ID

2173

Beschreibung

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

Link

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

19. September 2012

DOI

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Lizenz

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Lung Cancer NCT00049543 Follow-Up - Form 5 - On & Off Treatment Follow-Up Report - 2034584v3.0

Englisch

No Instruction available.

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

1. Patient Information

Pt. Serial #
Beschreibung

PatientStudyID,CoordinatingGroup

Datentyp

text

Hospital #
Beschreibung

PatientMedicalRecordNumber

Datentyp

text

Pt. Initials
Beschreibung

PatientInitialsName

Datentyp

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 #
Beschreibung

PatientStudyID,ParticipatingGroup

Datentyp

text

Site #
Beschreibung

NCIInstitutionNumber

Datentyp

text

Patient's Social Security # (USA only)
Beschreibung

PatientSocialSecurityNumber

Datentyp

double

Institution
Beschreibung

InstitutionName

Datentyp

text

Investigator
Beschreibung

RegisteredInvestigator

Datentyp

text

2. Month Of Report
Beschreibung

2. 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
C25716
UMLS 2011AA ObjectClass
C0545082
Unnamed1
Beschreibung

Unnamed1

Datentyp

text

3. Physical Exam
Beschreibung

3. Physical Exam

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
Weight (kg)
Beschreibung

PatientWeight

Datentyp

double

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

PerformanceStatus

Datentyp

text

4. Disease Status
Beschreibung

4. Disease Status

4. DISEASE STATUS
Beschreibung

CancerFollow-upStatus,Recent

Datentyp

text

5. Systemic Therapy Report
Beschreibung

5. Systemic Therapy Report

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

DoseModification(Change)

Datentyp

text

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

TherapyModificationReason

Datentyp

text

dose modification due toxicity - please specify toxicity and grade
Beschreibung

dosemodificationduetoxicity-pleasespecifytoxicityandgrade

Datentyp

text

temporary interruption for toxicity - please specify toxicity and grade
Beschreibung

temporaryinterruptionfortoxicity-pleasespecifytoxicityandgrade

Datentyp

text

Will this patient continue to receive protocol therapy?
Beschreibung

OffTreatmentIndicator

Datentyp

text

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

FirstDoseStartDate,FirstCycle

Datentyp

date

other: specify
Beschreibung

other:specify

Datentyp

text

Ncic Ctg Use Only
Beschreibung

Ncic Ctg Use Only

Logged
Beschreibung

LoggedEntryInitials

Datentyp

text

Unnamed2
Beschreibung

LoggedEntryDate

Datentyp

date

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

CoordinatorReviewInitials

Datentyp

text

Unnamed3
Beschreibung

CoordinatorReviewDate

Datentyp

date

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

PhysicianReviewInitials

Datentyp

text

Data Ent'd
Beschreibung

DataEntryInitials

Datentyp

text

Verified
Beschreibung

DataVerificationInitials

Datentyp

text

Unnamed1
Beschreibung

Unnamed1

Pt. Serial #
Beschreibung

PatientStudyID,CoordinatingGroup

Datentyp

text

Pt. Initials
Beschreibung

PatientInitialsName

Datentyp

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
Beschreibung

6. Notice Of New Primary

Have any other malignancies or myelodysplastic syndrome been diagnosed?
Beschreibung

NewPrimaryCancerInd

Datentyp

text

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

7. Hematology
Beschreibung

7. Hematology

Units (Note: please circle one)
Beschreibung

Lab,UnitsofMeasure

Datentyp

text

Date
Beschreibung

Lab,Hematology,SampleCollectionDate

Datentyp

date

Hemoglobin
Beschreibung

Lab,Hematology,Hemoglobin

Datentyp

double

Platelets
Beschreibung

Lab,Hematology,Platelets

Datentyp

double

WBC
Beschreibung

Lab,Hematology,WBC

Datentyp

double

Neutrophils %
Beschreibung

Lab,Hematology,Neutrophils,CellPercentage

Datentyp

double

Neutrophils x 109/L
Beschreibung

Lab,Hematology,NeutrophilCount

Datentyp

double

Bands* x 109/L
Beschreibung

Bands*x109/L

Datentyp

text

Bands* x 109/L
Beschreibung

Bands*x109/L

Datentyp

text

8. Biochemistry
Beschreibung

8. Biochemistry

Units (Note: please circle one)
Beschreibung

Lab,UnitsofMeasure

Datentyp

text

Date
Beschreibung

SpecimenCollectionDate

Datentyp

date

total bilirubin
Beschreibung

Lab,Hepatic,Bilirubin

Datentyp

double

U/L
Beschreibung

Lab,UnitsofMeasure

Datentyp

text

U/L
Beschreibung

Lab,UnitsofMeasure

Datentyp

text

U/L
Beschreibung

Lab,UnitsofMeasure

Datentyp

text

AST (SGOT)
Beschreibung

Lab,Hepatic,SGOT

Datentyp

double

Alkaline Phosphatase
Beschreibung

Lab,Hepatic,AlkalinePhosphatase

Datentyp

double

UNL
Beschreibung

UNL

Datentyp

text

9. Treatment Given Since Last Report To Ncic Ctg
Beschreibung

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)
Beschreibung

Non-ProtocolTherapyInd

Datentyp

text

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

Non-ProtocolHormonalTherapyInd

Datentyp

text

Non-Protocol Chemotherapy?
Beschreibung

Non-ProtocolChemotherapyInd

Datentyp

text

Non-Protocol Immunotherapy?
Beschreibung

Non-ProtocolImmunotherapyInd

Datentyp

text

Non-Protocol Biologic Response Modifier?
Beschreibung

Non-ProtocolBRMInd

Datentyp

text

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

Non-ProtocolHDC/ASCTInd

Datentyp

text

Non-Protocol Radiation Therapy?
Beschreibung

Non-ProtocolRTInd

Datentyp

text

Non-Protocol Surgery?
Beschreibung

Non-protocolSurgeryPerformedInd-3

Datentyp

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?
Beschreibung

OtherTherapyInd

Datentyp

text

(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
C2167
UMLS 2011AA ObjectClass
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
C25431
UMLS 2011AA ValueDomain
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
C2167
UMLS 2011AA ObjectClass
C1443775
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Date started(2nd)
Beschreibung

Non-ProtocolSecondChemotherapyBeginDate

Datentyp

date

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

Ncic Ctg Use2

1st line
Beschreibung

TypeofSecondLineChemotherapy

Datentyp

text

2nd line
Beschreibung

Secondlinetherapy

Datentyp

text

Unnamed2
Beschreibung

Unnamed2

Pt. Serial #
Beschreibung

PatientStudyID,CoordinatingGroup

Datentyp

text

Pt. Initials
Beschreibung

PatientInitialsName

Datentyp

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
Beschreibung

10. On Treatment Long Term Toxicity

NCIC CTG Use only
Beschreibung

NCICCTGUseonly

Datentyp

text

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

Didthepatientexperienceanytoxicitiesduringthetimeframeofthisreport?

Datentyp

text

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

CTCAdverseEventTerm

Datentyp

text

rash / acne (please circle)
Beschreibung

rash/acne

Datentyp

text

CTC Adverse Event Term, Other
Beschreibung

CTCAdverseEventTerm,Other

Datentyp

text

Category Code*
Beschreibung

CTCAdverseEventCategory

Datentyp

text

NCIC CTG use only Tox Code
Beschreibung

NCICCTGuseonlyToxCode

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

Datentyp

text

11. Comments
Beschreibung

11. Comments

COMMENTS
Beschreibung

Comments

Datentyp

text

12. Have You Attached Copies Of
Beschreibung

12. Have You Attached Copies Of

12. HAVE YOU ATTACHED COPIES OF
Beschreibung

HAVEYOUATTACHEDCOPIESOF

Datentyp

text

13. Investigator Signature
Beschreibung

13. Investigator Signature

Name of Clinical Research Associate
Beschreibung

PersonCompletingForm,LastName

Datentyp

text

Date
Beschreibung

InvestigatorSignature

Datentyp

text

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

InvestigatorSignature

Datentyp

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
Beschreibung

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

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
C25716
UMLS 2011AA ObjectClass
C0545082
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
SGPT
Beschreibung

Lab,Hepatic,SGPT

Datentyp

double

Lactate Dehydrogenase (LDH)
Beschreibung

Lab,Chemistry,LactateDehydrogenase

Datentyp

double

Creatinine
Beschreibung

Lab,Renal,Creatinine

Datentyp

double

BUN
Beschreibung

Lab,Renal,BUN

Datentyp

double

Potassium (K)
Beschreibung

Lab,Electrolytes,Potassium

Datentyp

double

Sodium (Na)
Beschreibung

Lab,Electrolytes,Sodium

Datentyp

double

Chloride (Cl)
Beschreibung

Lab,Electrolytes,Chloride

Datentyp

double

Calcium (Ca)
Beschreibung

Lab,Electrolytes,Calcium

Datentyp

double

Albumin
Beschreibung

Lab,Chemistry,Albumin

Datentyp

double

Imaging Site
Beschreibung

DiagnosticImagingAnatomicSite

Datentyp

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
Beschreibung

AssessmentType

Datentyp

text

Date of Evaluation
Beschreibung

AssessmentDate

Datentyp

date

Hemoglobin
Beschreibung

Lab,Hematology,Hemoglobin

Datentyp

double

CTC Adverse Event Term, Other
Beschreibung

CTCAdverseEventTerm,Other

Datentyp

text

Alkaline Phosphatase
Beschreibung

Lab,Hepatic,AlkalinePhosphatase

Datentyp

double

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1 Formulare
  1. StudyEvent: Form 5 - On & Off Treatment Follow-Up Report
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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