ID

10521

Descrizione

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

collegamento

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

Keywords

versioni (3)
  1. 19/09/12 19/09/12 -
  2. 01/06/15 01/06/15 -
  3. 03/06/15 03/06/15 -
Caricato su

3 giugno 2015

DOI

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Licenza

Creative Commons BY-NC 3.0 Legacy
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Off-Treatment Form NCT00058149

Inglese

No Instruction available.

1 moduli  
  1. StudyEvent: Off-Treatment Form
    1. No Instruction available.
ECOG clinical trial administrative data
Descrizione

ECOG clinical trial administrative data

ECOG Protocol No.
Descrizione

ECOGProtocolNo.

Tipo di dati

text

ECOG Patient ID
Descrizione

ECOGPatientID

Tipo di dati

text

Registration Step
Descrizione

RegistrationStep

Tipo di dati

text

Patient?s Name
Descrizione

Patient'sName

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

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

AmendedDataInd

Tipo di dati

boolean

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

Primary Cause of Death (if applicable)
Descrizione

DeathReason

Tipo di dati

text

Describe cause of death
Descrizione

DeathReason,Specify

Tipo di dati

text

Reason for treatment termination
Descrizione

OffTreatmentReason

Tipo di dati

text

specify date of progression/relapse:
Descrizione

ProgressionDate

Tipo di dati

date

other complicating disease, specify
Descrizione

OffTreatmentReason,ComplicatingDisease

Tipo di dati

text

error, specify
Descrizione

error,specify

Tipo di dati

text

other, specify
Descrizione

OffTreatmentReason,Other

Tipo di dati

text

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

LastDoseDate

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus ObjectClass-2
C25551
UMLS 2011AA ObjectClass-2
C1517741
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Comments
Descrizione

Comments

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 Off-treatment Form
Descrizione

Ccrr Module For Off-treatment Form

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Similar models

No Instruction available.

1 moduli
  1. StudyEvent: Off-Treatment Form
    1. No Instruction available.
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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
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-2)
C1517741 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
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 Off-treatment Form
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