Informatie:
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ID
10515
Beschrijving
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
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Versies (3)
- 19-09-12 19-09-12 -
- 01-06-15 01-06-15 -
- 03-06-15 03-06-15 -
Geüploaded op
3 juni 2015
DOI
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Licentie
Creative Commons BY-NC 3.0 Legacy
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Adverse Event Form NCT00058149
No Instruction available.
- StudyEvent: Adverse Event Form
Similar models
No Instruction available.
- StudyEvent: Adverse Event Form
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
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
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)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignatureDate
Item
Date
date
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