ID

10450

Beschrijving

Supplemental 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=A65C81E5-2ACA-42A6-E034-0003BA0B1A09

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A65C81E5-2ACA-42A6-E034-0003BA0B1A09

Trefwoorden

Versies (2)
  1. 20-09-12 20-09-12 -
  2. 02-06-15 02-06-15 -
Geüploaded op

2 juni 2015

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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Supplemental Form

Engels

No Instruction available.

1 Formulieren  
  1. StudyEvent: Supplemental Form
    1. No Instruction available.
ECOG clinical trial administrative data
Beschrijving

ECOG clinical trial administrative data

Registration Step
Beschrijving

RegistrationStep

Datatype

text

Patient?s Name
Beschrijving

Patient'sName

Datatype

text

ECOG Protocol No.
Beschrijving

ECOGProtocolNo.

Datatype

text

ECOG Protocol No.
Beschrijving

ECOGProtocolNo.

Datatype

text

ECOG Patient ID
Beschrijving

ECOGPatientID

Datatype

text

ECOG Patient ID
Beschrijving

ECOGPatientID

Datatype

text

Participating Group Protocol No.
Beschrijving

ParticipatingGroupProtocolNo.

Datatype

text

Participating Group Patient ID
Beschrijving

ParticipatingGroupPatientID

Datatype

text

Institution/Affiliate
Beschrijving

MainMemberInstitution/Affiliate

Datatype

text

Data amendment
Beschrijving

Data amendment

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

AmendedDataInd

Datatype

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)
Beschrijving

IntervalReportFromDate

Datatype

date

Reporting Period End Date (M D Y)
Beschrijving

IntervalReportToDate

Datatype

date

Cea
Beschrijving

Cea

Date CEA obtained (M D Y)
Beschrijving

CarcinoembryonicAntigenSpecimenCollectionDate

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25159
UMLS 2011AA ObjectClass
C0007082
NCI Thesaurus Property
C25453
UMLS 2011AA Property
C1516698
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
CEA Patient Value (ng/ml)
Beschrijving

CEA

Datatype

text

CEA ULN
Beschrijving

LaboratoryProcedureCarcinoembryonicAntigenOutcomeUpperLimitNormalValue

Datatype

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25159
UMLS 2011AA Property
C0007082
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Ca19-19
Beschrijving

Ca19-19

Date CA19-19 obtained (M D Y)
Beschrijving

DateCA19-9obtained

Datatype

text

CA19-19 Patient Value (U/ml)
Beschrijving

CA19-9

Datatype

text

Thrombosis / Embolism
Beschrijving

Thrombosis / Embolism

Did the patient have a deep vein thrombosis (DVT) this report period?
Beschrijving

AdverseEventDeepVeinThrombosisPresentInd-2

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C49343
UMLS 2011AA Property
C0149871
Did the patient have a pulmonary embolism this report period?
Beschrijving

Didthepatienthaveapulmonaryembolismthisreportperiod?

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Comments
Beschrijving

Comments

Comments
Beschrijving

Comments

Datatype

text

Investigator Signature
Beschrijving

InvestigatorSignature

Datatype

text

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

InvestigatorSignatureDate

Datatype

date

Ccrr Module For Supplemental Form
Beschrijving

Ccrr Module For Supplemental Form

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Similar models

No Instruction available.

1 Formulieren
  1. StudyEvent: Supplemental Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
Cea
CarcinoembryonicAntigenSpecimenCollectionDate
Item
Date CEA obtained (M D Y)
text
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25159 (NCI Thesaurus ObjectClass)
C0007082 (UMLS 2011AA ObjectClass)
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
CEA
Item
CEA Patient Value (ng/ml)
text
LaboratoryProcedureCarcinoembryonicAntigenOutcomeUpperLimitNormalValue
Item
CEA ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25159 (NCI Thesaurus Property)
C0007082 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Item Group
Ca19-19
DateCA19-9obtained
Item
Date CA19-19 obtained (M D Y)
text
CA19-9
Item
CA19-19 Patient Value (U/ml)
text
Item Group
Thrombosis / Embolism
Item
Did the patient have a deep vein thrombosis (DVT) this report period?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C49343 (NCI Thesaurus Property)
C0149871 (UMLS 2011AA Property)
CL.2
Code List
Did the patient have a deep vein thrombosis (DVT) this report period?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Did the patient have a pulmonary embolism this report period?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.3
Code List
Did the patient have a pulmonary embolism this report period?
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 Supplemental Form
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