ID

3343

Descrizione

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

collegamento

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

Keywords

versioni (3)
  1. 20/09/12 20/09/12 -
  2. 02/06/15 02/06/15 -
  3. 03/06/15 03/06/15 -
Caricato su

20 settembre 2012

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0 Legacy
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Pancreatic Cancer NCT00058149 Treatment - Treatment Form - 2048782v3.0

Inglese

No Instruction available.

1 moduli  
  1. StudyEvent: Treatment Form
    1. No Instruction available.
Unnamed1
Descrizione

Unnamed1

Registration Step
Descrizione

RegistrationStep

Tipo di dati

text

Patient?s Name
Descrizione

Patient'sName

Tipo di dati

text

ECOG Protocol No.
Descrizione

ECOGProtocolNo.

Tipo di dati

text

ECOG Protocol No.
Descrizione

ECOGProtocolNo.

Tipo di dati

text

ECOG Patient ID
Descrizione

ECOGPatientID

Tipo di dati

text

ECOG Patient ID
Descrizione

ECOGPatientID

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

Unnamed2
Descrizione

Unnamed2

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

AmendedDataInd

Tipo di dati

text

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

Vital Status

Patient?s Vital Status
Descrizione

Patient'sVitalStatus

Tipo di dati

text

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

DeathDate/LastContactDate

Tipo di dati

date

Cause of Death (if applicable)
Descrizione

Causeofdeath

Tipo di dati

text

Describe cause of death
Descrizione

DeathReason,Specify

Tipo di dati

text

Arm A
Descrizione

Arm A

Cycle Number
Descrizione

CycleNumber

Tipo di dati

text

Oxaliplatin Dose (mg)
Descrizione

AgentTotalDose

Tipo di dati

double

Oxaliplatin begin date (M D Y)
Descrizione

AgentBeginDate

Tipo di dati

date

Arm B
Descrizione

Arm B

Cycle Number
Descrizione

CycleNumber

Tipo di dati

text

Oxaliplatin Dose (mg)
Descrizione

AgentTotalDose

Tipo di dati

double

Oxaliplatin begin date (M D Y)
Descrizione

AgentBeginDate

Tipo di dati

date

Arm C
Descrizione

Arm C

Cycle Number
Descrizione

CycleNumber

Tipo di dati

text

Oxaliplatin Dose (mg)
Descrizione

AgentTotalDose

Tipo di dati

double

Oxaliplatin Dose (mg)
Descrizione

AgentTotalDose

Tipo di dati

double

Oxaliplatin begin date (M D Y)
Descrizione

AgentBeginDate

Tipo di dati

date

Oxaliplatin begin date (M D Y)
Descrizione

AgentBeginDate

Tipo di dati

date

If yes, choose one:
Descrizione

DoseModification(Change)

Tipo di dati

text

If yes, choose one:
Descrizione

DoseModification(Change)

Tipo di dati

text

Name of therapy
Descrizione

TherapyModificationName

Tipo di dati

text

Type of therapy modification
Descrizione

TherapyModificationText

Tipo di dati

text

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

DoseModificationReason

Tipo di dati

text

Non-protocol Therapy
Descrizione

Non-protocol Therapy

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

Non-ProtocolTherapyInd,DuringProtocol

Tipo di dati

text

Unnamed3
Descrizione

Unnamed3

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 Treatment Form
Descrizione

Ccrr Module For Treatment Form

Patient Weight
Descrizione

PatientWeight

Tipo di dati

double

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Similar models

No Instruction available.

1 moduli
  1. StudyEvent: Treatment Form
    1. No Instruction available.
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Unnamed1
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
Unnamed2
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)
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)
double
AgentBeginDate
Item
Oxaliplatin begin date (M D Y)
date
Item Group
Arm B
CycleNumber
Item
Cycle Number
text
AgentTotalDose
Item
Oxaliplatin Dose (mg)
double
AgentBeginDate
Item
Oxaliplatin begin date (M D Y)
date
Item Group
Arm C
CycleNumber
Item
Cycle Number
text
AgentTotalDose
Item
Oxaliplatin Dose (mg)
double
AgentTotalDose
Item
Oxaliplatin Dose (mg)
double
AgentBeginDate
Item
Oxaliplatin begin date (M D Y)
date
AgentBeginDate
Item
Oxaliplatin begin date (M D Y)
date
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)
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
Item
Was any non-protocol therapy given during protocol treatment (not previously reported)?
text
CL.6
Code List
Was any non-protocol therapy given during protocol treatment (not previously reported)?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Unnamed3
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
double
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