ID

10515

Description

Adverse Event 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=A6276505-5438-3D62-E034-0003BA0B1A09

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A6276505-5438-3D62-E034-0003BA0B1A09

Keywords

Versions (3)
  1. 9/19/12 9/19/12 -
  2. 6/1/15 6/1/15 -
  3. 6/3/15 6/3/15 -
Uploaded on

June 3, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Adverse Event Form NCT00058149

English

No Instruction available.

1 forms  
  1. StudyEvent: Adverse Event Form
    1. No Instruction available.
ECOG clinical trial administrative data
Description

ECOG clinical trial administrative data

ECOG Protocol No.
Description

ECOGProtocolNo.

Data type

text

ECOG Patient ID
Description

ECOGPatientID

Data type

text

Registration Step
Description

RegistrationStep

Data type

text

Adverse Event Reporting From Date (M D Y)
Description

CTCAdverseEventReportBeginDate

Data type

date

Adverse Event Reporting To Date (M D Y)
Description

CTCAdverseEventReportEndDate

Data type

date

Cycle Number (For Arm A, first cycle is 8 weeks, subsequent cycles are 4 weeks. For Arm B, 1 cycle=4 weeks. For Arm C, 1 cycle=2 weeks.)
Description

CycleNumber

Data type

text

Patient?s Name
Description

Patient'sName

Data type

text

Participating Group Protocol No.
Description

ParticipatingGroupProtocolNo.

Data type

text

Participating Group Patient ID
Description

ParticipatingGroupPatientID

Data type

text

Institution/Affiliate
Description

MainMemberInstitution/Affiliate

Data type

text

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

AmendedDataInd

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Adverse event
Description

Adverse event

CTC Adverse Event Term
Description

CTCAdverseEventTerm

Data type

text

CTC Adverse Event Grade (this period)
Description

CTCAdverseEventGrade

Data type

text

CTC Adverse Event Attribution Code
Description

CTCAdverseEventAttributionCode

Data type

text

Other CTC Adverse Event Term(s) not listed (Use CTC terminology)
Description

CTCAdverseEventTerm,Other

Data type

text

Comments
Description

Comments

Comments
Description

Comments

Data type

text

Investigator Signature
Description

InvestigatorSignature

Data type

text

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

InvestigatorSignatureDate

Data type

date

Ccrr Module For Adverse Event Form
Description

Ccrr Module For Adverse Event Form

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Similar models

No Instruction available.

1 forms
  1. StudyEvent: Adverse Event Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
ECOG clinical trial administrative data
ECOGProtocolNo.
Item
ECOG Protocol No.
text
ECOGPatientID
Item
ECOG Patient ID
text
RegistrationStep
Item
Registration Step
text
CTCAdverseEventReportBeginDate
Item
Adverse Event Reporting From Date (M D Y)
date
CTCAdverseEventReportEndDate
Item
Adverse Event Reporting To Date (M D Y)
date
CycleNumber
Item
Cycle Number (For Arm A, first cycle is 8 weeks, subsequent cycles are 4 weeks. For Arm B, 1 cycle=4 weeks. For Arm C, 1 cycle=2 weeks.)
text
Patient'sName
Item
Patient?s Name
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
ParticipatingGroupPatientID
Item
Participating Group Patient ID
text
MainMemberInstitution/Affiliate
Item
Institution/Affiliate
text
AmendedDataInd
Item
Are data amended? (If yes, please circle amended items in red)
boolean
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
Item Group
Adverse event
CTCAdverseEventTerm
Item
CTC Adverse Event Term
text
CTCAdverseEventGrade
Item
CTC Adverse Event Grade (this period)
text
CTCAdverseEventAttributionCode
Item
CTC Adverse Event Attribution Code
text
CTCAdverseEventTerm,Other
Item
Other CTC Adverse Event Term(s) not listed (Use CTC terminology)
text
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 Adverse Event Form
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