ID

2173

Descrizione

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

collegamento

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

Keywords

versioni (3)
  1. 19/09/12 19/09/12 -
  2. 09/01/15 09/01/15 - Martin Dugas
  3. 03/07/15 03/07/15 -
Caricato su

19 settembre 2012

DOI

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Licenza

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

Inglese

No Instruction available.

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

1. Patient Information

Pt. Serial #
Descrizione

PatientStudyID,CoordinatingGroup

Tipo di dati

text

Hospital #
Descrizione

PatientMedicalRecordNumber

Tipo di dati

text

Pt. Initials
Descrizione

PatientInitialsName

Tipo di dati

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 #
Descrizione

PatientStudyID,ParticipatingGroup

Tipo di dati

text

Site #
Descrizione

NCIInstitutionNumber

Tipo di dati

text

Patient's Social Security # (USA only)
Descrizione

PatientSocialSecurityNumber

Tipo di dati

double

Institution
Descrizione

InstitutionName

Tipo di dati

text

Investigator
Descrizione

RegisteredInvestigator

Tipo di dati

text

2. Month Of Report
Descrizione

2. Month Of Report

Month of report: (circle one)
Descrizione

VisitReportMonthCount

Tipo di dati

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
Descrizione

Unnamed1

Tipo di dati

text

3. Physical Exam
Descrizione

3. Physical Exam

Date of Attendance
Descrizione

CancerFollow-upStatusDate

Tipo di dati

date

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

PatientWeight

Tipo di dati

double

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

PerformanceStatus

Tipo di dati

text

4. Disease Status
Descrizione

4. Disease Status

4. DISEASE STATUS
Descrizione

CancerFollow-upStatus,Recent

Tipo di dati

text

5. Systemic Therapy Report
Descrizione

5. Systemic Therapy Report

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

DoseModification(Change)

Tipo di dati

text

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

TherapyModificationReason

Tipo di dati

text

dose modification due toxicity - please specify toxicity and grade
Descrizione

dosemodificationduetoxicity-pleasespecifytoxicityandgrade

Tipo di dati

text

temporary interruption for toxicity - please specify toxicity and grade
Descrizione

temporaryinterruptionfortoxicity-pleasespecifytoxicityandgrade

Tipo di dati

text

Will this patient continue to receive protocol therapy?
Descrizione

OffTreatmentIndicator

Tipo di dati

text

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

FirstDoseStartDate,FirstCycle

Tipo di dati

date

other: specify
Descrizione

other:specify

Tipo di dati

text

Ncic Ctg Use Only
Descrizione

Ncic Ctg Use Only

Logged
Descrizione

LoggedEntryInitials

Tipo di dati

text

Unnamed2
Descrizione

LoggedEntryDate

Tipo di dati

date

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

CoordinatorReviewInitials

Tipo di dati

text

Unnamed3
Descrizione

CoordinatorReviewDate

Tipo di dati

date

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

PhysicianReviewInitials

Tipo di dati

text

Data Ent'd
Descrizione

DataEntryInitials

Tipo di dati

text

Verified
Descrizione

DataVerificationInitials

Tipo di dati

text

Unnamed1
Descrizione

Unnamed1

Pt. Serial #
Descrizione

PatientStudyID,CoordinatingGroup

Tipo di dati

text

Pt. Initials
Descrizione

PatientInitialsName

Tipo di dati

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
Descrizione

6. Notice Of New Primary

Have any other malignancies or myelodysplastic syndrome been diagnosed?
Descrizione

NewPrimaryCancerInd

Tipo di dati

text

date of diagnosis
Descrizione

NewPrimaryCancerDate

Tipo di dati

date

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

NewPrimarySite

Tipo di dati

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.)
Descrizione

NewPrimaryDetail

Tipo di dati

text

Ncic Ctg Use
Descrizione

Ncic Ctg Use

Malignancy Type
Descrizione

NewPrimaryMalignancyType

Tipo di dati

text

7. Hematology
Descrizione

7. Hematology

Units (Note: please circle one)
Descrizione

Lab,UnitsofMeasure

Tipo di dati

text

Date
Descrizione

Lab,Hematology,SampleCollectionDate

Tipo di dati

date

Hemoglobin
Descrizione

Lab,Hematology,Hemoglobin

Tipo di dati

double

Platelets
Descrizione

Lab,Hematology,Platelets

Tipo di dati

double

WBC
Descrizione

Lab,Hematology,WBC

Tipo di dati

double

Neutrophils %
Descrizione

Lab,Hematology,Neutrophils,CellPercentage

Tipo di dati

double

Neutrophils x 109/L
Descrizione

Lab,Hematology,NeutrophilCount

Tipo di dati

double

Bands* x 109/L
Descrizione

Bands*x109/L

Tipo di dati

text

Bands* x 109/L
Descrizione

Bands*x109/L

Tipo di dati

text

8. Biochemistry
Descrizione

8. Biochemistry

Units (Note: please circle one)
Descrizione

Lab,UnitsofMeasure

Tipo di dati

text

Date
Descrizione

SpecimenCollectionDate

Tipo di dati

date

total bilirubin
Descrizione

Lab,Hepatic,Bilirubin

Tipo di dati

double

U/L
Descrizione

Lab,UnitsofMeasure

Tipo di dati

text

U/L
Descrizione

Lab,UnitsofMeasure

Tipo di dati

text

U/L
Descrizione

Lab,UnitsofMeasure

Tipo di dati

text

AST (SGOT)
Descrizione

Lab,Hepatic,SGOT

Tipo di dati

double

Alkaline Phosphatase
Descrizione

Lab,Hepatic,AlkalinePhosphatase

Tipo di dati

double

UNL
Descrizione

UNL

Tipo di dati

text

9. Treatment Given Since Last Report To Ncic Ctg
Descrizione

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)
Descrizione

Non-ProtocolTherapyInd

Tipo di dati

text

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

Non-ProtocolHormonalTherapyInd

Tipo di dati

text

Non-Protocol Chemotherapy?
Descrizione

Non-ProtocolChemotherapyInd

Tipo di dati

text

Non-Protocol Immunotherapy?
Descrizione

Non-ProtocolImmunotherapyInd

Tipo di dati

text

Non-Protocol Biologic Response Modifier?
Descrizione

Non-ProtocolBRMInd

Tipo di dati

text

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

Non-ProtocolHDC/ASCTInd

Tipo di dati

text

Non-Protocol Radiation Therapy?
Descrizione

Non-ProtocolRTInd

Tipo di dati

text

Non-Protocol Surgery?
Descrizione

Non-protocolSurgeryPerformedInd-3

Tipo di dati

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?
Descrizione

OtherTherapyInd

Tipo di dati

text

(specify)
Descrizione

OtherNon-ProtocolTherapyName

Tipo di dati

text

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

Non-ProtocolFirstChemotherapyAgentName

Tipo di dati

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
Descrizione

Non-ProtocolFirstChemotherapyBeginDate

Tipo di dati

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)
Descrizione

Non-ProtocolSecondChemotherapyAgentName

Tipo di dati

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)
Descrizione

Non-ProtocolSecondChemotherapyBeginDate

Tipo di dati

date

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

Ncic Ctg Use2

1st line
Descrizione

TypeofSecondLineChemotherapy

Tipo di dati

text

2nd line
Descrizione

Secondlinetherapy

Tipo di dati

text

Unnamed2
Descrizione

Unnamed2

Pt. Serial #
Descrizione

PatientStudyID,CoordinatingGroup

Tipo di dati

text

Pt. Initials
Descrizione

PatientInitialsName

Tipo di dati

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
Descrizione

10. On Treatment Long Term Toxicity

NCIC CTG Use only
Descrizione

NCICCTGUseonly

Tipo di dati

text

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

Didthepatientexperienceanytoxicitiesduringthetimeframeofthisreport?

Tipo di dati

text

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

CTCAdverseEventTerm

Tipo di dati

text

rash / acne (please circle)
Descrizione

rash/acne

Tipo di dati

text

CTC Adverse Event Term, Other
Descrizione

CTCAdverseEventTerm,Other

Tipo di dati

text

Category Code*
Descrizione

CTCAdverseEventCategory

Tipo di dati

text

NCIC CTG use only Tox Code
Descrizione

NCICCTGuseonlyToxCode

Tipo di dati

text

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

CTCAdverseEventGrade

Tipo di dati

text

Relation to Protocol Therapy
Descrizione

CTCAdverseEventAttributionCode

Tipo di dati

text

COMMENTS
Descrizione

Comments

Tipo di dati

text

11. Comments
Descrizione

11. Comments

COMMENTS
Descrizione

Comments

Tipo di dati

text

12. Have You Attached Copies Of
Descrizione

12. Have You Attached Copies Of

12. HAVE YOU ATTACHED COPIES OF
Descrizione

HAVEYOUATTACHEDCOPIESOF

Tipo di dati

text

13. Investigator Signature
Descrizione

13. Investigator Signature

Name of Clinical Research Associate
Descrizione

PersonCompletingForm,LastName

Tipo di dati

text

Date
Descrizione

InvestigatorSignature

Tipo di dati

text

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

InvestigatorSignature

Tipo di dati

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
Descrizione

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

Other
Descrizione

VisitReportMonthSpecify

Tipo di dati

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
Descrizione

PersonCompletingForm,FirstName

Tipo di dati

text

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

Lab,Hepatic,SGPT

Tipo di dati

double

Lactate Dehydrogenase (LDH)
Descrizione

Lab,Chemistry,LactateDehydrogenase

Tipo di dati

double

Creatinine
Descrizione

Lab,Renal,Creatinine

Tipo di dati

double

BUN
Descrizione

Lab,Renal,BUN

Tipo di dati

double

Potassium (K)
Descrizione

Lab,Electrolytes,Potassium

Tipo di dati

double

Sodium (Na)
Descrizione

Lab,Electrolytes,Sodium

Tipo di dati

double

Chloride (Cl)
Descrizione

Lab,Electrolytes,Chloride

Tipo di dati

double

Calcium (Ca)
Descrizione

Lab,Electrolytes,Calcium

Tipo di dati

double

Albumin
Descrizione

Lab,Chemistry,Albumin

Tipo di dati

double

Imaging Site
Descrizione

DiagnosticImagingAnatomicSite

Tipo di dati

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
Descrizione

AssessmentType

Tipo di dati

text

Date of Evaluation
Descrizione

AssessmentDate

Tipo di dati

date

Hemoglobin
Descrizione

Lab,Hematology,Hemoglobin

Tipo di dati

double

CTC Adverse Event Term, Other
Descrizione

CTCAdverseEventTerm,Other

Tipo di dati

text

Alkaline Phosphatase
Descrizione

Lab,Hepatic,AlkalinePhosphatase

Tipo di dati

double

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1 moduli
  1. StudyEvent: Form 5 - On & Off Treatment Follow-Up Report
    1. No Instruction available.
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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