ID

11392

Beschreibung

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

Link

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

Stichworte

Versionen (3)
  1. 19.09.12 19.09.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
  3. 03.07.15 03.07.15 -
Hochgeladen am

3. Juli 2015

DOI

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Form 5S - Post Progression Follow-Up Report NCT00049543

Englisch

No Instruction available.

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

Patient Information

Pt. Serial #
Beschreibung

PatientStudyID,CoordinatingGroup

Datentyp

text

Institution
Beschreibung

InstitutionName

Datentyp

text

Hospital #
Beschreibung

PatientMedicalRecordNumber

Datentyp

text

Investigator
Beschreibung

RegisteredInvestigator

Datentyp

text

Pt. Initials
Beschreibung

Patient Initials

Datentyp

text

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

Month Of Report

Month of report: (circle one)
Beschreibung

VisitReportMonthCount

Datentyp

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
Beschreibung

VisitReportMonthSpecify

Datentyp

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
Beschreibung

CancerFollow-upStatusDate

Datentyp

date

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

Disease Status

3. DISEASE STATUS
Beschreibung

CancerFollow-upStatus,Recent

Datentyp

text

Notice Of New Primary
Beschreibung

Notice Of New Primary

Have any other malignancies or myelodysplastic syndrome been diagnosed?
Beschreibung

NewPrimaryCancerInd

Datentyp

boolean

date of diagnosis
Beschreibung

NewPrimaryCancerDate

Datentyp

date

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

NewPrimarySite

Datentyp

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.)
Beschreibung

NewPrimaryDetail

Datentyp

text

Ncic Ctg Use
Beschreibung

Ncic Ctg Use

Malignancy Type
Beschreibung

NewPrimaryMalignancyType

Datentyp

text

Ncic Ctg Use Only
Beschreibung

Ncic Ctg Use Only

Logged
Beschreibung

LoggedEntryInitials

Datentyp

text

Logged Entry Date
Beschreibung

Logged Entry Date

Datentyp

date

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

CoordinatorReviewInitials

Datentyp

text

Coordinator Review Date
Beschreibung

Coordinator Review Date

Datentyp

date

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

PhysicianReviewInitials

Datentyp

text

Data Ent'd
Beschreibung

DataEntryInitials

Datentyp

text

Verified
Beschreibung

DataVerificationInitials

Datentyp

text

Header
Beschreibung

Header

Treatment Given Since Last Report To Ncic Ctg
Beschreibung

Treatment Given Since Last Report To Ncic Ctg

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

Non-ProtocolTherapyInd

Datentyp

boolean

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

Non-ProtocolHormonalTherapyInd

Datentyp

boolean

Non-Protocol Chemotherapy?
Beschreibung

Non-ProtocolChemotherapyInd

Datentyp

boolean

Non-Protocol Immunotherapy?
Beschreibung

Non-ProtocolImmunotherapyInd

Datentyp

boolean

Non-Protocol Biologic Response Modifier?
Beschreibung

Non-ProtocolBRMInd

Datentyp

boolean

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

Non-ProtocolHDC/ASCTInd

Datentyp

boolean

Non-Protocol Radiation Therapy?
Beschreibung

Non-ProtocolRTInd

Datentyp

boolean

Non-Protocol Surgery?
Beschreibung

Non-protocolSurgeryPerformedInd-3

Datentyp

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?
Beschreibung

OtherTherapyInd

Datentyp

boolean

(specify)
Beschreibung

OtherNon-ProtocolTherapyName

Datentyp

text

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

Non-ProtocolFirstChemotherapyAgentName

Datentyp

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
Beschreibung

Non-ProtocolFirstChemotherapyBeginDate

Datentyp

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)
Beschreibung

Non-ProtocolSecondChemotherapyAgentName

Datentyp

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
Beschreibung

Non-ProtocolSecondChemotherapyBeginDate

Datentyp

date

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

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)
Beschreibung

LateAdverseEventInd

Datentyp

boolean

Toxicity Term
Beschreibung

CTCAdverseEventTerm

Datentyp

text

Category Code*
Beschreibung

CTCAdverseEventCategory

Datentyp

text

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

CTCAdverseEventGrade

Datentyp

text

Relation to Protocol Therapy
Beschreibung

CTCAdverseEventAttributionCode

Datentyp

text

Comments
Beschreibung

Comments

COMMENTS
Beschreibung

Comments

Datentyp

text

Investigator Signature
Beschreibung

Investigator Signature

Signature of Responsible Investigator
Beschreibung

InvestigatorSignature

Datentyp

text

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

PersonCompletingForm,LastName

Datentyp

text

Date
Beschreibung

FormCompletionDate,Original

Datentyp

date

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

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

Person Completing Form, First Name
Beschreibung

PersonCompletingForm,FirstName

Datentyp

text

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

Non-ProtocolEpidermalGrowthFactorReceptorTyrosineKinaseInhibitorAdministeredInd-3

Datentyp

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
Beschreibung

CTCAdverseEventTerm,Other

Datentyp

text

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Ähnliche Modelle

No Instruction available.

1 Formulare
  1. StudyEvent: Form 5S - Post Progression Follow-Up Report
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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