ID

2978

Descripción

Off-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=A65D62C3-9044-4286-E034-0003BA0B1A09

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A65D62C3-9044-4286-E034-0003BA0B1A09

Palabras clave

Versiones (3)
  1. 19/9/12 19/9/12 -
  2. 1/6/15 1/6/15 -
  3. 3/6/15 3/6/15 -
Subido en

19 de septiembre de 2012

DOI

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Licencia

Creative Commons BY-NC 3.0 Legacy
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Pancreatic Cancer NCT00058149 Off Treatment - Off-Treatment Form - 2048355v3.0

Inglés

No Instruction available.

1 formularios  
  1. StudyEvent: Off-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

Primary Cause of Death (if applicable)
Descripción

DeathReason

Tipo de datos

text

Describe cause of death
Descripción

DeathReason,Specify

Tipo de datos

text

Reason for treatment termination
Descripción

OffTreatmentReason

Tipo de datos

text

specify date of progression/relapse:
Descripción

ProgressionDate

Tipo de datos

date

other complicating disease, specify
Descripción

OffTreatmentReason,ComplicatingDisease

Tipo de datos

text

error, specify
Descripción

error,specify

Tipo de datos

text

other, specify
Descripción

OffTreatmentReason,Other

Tipo de datos

text

Date of last dose of protocol treatment (M D Y)
Descripción

LastDoseDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus ObjectClass
C25551
UMLS 2011AA ObjectClass
C1517741
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
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 Off-treatment Form
Descripción

Ccrr Module For Off-treatment Form

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Similar models

No Instruction available.

1 formularios
  1. StudyEvent: Off-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
Primary Cause of Death (if applicable)
text
CL.3
Code List
Primary 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, Specify (Due to other diease)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
DeathReason,Specify
Item
Describe cause of death
text
Item
Reason for treatment termination
text
CL.4
Code List
Reason for treatment termination
CL Item
Treatment Completed Per Protocol Criteria (treatment completed per protocol criteria)
CL Item
Disease Progression, Relapse During Active Treatment (disease progression, relapse during active treatment)
CL Item
Toxicity/side Effects/complications (toxicity/side effects/complications (either physician directed or patient choice), specify in Comments)
CL Item
death of patient on study (without progressive disease) (death of patient on study (without progressive disease))
CL Item
patient withdrawal or refusal (patient withdrawal or refusal)
CL Item
Alternative Therapy (alternative therapy, complete the ECOG Non-Protocol Therapy Form)
CL Item
Other (other complicating disease, specify)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
error, specify (error, specify)
CL Item
Other, Specify (other, specify)
ProgressionDate
Item
specify date of progression/relapse:
date
OffTreatmentReason,ComplicatingDisease
Item
other complicating disease, specify
text
error,specify
Item
error, specify
text
OffTreatmentReason,Other
Item
other, specify
text
LastDoseDate
Item
Date of last dose of protocol treatment (M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25551 (NCI Thesaurus ObjectClass)
C1517741 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
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 Off-treatment Form
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