ID

2173

Beschrijving

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

Trefwoorden

  1. 19-09-12 19-09-12 -
  2. 09-01-15 09-01-15 - Martin Dugas
  3. 03-07-15 03-07-15 -
Geüploaded op

19 september 2012

DOI

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Licentie

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

No Instruction available.

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

1. Patient Information

Pt. Serial #
Beschrijving

PatientStudyID,CoordinatingGroup

Datatype

text

Hospital #
Beschrijving

PatientMedicalRecordNumber

Datatype

text

Pt. Initials
Beschrijving

PatientInitialsName

Datatype

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 #
Beschrijving

PatientStudyID,ParticipatingGroup

Datatype

text

Site #
Beschrijving

NCIInstitutionNumber

Datatype

text

Patient's Social Security # (USA only)
Beschrijving

PatientSocialSecurityNumber

Datatype

double

Institution
Beschrijving

InstitutionName

Datatype

text

Investigator
Beschrijving

RegisteredInvestigator

Datatype

text

2. Month Of Report
Beschrijving

2. Month Of Report

Month of report: (circle one)
Beschrijving

VisitReportMonthCount

Datatype

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
Beschrijving

Unnamed1

Datatype

text

3. Physical Exam
Beschrijving

3. Physical Exam

Date of Attendance
Beschrijving

CancerFollow-upStatusDate

Datatype

date

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

PatientWeight

Datatype

double

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

PerformanceStatus

Datatype

text

4. Disease Status
Beschrijving

4. Disease Status

4. DISEASE STATUS
Beschrijving

CancerFollow-upStatus,Recent

Datatype

text

5. Systemic Therapy Report
Beschrijving

5. Systemic Therapy Report

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

DoseModification(Change)

Datatype

text

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

TherapyModificationReason

Datatype

text

dose modification due toxicity - please specify toxicity and grade
Beschrijving

dosemodificationduetoxicity-pleasespecifytoxicityandgrade

Datatype

text

temporary interruption for toxicity - please specify toxicity and grade
Beschrijving

temporaryinterruptionfortoxicity-pleasespecifytoxicityandgrade

Datatype

text

Will this patient continue to receive protocol therapy?
Beschrijving

OffTreatmentIndicator

Datatype

text

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

FirstDoseStartDate,FirstCycle

Datatype

date

other: specify
Beschrijving

other:specify

Datatype

text

Ncic Ctg Use Only
Beschrijving

Ncic Ctg Use Only

Logged
Beschrijving

LoggedEntryInitials

Datatype

text

Unnamed2
Beschrijving

LoggedEntryDate

Datatype

date

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

CoordinatorReviewInitials

Datatype

text

Unnamed3
Beschrijving

CoordinatorReviewDate

Datatype

date

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

PhysicianReviewInitials

Datatype

text

Data Ent'd
Beschrijving

DataEntryInitials

Datatype

text

Verified
Beschrijving

DataVerificationInitials

Datatype

text

Unnamed1
Beschrijving

Unnamed1

Pt. Serial #
Beschrijving

PatientStudyID,CoordinatingGroup

Datatype

text

Pt. Initials
Beschrijving

PatientInitialsName

Datatype

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
Beschrijving

6. Notice Of New Primary

Have any other malignancies or myelodysplastic syndrome been diagnosed?
Beschrijving

NewPrimaryCancerInd

Datatype

text

date of diagnosis
Beschrijving

NewPrimaryCancerDate

Datatype

date

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

NewPrimarySite

Datatype

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.)
Beschrijving

NewPrimaryDetail

Datatype

text

Ncic Ctg Use
Beschrijving

Ncic Ctg Use

Malignancy Type
Beschrijving

NewPrimaryMalignancyType

Datatype

text

7. Hematology
Beschrijving

7. Hematology

Units (Note: please circle one)
Beschrijving

Lab,UnitsofMeasure

Datatype

text

Date
Beschrijving

Lab,Hematology,SampleCollectionDate

Datatype

date

Hemoglobin
Beschrijving

Lab,Hematology,Hemoglobin

Datatype

double

Platelets
Beschrijving

Lab,Hematology,Platelets

Datatype

double

WBC
Beschrijving

Lab,Hematology,WBC

Datatype

double

Neutrophils %
Beschrijving

Lab,Hematology,Neutrophils,CellPercentage

Datatype

double

Neutrophils x 109/L
Beschrijving

Lab,Hematology,NeutrophilCount

Datatype

double

Bands* x 109/L
Beschrijving

Bands*x109/L

Datatype

text

Bands* x 109/L
Beschrijving

Bands*x109/L

Datatype

text

8. Biochemistry
Beschrijving

8. Biochemistry

Units (Note: please circle one)
Beschrijving

Lab,UnitsofMeasure

Datatype

text

Date
Beschrijving

SpecimenCollectionDate

Datatype

date

total bilirubin
Beschrijving

Lab,Hepatic,Bilirubin

Datatype

double

U/L
Beschrijving

Lab,UnitsofMeasure

Datatype

text

U/L
Beschrijving

Lab,UnitsofMeasure

Datatype

text

U/L
Beschrijving

Lab,UnitsofMeasure

Datatype

text

AST (SGOT)
Beschrijving

Lab,Hepatic,SGOT

Datatype

double

Alkaline Phosphatase
Beschrijving

Lab,Hepatic,AlkalinePhosphatase

Datatype

double

UNL
Beschrijving

UNL

Datatype

text

9. Treatment Given Since Last Report To Ncic Ctg
Beschrijving

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)
Beschrijving

Non-ProtocolTherapyInd

Datatype

text

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

Non-ProtocolHormonalTherapyInd

Datatype

text

Non-Protocol Chemotherapy?
Beschrijving

Non-ProtocolChemotherapyInd

Datatype

text

Non-Protocol Immunotherapy?
Beschrijving

Non-ProtocolImmunotherapyInd

Datatype

text

Non-Protocol Biologic Response Modifier?
Beschrijving

Non-ProtocolBRMInd

Datatype

text

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

Non-ProtocolHDC/ASCTInd

Datatype

text

Non-Protocol Radiation Therapy?
Beschrijving

Non-ProtocolRTInd

Datatype

text

Non-Protocol Surgery?
Beschrijving

Non-protocolSurgeryPerformedInd-3

Datatype

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?
Beschrijving

OtherTherapyInd

Datatype

text

(specify)
Beschrijving

OtherNon-ProtocolTherapyName

Datatype

text

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

Non-ProtocolFirstChemotherapyAgentName

Datatype

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
Beschrijving

Non-ProtocolFirstChemotherapyBeginDate

Datatype

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)
Beschrijving

Non-ProtocolSecondChemotherapyAgentName

Datatype

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)
Beschrijving

Non-ProtocolSecondChemotherapyBeginDate

Datatype

date

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

Ncic Ctg Use2

1st line
Beschrijving

TypeofSecondLineChemotherapy

Datatype

text

2nd line
Beschrijving

Secondlinetherapy

Datatype

text

Unnamed2
Beschrijving

Unnamed2

Pt. Serial #
Beschrijving

PatientStudyID,CoordinatingGroup

Datatype

text

Pt. Initials
Beschrijving

PatientInitialsName

Datatype

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
Beschrijving

10. On Treatment Long Term Toxicity

NCIC CTG Use only
Beschrijving

NCICCTGUseonly

Datatype

text

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

Didthepatientexperienceanytoxicitiesduringthetimeframeofthisreport?

Datatype

text

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

CTCAdverseEventTerm

Datatype

text

rash / acne (please circle)
Beschrijving

rash/acne

Datatype

text

CTC Adverse Event Term, Other
Beschrijving

CTCAdverseEventTerm,Other

Datatype

text

Category Code*
Beschrijving

CTCAdverseEventCategory

Datatype

text

NCIC CTG use only Tox Code
Beschrijving

NCICCTGuseonlyToxCode

Datatype

text

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

CTCAdverseEventGrade

Datatype

text

Relation to Protocol Therapy
Beschrijving

CTCAdverseEventAttributionCode

Datatype

text

COMMENTS
Beschrijving

Comments

Datatype

text

11. Comments
Beschrijving

11. Comments

COMMENTS
Beschrijving

Comments

Datatype

text

12. Have You Attached Copies Of
Beschrijving

12. Have You Attached Copies Of

12. HAVE YOU ATTACHED COPIES OF
Beschrijving

HAVEYOUATTACHEDCOPIESOF

Datatype

text

13. Investigator Signature
Beschrijving

13. Investigator Signature

Name of Clinical Research Associate
Beschrijving

PersonCompletingForm,LastName

Datatype

text

Date
Beschrijving

InvestigatorSignature

Datatype

text

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

InvestigatorSignature

Datatype

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
Beschrijving

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

Other
Beschrijving

VisitReportMonthSpecify

Datatype

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
Beschrijving

PersonCompletingForm,FirstName

Datatype

text

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

Lab,Hepatic,SGPT

Datatype

double

Lactate Dehydrogenase (LDH)
Beschrijving

Lab,Chemistry,LactateDehydrogenase

Datatype

double

Creatinine
Beschrijving

Lab,Renal,Creatinine

Datatype

double

BUN
Beschrijving

Lab,Renal,BUN

Datatype

double

Potassium (K)
Beschrijving

Lab,Electrolytes,Potassium

Datatype

double

Sodium (Na)
Beschrijving

Lab,Electrolytes,Sodium

Datatype

double

Chloride (Cl)
Beschrijving

Lab,Electrolytes,Chloride

Datatype

double

Calcium (Ca)
Beschrijving

Lab,Electrolytes,Calcium

Datatype

double

Albumin
Beschrijving

Lab,Chemistry,Albumin

Datatype

double

Imaging Site
Beschrijving

DiagnosticImagingAnatomicSite

Datatype

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
Beschrijving

AssessmentType

Datatype

text

Date of Evaluation
Beschrijving

AssessmentDate

Datatype

date

Hemoglobin
Beschrijving

Lab,Hematology,Hemoglobin

Datatype

double

CTC Adverse Event Term, Other
Beschrijving

CTCAdverseEventTerm,Other

Datatype

text

Alkaline Phosphatase
Beschrijving

Lab,Hepatic,AlkalinePhosphatase

Datatype

double

Similar models

No Instruction available.

  1. StudyEvent: Form 5 - On & Off Treatment Follow-Up Report
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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)
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
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
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
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
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
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
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
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
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
Code List
total bilirubin
CL Item
Not Done (Not Done)
Item
U/L
text
Code List
U/L
CL Item
U/l (U/L)
Item
U/L
text
Code List
U/L
CL Item
U/l (U/L)
Item
U/L
text
Code List
U/L
CL Item
U/l (U/L)
Item
AST (SGOT)
double
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
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
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
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
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
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
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
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)
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
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
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)
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
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
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
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
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
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
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)
Code List
Imaging Site
CL Item
Chest (Chest)
C25389 (NCI Thesaurus)
C0817096 (UMLS 2011AA)
Item
Method of Evaluation
text
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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