ID

10501

Beschrijving

Treatment 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=A65C8791-5AF1-42A8-E034-0003BA0B1A09

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A65C8791-5AF1-42A8-E034-0003BA0B1A09

Trefwoorden

Versies (3)
  1. 20-09-12 20-09-12 -
  2. 02-06-15 02-06-15 -
  3. 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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Treatment Form NCT00058149

Engels

No Instruction available.

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

ECOG clinical trial administrative data

ECOG Protocol No.
Beschrijving

ECOGProtocolNo.

Datatype

text

ECOG Patient ID
Beschrijving

ECOGPatientID

Datatype

text

Registration Step
Beschrijving

RegistrationStep

Datatype

text

Patient?s Name
Beschrijving

Patient'sName

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

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

AmendedDataInd

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Vital Status
Beschrijving

Vital Status

Patient?s Vital Status
Beschrijving

Patient'sVitalStatus

Datatype

text

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

DeathDate/LastContactDate

Datatype

date

Cause of Death (if applicable)
Beschrijving

Causeofdeath

Datatype

text

Describe cause of death
Beschrijving

DeathReason,Specify

Datatype

text

Arm A
Beschrijving

Arm A

Cycle Number
Beschrijving

CycleNumber

Datatype

text

Oxaliplatin Dose (mg)
Beschrijving

AgentTotalDose

Datatype

float

Oxaliplatin begin date (M D Y)
Beschrijving

AgentBeginDate

Datatype

date

Arm B
Beschrijving

Arm B

Arm C
Beschrijving

Arm C

If yes, choose one:
Beschrijving

DoseModification(Change)

Datatype

text

Name of therapy
Beschrijving

TherapyModificationName

Datatype

text

Type of therapy modification
Beschrijving

TherapyModificationText

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25572
Reason for therapy modification
Beschrijving

DoseModificationReason

Datatype

text

Non-protocol Therapy
Beschrijving

Non-protocol Therapy

Was any non-protocol therapy given during protocol treatment (not previously reported)?
Beschrijving

Non-ProtocolTherapyInd,DuringProtocol

Datatype

boolean

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 Treatment Form
Beschrijving

Ccrr Module For Treatment Form

Patient Weight
Beschrijving

PatientWeight

Datatype

float

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Similar models

No Instruction available.

1 Formulieren
  1. StudyEvent: Treatment Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
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
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
Cause of Death (if applicable)
text
CL.3
Code List
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 (Due to other cause)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
DeathReason,Specify
Item
Describe cause of death
text
Item Group
Arm A
CycleNumber
Item
Cycle Number
text
AgentTotalDose
Item
Oxaliplatin Dose (mg)
float
AgentBeginDate
Item
Oxaliplatin begin date (M D Y)
date
Item Group
Arm B
Item Group
Arm C
Item
If yes, choose one:
text
CL.5
Code List
If yes, choose one:
CL Item
(i.e., The Treatment Was Changed According To Protocol Guidelines) (Planned (i.e., the treatment was changed according to protocol guidelines))
CL Item
(i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Unplanned (i.e., the treatment change was not part of protocol guidelines))
CL Item
Both planned and unplanned, specify unplanned changes above (Both planned and unplanned, specify unplanned changes above)
TherapyModificationName
Item
Name of therapy
text
TherapyModificationText
Item
Type of therapy modification
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
DoseModificationReason
Item
Reason for therapy modification
text
Item Group
Non-protocol Therapy
Non-ProtocolTherapyInd,DuringProtocol
Item
Was any non-protocol therapy given during protocol treatment (not previously reported)?
boolean
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 Treatment Form
PatientWeight
Item
Patient Weight
float
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