ID

11390

Descripción

Form 5 - On & Off Treatment 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=A0E01D72-7CAF-3016-E034-080020C9C0E0

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A0E01D72-7CAF-3016-E034-080020C9C0E0

Palabras clave

Versiones (3)
  1. 19/9/12 19/9/12 -
  2. 9/1/15 9/1/15 - Martin Dugas
  3. 3/7/15 3/7/15 -
Subido en

3 de julio de 2015

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0 Legacy
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Form 5 - On & Off Treatment Follow-Up Report NCT00049543

Inglés

No Instruction available.

1 formularios  
  1. StudyEvent: Form 5 - On & Off Treatment Follow-Up Report
    1. No Instruction available.
1. Patient Information
Descripción

1. Patient Information

Pt. Serial #
Descripción

PatientStudyID,CoordinatingGroup

Tipo de datos

text

Hospital #
Descripción

PatientMedicalRecordNumber

Tipo de datos

text

Pt. Initials
Descripción

Patient Initials

Tipo de datos

text

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

PatientStudyID,ParticipatingGroup

Tipo de datos

text

Site #
Descripción

NCIInstitutionNumber

Tipo de datos

text

Patient's Social Security # (USA only)
Descripción

PatientSocialSecurityNumber

Tipo de datos

float

Institution
Descripción

InstitutionName

Tipo de datos

text

Investigator
Descripción

RegisteredInvestigator

Tipo de datos

text

2. Month Of Report
Descripción

2. Month Of Report

Month of report: (circle one)
Descripción

VisitReportMonthCount

Tipo de datos

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
Header
Descripción

Header

Tipo de datos

text

3. Physical Exam
Descripción

3. Physical Exam

Date of Attendance
Descripción

CancerFollow-upStatusDate

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Weight (kg)
Descripción

PatientWeight

Tipo de datos

float

Performance status (ECOG circle one see Appendix II of protocol)
Descripción

PerformanceStatus

Tipo de datos

text

4. Disease Status
Descripción

4. Disease Status

4. DISEASE STATUS
Descripción

CancerFollow-upStatus,Recent

Tipo de datos

text

5. Systemic Therapy Report
Descripción

5. Systemic Therapy Report

During the timeframe of this report, were full doses of Iressa/placebo taken daily by the patient?
Descripción

DoseModification(Change)

Tipo de datos

text

give reason (If no, check _ all that apply)
Descripción

TherapyModificationReason

Tipo de datos

text

dose modification due toxicity - please specify toxicity and grade
Descripción

dosemodificationduetoxicity-pleasespecifytoxicityandgrade

Tipo de datos

text

temporary interruption for toxicity - please specify toxicity and grade
Descripción

temporaryinterruptionfortoxicity-pleasespecifytoxicityandgrade

Tipo de datos

text

other: specify
Descripción

other:specify

Tipo de datos

text

Will this patient continue to receive protocol therapy?
Descripción

OffTreatmentIndicator

Tipo de datos

boolean

If this is the first On Treatment Follow-up, give date study medication was first taken
Descripción

FirstDoseStartDate,FirstCycle

Tipo de datos

date

Ncic Ctg Use Only
Descripción

Ncic Ctg Use Only

Logged
Descripción

LoggedEntryInitials

Tipo de datos

text

Entry date
Descripción

Entry date

Tipo de datos

date

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

CoordinatorReviewInitials

Tipo de datos

text

Coordinator Review Date
Descripción

Coordinator Review Date

Tipo de datos

date

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

PhysicianReviewInitials

Tipo de datos

text

Data Ent'd
Descripción

DataEntryInitials

Tipo de datos

text

Verified
Descripción

DataVerificationInitials

Tipo de datos

text

Header
Descripción

Header

6. Notice Of New Primary
Descripción

6. Notice Of New Primary

Have any other malignancies or myelodysplastic syndrome been diagnosed?
Descripción

NewPrimaryCancerInd

Tipo de datos

boolean

date of diagnosis
Descripción

NewPrimaryCancerDate

Tipo de datos

date

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

NewPrimarySite

Tipo de datos

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.)
Descripción

NewPrimaryDetail

Tipo de datos

text

Ncic Ctg Use
Descripción

Ncic Ctg Use

Malignancy Type
Descripción

NewPrimaryMalignancyType

Tipo de datos

text

7. Hematology
Descripción

7. Hematology

Units (Note: please circle one)
Descripción

Lab,UnitsofMeasure

Tipo de datos

text

Date
Descripción

Lab,Hematology,SampleCollectionDate

Tipo de datos

date

Hemoglobin
Descripción

Lab,Hematology,Hemoglobin

Tipo de datos

float

Platelets
Descripción

Lab,Hematology,Platelets

Tipo de datos

float

WBC
Descripción

Lab,Hematology,WBC

Tipo de datos

float

Neutrophils %
Descripción

Lab,Hematology,Neutrophils,CellPercentage

Tipo de datos

float

Neutrophils x 109/L
Descripción

Lab,Hematology,NeutrophilCount

Tipo de datos

float

Bands* x 109/L
Descripción

Bands*x109/L

Tipo de datos

text

8. Biochemistry
Descripción

8. Biochemistry

Date
Descripción

SpecimenCollectionDate

Tipo de datos

date

total bilirubin
Descripción

Lab,Hepatic,Bilirubin

Tipo de datos

float

U/L
Descripción

Lab,UnitsofMeasure

Tipo de datos

text

AST (SGOT)
Descripción

Lab,Hepatic,SGOT

Tipo de datos

float

Alkaline Phosphatase
Descripción

Lab,Hepatic,AlkalinePhosphatase

Tipo de datos

float

UNL
Descripción

UNL

Tipo de datos

text

9. Treatment Given Since Last Report To Ncic Ctg
Descripción

9. Treatment Given Since Last Report To Ncic Ctg

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

Non-ProtocolTherapyInd

Tipo de datos

boolean

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

Non-ProtocolHormonalTherapyInd

Tipo de datos

boolean

Non-Protocol Chemotherapy?
Descripción

Non-ProtocolChemotherapyInd

Tipo de datos

boolean

Non-Protocol Immunotherapy?
Descripción

Non-ProtocolImmunotherapyInd

Tipo de datos

boolean

Non-Protocol Biologic Response Modifier?
Descripción

Non-ProtocolBRMInd

Tipo de datos

boolean

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

Non-ProtocolHDC/ASCTInd

Tipo de datos

boolean

Non-Protocol Radiation Therapy?
Descripción

Non-ProtocolRTInd

Tipo de datos

boolean

Non-Protocol Surgery?
Descripción

Non-protocolSurgeryPerformedInd-3

Tipo de datos

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?
Descripción

OtherTherapyInd

Tipo de datos

boolean

(specify)
Descripción

OtherNon-ProtocolTherapyName

Tipo de datos

text

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

Non-ProtocolFirstChemotherapyAgentName

Tipo de datos

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
Descripción

Non-ProtocolFirstChemotherapyBeginDate

Tipo de datos

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)
Descripción

Non-ProtocolSecondChemotherapyAgentName

Tipo de datos

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)
Descripción

Non-ProtocolSecondChemotherapyBeginDate

Tipo de datos

date

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

Ncic Ctg Use2

1st line
Descripción

TypeofSecondLineChemotherapy

Tipo de datos

text

2nd line
Descripción

Secondlinetherapy

Tipo de datos

text

10. On Treatment Long Term Toxicity
Descripción

10. On Treatment Long Term Toxicity

NCIC CTG Use only
Descripción

NCICCTGUseonly

Tipo de datos

text

Did the patient experience any toxicities during the timeframe of this report? (if yes, please complete form below)
Descripción

Didthepatientexperienceanytoxicitiesduringthetimeframeofthisreport?

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Toxicity Term
Descripción

CTCAdverseEventTerm

Tipo de datos

text

rash / acne (please circle)
Descripción

rash/acne

Tipo de datos

text

CTC Adverse Event Term, Other
Descripción

CTCAdverseEventTerm,Other

Tipo de datos

text

Category Code*
Descripción

CTCAdverseEventCategory

Tipo de datos

text

NCIC CTG use only Tox Code
Descripción

NCICCTGuseonlyToxCode

Tipo de datos

text

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

CTCAdverseEventGrade

Tipo de datos

text

Relation to Protocol Therapy
Descripción

CTCAdverseEventAttributionCode

Tipo de datos

text

COMMENTS
Descripción

Comments

Tipo de datos

text

11. Comments
Descripción

11. Comments

12. Have You Attached Copies Of
Descripción

12. Have You Attached Copies Of

12. HAVE YOU ATTACHED COPIES OF
Descripción

HAVEYOUATTACHEDCOPIESOF

Tipo de datos

text

13. Investigator Signature
Descripción

13. Investigator Signature

Date
Descripción

InvestigatorSignature

Tipo de datos

text

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

PersonCompletingForm,LastName

Tipo de datos

text

Ccrr Module For Form 5 - On & Off Treatment Follow-up Report
Descripción

Ccrr Module For Form 5 - On & Off Treatment Follow-up Report

Other
Descripción

VisitReportMonthSpecify

Tipo de datos

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
Person Completing Form, First Name
Descripción

PersonCompletingForm,FirstName

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
SGPT
Descripción

Lab,Hepatic,SGPT

Tipo de datos

float

Lactate Dehydrogenase (LDH)
Descripción

Lab,Chemistry,LactateDehydrogenase

Tipo de datos

float

Creatinine
Descripción

Lab,Renal,Creatinine

Tipo de datos

float

BUN
Descripción

Lab,Renal,BUN

Tipo de datos

float

Potassium (K)
Descripción

Lab,Electrolytes,Potassium

Tipo de datos

float

Sodium (Na)
Descripción

Lab,Electrolytes,Sodium

Tipo de datos

float

Chloride (Cl)
Descripción

Lab,Electrolytes,Chloride

Tipo de datos

float

Calcium (Ca)
Descripción

Lab,Electrolytes,Calcium

Tipo de datos

float

Albumin
Descripción

Lab,Chemistry,Albumin

Tipo de datos

float

Imaging Site
Descripción

DiagnosticImagingAnatomicSite

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus ObjectClass
C16502
UMLS 2011AA ObjectClass
C0011923
NCI Thesaurus Property-2
C25421
UMLS 2011AA Property-2
C0002808
Method of Evaluation
Descripción

AssessmentType

Tipo de datos

text

Date of Evaluation
Descripción

AssessmentDate

Tipo de datos

date

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No Instruction available.

1 formularios
  1. StudyEvent: Form 5 - On & Off Treatment Follow-Up Report
    1. No Instruction available.
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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. 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
27 Months (27)
CL Item
1 (1)
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)
Header
Item
Header
text
Item Group
3. Physical Exam
CancerFollow-upStatusDate
Item
Date of Attendance
date
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
PatientWeight
Item
Weight (kg)
float
Item
Performance status (ECOG circle one see Appendix II of protocol)
text
CL.2
Code List
Performance status (ECOG circle one see Appendix II of protocol)
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
CL Item
1 (1)
CL Item
2 (2)
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
3 (3)
CL Item
4 (4)
Item Group
4. Disease Status
Item
4. DISEASE STATUS
text
CL.3
Code List
4. DISEASE STATUS
CL Item
No Evidence Of Disease (Absent)
CL Item
Cancer Present (Present)
Item Group
5. Systemic Therapy Report
Item
During the timeframe of this report, were full doses of Iressa/placebo taken daily by the patient?
text
CL.4
Code List
During the timeframe of this report, were full doses of Iressa/placebo taken daily by the patient?
CL Item
(i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
(i.e, The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)
Item
give reason (If no, check _ all that apply)
text
CL.5
Code List
give reason (If no, check _ all that apply)
CL Item
dose modification due toxicity (dose modification due toxicity)
CL Item
temporary interruption for toxicity (temporary interruption for toxicity)
CL Item
patient non compliant/forgot (patient non compliant/forgot)
CL Item
other: specify (other: specify)
CL Item
permanent cessation of protocol therapy (permanent cessation of protocol therapy)
dosemodificationduetoxicity-pleasespecifytoxicityandgrade
Item
dose modification due toxicity - please specify toxicity and grade
text
temporaryinterruptionfortoxicity-pleasespecifytoxicityandgrade
Item
temporary interruption for toxicity - please specify toxicity and grade
text
other:specify
Item
other: specify
text
OffTreatmentIndicator
Item
Will this patient continue to receive protocol therapy?
boolean
FirstDoseStartDate,FirstCycle
Item
If this is the first On Treatment Follow-up, give date study medication was first taken
date
Item Group
Ncic Ctg Use Only
LoggedEntryInitials
Item
Logged
text
LoggedEntryDate
Item
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
6. 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
7. Hematology
Item
Units (Note: please circle one)
text
CL.9
Code List
Units (Note: please circle one)
CL Item
X10^9/l (10^9/L)
CL Item
S/i (SI Units)
CL Item
Imperial (US Imperial Units)
CL Item
1000/mm3 (1000/mm3)
CL Item
Ul (ul)
CL Item
U/l (U/L)
CL Item
Mg/dl (mg/dL)
CL Item
Umol/l (umol/L)
CL Item
Meq/l (mEq/L)
CL Item
Mmol/l (mmol/L)
CL Item
G/dl (g/dl)
CL Item
G/l (g/L)
Lab,Hematology,SampleCollectionDate
Item
Date
date
Lab,Hematology,Hemoglobin
Item
Hemoglobin
float
Lab,Hematology,Platelets
Item
Platelets
float
Lab,Hematology,WBC
Item
WBC
float
Lab,Hematology,Neutrophils,CellPercentage
Item
Neutrophils %
float
Lab,Hematology,NeutrophilCount
Item
Neutrophils x 109/L
float
Bands*x109/L
Item
Bands* x 109/L
text
Item Group
8. Biochemistry
SpecimenCollectionDate
Item
Date
date
Lab,Hepatic,Bilirubin
Item
total bilirubin
float
Item
U/L
text
CL.15
Code List
U/L
CL Item
U/l (U/L)
Lab,Hepatic,SGOT
Item
AST (SGOT)
float
Lab,Hepatic,AlkalinePhosphatase
Item
Alkaline Phosphatase
float
UNL
Item
UNL
text
Item Group
9. 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
TypeofSecondLineChemotherapy
Item
1st line
text
Secondlinetherapy
Item
2nd line
text
Item Group
10. On Treatment Long Term Toxicity
Item
NCIC CTG Use only
text
CL.25
Code List
NCIC CTG Use only
CL Item
Acute Toxicity Database (Acute toxicity database)
CL Item
Delayed Toxicity Database (Delayed toxicity database)
Didthepatientexperienceanytoxicitiesduringthetimeframeofthisreport?
Item
Did the patient experience any toxicities during the timeframe of this report? (if yes, please complete form below)
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Item
Toxicity Term
text
CL.27
Code List
Toxicity Term
CL Item
diarrhea (diarrhea)
CL Item
Chest Pain (CHEST PAIN (NON-CARDIAC AND NON-PLEURITIC))
C38665 (NCI Thesaurus)
C0008031 (UMLS 2011AA)
CL Item
Infection Without Neutropenia (INFECTION (WITHOUT NEUTROPENIA))
CL Item
Fatigue (FATIGUE (LETHARGY, MALAISE, ASTHENIA))
C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)
CL Item
Dyspnea (DYSPNEA (SHORTNESS OF BREATH))
C2998 (NCI Thesaurus)
C0013404 (UMLS 2011AA)
CL Item
Rash/desquamation (RASH/DESQUAMATION)
CL Item
Dry Skin (DRY SKIN)
C0151908 (NCI Metathesaurus)
CL Item
Anorexia (ANOREXIA)
C2875 (NCI Thesaurus)
C0003123 (UMLS 2011AA)
CL Item
Pruritus (PRURITUS)
C3344 (NCI Thesaurus)
C0033774 (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
Nausea (nausea)
C3258 (NCI Thesaurus)
C0027497 (UMLS 2011AA)
CL Item
Vomiting (vomiting)
C3442 (NCI Thesaurus)
C0042963 (UMLS 2011AA)
CL Item
fatigue (fatigue)
CL Item
uveitis/keratitis (uveitis/keratitis)
CL Item
rash / acne (rash / acne)
CL Item
Unnamed2 (Unnamed2)
Item
rash / acne (please circle)
text
CL.28
Code List
rash / acne (please circle)
CL Item
Rash (rash)
CL Item
Acne (acne)
CTCAdverseEventTerm,Other
Item
CTC Adverse Event Term, Other
text
Item
Category Code*
text
CL.29
Code List
Category Code*
CL Item
GI (GI)
CL Item
Gastrointestinal (Gastrointestinal)
C13359 (NCI Thesaurus)
C0521362 (UMLS 2011AA)
CL Item
Dermatology/skin (Dermatology/Skin)
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
Pain (Pain)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
CL Item
FL (FL)
CL Item
OC (OC)
CL Item
SK (SK)
Item
NCIC CTG use only Tox Code
text
CL.30
Code List
NCIC CTG use only Tox Code
CL Item
Dia (DIA)
CL Item
Nau (NAU)
CL Item
Vom (VOM)
CL Item
Let (LET)
CL Item
Ker (KER)
CL Item
Ras (RAS)
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.31
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
11. Comments
Item Group
12. Have You Attached Copies Of
Item
12. HAVE YOU ATTACHED COPIES OF
text
CL.32
Code List
12. HAVE YOU ATTACHED COPIES OF
CL Item
Supporting documentation (Supporting documentation)
Item Group
13. Investigator Signature
InvestigatorSignature
Item
Date
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
Item Group
Ccrr Module For Form 5 - On & Off Treatment Follow-up Report
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)
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)
Lab,Hepatic,SGPT
Item
SGPT
float
Lab,Chemistry,LactateDehydrogenase
Item
Lactate Dehydrogenase (LDH)
float
Lab,Renal,Creatinine
Item
Creatinine
float
Lab,Renal,BUN
Item
BUN
float
Lab,Electrolytes,Potassium
Item
Potassium (K)
float
Lab,Electrolytes,Sodium
Item
Sodium (Na)
float
Lab,Electrolytes,Chloride
Item
Chloride (Cl)
float
Lab,Electrolytes,Calcium
Item
Calcium (Ca)
float
Lab,Chemistry,Albumin
Item
Albumin
float
Item
Imaging Site
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C25421 (NCI Thesaurus Property-2)
C0002808 (UMLS 2011AA Property-2)
CL.33
Code List
Imaging Site
CL Item
Chest (Chest)
C25389 (NCI Thesaurus)
C0817096 (UMLS 2011AA)
Item
Method of Evaluation
text
CL.34
Code List
Method of Evaluation
CL Item
Chest X-ray (Chest X-Ray)
CL Item
Not Evaluated (Not evaluated)
CL Item
Mri (MRI (NMR))
CL Item
Ct Scan (CT Scan)
AssessmentDate
Item
Date of Evaluation
date
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