ID

10518

Description

Long-Term Follow-up Form NCT00058149 A Phase III, Randomized Study of Gemcitabine (Fixed-Dose Rate Infusion) and Oxaliplatin (NSC 266046) Versus Gemcitabine (Fixed-Dose Rate Infusion) Versus Gemcitabine (30-Minute Infusion) in Pancreatic Carcinoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A65D4EB3-58E5-427C-E034-0003BA0B1A09

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A65D4EB3-58E5-427C-E034-0003BA0B1A09

Mots-clés

Versions (3)
  1. 19/09/2012 19/09/2012 -
  2. 01/06/2015 01/06/2015 -
  3. 03/06/2015 03/06/2015 -
Téléchargé le

3 juin 2015

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy
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Long-Term Follow-up Form NCT00058149

Anglais

No Instruction available.

1 Formulaires  
  1. StudyEvent: Long-Term Follow-up Form
    1. No Instruction available.
ECOG clinical trial administrative data
Description

ECOG clinical trial administrative data

Registration Step
Description

RegistrationStep

Type de données

text

Patient?s Name
Description

Patient'sName

Type de données

text

ECOG Protocol No.
Description

ECOGProtocolNo.

Type de données

text

ECOG Protocol No.
Description

ECOGProtocolNo.

Type de données

text

ECOG Patient ID
Description

ECOGPatientID

Type de données

text

ECOG Patient ID
Description

ECOGPatientID

Type de données

text

Participating Group Protocol No.
Description

ParticipatingGroupProtocolNo.

Type de données

text

Participating Group Patient ID
Description

ParticipatingGroupPatientID

Type de données

text

Institution/Affiliate
Description

MainMemberInstitution/Affiliate

Type de données

text

Data amendment
Description

Data amendment

Are data amended? (If yes, please circle amended items in red)
Description

AmendedDataInd

Type de données

text

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Reporting Period Start Date: (M D Y)
Description

IntervalReportFromDate

Type de données

date

Reporting Period End Date: (M D Y)
Description

IntervalReportToDate

Type de données

date

Vital Status
Description

Vital Status

Patient's Vital Status
Description

Patient'sVitalStatus

Type de données

text

Date of Last Contact or Death (M D Y)
Description

DeathDate/LastContactDate

Type de données

date

Primary Cause of Death (if applicable)
Description

DeathReason

Type de données

text

Describe cause of death
Description

DeathReason,Specify

Type de données

text

Disease Follow-up Status
Description

Disease Follow-up Status

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

CancerFollow-upStatusInd

Type de données

text

Date of last clinical assessment: (Submit appropriate ECOG Disease Evaluation Form)
Description

CancerFollow-upStatusDate

Type de données

date

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

Notice Of Progression

Has the patient developed a first progression that has not been previously reported?
Description

ProgressionInd

Type de données

text

Date of progression (If yes)
Description

ProgressionDate

Type de données

date

Site(s) of progression (If yes)
Description

ProgressionSite

Type de données

text

Did a physician make a formal diagnosis of progressive disease? (If no or unknown, specify basis of PD in Comments)
Description

PhysicianProgressiveDiagnosisInd-3

Type de données

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25741
UMLS 2011AA ObjectClass
C0031831
NCI Thesaurus Property
C25254
UMLS 2011AA Property
C0205329
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Notice Of New Primary
Description

Notice Of New Primary

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

NewPrimaryCancerInd

Type de données

text

Site(s) of new primary:
Description

NewPrimarySite

Type de données

text

Toxicity
Description

Toxicity

Has the patient experienced (prior to diagnosis of recurrence or second primary) any severe (Grade >= 3) long term toxicity that has not been previously reported? (NOTE: Do not report toxicities occurring after start of non-protocol therapy.)
Description

LateAdverseEventInd

Type de données

text

Non-protocol Therapy
Description

Non-protocol Therapy

Has the patient received any non-protocol cancer therapy prior to first progression (not previously reported)?
Description

Hasthepatientreceivedanynon-protocolcancertherapypriortofirstprogression(notpreviouslyreported)?

Type de données

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Comments
Description

Comments

Comments
Description

Comments

Type de données

text

Investigator Signature
Description

InvestigatorSignature

Type de données

text

Alias
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Date
Description

InvestigatorSignatureDate

Type de données

date

Ccrr Module For Long-term Follow-up Form
Description

Ccrr Module For Long-term Follow-up Form

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Similar models

No Instruction available.

1 Formulaires
  1. StudyEvent: Long-Term Follow-up Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
ECOG clinical trial administrative data
RegistrationStep
Item
Registration Step
text
Patient'sName
Item
Patient?s Name
text
ECOGProtocolNo.
Item
ECOG Protocol No.
text
ECOGProtocolNo.
Item
ECOG Protocol No.
text
ECOGPatientID
Item
ECOG Patient ID
text
ECOGPatientID
Item
ECOG Patient ID
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
ParticipatingGroupPatientID
Item
Participating Group Patient ID
text
MainMemberInstitution/Affiliate
Item
Institution/Affiliate
text
Item Group
Data amendment
Item
Are data amended? (If yes, please circle amended items in red)
text
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
CL.1
Code List
Are data amended? (If yes, please circle amended items in red)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
IntervalReportFromDate
Item
Reporting Period Start Date: (M D Y)
date
IntervalReportToDate
Item
Reporting Period End Date: (M D Y)
date
Item Group
Vital Status
Item
Patient's Vital Status
text
CL.2
Code List
Patient's Vital Status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
DeathDate/LastContactDate
Item
Date of Last Contact or Death (M D Y)
date
Item
Primary Cause of Death (if applicable)
text
CL.3
Code List
Primary Cause of Death (if applicable)
CL Item
Due To Protocol Treatment (Due to protocol treatment)
CL Item
Due To This Disease (Due to this disease)
CL Item
Due To Other Cause, Specify (Due to other diease)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
DeathReason,Specify
Item
Describe cause of death
text
Item Group
Disease Follow-up Status
Item
Has the patient had a documented clinical assessment for this cancer (since submission of the previous follow-up form)?
text
CL.4
Code List
Has the 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)
CL Item
Unknown (Unknown, explain in Comments)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CancerFollow-upStatusDate
Item
Date of last clinical assessment: (Submit appropriate ECOG Disease Evaluation 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 developed a first progression that has not been previously reported?
text
CL.5
Code List
Has the patient developed a first progression 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)
CL Item
Unknown (Unknown, explain in Comments)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
ProgressionDate
Item
Date of progression (If yes)
date
ProgressionSite
Item
Site(s) of progression (If yes)
text
Item
Did a physician make a formal diagnosis of progressive disease? (If no or unknown, specify basis of PD in Comments)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25254 (NCI Thesaurus Property)
C0205329 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
CL.6
Code List
Did a physician make a formal diagnosis of progressive disease? (If no or unknown, specify basis of PD in Comments)
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
Notice Of New Primary
Item
Has a new primary cancer or MDS been diagnosed that has not been previously reported?
text
CL.7
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)
NewPrimarySite
Item
Site(s) of new primary:
text
Item Group
Toxicity
Item
Has the patient experienced (prior to diagnosis of recurrence or second primary) any severe (Grade >= 3) long term toxicity that has not been previously reported? (NOTE: Do not report toxicities occurring after start of non-protocol therapy.)
text
CL.8
Code List
Has the patient experienced (prior to diagnosis of recurrence or second primary) any severe (Grade >= 3) long term toxicity that has not been previously reported? (NOTE: Do not report toxicities occurring after start of non-protocol therapy.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Non-protocol Therapy
Item
Has the patient received any non-protocol cancer therapy prior to first progression (not previously reported)?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.9
Code List
Has the patient received any non-protocol cancer therapy prior to first progression (not previously reported)?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Comments
Comments
Item
Comments
text
InvestigatorSignature
Item
Investigator Signature
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignatureDate
Item
Date
date
Item Group
Ccrr Module For Long-term Follow-up Form
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