ID

10638

Beschreibung

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

Stichworte

Versionen (4)
  1. 26.08.12 26.08.12 -
  2. 22.05.15 22.05.15 -
  3. 03.06.15 03.06.15 -
  4. 03.06.15 03.06.15 -
Hochgeladen am

3. Juni 2015

DOI

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Creative Commons BY-NC 3.0 Legacy
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CALGB: 49808 FOLLOW-UP FORM NCT00016276

Englisch

No Instruction available.

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

CALGB clinical trial administrative data

CALGB Form
Beschreibung

CALGBForm

Datentyp

text

CALGB Study No
Beschreibung

CALGBProtocolNumber

Datentyp

text

CALGB Patient ID
Beschreibung

CALGBPatientID

Datentyp

text

From
Beschreibung

From

Datentyp

text

To (Date of last contact or death)
Beschreibung

To

Datentyp

text

Amended data?
Beschreibung

AmendedDataInd

Datentyp

text

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

Patient demographics

Patient's Name
Beschreibung

Patient'sName

Datentyp

text

Participating Group
Beschreibung

ParticipatingGroup

Datentyp

text

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

PatientHospitalNumber

Datentyp

text

Participating Group Protocol No.
Beschreibung

ParticipatingGroupProtocolNo.

Datentyp

text

Main Member Institution/Adjunct
Beschreibung

MainMemberInstitution/Adjunct

Datentyp

text

Participating Group Patient No.
Beschreibung

ParticipatingGroupPatientNo.

Datentyp

text

Patient vital status
Beschreibung

Patient vital status

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

Patient'sVitalStatus

Datentyp

text

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

Causeofdeath(ifdead)

Datentyp

text

Describe cause of death
Beschreibung

DeathReason,Specify

Datentyp

text

Disease Assessment
Beschreibung

Disease Assessment

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

Haspatienthadadocumentedclinicalassessmentforthiscancersincesubmissionofthepreviousfollow-upform?

Datentyp

text

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

CancerFollow-upStatusDate

Datentyp

date

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

Notice Of Progression

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

Hasthepatientbeendiagnosedwithanewlocal-regionalrecurrencesincesubmissionofthelastfollow-upform?

Datentyp

text

Date of new local-regional recurrence
Beschreibung

DateofnewLocal-RegionalRecurrence

Datentyp

text

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

Site(s)ofFirstLocal-RegionalRecurrence

Datentyp

text

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

Howwasthisrecurrenceinformationobtained?

Datentyp

text

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

Hasthepatientbeendiagnosedwithafirstdistantprogressionsincesubmissionofthelastfollow-upform?

Datentyp

text

Date of first distant progression
Beschreibung

ProgressionDate,FirstDistant

Datentyp

date

Site(s) of first distant progression
Beschreibung

Site(s)ofFirstDistantProgression

Datentyp

text

How was this progression information obtained?
Beschreibung

Howwasthisprogressioninformationobtained?

Datentyp

text

Notice Of New Primary
Beschreibung

Notice Of New Primary

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

Hasanewprimarycancerormyelodysplasticsyndrome(MDS)beendiagnosedthathasnotbeenpreviouslyreported?

Datentyp

text

Date of diagnosis
Beschreibung

NewPrimaryCancerDate

Datentyp

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)
Beschreibung

NewPrimarySite

Datentyp

text

Long-term Toxicity
Beschreibung

Long-term Toxicity

IMT Code
Beschreibung

IMTCode

Datentyp

text

CTC Adverse Event Term
Beschreibung

CTCAdverseEventTerm

Datentyp

text

CTC Grade (only 3, 4, 5)
Beschreibung

CTCGrade

Datentyp

text

Date of Onset
Beschreibung

DateofOnset

Datentyp

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?
Beschreibung

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

Datentyp

text

Long-term Therapy
Beschreibung

Long-term Therapy

Did this patient receive any tamoxifen?
Beschreibung

PastTamoxifenInd

Datentyp

text

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

CurrentTamoxifenInd

Datentyp

text

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

Ifpatientdiscontinuedtamoxifensincelastfollow-up,givedate.

Datentyp

text

Completed By
Beschreibung

CompletedBy

Datentyp

text

Date Completed
Beschreibung

DateCompleted

Datentyp

date

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Ähnliche Modelle

No Instruction available.

1 Formulare
  1. StudyEvent: CALGB: 49808 FOLLOW-UP FORM
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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)
CL.1
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
CL.2
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
CL.3
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
CL.4
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
CL.5
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
CL.6
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
CL.7
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
CL.8
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
CL.9
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
CL.10
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
CL.11
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
CL.12
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
CL.13
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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