ID

10638

Beschrijving

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

Trefwoorden

Versies (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 -
Geüploaded op

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

Engels

No Instruction available.

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

CALGB clinical trial administrative data

CALGB Form
Beschrijving

CALGBForm

Datatype

text

CALGB Study No
Beschrijving

CALGBProtocolNumber

Datatype

text

CALGB Patient ID
Beschrijving

CALGBPatientID

Datatype

text

From
Beschrijving

From

Datatype

text

To (Date of last contact or death)
Beschrijving

To

Datatype

text

Amended data?
Beschrijving

AmendedDataInd

Datatype

text

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

Patient demographics

Patient's Name
Beschrijving

Patient'sName

Datatype

text

Participating Group
Beschrijving

ParticipatingGroup

Datatype

text

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

PatientHospitalNumber

Datatype

text

Participating Group Protocol No.
Beschrijving

ParticipatingGroupProtocolNo.

Datatype

text

Main Member Institution/Adjunct
Beschrijving

MainMemberInstitution/Adjunct

Datatype

text

Participating Group Patient No.
Beschrijving

ParticipatingGroupPatientNo.

Datatype

text

Patient vital status
Beschrijving

Patient vital status

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

Patient'sVitalStatus

Datatype

text

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

Causeofdeath(ifdead)

Datatype

text

Describe cause of death
Beschrijving

DeathReason,Specify

Datatype

text

Disease Assessment
Beschrijving

Disease Assessment

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

Haspatienthadadocumentedclinicalassessmentforthiscancersincesubmissionofthepreviousfollow-upform?

Datatype

text

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

CancerFollow-upStatusDate

Datatype

date

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

Notice Of Progression

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

Hasthepatientbeendiagnosedwithanewlocal-regionalrecurrencesincesubmissionofthelastfollow-upform?

Datatype

text

Date of new local-regional recurrence
Beschrijving

DateofnewLocal-RegionalRecurrence

Datatype

text

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

Site(s)ofFirstLocal-RegionalRecurrence

Datatype

text

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

Howwasthisrecurrenceinformationobtained?

Datatype

text

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

Hasthepatientbeendiagnosedwithafirstdistantprogressionsincesubmissionofthelastfollow-upform?

Datatype

text

Date of first distant progression
Beschrijving

ProgressionDate,FirstDistant

Datatype

date

Site(s) of first distant progression
Beschrijving

Site(s)ofFirstDistantProgression

Datatype

text

How was this progression information obtained?
Beschrijving

Howwasthisprogressioninformationobtained?

Datatype

text

Notice Of New Primary
Beschrijving

Notice Of New Primary

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

Hasanewprimarycancerormyelodysplasticsyndrome(MDS)beendiagnosedthathasnotbeenpreviouslyreported?

Datatype

text

Date of diagnosis
Beschrijving

NewPrimaryCancerDate

Datatype

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)
Beschrijving

NewPrimarySite

Datatype

text

Long-term Toxicity
Beschrijving

Long-term Toxicity

IMT Code
Beschrijving

IMTCode

Datatype

text

CTC Adverse Event Term
Beschrijving

CTCAdverseEventTerm

Datatype

text

CTC Grade (only 3, 4, 5)
Beschrijving

CTCGrade

Datatype

text

Date of Onset
Beschrijving

DateofOnset

Datatype

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?
Beschrijving

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

Datatype

text

Long-term Therapy
Beschrijving

Long-term Therapy

Did this patient receive any tamoxifen?
Beschrijving

PastTamoxifenInd

Datatype

text

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

CurrentTamoxifenInd

Datatype

text

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

Ifpatientdiscontinuedtamoxifensincelastfollow-up,givedate.

Datatype

text

Completed By
Beschrijving

CompletedBy

Datatype

text

Date Completed
Beschrijving

DateCompleted

Datatype

date

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Similar models

No Instruction available.

1 Formulieren
  1. StudyEvent: CALGB: 49808 FOLLOW-UP FORM
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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