ID

849

Description

FORM 5M - MINIMAL 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=ABF3BD71-F788-63E3-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=ABF3BD71-F788-63E3-E034-0003BA12F5E7

Keywords

  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

August 26, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT00090974 Follow-Up - FORM 5M - MINIMAL FOLLOW-UP REPORT - 2064122v3.0

USA Centres: Send CRFs to CTSU.

  1. StudyEvent: FORM 5M - MINIMAL FOLLOW-UP REPORT
    1. USA Centres: Send CRFs to CTSU.
Patient Information
Description

Patient Information

Patient Study ID, Coordinating Group
Description

PatientStudyID,CoordinatingGroup

Data type

text

Patient Initials (first - middle - last)
Description

PatientInitialsName

Data type

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
Description

PatientMedicalRecordNumber

Data type

text

Investigator Name
Description

InvestigatorName

Data type

text

Institution Name
Description

InstitutionName

Data type

text

Registered Investigator (NCI Investigator #)
Description

RegisteredInvestigator

Data type

text

Status
Description

Status

Date of Last Contact or Death (yyyy mmm dd)
Description

DeathDate/LastContactDate

Data type

date

Patient's Vital Status
Description

Patient'sVitalStatus

Data type

text

Primary Cause of Death
Description

PrimaryCauseofDeath

Data type

text

Due to other cause, describe primary cause of death
Description

DeathReason,Specify

Data type

text

Due to other cause, describe primary cause of death
Description

DeathReason,Specify

Data type

text

Has the patient been diagnosed with first local-regional recurrence? (since submission of the last follow-up form)
Description

ProgressionInd,FirstLocal-Regional

Data type

text

Date of First Local-Regional Progression (yyyy mmm dd)
Description

ProgressionDate,FirstLocal-Regional

Data type

date

Has the patient been diagnosed with first distant recurrence/progression?
Description

ProgressionInd,FirstDistant

Data type

text

Date of First Distant Progression (yyyy mmm dd)
Description

ProgressionDate,FirstDistant

Data type

date

Has the patient been diagnosed with contralateral breast cancer? (since submission of the last follow-up form)
Description

Hasthepatientbeendiagnosedwithcontralateralbreastcancer?

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Date of Diagnosis of Contralateral Breast Cancer (yyyy mmm dd)
Description

ContralateralBreastCancerDiagnosisDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass
C25307
UMLS 2011AA ObjectClass
C0441988
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Other Malignancies Or Myelodysplastic Syndrome
Description

Other Malignancies Or Myelodysplastic Syndrome

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

NewPrimaryCancerInd

Data type

text

Date of diagnosis (yyyy mmm dd)
Description

NewPrimaryCancerDate

Data type

date

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

MalignancyType

Data type

text

Site(s) of New Primary
Description

NewPrimarySite

Data type

text

Describe (new primary cancer or MDS)
Description

NewPrimaryDiagnosis

Data type

text

Unnamed1
Description

Unnamed1

Patient Study ID, Coordinating Group
Description

PatientStudyID,CoordinatingGroup

Data type

text

Patient Initials (first - middle - last)
Description

PatientInitialsName

Data type

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
Comments
Description

Comments

COMMENTS
Description

Comments

Data type

text

Investigator Signature
Description

Investigator Signature

Investigator Signature
Description

InvestigatorSignature

Data type

text

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

PersonCompletingForm,LastName

Data type

text

Person Completing Form, First Name
Description

PersonCompletingForm,FirstName

Data type

text

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

FormCompletionDate,Original

Data type

date

Ccrr Module For Form 5m - Minimal Follow-up Report
Description

Ccrr Module For Form 5m - Minimal Follow-up Report

Similar models

USA Centres: Send CRFs to CTSU.

  1. StudyEvent: FORM 5M - MINIMAL FOLLOW-UP REPORT
    1. USA Centres: Send CRFs to CTSU.
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Status
DeathDate/LastContactDate
Item
Date of Last Contact or Death (yyyy mmm dd)
date
Item
Patient's Vital Status
text
Code List
Patient's Vital Status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
Item
Primary Cause of Death
text
Code List
Primary Cause of Death
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)
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
Has the patient been diagnosed with first local-regional recurrence? (since submission of the last follow-up form)
text
Code List
Has the patient been diagnosed with first local-regional recurrence? (since submission of the last follow-up form)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
ProgressionDate,FirstLocal-Regional
Item
Date of First Local-Regional Progression (yyyy mmm dd)
date
Item
Has the patient been diagnosed with first distant recurrence/progression?
text
Code List
Has the patient been diagnosed with first distant recurrence/progression?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
ProgressionDate,FirstDistant
Item
Date of First Distant Progression (yyyy mmm dd)
date
Item
Has the patient been diagnosed with contralateral breast cancer? (since submission of the last follow-up form)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
Has the patient been diagnosed with contralateral breast cancer? (since submission of the last follow-up form)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
ContralateralBreastCancerDiagnosisDate
Item
Date of Diagnosis of Contralateral Breast Cancer (yyyy mmm dd)
date
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25307 (NCI Thesaurus ObjectClass)
C0441988 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Other Malignancies Or Myelodysplastic Syndrome
Item
Has a new primary cancer or MDS been diagnosed that has not been previously reported?
text
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
Comments
Comments
Item
COMMENTS
text
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 5m - Minimal Follow-up Report

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