ID

11392

Description

Form 5S - Post Progression Follow-Up 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=A0E053B5-CFD0-32A7-E034-080020C9C0E0

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A0E053B5-CFD0-32A7-E034-080020C9C0E0

Mots-clés

Versions (3)
  1. 19/09/2012 19/09/2012 -
  2. 09/01/2015 09/01/2015 - Martin Dugas
  3. 03/07/2015 03/07/2015 -
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3 juillet 2015

DOI

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Creative Commons BY-NC 3.0 Legacy
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Form 5S - Post Progression Follow-Up Report NCT00049543

Anglais

No Instruction available.

1 Formulaires  
  1. StudyEvent: Form 5S - Post Progression Follow-Up Report
    1. No Instruction available.
Patient Information
Description

Patient Information

Pt. Serial #
Description

PatientStudyID,CoordinatingGroup

Type de données

text

Institution
Description

InstitutionName

Type de données

text

Hospital #
Description

PatientMedicalRecordNumber

Type de données

text

Investigator
Description

RegisteredInvestigator

Type de données

text

Pt. Initials
Description

Patient Initials

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Month Of Report
Description

Month Of Report

Month of report: (circle one)
Description

VisitReportMonthCount

Type de données

text

Alias
NCI Thesaurus Property
C29846
UMLS 2011AA Property
C0439231
NCI Thesaurus ObjectClass
C25375
UMLS 2011AA ObjectClass
C0684224
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ObjectClass-2
C25716
UMLS 2011AA ObjectClass-2
C0545082
Other
Description

VisitReportMonthSpecify

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C29846
UMLS 2011AA Property
C0439231
NCI Thesaurus ObjectClass
C25375
UMLS 2011AA ObjectClass
C0684224
NCI Thesaurus ObjectClass-2
C25716
UMLS 2011AA ObjectClass-2
C0545082
Date of Attendance
Description

CancerFollow-upStatusDate

Type de données

date

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Disease Status
Description

Disease Status

3. DISEASE STATUS
Description

CancerFollow-upStatus,Recent

Type de données

text

Notice Of New Primary
Description

Notice Of New Primary

Have any other malignancies or myelodysplastic syndrome been diagnosed?
Description

NewPrimaryCancerInd

Type de données

boolean

date of diagnosis
Description

NewPrimaryCancerDate

Type de données

date

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

NewPrimarySite

Type de données

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

Type de données

text

Ncic Ctg Use
Description

Ncic Ctg Use

Malignancy Type
Description

NewPrimaryMalignancyType

Type de données

text

Ncic Ctg Use Only
Description

Ncic Ctg Use Only

Logged
Description

LoggedEntryInitials

Type de données

text

Logged Entry Date
Description

Logged Entry Date

Type de données

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0011008
Study Coord
Description

CoordinatorReviewInitials

Type de données

text

Coordinator Review Date
Description

Coordinator Review Date

Type de données

date

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

PhysicianReviewInitials

Type de données

text

Data Ent'd
Description

DataEntryInitials

Type de données

text

Verified
Description

DataVerificationInitials

Type de données

text

Header
Description

Header

Treatment Given Since Last Report To Ncic Ctg
Description

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

Type de données

boolean

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

Non-ProtocolHormonalTherapyInd

Type de données

boolean

Non-Protocol Chemotherapy?
Description

Non-ProtocolChemotherapyInd

Type de données

boolean

Non-Protocol Immunotherapy?
Description

Non-ProtocolImmunotherapyInd

Type de données

boolean

Non-Protocol Biologic Response Modifier?
Description

Non-ProtocolBRMInd

Type de données

boolean

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

Non-ProtocolHDC/ASCTInd

Type de données

boolean

Non-Protocol Radiation Therapy?
Description

Non-ProtocolRTInd

Type de données

boolean

Non-Protocol Surgery?
Description

Non-protocolSurgeryPerformedInd-3

Type de données

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

Type de données

boolean

(specify)
Description

OtherNon-ProtocolTherapyName

Type de données

text

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

Non-ProtocolFirstChemotherapyAgentName

Type de données

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

Type de données

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

Type de données

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 started2nd
Description

Non-ProtocolSecondChemotherapyBeginDate

Type de données

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Long Term Toxicity
Description

Long Term Toxicity

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

Type de données

boolean

Toxicity Term
Description

CTCAdverseEventTerm

Type de données

text

Category Code*
Description

CTCAdverseEventCategory

Type de données

text

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

CTCAdverseEventGrade

Type de données

text

Relation to Protocol Therapy
Description

CTCAdverseEventAttributionCode

Type de données

text

Comments
Description

Comments

COMMENTS
Description

Comments

Type de données

text

Investigator Signature
Description

Investigator Signature

Signature of Responsible Investigator
Description

InvestigatorSignature

Type de données

text

Alias
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Person Completing Form, Last Name
Description

PersonCompletingForm,LastName

Type de données

text

Date
Description

FormCompletionDate,Original

Type de données

date

Ccrr Module For Form 5s - Post Progression Follow-up Report
Description

Ccrr Module For Form 5s - Post Progression Follow-up Report

Person Completing Form, First Name
Description

PersonCompletingForm,FirstName

Type de données

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Non-Protocol EGFR Inhibitor Ind
Description

Non-ProtocolEpidermalGrowthFactorReceptorTyrosineKinaseInhibitorAdministeredInd-3

Type de données

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
CTC Adverse Event Term, Other
Description

CTCAdverseEventTerm,Other

Type de données

text

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Similar models

No Instruction available.

1 Formulaires
  1. StudyEvent: Form 5S - Post Progression Follow-Up Report
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Patient Information
PatientStudyID,CoordinatingGroup
Item
Pt. Serial #
text
InstitutionName
Item
Institution
text
PatientMedicalRecordNumber
Item
Hospital #
text
RegisteredInvestigator
Item
Investigator
text
Patient Initials
Item
Pt. Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Item Group
Month Of Report
Item
Month of report: (circle one)
text
C29846 (NCI Thesaurus Property)
C0439231 (UMLS 2011AA Property)
C25375 (NCI Thesaurus ObjectClass)
C0684224 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25716 (NCI Thesaurus ObjectClass-2)
C0545082 (UMLS 2011AA ObjectClass-2)
CL.1
Code List
Month of report: (circle one)
CL Item
Other Month (OTHER)
CL Item
3 (3)
CL Item
6 (6)
CL Item
9 (9)
CL Item
12 (12)
CL Item
15 (15)
CL Item
18 (18)
CL Item
21 (21)
CL Item
24 (24)
CL Item
30 (30)
CL Item
36 (36)
CL Item
42 (42)
CL Item
48 (48)
CL Item
54 (54)
CL Item
60 (60)
VisitReportMonthSpecify
Item
Other
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C29846 (NCI Thesaurus Property)
C0439231 (UMLS 2011AA Property)
C25375 (NCI Thesaurus ObjectClass)
C0684224 (UMLS 2011AA ObjectClass)
C25716 (NCI Thesaurus ObjectClass-2)
C0545082 (UMLS 2011AA ObjectClass-2)
CancerFollow-upStatusDate
Item
Date of Attendance
date
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item Group
Disease Status
Item
3. DISEASE STATUS
text
CL.2
Code List
3. DISEASE STATUS
CL Item
No Evidence Of Disease (Absent)
CL Item
Cancer Present (Present)
CL Item
Unknown (Unknown)
Item Group
Notice Of New Primary
NewPrimaryCancerInd
Item
Have any other malignancies or myelodysplastic syndrome 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
Logged Entry Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS CUI-1)
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
Header
Item Group
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 started2nd
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Long Term Toxicity
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
Toxicity Term
text
CL.14
Code List
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.15
Code List
Category Code*
CL Item
Gastrointestinal (Gastrointestinal)
CL Item
Pain (Pain)
CL Item
Constitutional Symptoms (Constitutional Symptoms)
CL Item
Infection (Infection)
CL Item
Pulmonary (Pulmonary)
CL Item
Dermatology/skin (Dermatology/Skin)
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.16
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)
Item Group
Comments
Comments
Item
COMMENTS
text
Item Group
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
Person Completing Form, Last Name
text
FormCompletionDate,Original
Item
Date
date
Item Group
Ccrr Module For Form 5s - Post Progression Follow-up 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)
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)
CTCAdverseEventTerm,Other
Item
CTC Adverse Event Term, Other
text
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