ID

11393

Descrizione

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

collegamento

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

Keywords

versioni (3)
  1. 19/09/12 19/09/12 -
  2. 09/01/15 09/01/15 - Martin Dugas
  3. 03/07/15 03/07/15 -
Caricato su

3 luglio 2015

DOI

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Licenza

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

Inglese

No Instruction available.

1 moduli  
  1. StudyEvent: Form 6 - Final Report
    1. No Instruction available.
1. Patient Information
Descrizione

1. Patient Information

Pt. Serial #
Descrizione

PatientStudyID,CoordinatingGroup

Tipo di dati

text

Hospital #
Descrizione

PatientMedicalRecordNumber

Tipo di dati

text

Pt. Initials
Descrizione

Patient Initials

Tipo di dati

text

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

PatientStudyID,ParticipatingGroup

Tipo di dati

text

Site #
Descrizione

NCIInstitutionNumber

Tipo di dati

text

Patient's Social Security # (USA only)
Descrizione

PatientSocialSecurityNumber

Tipo di dati

float

Institution
Descrizione

InstitutionName

Tipo di dati

text

Investigator
Descrizione

RegisteredInvestigator

Tipo di dati

text

2. Cause Of Death
Descrizione

2. Cause Of Death

Date of death
Descrizione

DeathDocumentedDate

Tipo di dati

date

Cause of Death
Descrizione

DeathReason

Tipo di dati

text

other primary malignancy (specify & send report)
Descrizione

OtherPrimaryMalignantNeoplasmPresentStatus

Tipo di dati

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
Descrizione

NCICCTGuseonlycode

Tipo di dati

text

Describe
Descrizione

DeathReason,Specify

Tipo di dati

text

Status of NSCLC at Time of Death
Descrizione

StatusofNSCLCatTimeofDeath

Tipo di dati

text

3. Autopsy
Descrizione

3. Autopsy

Autopsy performed
Descrizione

AutopsyInd

Tipo di dati

text

NCIC CTG Use only: Received
Descrizione

NCICCTGUseonly:Received

Tipo di dati

text

4. Other Malignancies Or Marrow Dysplasia
Descrizione

4. Other Malignancies Or Marrow Dysplasia

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

NewPrimaryCancerInd

Tipo di dati

boolean

Date of diagnosis
Descrizione

NewPrimaryCancerDate

Tipo di dati

date

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

NewPrimarySite

Tipo di dati

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.)
Descrizione

NewPrimaryDetail

Tipo di dati

text

Ncic Ctg Use
Descrizione

Ncic Ctg Use

Malignancy Type
Descrizione

NewPrimaryMalignancyType

Tipo di dati

text

Ncic Ctg Use Only
Descrizione

Ncic Ctg Use Only

Logged
Descrizione

LoggedEntryInitials

Tipo di dati

text

Header
Descrizione

LoggedEntryDate

Tipo di dati

date

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

CoordinatorReviewInitials

Tipo di dati

text

Coordinator Review Date
Descrizione

Coordinator Review Date

Tipo di dati

date

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

PhysicianReviewInitials

Tipo di dati

text

Data Ent'd
Descrizione

DataEntryInitials

Tipo di dati

text

Verified
Descrizione

DataVerificationInitials

Tipo di dati

text

5. Treatment Given Since Last Report To Ncic Ctg
Descrizione

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)
Descrizione

Non-ProtocolTherapyInd

Tipo di dati

boolean

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

Non-ProtocolHormonalTherapyInd

Tipo di dati

boolean

Non-Protocol Chemotherapy?
Descrizione

Non-ProtocolChemotherapyInd

Tipo di dati

boolean

Non-Protocol Immunotherapy?
Descrizione

Non-ProtocolImmunotherapyInd

Tipo di dati

boolean

Non-Protocol Biologic Response Modifier?
Descrizione

Non-ProtocolBRMInd

Tipo di dati

boolean

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

Non-ProtocolHDC/ASCTInd

Tipo di dati

boolean

Non-Protocol Radiation Therapy?
Descrizione

Non-ProtocolRTInd

Tipo di dati

boolean

Non-Protocol Surgery?
Descrizione

Non-protocolSurgeryPerformedInd-3

Tipo di dati

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?
Descrizione

OtherTherapyInd

Tipo di dati

boolean

(specify)
Descrizione

OtherNon-ProtocolTherapyName

Tipo di dati

text

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

Non-ProtocolFirstChemotherapyAgentName

Tipo di dati

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
Descrizione

Non-ProtocolFirstChemotherapyBeginDate

Tipo di dati

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)
Descrizione

Non-ProtocolSecondChemotherapyAgentName

Tipo di dati

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)
Descrizione

Non-ProtocolSecondChemotherapyBeginDate

Tipo di dati

date

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

Ncic Ctg Use2

1st line
Descrizione

1stline

Tipo di dati

text

2nd line
Descrizione

2ndline

Tipo di dati

text

6. Delayed Toxicity/adverse Event/intercurrent Illness
Descrizione

6. Delayed Toxicity/adverse Event/intercurrent Illness

NCIC CTG use only
Descrizione

NCICCTGuseonly

Tipo di dati

text

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

LateAdverseEventInd

Tipo di dati

boolean

Late Toxicity Term
Descrizione

CTCAdverseEventTerm

Tipo di dati

text

Category Code*
Descrizione

CTCAdverseEventCategory

Tipo di dati

text

NCIC CTG use only Tox Code
Descrizione

NCICCTGuseonlyToxCode

Tipo di dati

text

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

CTCAdverseEventGrade

Tipo di dati

text

Relation to Protocol Therapy
Descrizione

CTCAdverseEventAttributionCode

Tipo di dati

text

COMMENTS
Descrizione

Comments

Tipo di dati

text

7. Comments
Descrizione

7. Comments

8. Have You Attached Copies Of
Descrizione

8. Have You Attached Copies Of

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

HAVEYOUATTACHEDCOPIESOF

Tipo di dati

text

9. Investigator Signature
Descrizione

9. Investigator Signature

Signature of Responsible Investigator
Descrizione

InvestigatorSignature

Tipo di dati

text

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

PersonCompletingForm,LastName

Tipo di dati

text

Date
Descrizione

FormCompletionDate,Original

Tipo di dati

date

Ccrr Module For Form 6 - Final Report
Descrizione

Ccrr Module For Form 6 - Final Report

Person Completing Form, First Name
Descrizione

PersonCompletingForm,FirstName

Tipo di dati

text

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

CTCAdverseEventTerm,Other

Tipo di dati

text

Non-Protocol EGFR Inhibitor Ind
Descrizione

Non-ProtocolEpidermalGrowthFactorReceptorTyrosineKinaseInhibitorAdministeredInd-3

Tipo di dati

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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No Instruction available.

1 moduli
  1. StudyEvent: Form 6 - Final Report
    1. No Instruction available.
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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