ID

11393

Description

Form 6 - Final Report NCT00049543 Gefitinib in Treating Patients With Non-Small Cell Lung Cancer That Has Been Surgically Removed Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A1AD599A-E8FC-3686-E034-080020C9C0E0

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A1AD599A-E8FC-3686-E034-080020C9C0E0

Keywords

Versions (3)
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 7/3/15 7/3/15 -
Uploaded on

July 3, 2015

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Creative Commons BY-NC 3.0 Legacy
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Form 6 - Final Report NCT00049543

English

No Instruction available.

1 forms  
  1. StudyEvent: Form 6 - Final Report
    1. No Instruction available.
1. Patient Information
Description

1. Patient Information

Pt. Serial #
Description

PatientStudyID,CoordinatingGroup

Data type

text

Hospital #
Description

PatientMedicalRecordNumber

Data type

text

Pt. Initials
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Intergroup Patient Serial #
Description

PatientStudyID,ParticipatingGroup

Data type

text

Site #
Description

NCIInstitutionNumber

Data type

text

Patient's Social Security # (USA only)
Description

PatientSocialSecurityNumber

Data type

float

Institution
Description

InstitutionName

Data type

text

Investigator
Description

RegisteredInvestigator

Data type

text

2. Cause Of Death
Description

2. Cause Of Death

Date of death
Description

DeathDocumentedDate

Data type

date

Cause of Death
Description

DeathReason

Data type

text

other primary malignancy (specify & send report)
Description

OtherPrimaryMalignantNeoplasmPresentStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C17649
UMLS 2011AA ObjectClass
C0205394
NCI Thesaurus ObjectClass-2
C25251
UMLS 2011AA ObjectClass-2
C0205225
NCI Thesaurus ObjectClass-3
C9305
UMLS 2011AA ObjectClass-3
C0006826
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
NCIC CTG use only code
Description

NCICCTGuseonlycode

Data type

text

Describe
Description

DeathReason,Specify

Data type

text

Status of NSCLC at Time of Death
Description

StatusofNSCLCatTimeofDeath

Data type

text

3. Autopsy
Description

3. Autopsy

Autopsy performed
Description

AutopsyInd

Data type

text

NCIC CTG Use only: Received
Description

NCICCTGUseonly:Received

Data type

text

4. Other Malignancies Or Marrow Dysplasia
Description

4. Other Malignancies Or Marrow Dysplasia

Have any other malignancies or myelodysplastic syndrome (MDS) been diagnosed?
Description

NewPrimaryCancerInd

Data type

boolean

Date of diagnosis
Description

NewPrimaryCancerDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Site of new primary
Description

NewPrimarySite

Data type

text

Describe (An Adverse Event Report must be sent to NCIC CTG within 15 working days that diagnosis is known to the investigator. See protocol section 11.0 for details.)
Description

NewPrimaryDetail

Data type

text

Ncic Ctg Use
Description

Ncic Ctg Use

Malignancy Type
Description

NewPrimaryMalignancyType

Data type

text

Ncic Ctg Use Only
Description

Ncic Ctg Use Only

Logged
Description

LoggedEntryInitials

Data type

text

Header
Description

LoggedEntryDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Study Coord
Description

CoordinatorReviewInitials

Data type

text

Coordinator Review Date
Description

Coordinator Review Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0011008
Phy
Description

PhysicianReviewInitials

Data type

text

Data Ent'd
Description

DataEntryInitials

Data type

text

Verified
Description

DataVerificationInitials

Data type

text

5. Treatment Given Since Last Report To Ncic Ctg
Description

5. Treatment Given Since Last Report To Ncic Ctg

Is the patient receiving any non-protocol cancer therapy not previously reported? (if yes, specify below)
Description

Non-ProtocolTherapyInd

Data type

boolean

Non-Protocol Hormonal Therapy? (include medical and surgical)
Description

Non-ProtocolHormonalTherapyInd

Data type

boolean

Non-Protocol Chemotherapy?
Description

Non-ProtocolChemotherapyInd

Data type

boolean

Non-Protocol Immunotherapy?
Description

Non-ProtocolImmunotherapyInd

Data type

boolean

Non-Protocol Biologic Response Modifier?
Description

Non-ProtocolBRMInd

Data type

boolean

Non-Protocol High Dose Chemotherapy/ Autologous Stem Cell Transplant?
Description

Non-ProtocolHDC/ASCTInd

Data type

boolean

Non-Protocol Radiation Therapy?
Description

Non-ProtocolRTInd

Data type

boolean

Non-Protocol Surgery?
Description

Non-protocolSurgeryPerformedInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass-2
C1518384
Other Non-Protocol Therapy?
Description

OtherTherapyInd

Data type

boolean

(specify)
Description

OtherNon-ProtocolTherapyName

Data type

text

First ever chemotherapy or EGFR inhibitor given: (specify)
Description

Non-ProtocolFirstChemotherapyAgentName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus ObjectClass-2
C2167
UMLS 2011AA ObjectClass-2
C1443775
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Date started
Description

Non-ProtocolFirstChemotherapyBeginDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
Second ever chemotherapy or EGFR inhibitor given: (specify)
Description

Non-ProtocolSecondChemotherapyAgentName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus ObjectClass-2
C2167
UMLS 2011AA ObjectClass-2
C1443775
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Date started(2nd)
Description

Non-ProtocolSecondChemotherapyBeginDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Ncic Ctg Use2
Description

Ncic Ctg Use2

1st line
Description

1stline

Data type

text

2nd line
Description

2ndline

Data type

text

6. Delayed Toxicity/adverse Event/intercurrent Illness
Description

6. Delayed Toxicity/adverse Event/intercurrent Illness

NCIC CTG use only
Description

NCICCTGuseonly

Data type

text

Did the patient experience any long term toxicities of protocol treatment that has not yet been reported? (if yes, please complete form below)
Description

LateAdverseEventInd

Data type

boolean

Late Toxicity Term
Description

CTCAdverseEventTerm

Data type

text

Category Code*
Description

CTCAdverseEventCategory

Data type

text

NCIC CTG use only Tox Code
Description

NCICCTGuseonlyToxCode

Data type

text

Worst Severity/Grade* (0=None NA=Not Assessed * Code/grade according to Common Toxicity Criteria, Version 2.0)
Description

CTCAdverseEventGrade

Data type

text

Relation to Protocol Therapy
Description

CTCAdverseEventAttributionCode

Data type

text

COMMENTS
Description

Comments

Data type

text

7. Comments
Description

7. Comments

8. Have You Attached Copies Of
Description

8. Have You Attached Copies Of

8. HAVE YOU ATTACHED COPIES OF (please _)
Description

HAVEYOUATTACHEDCOPIESOF

Data type

text

9. Investigator Signature
Description

9. Investigator Signature

Signature of Responsible Investigator
Description

InvestigatorSignature

Data type

text

Alias
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Name of Clinical Research Associate
Description

PersonCompletingForm,LastName

Data type

text

Date
Description

FormCompletionDate,Original

Data type

date

Ccrr Module For Form 6 - Final Report
Description

Ccrr Module For Form 6 - Final Report

Person Completing Form, First Name
Description

PersonCompletingForm,FirstName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
CTC Adverse Event Term, Other
Description

CTCAdverseEventTerm,Other

Data type

text

Non-Protocol EGFR Inhibitor Ind
Description

Non-ProtocolEpidermalGrowthFactorReceptorTyrosineKinaseInhibitorAdministeredInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus ObjectClass-2
C2167
UMLS 2011AA ObjectClass-2
C1443775
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
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Similar models

No Instruction available.

1 forms
  1. StudyEvent: Form 6 - Final Report
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
1. Patient Information
PatientStudyID,CoordinatingGroup
Item
Pt. Serial #
text
PatientMedicalRecordNumber
Item
Hospital #
text
Patient Initials
Item
Pt. Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
PatientStudyID,ParticipatingGroup
Item
Intergroup Patient Serial #
text
NCIInstitutionNumber
Item
Site #
text
PatientSocialSecurityNumber
Item
Patient's Social Security # (USA only)
float
InstitutionName
Item
Institution
text
RegisteredInvestigator
Item
Investigator
text
Item Group
2. Cause Of Death
DeathDocumentedDate
Item
Date of death
date
Item
Cause of Death
text
CL.1
Code List
Cause of Death
CL Item
Due To This Disease (NSCLC)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Due To Protocol Treatment (protocol treatment complication)
CL Item
combination NSCLC and protocol treatment complication (combination NSCLC and protocol treatment complication)
CL Item
non-protocol treatment complication (non-protocol treatment complication)
CL Item
combination NSCLC and non-protocol treatment complication (combination NSCLC and non-protocol treatment complication)
CL Item
other primary malignancy (other primary malignancy)
CL Item
Due To Other Cause (other condition or circumstance)
OtherPrimaryMalignantNeoplasmPresentStatus
Item
other primary malignancy (specify & send report)
text
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C9305 (NCI Thesaurus ObjectClass-3)
C0006826 (UMLS 2011AA ObjectClass-3)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
NCICCTGuseonlycode
Item
NCIC CTG use only code
text
DeathReason,Specify
Item
Describe
text
Item
Status of NSCLC at Time of Death
text
CL.2
Code List
Status of NSCLC at Time of Death
CL Item
Absent (Absent)
CL Item
Present (Present)
CL Item
Unknown (Unknown)
Item Group
3. Autopsy
Item
Autopsy performed
text
CL.3
Code List
Autopsy performed
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
NCICCTGUseonly:Received
Item
NCIC CTG Use only: Received
text
Item Group
4. Other Malignancies Or Marrow Dysplasia
NewPrimaryCancerInd
Item
Have any other malignancies or myelodysplastic syndrome (MDS) been diagnosed?
boolean
NewPrimaryCancerDate
Item
Date of diagnosis
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
NewPrimarySite
Item
Site of new primary
text
NewPrimaryDetail
Item
Describe (An Adverse Event Report must be sent to NCIC CTG within 15 working days that diagnosis is known to the investigator. See protocol section 11.0 for details.)
text
Item Group
Ncic Ctg Use
NewPrimaryMalignancyType
Item
Malignancy Type
text
Item Group
Ncic Ctg Use Only
LoggedEntryInitials
Item
Logged
text
LoggedEntryDate
Item
Header
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
CoordinatorReviewInitials
Item
Study Coord
text
CoordinatorReviewDate
Item
Coordinator Review Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS CUI-1)
PhysicianReviewInitials
Item
Phy
text
DataEntryInitials
Item
Data Ent'd
text
DataVerificationInitials
Item
Verified
text
Item Group
5. Treatment Given Since Last Report To Ncic Ctg
Non-ProtocolTherapyInd
Item
Is the patient receiving any non-protocol cancer therapy not previously reported? (if yes, specify below)
boolean
Non-ProtocolHormonalTherapyInd
Item
Non-Protocol Hormonal Therapy? (include medical and surgical)
boolean
Non-ProtocolChemotherapyInd
Item
Non-Protocol Chemotherapy?
boolean
Non-ProtocolImmunotherapyInd
Item
Non-Protocol Immunotherapy?
boolean
Non-ProtocolBRMInd
Item
Non-Protocol Biologic Response Modifier?
boolean
Non-ProtocolHDC/ASCTInd
Item
Non-Protocol High Dose Chemotherapy/ Autologous Stem Cell Transplant?
boolean
Non-ProtocolRTInd
Item
Non-Protocol Radiation Therapy?
boolean
Non-protocolSurgeryPerformedInd-3
Item
Non-Protocol Surgery?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass-2)
OtherTherapyInd
Item
Other Non-Protocol Therapy?
boolean
OtherNon-ProtocolTherapyName
Item
(specify)
text
Non-ProtocolFirstChemotherapyAgentName
Item
First ever chemotherapy or EGFR inhibitor given: (specify)
text
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C2167 (NCI Thesaurus ObjectClass-2)
C1443775 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Non-ProtocolFirstChemotherapyBeginDate
Item
Date started
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
Non-ProtocolSecondChemotherapyAgentName
Item
Second ever chemotherapy or EGFR inhibitor given: (specify)
text
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C2167 (NCI Thesaurus ObjectClass-2)
C1443775 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Non-ProtocolSecondChemotherapyBeginDate
Item
Date started(2nd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Ncic Ctg Use2
1stline
Item
1st line
text
2ndline
Item
2nd line
text
Item Group
6. Delayed Toxicity/adverse Event/intercurrent Illness
Item
NCIC CTG use only
text
CL.14
Code List
NCIC CTG use only
CL Item
Acute Toxicity Database (Acute toxicity database)
CL Item
Delayed Toxicity Database (Delayed toxicity database)
LateAdverseEventInd
Item
Did the patient experience any long term toxicities of protocol treatment that has not yet been reported? (if yes, please complete form below)
boolean
Item
Late Toxicity Term
text
CL.16
Code List
Late Toxicity Term
CL Item
Anorexia (Anorexia)
C2875 (NCI Thesaurus)
C0003123 (UMLS 2011AA)
CL Item
Chest Pain (Chest Pain (non-cardiac and non-pleuritic))
C38665 (NCI Thesaurus)
C0008031 (UMLS 2011AA)
CL Item
Constipation (CONSTIPATION)
C37930 (NCI Thesaurus)
C0009806 (UMLS 2011AA)
CL Item
Diarrhea For Patients Without Colostomy (Diarrhea (patients without colostomy))
CL Item
Dry Skin (Dry skin)
C0151908 (NCI Metathesaurus)
CL Item
Vomiting (Vomiting)
C3442 (NCI Thesaurus)
C0042963 (UMLS 2011AA)
CL Item
Fatigue (Fatigue (lethargy, malaise, asthenia))
C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)
CL Item
Infection Without Neutropenia (Infection (without neutropenia))
CL Item
Nausea (Nausea)
C3258 (NCI Thesaurus)
C0027497 (UMLS 2011AA)
CL Item
Pruritus (Pruritus)
C3344 (NCI Thesaurus)
C0033774 (UMLS 2011AA)
CL Item
Rash/desquamation (Rash/Desquamation)
CL Item
Dyspnea (Dyspnea (shortness of breath))
C2998 (NCI Thesaurus)
C0013404 (UMLS 2011AA)
Item
Category Code*
text
CL.17
Code List
Category Code*
CL Item
Gastrointestinal (GASTROINTESTINAL)
C13359 (NCI Thesaurus)
C0521362 (UMLS 2011AA)
CL Item
Pain (Pain)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
CL Item
Infection (Infection)
C0021311 (NCI Metathesaurus)
CL Item
Pulmonary (PULMONARY)
C13304 (NCI Thesaurus)
C2709248 (UMLS 2011AA)
CL Item
Constitutional Symptoms (Constitutional Symptoms)
CL Item
Dermatology/skin (Dermatology/Skin)
NCICCTGuseonlyToxCode
Item
NCIC CTG use only Tox Code
text
CTCAdverseEventGrade
Item
Worst Severity/Grade* (0=None NA=Not Assessed * Code/grade according to Common Toxicity Criteria, Version 2.0)
text
Item
Relation to Protocol Therapy
text
CL.18
Code List
Relation to Protocol Therapy
CL Item
Unrelated (1=unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (2=unlikely)
CL Item
Possibly (3=possible)
CL Item
Probably (4=probable)
CL Item
Definitely (5=definite)
Comments
Item
COMMENTS
text
Item Group
7. Comments
Item Group
8. Have You Attached Copies Of
Item
8. HAVE YOU ATTACHED COPIES OF (please _)
text
CL.19
Code List
8. HAVE YOU ATTACHED COPIES OF (please _)
CL Item
Autopsy Report (if applicable) (Autopsy Report (if applicable))
CL Item
Supporting documentation (if applicable) (Supporting documentation (if applicable))
Item Group
9. Investigator Signature
InvestigatorSignature
Item
Signature of Responsible Investigator
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
PersonCompletingForm,LastName
Item
Name of Clinical Research Associate
text
FormCompletionDate,Original
Item
Date
date
Item Group
Ccrr Module For Form 6 - Final Report
PersonCompletingForm,FirstName
Item
Person Completing Form, First Name
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CTCAdverseEventTerm,Other
Item
CTC Adverse Event Term, Other
text
Non-ProtocolEpidermalGrowthFactorReceptorTyrosineKinaseInhibitorAdministeredInd-3
Item
Non-Protocol EGFR Inhibitor Ind
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C2167 (NCI Thesaurus ObjectClass-2)
C1443775 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
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