ID

10521

Description

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

Link

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

Keywords

Versions (3)
  1. 9/19/12 9/19/12 -
  2. 6/1/15 6/1/15 -
  3. 6/3/15 6/3/15 -
Uploaded on

June 3, 2015

DOI

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License

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

English

No Instruction available.

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

ECOG clinical trial administrative data

ECOG Protocol No.
Description

ECOGProtocolNo.

Data type

text

ECOG Patient ID
Description

ECOGPatientID

Data type

text

Registration Step
Description

RegistrationStep

Data type

text

Patient?s Name
Description

Patient'sName

Data type

text

Participating Group Protocol No.
Description

ParticipatingGroupProtocolNo.

Data type

text

Participating Group Patient ID
Description

ParticipatingGroupPatientID

Data type

text

Institution/Affiliate
Description

MainMemberInstitution/Affiliate

Data type

text

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

AmendedDataInd

Data type

boolean

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

Vital Status

Patient's Vital Status
Description

Patient'sVitalStatus

Data type

text

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

DeathDate/LastContactDate

Data type

date

Primary Cause of Death (if applicable)
Description

DeathReason

Data type

text

Describe cause of death
Description

DeathReason,Specify

Data type

text

Reason for treatment termination
Description

OffTreatmentReason

Data type

text

specify date of progression/relapse:
Description

ProgressionDate

Data type

date

other complicating disease, specify
Description

OffTreatmentReason,ComplicatingDisease

Data type

text

error, specify
Description

error,specify

Data type

text

other, specify
Description

OffTreatmentReason,Other

Data type

text

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

LastDoseDate

Data type

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
Description

Comments

Comments
Description

Comments

Data type

text

Investigator Signature
Description

InvestigatorSignature

Data type

text

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

InvestigatorSignatureDate

Data type

date

Ccrr Module For Off-treatment Form
Description

Ccrr Module For Off-treatment Form

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Similar models

No Instruction available.

1 forms
  1. StudyEvent: Off-Treatment Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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