

text

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

BoneFractureDate

Datatyp

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?
Beskrivning

Hasthepatienthadanewdiagnosisofosteoporosissincesubmissionoflastfollow-upform?

Datatyp

boolean

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

DiseaseOsteoporosisDiagnosisDate

Datatyp

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?
Beskrivning

Hasthepatientsufferedcardiovasculardiseasesincesubmissionoflastfollow-upform?

Datatyp

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.)
Beskrivning

CardiovascularEvent,Myocardialinfarction

Datatyp

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.)
Beskrivning

CardiovascularEvent,Stroke/transientischemicattack(TIA)

Datatyp

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.)
Beskrivning

CardiovascularEvent,On-goingangina(nosurgicalintervention)

Datatyp

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.)
Beskrivning

HeartPatientAnginaPercutaneousTransluminalCoronaryAngioplastyPersonalMedicalHistoryInd-3

Datatyp

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.)
Beskrivning

CardiovascularEvent,Thromboembolicevent

Datatyp

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.)
Beskrivning

CardiovascularEvent,Other(specify)

Datatyp

text

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

pleasedescribeevent(cardiovascularevent)

Datatyp

text

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

DateofMostRecentEpisode

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Treatment Given Since Last Report To Ncic Ctg
Beskrivning

Treatment Given Since Last Report To Ncic Ctg

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

Non-ProtocolTherapyInd

Datatyp

boolean

Non-Protocol Raloxifene Therapy?
Beskrivning

Non-ProtocolRaloxifeneTherapy

Datatyp

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?
Beskrivning

Non-ProtocolTherapeuticProcedureBiphosphonateAdministeredInd-3

Datatyp

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?
Beskrivning

Non-ProtocolLipidLoweringTherapy

Datatyp

boolean

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

OtherTherapyInd

Datatyp

boolean

Other Non-Protocol Therapy Name
Beskrivning

OtherNon-ProtocolTherapyName

Datatyp

text

Comments
Beskrivning

Comments

Supporting Documentation
Beskrivning

Supporting Documentation

Investigator Signature
Beskrivning

Investigator Signature

Investigator Signature
Beskrivning

InvestigatorSignature

Datatyp

text

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

PersonCompletingForm,LastName

Datatyp

text

Person Completing Form, First Name
Beskrivning

PersonCompletingForm,FirstName

Datatyp

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)
Beskrivning

FormCompletionDate,Original

Datatyp

date

Ccrr Module For Form 6 - Final Report
Beskrivning

Ccrr Module For Form 6 - Final Report

Similar models

To be submitted within 6 weeks of the patient's death.

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
Cause Of Death
DeathDate/LastContactDate
Item
Date of death (yyyy mmm dd)
date
Item
Primary Cause of Death (check one)
text
Code List
Primary Cause of Death (check one)
CL Item
Due To This Disease (Due to this disease)
CL Item
Due To Protocol Treatment (Due to protocol treatment)
CL Item
Cardiovascular death (specify) (Cardiovascular death (specify))
CL Item
Due To Other Cause, Specify (Due to other cause, describe primary cause of death)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
DeathReason,Specify
Item
Due to other cause, describe primary cause of death
text
Item Group
Autopsy
Item
Autopsy?
text
Code List
Autopsy?
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 Group
Disease Status
Item
Status of most recent clinical assessment
text
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
Toxicity Evaluation
Didthepatientexperienceanyneworcontinuingtoxicitiessincethelastreport?
Item
Did the patient experience any new or continuing toxicities since the last report?
boolean
Item
CTC Adverse Event Term (Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
text
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
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
Code List
CTC Adverse Event Attribution Code
CL Item
Unrelated (unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (unlikely)
CL Item
possible (possible)
CL Item
Probably (probable)
CL Item
Definitely (definite)
Comments
Item
COMMENTS
text
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)
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)
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)
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)
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)
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)
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)
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)
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?
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)
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)
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)
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)
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)
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)
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
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)
OtherTherapyInd
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 6 - Final Report

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