ID

2173

Beskrivning

Form 5 - On & Off Treatment Follow-Up Report 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

Länk

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

Nyckelord

Versioner (3)
  1. 2012-09-19 2012-09-19 -
  2. 2015-01-09 2015-01-09 - Martin Dugas
  3. 2015-07-03 2015-07-03 -
Uppladdad den

19 september 2012

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy
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Lung Cancer NCT00049543 Follow-Up - Form 5 - On & Off Treatment Follow-Up Report - 2034584v3.0

Engelsk

No Instruction available.

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

1. Patient Information

Pt. Serial #
Beskrivning

PatientStudyID,CoordinatingGroup

Datatyp

text

Hospital #
Beskrivning

PatientMedicalRecordNumber

Datatyp

text

Pt. Initials
Beskrivning

PatientInitialsName

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Intergroup Patient Serial #
Beskrivning

PatientStudyID,ParticipatingGroup

Datatyp

text

Site #
Beskrivning

NCIInstitutionNumber

Datatyp

text

Patient's Social Security # (USA only)
Beskrivning

PatientSocialSecurityNumber

Datatyp

double

Institution
Beskrivning

InstitutionName

Datatyp

text

Investigator
Beskrivning

RegisteredInvestigator

Datatyp

text

2. Month Of Report
Beskrivning

2. Month Of Report

Month of report: (circle one)
Beskrivning

VisitReportMonthCount

Datatyp

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
C25716
UMLS 2011AA ObjectClass
C0545082
Unnamed1
Beskrivning

Unnamed1

Datatyp

text

3. Physical Exam
Beskrivning

3. Physical Exam

Date of Attendance
Beskrivning

CancerFollow-upStatusDate

Datatyp

date

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

PatientWeight

Datatyp

double

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

PerformanceStatus

Datatyp

text

4. Disease Status
Beskrivning

4. Disease Status

4. DISEASE STATUS
Beskrivning

CancerFollow-upStatus,Recent

Datatyp

text

5. Systemic Therapy Report
Beskrivning

5. Systemic Therapy Report

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

DoseModification(Change)

Datatyp

text

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

TherapyModificationReason

Datatyp

text

dose modification due toxicity - please specify toxicity and grade
Beskrivning

dosemodificationduetoxicity-pleasespecifytoxicityandgrade

Datatyp

text

temporary interruption for toxicity - please specify toxicity and grade
Beskrivning

temporaryinterruptionfortoxicity-pleasespecifytoxicityandgrade

Datatyp

text

Will this patient continue to receive protocol therapy?
Beskrivning

OffTreatmentIndicator

Datatyp

text

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

FirstDoseStartDate,FirstCycle

Datatyp

date

other: specify
Beskrivning

other:specify

Datatyp

text

Ncic Ctg Use Only
Beskrivning

Ncic Ctg Use Only

Logged
Beskrivning

LoggedEntryInitials

Datatyp

text

Unnamed2
Beskrivning

LoggedEntryDate

Datatyp

date

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

CoordinatorReviewInitials

Datatyp

text

Unnamed3
Beskrivning

CoordinatorReviewDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Phy
Beskrivning

PhysicianReviewInitials

Datatyp

text

Data Ent'd
Beskrivning

DataEntryInitials

Datatyp

text

Verified
Beskrivning

DataVerificationInitials

Datatyp

text

Unnamed1
Beskrivning

Unnamed1

Pt. Serial #
Beskrivning

PatientStudyID,CoordinatingGroup

Datatyp

text

Pt. Initials
Beskrivning

PatientInitialsName

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
6. Notice Of New Primary
Beskrivning

6. Notice Of New Primary

Have any other malignancies or myelodysplastic syndrome been diagnosed?
Beskrivning

NewPrimaryCancerInd

Datatyp

text

date of diagnosis
Beskrivning

NewPrimaryCancerDate

Datatyp

date

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

NewPrimarySite

Datatyp

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.)
Beskrivning

NewPrimaryDetail

Datatyp

text

Ncic Ctg Use
Beskrivning

Ncic Ctg Use

Malignancy Type
Beskrivning

NewPrimaryMalignancyType

Datatyp

text

7. Hematology
Beskrivning

7. Hematology

Units (Note: please circle one)
Beskrivning

Lab,UnitsofMeasure

Datatyp

text

Date
Beskrivning

Lab,Hematology,SampleCollectionDate

Datatyp

date

Hemoglobin
Beskrivning

Lab,Hematology,Hemoglobin

Datatyp

double

Platelets
Beskrivning

Lab,Hematology,Platelets

Datatyp

double

WBC
Beskrivning

Lab,Hematology,WBC

Datatyp

double

Neutrophils %
Beskrivning

Lab,Hematology,Neutrophils,CellPercentage

Datatyp

double

Neutrophils x 109/L
Beskrivning

Lab,Hematology,NeutrophilCount

Datatyp

double

Bands* x 109/L
Beskrivning

Bands*x109/L

Datatyp

text

Bands* x 109/L
Beskrivning

Bands*x109/L

Datatyp

text

8. Biochemistry
Beskrivning

8. Biochemistry

Units (Note: please circle one)
Beskrivning

Lab,UnitsofMeasure

Datatyp

text

Date
Beskrivning

SpecimenCollectionDate

Datatyp

date

total bilirubin
Beskrivning

Lab,Hepatic,Bilirubin

Datatyp

double

U/L
Beskrivning

Lab,UnitsofMeasure

Datatyp

text

U/L
Beskrivning

Lab,UnitsofMeasure

Datatyp

text

U/L
Beskrivning

Lab,UnitsofMeasure

Datatyp

text

AST (SGOT)
Beskrivning

Lab,Hepatic,SGOT

Datatyp

double

Alkaline Phosphatase
Beskrivning

Lab,Hepatic,AlkalinePhosphatase

Datatyp

double

UNL
Beskrivning

UNL

Datatyp

text

9. Treatment Given Since Last Report To Ncic Ctg
Beskrivning

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)
Beskrivning

Non-ProtocolTherapyInd

Datatyp

text

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

Non-ProtocolHormonalTherapyInd

Datatyp

text

Non-Protocol Chemotherapy?
Beskrivning

Non-ProtocolChemotherapyInd

Datatyp

text

Non-Protocol Immunotherapy?
Beskrivning

Non-ProtocolImmunotherapyInd

Datatyp

text

Non-Protocol Biologic Response Modifier?
Beskrivning

Non-ProtocolBRMInd

Datatyp

text

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

Non-ProtocolHDC/ASCTInd

Datatyp

text

Non-Protocol Radiation Therapy?
Beskrivning

Non-ProtocolRTInd

Datatyp

text

Non-Protocol Surgery?
Beskrivning

Non-protocolSurgeryPerformedInd-3

Datatyp

text

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
C25590
UMLS 2011AA ObjectClass
C1518384
Other Non-Protocol Therapy?
Beskrivning

OtherTherapyInd

Datatyp

text

(specify)
Beskrivning

OtherNon-ProtocolTherapyName

Datatyp

text

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

Non-ProtocolFirstChemotherapyAgentName

Datatyp

text

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

Non-ProtocolFirstChemotherapyBeginDate

Datatyp

date

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

Non-ProtocolSecondChemotherapyAgentName

Datatyp

text

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

Non-ProtocolSecondChemotherapyBeginDate

Datatyp

date

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

Ncic Ctg Use2

1st line
Beskrivning

TypeofSecondLineChemotherapy

Datatyp

text

2nd line
Beskrivning

Secondlinetherapy

Datatyp

text

Unnamed2
Beskrivning

Unnamed2

Pt. Serial #
Beskrivning

PatientStudyID,CoordinatingGroup

Datatyp

text

Pt. Initials
Beskrivning

PatientInitialsName

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
10. On Treatment Long Term Toxicity
Beskrivning

10. On Treatment Long Term Toxicity

NCIC CTG Use only
Beskrivning

NCICCTGUseonly

Datatyp

text

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

Didthepatientexperienceanytoxicitiesduringthetimeframeofthisreport?

Datatyp

text

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

CTCAdverseEventTerm

Datatyp

text

rash / acne (please circle)
Beskrivning

rash/acne

Datatyp

text

CTC Adverse Event Term, Other
Beskrivning

CTCAdverseEventTerm,Other

Datatyp

text

Category Code*
Beskrivning

CTCAdverseEventCategory

Datatyp

text

NCIC CTG use only Tox Code
Beskrivning

NCICCTGuseonlyToxCode

Datatyp

text

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

CTCAdverseEventGrade

Datatyp

text

Relation to Protocol Therapy
Beskrivning

CTCAdverseEventAttributionCode

Datatyp

text

COMMENTS
Beskrivning

Comments

Datatyp

text

11. Comments
Beskrivning

11. Comments

COMMENTS
Beskrivning

Comments

Datatyp

text

12. Have You Attached Copies Of
Beskrivning

12. Have You Attached Copies Of

12. HAVE YOU ATTACHED COPIES OF
Beskrivning

HAVEYOUATTACHEDCOPIESOF

Datatyp

text

13. Investigator Signature
Beskrivning

13. Investigator Signature

Name of Clinical Research Associate
Beskrivning

PersonCompletingForm,LastName

Datatyp

text

Date
Beskrivning

InvestigatorSignature

Datatyp

text

Alias
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Date
Beskrivning

InvestigatorSignature

Datatyp

text

Alias
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Ccrr Module For Form 5 - On & Off Treatment Follow-up Report
Beskrivning

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

Other
Beskrivning

VisitReportMonthSpecify

Datatyp

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
C25716
UMLS 2011AA ObjectClass
C0545082
Person Completing Form, First Name
Beskrivning

PersonCompletingForm,FirstName

Datatyp

text

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

Lab,Hepatic,SGPT

Datatyp

double

Lactate Dehydrogenase (LDH)
Beskrivning

Lab,Chemistry,LactateDehydrogenase

Datatyp

double

Creatinine
Beskrivning

Lab,Renal,Creatinine

Datatyp

double

BUN
Beskrivning

Lab,Renal,BUN

Datatyp

double

Potassium (K)
Beskrivning

Lab,Electrolytes,Potassium

Datatyp

double

Sodium (Na)
Beskrivning

Lab,Electrolytes,Sodium

Datatyp

double

Chloride (Cl)
Beskrivning

Lab,Electrolytes,Chloride

Datatyp

double

Calcium (Ca)
Beskrivning

Lab,Electrolytes,Calcium

Datatyp

double

Albumin
Beskrivning

Lab,Chemistry,Albumin

Datatyp

double

Imaging Site
Beskrivning

DiagnosticImagingAnatomicSite

Datatyp

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
C25421
UMLS 2011AA Property
C0002808
Method of Evaluation
Beskrivning

AssessmentType

Datatyp

text

Date of Evaluation
Beskrivning

AssessmentDate

Datatyp

date

Hemoglobin
Beskrivning

Lab,Hematology,Hemoglobin

Datatyp

double

CTC Adverse Event Term, Other
Beskrivning

CTCAdverseEventTerm,Other

Datatyp

text

Alkaline Phosphatase
Beskrivning

Lab,Hepatic,AlkalinePhosphatase

Datatyp

double

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Similar models

No Instruction available.

1 Formulär
  1. StudyEvent: Form 5 - On & Off Treatment Follow-Up Report
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
1. Patient Information
PatientStudyID,CoordinatingGroup
Item
Pt. Serial #
text
PatientMedicalRecordNumber
Item
Hospital #
text
PatientInitialsName
Item
Pt. Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
PatientStudyID,ParticipatingGroup
Item
Intergroup Patient Serial #
text
NCIInstitutionNumber
Item
Site #
text
PatientSocialSecurityNumber
Item
Patient's Social Security # (USA only)
double
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)
C0545082 (UMLS 2011AA ObjectClass)
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)
Unnamed1
Item
Unnamed1
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)
double
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
Item
Will this patient continue to receive protocol therapy?
text
CL.6
Code List
Will this patient continue to receive protocol therapy?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
FirstDoseStartDate,FirstCycle
Item
If this is the first On Treatment Follow-up, give date study medication was first taken
date
other:specify
Item
other: specify
text
Item Group
Ncic Ctg Use Only
LoggedEntryInitials
Item
Logged
text
LoggedEntryDate
Item
Unnamed2
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
CoordinatorReviewInitials
Item
Study Coord
text
CoordinatorReviewDate
Item
Unnamed3
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
PhysicianReviewInitials
Item
Phy
text
DataEntryInitials
Item
Data Ent'd
text
DataVerificationInitials
Item
Verified
text
Item Group
Unnamed1
PatientStudyID,CoordinatingGroup
Item
Pt. Serial #
text
PatientInitialsName
Item
Pt. Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
Item Group
6. Notice Of New Primary
Item
Have any other malignancies or myelodysplastic syndrome been diagnosed?
text
CL.7
Code List
Have any other malignancies or myelodysplastic syndrome been diagnosed?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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
double
Lab,Hematology,Platelets
Item
Platelets
double
Lab,Hematology,WBC
Item
WBC
double
Lab,Hematology,Neutrophils,CellPercentage
Item
Neutrophils %
double
Lab,Hematology,NeutrophilCount
Item
Neutrophils x 109/L
double
Bands*x109/L
Item
Bands* x 109/L
text
Bands*x109/L
Item
Bands* x 109/L
text
Item Group
8. Biochemistry
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)
SpecimenCollectionDate
Item
Date
date
Item
total bilirubin
double
CL.10
Code List
total bilirubin
CL Item
Not Done (Not Done)
Item
U/L
text
CL.15
Code List
U/L
CL Item
U/l (U/L)
Item
U/L
text
CL.15
Code List
U/L
CL Item
U/l (U/L)
Item
U/L
text
CL.15
Code List
U/L
CL Item
U/l (U/L)
Item
AST (SGOT)
double
CL.12
Code List
AST (SGOT)
CL Item
Not Done (Not Done)
Lab,Hepatic,AlkalinePhosphatase
Item
Alkaline Phosphatase
double
UNL
Item
UNL
text
Item Group
9. Treatment Given Since Last Report To Ncic Ctg
Item
Is the patient receiving any non-protocol cancer therapy not previously reported? (if yes, specify below)
text
CL.16
Code List
Is the patient receiving any non-protocol cancer therapy not previously reported? (if yes, specify below)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Non-Protocol Hormonal Therapy? (include medical and surgical)
text
CL.17
Code List
Non-Protocol Hormonal Therapy? (include medical and surgical)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Non-Protocol Chemotherapy?
text
CL.18
Code List
Non-Protocol Chemotherapy?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Non-Protocol Immunotherapy?
text
CL.19
Code List
Non-Protocol Immunotherapy?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Non-Protocol Biologic Response Modifier?
text
CL.20
Code List
Non-Protocol Biologic Response Modifier?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Non-Protocol High Dose Chemotherapy/ Autologous Stem Cell Transplant?
text
CL.21
Code List
Non-Protocol High Dose Chemotherapy/ Autologous Stem Cell Transplant?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Non-Protocol Radiation Therapy?
text
CL.22
Code List
Non-Protocol Radiation Therapy?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Non-Protocol Surgery?
text
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)
C1518384 (UMLS 2011AA ObjectClass)
CL.23
Code List
Non-Protocol Surgery?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Other Non-Protocol Therapy?
text
CL.24
Code List
Other Non-Protocol Therapy?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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)
C1443775 (UMLS 2011AA ObjectClass)
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)
C0439659 (UMLS 2011AA ValueDomain)
Non-ProtocolSecondChemotherapyAgentName
Item
Second ever chemotherapy or EGFR inhibitor given: (specify)
text
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C2167 (NCI Thesaurus ObjectClass)
C1443775 (UMLS 2011AA ObjectClass)
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
Unnamed2
PatientStudyID,CoordinatingGroup
Item
Pt. Serial #
text
PatientInitialsName
Item
Pt. Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
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)
Item
Did the patient experience any toxicities during the timeframe of this report? (if yes, please complete form below)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.26
Code List
Did the patient experience any toxicities during the timeframe of this report? (if yes, please complete form below)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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
Comments
Item
COMMENTS
text
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
PersonCompletingForm,LastName
Item
Name of Clinical Research Associate
text
InvestigatorSignature
Item
Date
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignature
Item
Date
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
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)
C0545082 (UMLS 2011AA ObjectClass)
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
double
Lab,Chemistry,LactateDehydrogenase
Item
Lactate Dehydrogenase (LDH)
double
Lab,Renal,Creatinine
Item
Creatinine
double
Lab,Renal,BUN
Item
BUN
double
Lab,Electrolytes,Potassium
Item
Potassium (K)
double
Lab,Electrolytes,Sodium
Item
Sodium (Na)
double
Lab,Electrolytes,Chloride
Item
Chloride (Cl)
double
Lab,Electrolytes,Calcium
Item
Calcium (Ca)
double
Lab,Chemistry,Albumin
Item
Albumin
double
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)
C0002808 (UMLS 2011AA Property)
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
Lab,Hematology,Hemoglobin
Item
Hemoglobin
double
CTCAdverseEventTerm,Other
Item
CTC Adverse Event Term, Other
text
Lab,Hepatic,AlkalinePhosphatase
Item
Alkaline Phosphatase
double
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