ID

10425

Beschreibung

Long-Term Follow-up Form 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

Link

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

Stichworte

Versionen (3)
  1. 19.09.12 19.09.12 -
  2. 01.06.15 01.06.15 -
  3. 03.06.15 03.06.15 -
Hochgeladen am

1. Juni 2015

DOI

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Lizenz

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

Englisch

No Instruction available.

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

ECOG clinical trial administrative data

Registration Step
Beschreibung

RegistrationStep

Datentyp

text

Patient?s Name
Beschreibung

Patient'sName

Datentyp

text

ECOG Protocol No.
Beschreibung

ECOGProtocolNo.

Datentyp

text

ECOG Protocol No.
Beschreibung

ECOGProtocolNo.

Datentyp

text

ECOG Patient ID
Beschreibung

ECOGPatientID

Datentyp

text

ECOG Patient ID
Beschreibung

ECOGPatientID

Datentyp

text

Participating Group Protocol No.
Beschreibung

ParticipatingGroupProtocolNo.

Datentyp

text

Participating Group Patient ID
Beschreibung

ParticipatingGroupPatientID

Datentyp

text

Institution/Affiliate
Beschreibung

MainMemberInstitution/Affiliate

Datentyp

text

Data amendment
Beschreibung

Data amendment

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

AmendedDataInd

Datentyp

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)
Beschreibung

IntervalReportFromDate

Datentyp

date

Reporting Period End Date: (M D Y)
Beschreibung

IntervalReportToDate

Datentyp

date

Vital Status
Beschreibung

Vital Status

Patient's Vital Status
Beschreibung

Patient'sVitalStatus

Datentyp

text

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

DeathDate/LastContactDate

Datentyp

date

Primary Cause of Death (if applicable)
Beschreibung

DeathReason

Datentyp

text

Describe cause of death
Beschreibung

DeathReason,Specify

Datentyp

text

Disease Follow-up Status
Beschreibung

Disease Follow-up Status

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

CancerFollow-upStatusInd

Datentyp

text

Date of last clinical assessment: (Submit appropriate ECOG Disease Evaluation 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 developed a first progression that has not been previously reported?
Beschreibung

ProgressionInd

Datentyp

text

Date of progression (If yes)
Beschreibung

ProgressionDate

Datentyp

date

Site(s) of progression (If yes)
Beschreibung

ProgressionSite

Datentyp

text

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

PhysicianProgressiveDiagnosisInd-3

Datentyp

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
Beschreibung

Notice Of New Primary

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

NewPrimaryCancerInd

Datentyp

text

Site(s) of new primary:
Beschreibung

NewPrimarySite

Datentyp

text

Toxicity
Beschreibung

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.)
Beschreibung

LateAdverseEventInd

Datentyp

text

Non-protocol Therapy
Beschreibung

Non-protocol Therapy

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

Hasthepatientreceivedanynon-protocolcancertherapypriortofirstprogression(notpreviouslyreported)?

Datentyp

text

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

Comments

Comments
Beschreibung

Comments

Datentyp

text

Investigator Signature
Beschreibung

InvestigatorSignature

Datentyp

text

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

InvestigatorSignatureDate

Datentyp

date

Ccrr Module For Long-term Follow-up Form
Beschreibung

Ccrr Module For Long-term Follow-up Form

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Ähnliche Modelle

No Instruction available.

1 Formulare
  1. StudyEvent: Long-Term Follow-up Form
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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