ID

10638

Descrição

CALGB: 49808 FOLLOW-UP FORM NCT00016276 Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9E35395C-87AF-227A-E034-080020C9C0E0

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9E35395C-87AF-227A-E034-080020C9C0E0

Palavras-chave

  1. 26/08/2012 26/08/2012 -
  2. 22/05/2015 22/05/2015 -
  3. 03/06/2015 03/06/2015 -
  4. 03/06/2015 03/06/2015 -
Transferido a

3 de junho de 2015

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy

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CALGB: 49808 FOLLOW-UP FORM NCT00016276

No Instruction available.

  1. StudyEvent: CALGB: 49808 FOLLOW-UP FORM
    1. No Instruction available.
CALGB clinical trial administrative data
Descrição

CALGB clinical trial administrative data

CALGB Form
Descrição

CALGBForm

Tipo de dados

text

CALGB Study No
Descrição

CALGBProtocolNumber

Tipo de dados

text

CALGB Patient ID
Descrição

CALGBPatientID

Tipo de dados

text

From
Descrição

From

Tipo de dados

text

To (Date of last contact or death)
Descrição

To

Tipo de dados

text

Amended data?
Descrição

AmendedDataInd

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Patient demographics
Descrição

Patient demographics

Patient's Name
Descrição

Patient'sName

Tipo de dados

text

Participating Group
Descrição

ParticipatingGroup

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C17005
UMLS 2011AA ObjectClass
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Patient Hospital Number
Descrição

PatientHospitalNumber

Tipo de dados

text

Participating Group Protocol No.
Descrição

ParticipatingGroupProtocolNo.

Tipo de dados

text

Main Member Institution/Adjunct
Descrição

MainMemberInstitution/Adjunct

Tipo de dados

text

Participating Group Patient No.
Descrição

ParticipatingGroupPatientNo.

Tipo de dados

text

Patient vital status
Descrição

Patient vital status

Patient's Vital Status (mark one with an X)
Descrição

Patient'sVitalStatus

Tipo de dados

text

Cause of death (if dead) (mark one with an X)
Descrição

Causeofdeath(ifdead)

Tipo de dados

text

Describe cause of death
Descrição

DeathReason,Specify

Tipo de dados

text

Disease Assessment
Descrição

Disease Assessment

Has patient had a documented clinical assessment for this cancer since submission of the previous follow-up form?
Descrição

Haspatienthadadocumentedclinicalassessmentforthiscancersincesubmissionofthepreviousfollow-upform?

Tipo de dados

text

Date of last clinical assessment (only provide date if assessment was done since submission of previous follow-up form)
Descrição

CancerFollow-upStatusDate

Tipo de dados

date

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Notice Of Progression
Descrição

Notice Of Progression

Has the patient been diagnosed with a new local-regional recurrence since submission of the last follow-up form?
Descrição

Hasthepatientbeendiagnosedwithanewlocal-regionalrecurrencesincesubmissionofthelastfollow-upform?

Tipo de dados

text

Date of new local-regional recurrence
Descrição

DateofnewLocal-RegionalRecurrence

Tipo de dados

text

Site(s) of first local-regional recurrence (mark all that apply with an X)
Descrição

Site(s)ofFirstLocal-RegionalRecurrence

Tipo de dados

text

How was this recurrence information obtained? (mark one with an X)
Descrição

Howwasthisrecurrenceinformationobtained?

Tipo de dados

text

Has the patient been diagnosed with a first distant progression since submission of the last follow-up form?
Descrição

Hasthepatientbeendiagnosedwithafirstdistantprogressionsincesubmissionofthelastfollow-upform?

Tipo de dados

text

Date of first distant progression
Descrição

ProgressionDate,FirstDistant

Tipo de dados

date

Site(s) of first distant progression
Descrição

Site(s)ofFirstDistantProgression

Tipo de dados

text

How was this progression information obtained?
Descrição

Howwasthisprogressioninformationobtained?

Tipo de dados

text

Notice Of New Primary
Descrição

Notice Of New Primary

Has a new primary cancer or myelodysplastic syndrome (MDS) been diagnosed that has not been previously reported?
Descrição

Hasanewprimarycancerormyelodysplasticsyndrome(MDS)beendiagnosedthathasnotbeenpreviouslyreported?

Tipo de dados

text

Date of diagnosis
Descrição

NewPrimaryCancerDate

Tipo de dados

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Site(s) of New Primary (If new primary site is AML/MDS, please submit NCI AML/MDS form. All other new primaries must be reported using the MEDWATCH form. Submit to CALGB Central Office)
Descrição

NewPrimarySite

Tipo de dados

text

Long-term Toxicity
Descrição

Long-term Toxicity

IMT Code
Descrição

IMTCode

Tipo de dados

text

CTC Adverse Event Term
Descrição

CTCAdverseEventTerm

Tipo de dados

text

CTC Grade (only 3, 4, 5)
Descrição

CTCGrade

Tipo de dados

text

Date of Onset
Descrição

DateofOnset

Tipo de dados

text

Has the patient experienced (prior to diagnosis of recurrence or second primary) any severe (Grade >=3), long term toxicity related to protocol treatment that has not been previously reported?
Descrição

Hasthepatientexperienced(priortodiagnosisofrecurrenceorsecondprimary)anysevere(Grade>=3),longtermtoxicityrelatedtoprotocoltreatmentthathasnotbeenpreviouslyreported?

Tipo de dados

text

Long-term Therapy
Descrição

Long-term Therapy

Did this patient receive any tamoxifen?
Descrição

PastTamoxifenInd

Tipo de dados

text

Is the patient still receiving tamoxifen? (If Yes: )
Descrição

CurrentTamoxifenInd

Tipo de dados

text

If patient discontinued tamoxifen since last follow-up, give date.
Descrição

Ifpatientdiscontinuedtamoxifensincelastfollow-up,givedate.

Tipo de dados

text

Completed By
Descrição

CompletedBy

Tipo de dados

text

Date Completed
Descrição

DateCompleted

Tipo de dados

date

Similar models

No Instruction available.

  1. StudyEvent: CALGB: 49808 FOLLOW-UP FORM
    1. No Instruction available.
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
CALGB clinical trial administrative data
CALGBForm
Item
CALGB Form
text
CALGBProtocolNumber
Item
CALGB Study No
text
CALGBPatientID
Item
CALGB Patient ID
text
From
Item
From
text
To
Item
To (Date of last contact or death)
text
Item
Amended data?
text
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
Code List
Amended data?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Patient demographics
Patient'sName
Item
Patient's Name
text
ParticipatingGroup
Item
Participating Group
text
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientHospitalNumber
Item
Patient Hospital Number
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
MainMemberInstitution/Adjunct
Item
Main Member Institution/Adjunct
text
ParticipatingGroupPatientNo.
Item
Participating Group Patient No.
text
Item Group
Patient vital status
Item
Patient's Vital Status (mark one with an X)
text
Code List
Patient's Vital Status (mark one with an X)
CL Item
Alive (Alive)
CL Item
Dead (Dead)
CL Item
Lost (Lost)
Item
Cause of death (if dead) (mark one with an X)
text
Code List
Cause of death (if dead) (mark one with an X)
CL Item
Due To This Disease (Due to this disease)
CL Item
Due To Protocol Treatment (Due to protocol treatment)
CL Item
Due To Other Cause (Due to other cause)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
DeathReason,Specify
Item
Describe cause of death
text
Item Group
Disease Assessment
Item
Has patient had a documented clinical assessment for this cancer since submission of the previous follow-up form?
text
Code List
Has patient had a documented clinical assessment for this cancer since submission of the previous follow-up form?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CancerFollow-upStatusDate
Item
Date of last clinical assessment (only provide date if assessment was done since submission of previous follow-up form)
date
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item Group
Notice Of Progression
Item
Has the patient been diagnosed with a new local-regional recurrence since submission of the last follow-up form?
text
Code List
Has the patient been diagnosed with a new local-regional recurrence 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)
DateofnewLocal-RegionalRecurrence
Item
Date of new local-regional recurrence
text
Item
Site(s) of first local-regional recurrence (mark all that apply with an X)
text
Code List
Site(s) of first local-regional recurrence (mark all that apply with an X)
CL Item
Ipsilateral Breast (Ipsilateral breast)
CL Item
Axillary Nodes (Axillary nodes)
CL Item
Supraclavicular Nodes (Supraclavicular nodes)
CL Item
Infraclavicular Nodes (Infraclavicular nodes)
CL Item
Chest Wall (Chest wall)
CL035093 (NCI Metathesaurus)
C62484 (NCI Thesaurus)
C0205076 (UMLS 2011AA)
CL Item
Internal mammary nodes (Internal mammary nodes)
CL Item
Axilla (Axilla)
C12674 (NCI Thesaurus)
C0004454 (UMLS 2011AA)
Item
How was this recurrence information obtained? (mark one with an X)
text
Code List
How was this recurrence information obtained? (mark one with an X)
CL Item
Documented Clinical Assessment (Documented clinical assessment)
CL Item
Patient Self Report Only (Patient self report only)
Item
Has the patient been diagnosed with a first distant progression since submission of the last follow-up form?
text
Code List
Has the patient been diagnosed with a first distant progression 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)
ProgressionDate,FirstDistant
Item
Date of first distant progression
date
Site(s)ofFirstDistantProgression
Item
Site(s) of first distant progression
text
Item
How was this progression information obtained?
text
Code List
How was this progression information obtained?
CL Item
Documented clinical assessment (Documented clinical assessment)
CL Item
Patient self report only (Patient self report only)
Item Group
Notice Of New Primary
Item
Has a new primary cancer or myelodysplastic syndrome (MDS) been diagnosed that has not been previously reported?
text
Code List
Has a new primary cancer or myelodysplastic syndrome (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
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
NewPrimarySite
Item
Site(s) of New Primary (If new primary site is AML/MDS, please submit NCI AML/MDS form. All other new primaries must be reported using the MEDWATCH form. Submit to CALGB Central Office)
text
Item Group
Long-term Toxicity
IMTCode
Item
IMT Code
text
CTCAdverseEventTerm
Item
CTC Adverse Event Term
text
CTCGrade
Item
CTC Grade (only 3, 4, 5)
text
DateofOnset
Item
Date of Onset
text
Item
Has the patient experienced (prior to diagnosis of recurrence or second primary) any severe (Grade >=3), long term toxicity related to protocol treatment that has not been previously reported?
text
Code List
Has the patient experienced (prior to diagnosis of recurrence or second primary) any severe (Grade >=3), long term toxicity related to protocol treatment that has not been previously reported?
CL Item
No (No)
CL Item
Yes, specify below (Yes, specify below)
Item Group
Long-term Therapy
Item
Did this patient receive any tamoxifen?
text
Code List
Did this patient receive any tamoxifen?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Is the patient still receiving tamoxifen? (If Yes: )
text
Code List
Is the patient still receiving tamoxifen? (If Yes: )
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Ifpatientdiscontinuedtamoxifensincelastfollow-up,givedate.
Item
If patient discontinued tamoxifen since last follow-up, give date.
text
CompletedBy
Item
Completed By
text
DateCompleted
Item
Date Completed
date

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