ID

3343

Descripción

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

Link

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

Palabras clave

Versiones (3)
  1. 20/9/12 20/9/12 -
  2. 2/6/15 2/6/15 -
  3. 3/6/15 3/6/15 -
Subido en

20 de septiembre de 2012

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

Inglés

No Instruction available.

1 formularios  
  1. StudyEvent: Treatment Form
    1. No Instruction available.
Unnamed1
Descripción

Unnamed1

Registration Step
Descripción

RegistrationStep

Tipo de datos

text

Patient?s Name
Descripción

Patient'sName

Tipo de datos

text

ECOG Protocol No.
Descripción

ECOGProtocolNo.

Tipo de datos

text

ECOG Protocol No.
Descripción

ECOGProtocolNo.

Tipo de datos

text

ECOG Patient ID
Descripción

ECOGPatientID

Tipo de datos

text

ECOG Patient ID
Descripción

ECOGPatientID

Tipo de datos

text

Participating Group Protocol No.
Descripción

ParticipatingGroupProtocolNo.

Tipo de datos

text

Participating Group Patient ID
Descripción

ParticipatingGroupPatientID

Tipo de datos

text

Institution/Affiliate
Descripción

MainMemberInstitution/Affiliate

Tipo de datos

text

Unnamed2
Descripción

Unnamed2

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

AmendedDataInd

Tipo de datos

text

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

Vital Status

Patient?s Vital Status
Descripción

Patient'sVitalStatus

Tipo de datos

text

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

DeathDate/LastContactDate

Tipo de datos

date

Cause of Death (if applicable)
Descripción

Causeofdeath

Tipo de datos

text

Describe cause of death
Descripción

DeathReason,Specify

Tipo de datos

text

Arm A
Descripción

Arm A

Cycle Number
Descripción

CycleNumber

Tipo de datos

text

Oxaliplatin Dose (mg)
Descripción

AgentTotalDose

Tipo de datos

double

Oxaliplatin begin date (M D Y)
Descripción

AgentBeginDate

Tipo de datos

date

Arm B
Descripción

Arm B

Cycle Number
Descripción

CycleNumber

Tipo de datos

text

Oxaliplatin Dose (mg)
Descripción

AgentTotalDose

Tipo de datos

double

Oxaliplatin begin date (M D Y)
Descripción

AgentBeginDate

Tipo de datos

date

Arm C
Descripción

Arm C

Cycle Number
Descripción

CycleNumber

Tipo de datos

text

Oxaliplatin Dose (mg)
Descripción

AgentTotalDose

Tipo de datos

double

Oxaliplatin Dose (mg)
Descripción

AgentTotalDose

Tipo de datos

double

Oxaliplatin begin date (M D Y)
Descripción

AgentBeginDate

Tipo de datos

date

Oxaliplatin begin date (M D Y)
Descripción

AgentBeginDate

Tipo de datos

date

If yes, choose one:
Descripción

DoseModification(Change)

Tipo de datos

text

If yes, choose one:
Descripción

DoseModification(Change)

Tipo de datos

text

Name of therapy
Descripción

TherapyModificationName

Tipo de datos

text

Type of therapy modification
Descripción

TherapyModificationText

Tipo de datos

text

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

DoseModificationReason

Tipo de datos

text

Non-protocol Therapy
Descripción

Non-protocol Therapy

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

Non-ProtocolTherapyInd,DuringProtocol

Tipo de datos

text

Unnamed3
Descripción

Unnamed3

Comments
Descripción

Comments

Tipo de datos

text

Investigator Signature
Descripción

InvestigatorSignature

Tipo de datos

text

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

InvestigatorSignatureDate

Tipo de datos

date

Ccrr Module For Treatment Form
Descripción

Ccrr Module For Treatment Form

Patient Weight
Descripción

PatientWeight

Tipo de datos

double

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Similar models

No Instruction available.

1 formularios
  1. StudyEvent: Treatment Form
    1. No Instruction available.
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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