ID

10515

Descrizione

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

collegamento

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

Keywords

  1. 19/09/12 19/09/12 -
  2. 01/06/15 01/06/15 -
  3. 03/06/15 03/06/15 -
Caricato su

3 giugno 2015

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0 Legacy

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Adverse Event Form NCT00058149

No Instruction available.

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

ECOG clinical trial administrative data

ECOG Protocol No.
Descrizione

ECOGProtocolNo.

Tipo di dati

text

ECOG Patient ID
Descrizione

ECOGPatientID

Tipo di dati

text

Registration Step
Descrizione

RegistrationStep

Tipo di dati

text

Adverse Event Reporting From Date (M D Y)
Descrizione

CTCAdverseEventReportBeginDate

Tipo di dati

date

Adverse Event Reporting To Date (M D Y)
Descrizione

CTCAdverseEventReportEndDate

Tipo di dati

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.)
Descrizione

CycleNumber

Tipo di dati

text

Patient?s Name
Descrizione

Patient'sName

Tipo di dati

text

Participating Group Protocol No.
Descrizione

ParticipatingGroupProtocolNo.

Tipo di dati

text

Participating Group Patient ID
Descrizione

ParticipatingGroupPatientID

Tipo di dati

text

Institution/Affiliate
Descrizione

MainMemberInstitution/Affiliate

Tipo di dati

text

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

AmendedDataInd

Tipo di dati

boolean

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

Adverse event

CTC Adverse Event Term
Descrizione

CTCAdverseEventTerm

Tipo di dati

text

CTC Adverse Event Grade (this period)
Descrizione

CTCAdverseEventGrade

Tipo di dati

text

CTC Adverse Event Attribution Code
Descrizione

CTCAdverseEventAttributionCode

Tipo di dati

text

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

CTCAdverseEventTerm,Other

Tipo di dati

text

Comments
Descrizione

Comments

Comments
Descrizione

Comments

Tipo di dati

text

Investigator Signature
Descrizione

InvestigatorSignature

Tipo di dati

text

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

InvestigatorSignatureDate

Tipo di dati

date

Ccrr Module For Adverse Event Form
Descrizione

Ccrr Module For Adverse Event Form

Similar models

No Instruction available.

  1. StudyEvent: Adverse Event Form
    1. No Instruction available.
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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