ID

828

Beschreibung

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

Link

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

Stichworte

Versionen (3)
  1. 26.08.12 26.08.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
  3. 05.07.15 05.07.15 -
Hochgeladen am

26. August 2012

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00090974 Follow-Up - FORM 6 - FINAL REPORT - 2059791v3.0

Englisch

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

1 Formulare  
Patient Information
Beschreibung

Patient Information

Patient Study ID, Coordinating Group
Beschreibung

PatientStudyID,CoordinatingGroup

Datentyp

text

Patient Initials (first - middle - last)
Beschreibung

PatientInitialsName

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Patient Medical Record Number
Beschreibung

PatientMedicalRecordNumber

Datentyp

text

Investigator Name
Beschreibung

InvestigatorName

Datentyp

text

Institution Name
Beschreibung

InstitutionName

Datentyp

text

Registered Investigator (NCI Investigator #)
Beschreibung

RegisteredInvestigator

Datentyp

text

Cause Of Death
Beschreibung

Cause Of Death

Date of death (yyyy mmm dd)
Beschreibung

DeathDate/LastContactDate

Datentyp

date

Primary Cause of Death (check one)
Beschreibung

PrimaryCauseofDeath

Datentyp

text

Due to other cause, describe primary cause of death
Beschreibung

DeathReason,Specify

Datentyp

text

Due to other cause, describe primary cause of death
Beschreibung

DeathReason,Specify

Datentyp

text

Autopsy
Beschreibung

Autopsy

Autopsy?
Beschreibung

AutopsyInd

Datentyp

text

Disease Status
Beschreibung

Disease Status

Status of most recent clinical assessment
Beschreibung

CancerFollow-upStatus,Recent

Datentyp

text

Other Malignancies Or Myelodysplastic Syndrome
Beschreibung

Other Malignancies Or Myelodysplastic Syndrome

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

NewPrimaryCancerInd

Datentyp

text

Date of diagnosis (yyyy mmm dd)
Beschreibung

NewPrimaryCancerDate

Datentyp

date

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

MalignancyType

Datentyp

text

Site(s) of New Primary
Beschreibung

NewPrimarySite

Datentyp

text

Describe (new primary cancer or MDS)
Beschreibung

NewPrimaryDiagnosis

Datentyp

text

Unnamed1
Beschreibung

Unnamed1

Patient Study ID, Coordinating Group
Beschreibung

PatientStudyID,CoordinatingGroup

Datentyp

text

Patient Initials (first - middle - last)
Beschreibung

PatientInitialsName

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Toxicity Evaluation
Beschreibung

Toxicity Evaluation

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

Didthepatientexperienceanyneworcontinuingtoxicitiessincethelastreport?

Datentyp

text

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

CTCAdverseEventTerm

Datentyp

text

CTC Adverse Event Term, Other (specify)
Beschreibung

CTCAdverseEventTerm,Other

Datentyp

text

CTC Adverse Event Term, Other (specify)
Beschreibung

CTCAdverseEventTerm,Other

Datentyp

text

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

CTCAdverseEventCategory

Datentyp

text

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

CTCAdverseEventGrade

Datentyp

text

CTC Adverse Event Attribution Code
Beschreibung

CTCAdverseEventAttributionCode

Datentyp

text

COMMENTS
Beschreibung

Comments

Datentyp

text

Unnamed2
Beschreibung

Unnamed2

Patient Study ID, Coordinating Group
Beschreibung

PatientStudyID,CoordinatingGroup

Datentyp

text

Patient Initials (first - middle - last)
Beschreibung

PatientInitialsName

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Adverse Events
Beschreibung

Adverse Events

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

Hasthepatientexperiencedabonefracturesincesubmissionoflastfollow-upform?

Datentyp

text

Bone Fracture Site, Spinal (Check)
Beschreibung

BoneFractureSite,Spinal

Datentyp

text

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

BoneFractureSite,Wrist

Datentyp

text

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

BoneFractureSite,Pelvis

Datentyp

text

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

BoneFractureSite,Hip

Datentyp

text

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

BoneFractureSite,Femur

Datentyp

text

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

BoneFractureSite,Tibia

Datentyp

text

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

BoneFractureSite,Ankle

Datentyp

text

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

BoneFractureSite,Other(specify)

Datentyp

text

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

indicatesite(bonefracturesite)

Datentyp

text

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

BoneFractureDate

Datentyp

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?
Beschreibung

Hasthepatienthadanewdiagnosisofosteoporosissincesubmissionoflastfollow-upform?

Datentyp

text

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

DiseaseOsteoporosisDiagnosisDate

Datentyp

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
C15220
UMLS 2011AA Property
C0011900
Has the patient suffered cardiovascular disease since submission of last follow-up form?
Beschreibung

Hasthepatientsufferedcardiovasculardiseasesincesubmissionoflastfollow-upform?

Datentyp

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.)
Beschreibung

CardiovascularEvent,Myocardialinfarction

Datentyp

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.)
Beschreibung

CardiovascularEvent,Stroke/transientischemicattack(TIA)

Datentyp

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.)
Beschreibung

CardiovascularEvent,On-goingangina(nosurgicalintervention)

Datentyp

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.)
Beschreibung

HeartPatientAnginaPercutaneousTransluminalCoronaryAngioplastyPersonalMedicalHistoryInd-3

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus Property
C51221
UMLS 2011AA Property
C0002962
NCI Thesaurus Property
C38078
UMLS 2011AA Property
C2936173
NCI Thesaurus Property
C18772
UMLS 2011AA Property
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.)
Beschreibung

CardiovascularEvent,Thromboembolicevent

Datentyp

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.)
Beschreibung

CardiovascularEvent,Other(specify)

Datentyp

text

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

pleasedescribeevent(cardiovascularevent)

Datentyp

text

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

DateofMostRecentEpisode

Datentyp

date

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

Unnamed3

Patient Study ID, Coordinating Group
Beschreibung

PatientStudyID,CoordinatingGroup

Datentyp

text

Patient Initials (first - middle - last)
Beschreibung

PatientInitialsName

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Treatment Given Since Last Report To Ncic Ctg
Beschreibung

Treatment Given Since Last Report To Ncic Ctg

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

Non-ProtocolTherapyInd

Datentyp

text

Non-Protocol Raloxifene Therapy?
Beschreibung

Non-ProtocolRaloxifeneTherapy

Datentyp

text

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
C25382
UMLS 2011AA Property
C1521801
Non-Protocol Bisphosphonate Therapy?
Beschreibung

Non-ProtocolTherapeuticProcedureBiphosphonateAdministeredInd-3

Datentyp

text

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

Non-ProtocolLipidLoweringTherapy

Datentyp

text

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

OtherTherapyInd

Datentyp

text

Other Non-Protocol Therapy Name
Beschreibung

OtherNon-ProtocolTherapyName

Datentyp

text

Comments
Beschreibung

Comments

COMMENTS
Beschreibung

Comments

Datentyp

text

Supporting Documentation
Beschreibung

Supporting Documentation

Investigator Signature
Beschreibung

Investigator Signature

Investigator Signature
Beschreibung

InvestigatorSignature

Datentyp

text

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

PersonCompletingForm,LastName

Datentyp

text

Person Completing Form, First Name
Beschreibung

PersonCompletingForm,FirstName

Datentyp

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)
Beschreibung

FormCompletionDate,Original

Datentyp

date

Ccrr Module For Form 6 - Final Report
Beschreibung

Ccrr Module For Form 6 - Final Report

Zum Seitenanfang zurückkehren

Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Patient Information
PatientStudyID,CoordinatingGroup
Item
Patient Study ID, Coordinating Group
text
PatientInitialsName
Item
Patient Initials (first - middle - last)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
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
CL.1
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
DeathReason,Specify
Item
Due to other cause, describe primary cause of death
text
Item Group
Autopsy
Item
Autopsy?
text
CL.2
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
CL.3
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
Item
Has a new primary cancer or MDS been diagnosed that has not been previously reported?
text
CL.4
Code List
Has a new primary cancer or MDS been diagnosed that has not been previously reported?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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
Unnamed1
PatientStudyID,CoordinatingGroup
Item
Patient Study ID, Coordinating Group
text
PatientInitialsName
Item
Patient Initials (first - middle - last)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
Item Group
Toxicity Evaluation
Item
Did the patient experience any new or continuing toxicities since the last report?
text
CL.5
Code List
Did the patient experience any new or continuing toxicities since the last report?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
CTC Adverse Event Term (Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
text
CL.6
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.7
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.8
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
Unnamed2
PatientStudyID,CoordinatingGroup
Item
Patient Study ID, Coordinating Group
text
PatientInitialsName
Item
Patient Initials (first - middle - last)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
Item Group
Adverse Events
Item
Has the patient experienced a bone fracture since submission of last follow-up form?
text
CL.9
Code List
Has the patient experienced a bone fracture since submission of last follow-up form?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Bone Fracture Site, Spinal (Check)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.10
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.11
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.12
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.13
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.14
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.15
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.16
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.17
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)
Item
Has the patient had a new diagnosis of osteoporosis since submission of last follow-up form?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.18
Code List
Has the patient had a new diagnosis of osteoporosis since submission of last follow-up form?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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)
C0011900 (UMLS 2011AA Property)
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.19
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.20
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.21
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)
C0018787 (UMLS 2011AA ObjectClass)
C51221 (NCI Thesaurus Property)
C0002962 (UMLS 2011AA Property)
C38078 (NCI Thesaurus Property)
C2936173 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.22
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.23
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.24
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
PatientInitialsName
Item
Patient Initials (first - middle - last)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
Item Group
Treatment Given Since Last Report To Ncic Ctg
Item
Is the patient receiving any non-protocol cancer therapy not previously reported?
text
CL.25
Code List
Is the patient receiving any non-protocol cancer therapy not previously reported?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Non-Protocol Raloxifene Therapy?
text
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)
C1521801 (UMLS 2011AA Property)
CL.26
Code List
Non-Protocol Raloxifene Therapy?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Non-Protocol Bisphosphonate Therapy?
text
C49236 (NCI Thesaurus ObjectClass)
C0087111 (UMLS 2011AA ObjectClass)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C443 (NCI Thesaurus Property)
C0012544 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.27
Code List
Non-Protocol Bisphosphonate Therapy?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Non-Protocol Lipid Lowering Therapy?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.28
Code List
Non-Protocol Lipid Lowering Therapy?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Other Non-Protocol Therapy?
text
CL.29
Code List
Other Non-Protocol Therapy?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
OtherNon-ProtocolTherapyName
Item
Other Non-Protocol Therapy Name
text
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 6 - Final Report
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