ID

11390

Description

Form 5 - On & Off Treatment Follow-Up Report NCT00049543 Gefitinib in Treating Patients With Non-Small Cell Lung Cancer That Has Been Surgically Removed Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A0E01D72-7CAF-3016-E034-080020C9C0E0

Lien

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

Mots-clés

Versions (3)
  1. 19/09/2012 19/09/2012 -
  2. 09/01/2015 09/01/2015 - Martin Dugas
  3. 03/07/2015 03/07/2015 -
Téléchargé le

3 juillet 2015

DOI

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

Anglais

No Instruction available.

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

1. Patient Information

Pt. Serial #
Description

PatientStudyID,CoordinatingGroup

Type de données

text

Hospital #
Description

PatientMedicalRecordNumber

Type de données

text

Pt. Initials
Description

Patient Initials

Type de données

text

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

PatientStudyID,ParticipatingGroup

Type de données

text

Site #
Description

NCIInstitutionNumber

Type de données

text

Patient's Social Security # (USA only)
Description

PatientSocialSecurityNumber

Type de données

float

Institution
Description

InstitutionName

Type de données

text

Investigator
Description

RegisteredInvestigator

Type de données

text

2. Month Of Report
Description

2. Month Of Report

Month of report: (circle one)
Description

VisitReportMonthCount

Type de données

text

Alias
NCI Thesaurus Property
C29846
UMLS 2011AA Property
C0439231
NCI Thesaurus ObjectClass
C25375
UMLS 2011AA ObjectClass
C0684224
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ObjectClass-2
C25716
UMLS 2011AA ObjectClass-2
C0545082
Header
Description

Header

Type de données

text

3. Physical Exam
Description

3. Physical Exam

Date of Attendance
Description

CancerFollow-upStatusDate

Type de données

date

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

PatientWeight

Type de données

float

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

PerformanceStatus

Type de données

text

4. Disease Status
Description

4. Disease Status

4. DISEASE STATUS
Description

CancerFollow-upStatus,Recent

Type de données

text

5. Systemic Therapy Report
Description

5. Systemic Therapy Report

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

DoseModification(Change)

Type de données

text

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

TherapyModificationReason

Type de données

text

dose modification due toxicity - please specify toxicity and grade
Description

dosemodificationduetoxicity-pleasespecifytoxicityandgrade

Type de données

text

temporary interruption for toxicity - please specify toxicity and grade
Description

temporaryinterruptionfortoxicity-pleasespecifytoxicityandgrade

Type de données

text

other: specify
Description

other:specify

Type de données

text

Will this patient continue to receive protocol therapy?
Description

OffTreatmentIndicator

Type de données

boolean

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

FirstDoseStartDate,FirstCycle

Type de données

date

Ncic Ctg Use Only
Description

Ncic Ctg Use Only

Logged
Description

LoggedEntryInitials

Type de données

text

Entry date
Description

Entry date

Type de données

date

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

CoordinatorReviewInitials

Type de données

text

Coordinator Review Date
Description

Coordinator Review Date

Type de données

date

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

PhysicianReviewInitials

Type de données

text

Data Ent'd
Description

DataEntryInitials

Type de données

text

Verified
Description

DataVerificationInitials

Type de données

text

Header
Description

Header

6. Notice Of New Primary
Description

6. Notice Of New Primary

Have any other malignancies or myelodysplastic syndrome been diagnosed?
Description

NewPrimaryCancerInd

Type de données

boolean

date of diagnosis
Description

NewPrimaryCancerDate

Type de données

date

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

NewPrimarySite

Type de données

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.)
Description

NewPrimaryDetail

Type de données

text

Ncic Ctg Use
Description

Ncic Ctg Use

Malignancy Type
Description

NewPrimaryMalignancyType

Type de données

text

7. Hematology
Description

7. Hematology

Units (Note: please circle one)
Description

Lab,UnitsofMeasure

Type de données

text

Date
Description

Lab,Hematology,SampleCollectionDate

Type de données

date

Hemoglobin
Description

Lab,Hematology,Hemoglobin

Type de données

float

Platelets
Description

Lab,Hematology,Platelets

Type de données

float

WBC
Description

Lab,Hematology,WBC

Type de données

float

Neutrophils %
Description

Lab,Hematology,Neutrophils,CellPercentage

Type de données

float

Neutrophils x 109/L
Description

Lab,Hematology,NeutrophilCount

Type de données

float

Bands* x 109/L
Description

Bands*x109/L

Type de données

text

8. Biochemistry
Description

8. Biochemistry

Date
Description

SpecimenCollectionDate

Type de données

date

total bilirubin
Description

Lab,Hepatic,Bilirubin

Type de données

float

U/L
Description

Lab,UnitsofMeasure

Type de données

text

AST (SGOT)
Description

Lab,Hepatic,SGOT

Type de données

float

Alkaline Phosphatase
Description

Lab,Hepatic,AlkalinePhosphatase

Type de données

float

UNL
Description

UNL

Type de données

text

9. Treatment Given Since Last Report To Ncic Ctg
Description

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)
Description

Non-ProtocolTherapyInd

Type de données

boolean

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

Non-ProtocolHormonalTherapyInd

Type de données

boolean

Non-Protocol Chemotherapy?
Description

Non-ProtocolChemotherapyInd

Type de données

boolean

Non-Protocol Immunotherapy?
Description

Non-ProtocolImmunotherapyInd

Type de données

boolean

Non-Protocol Biologic Response Modifier?
Description

Non-ProtocolBRMInd

Type de données

boolean

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

Non-ProtocolHDC/ASCTInd

Type de données

boolean

Non-Protocol Radiation Therapy?
Description

Non-ProtocolRTInd

Type de données

boolean

Non-Protocol Surgery?
Description

Non-protocolSurgeryPerformedInd-3

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass-2
C1518384
Other Non-Protocol Therapy?
Description

OtherTherapyInd

Type de données

boolean

(specify)
Description

OtherNon-ProtocolTherapyName

Type de données

text

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

Non-ProtocolFirstChemotherapyAgentName

Type de données

text

Alias
NCI Thesaurus ObjectClass
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus ObjectClass-2
C2167
UMLS 2011AA ObjectClass-2
C1443775
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Date started
Description

Non-ProtocolFirstChemotherapyBeginDate

Type de données

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
Second ever chemotherapy or EGFR inhibitor given: (specify)
Description

Non-ProtocolSecondChemotherapyAgentName

Type de données

text

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

Non-ProtocolSecondChemotherapyBeginDate

Type de données

date

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

Ncic Ctg Use2

1st line
Description

TypeofSecondLineChemotherapy

Type de données

text

2nd line
Description

Secondlinetherapy

Type de données

text

10. On Treatment Long Term Toxicity
Description

10. On Treatment Long Term Toxicity

NCIC CTG Use only
Description

NCICCTGUseonly

Type de données

text

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

Didthepatientexperienceanytoxicitiesduringthetimeframeofthisreport?

Type de données

boolean

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

CTCAdverseEventTerm

Type de données

text

rash / acne (please circle)
Description

rash/acne

Type de données

text

CTC Adverse Event Term, Other
Description

CTCAdverseEventTerm,Other

Type de données

text

Category Code*
Description

CTCAdverseEventCategory

Type de données

text

NCIC CTG use only Tox Code
Description

NCICCTGuseonlyToxCode

Type de données

text

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

CTCAdverseEventGrade

Type de données

text

Relation to Protocol Therapy
Description

CTCAdverseEventAttributionCode

Type de données

text

COMMENTS
Description

Comments

Type de données

text

11. Comments
Description

11. Comments

12. Have You Attached Copies Of
Description

12. Have You Attached Copies Of

12. HAVE YOU ATTACHED COPIES OF
Description

HAVEYOUATTACHEDCOPIESOF

Type de données

text

13. Investigator Signature
Description

13. Investigator Signature

Date
Description

InvestigatorSignature

Type de données

text

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

PersonCompletingForm,LastName

Type de données

text

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

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

Other
Description

VisitReportMonthSpecify

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C29846
UMLS 2011AA Property
C0439231
NCI Thesaurus ObjectClass
C25375
UMLS 2011AA ObjectClass
C0684224
NCI Thesaurus ObjectClass-2
C25716
UMLS 2011AA ObjectClass-2
C0545082
Person Completing Form, First Name
Description

PersonCompletingForm,FirstName

Type de données

text

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

Lab,Hepatic,SGPT

Type de données

float

Lactate Dehydrogenase (LDH)
Description

Lab,Chemistry,LactateDehydrogenase

Type de données

float

Creatinine
Description

Lab,Renal,Creatinine

Type de données

float

BUN
Description

Lab,Renal,BUN

Type de données

float

Potassium (K)
Description

Lab,Electrolytes,Potassium

Type de données

float

Sodium (Na)
Description

Lab,Electrolytes,Sodium

Type de données

float

Chloride (Cl)
Description

Lab,Electrolytes,Chloride

Type de données

float

Calcium (Ca)
Description

Lab,Electrolytes,Calcium

Type de données

float

Albumin
Description

Lab,Chemistry,Albumin

Type de données

float

Imaging Site
Description

DiagnosticImagingAnatomicSite

Type de données

text

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

AssessmentType

Type de données

text

Date of Evaluation
Description

AssessmentDate

Type de données

date

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1 Formulaires
  1. StudyEvent: Form 5 - On & Off Treatment Follow-Up Report
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
1. Patient Information
PatientStudyID,CoordinatingGroup
Item
Pt. Serial #
text
PatientMedicalRecordNumber
Item
Hospital #
text
Patient Initials
Item
Pt. Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
PatientStudyID,ParticipatingGroup
Item
Intergroup Patient Serial #
text
NCIInstitutionNumber
Item
Site #
text
PatientSocialSecurityNumber
Item
Patient's Social Security # (USA only)
float
InstitutionName
Item
Institution
text
RegisteredInvestigator
Item
Investigator
text
Item Group
2. Month Of Report
Item
Month of report: (circle one)
text
C29846 (NCI Thesaurus Property)
C0439231 (UMLS 2011AA Property)
C25375 (NCI Thesaurus ObjectClass)
C0684224 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25716 (NCI Thesaurus ObjectClass-2)
C0545082 (UMLS 2011AA ObjectClass-2)
CL.1
Code List
Month of report: (circle one)
CL Item
Other Month (Other)
CL Item
27 Months (27)
CL Item
1 (1)
CL Item
3 (3)
CL Item
6 (6)
CL Item
9 (9)
CL Item
12 (12)
CL Item
15 (15)
CL Item
18 (18)
CL Item
21 (21)
CL Item
24 (24)
CL Item
30 (30)
CL Item
36 (36)
CL Item
42 (42)
CL Item
48 (48)
CL Item
54 (54)
CL Item
60 (60)
Header
Item
Header
text
Item Group
3. Physical Exam
CancerFollow-upStatusDate
Item
Date of Attendance
date
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
PatientWeight
Item
Weight (kg)
float
Item
Performance status (ECOG circle one see Appendix II of protocol)
text
CL.2
Code List
Performance status (ECOG circle one see Appendix II of protocol)
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
CL Item
1 (1)
CL Item
2 (2)
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
3 (3)
CL Item
4 (4)
Item Group
4. Disease Status
Item
4. DISEASE STATUS
text
CL.3
Code List
4. DISEASE STATUS
CL Item
No Evidence Of Disease (Absent)
CL Item
Cancer Present (Present)
Item Group
5. Systemic Therapy Report
Item
During the timeframe of this report, were full doses of Iressa/placebo taken daily by the patient?
text
CL.4
Code List
During the timeframe of this report, were full doses of Iressa/placebo taken daily by the patient?
CL Item
(i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
(i.e, The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)
Item
give reason (If no, check _ all that apply)
text
CL.5
Code List
give reason (If no, check _ all that apply)
CL Item
dose modification due toxicity (dose modification due toxicity)
CL Item
temporary interruption for toxicity (temporary interruption for toxicity)
CL Item
patient non compliant/forgot (patient non compliant/forgot)
CL Item
other: specify (other: specify)
CL Item
permanent cessation of protocol therapy (permanent cessation of protocol therapy)
dosemodificationduetoxicity-pleasespecifytoxicityandgrade
Item
dose modification due toxicity - please specify toxicity and grade
text
temporaryinterruptionfortoxicity-pleasespecifytoxicityandgrade
Item
temporary interruption for toxicity - please specify toxicity and grade
text
other:specify
Item
other: specify
text
OffTreatmentIndicator
Item
Will this patient continue to receive protocol therapy?
boolean
FirstDoseStartDate,FirstCycle
Item
If this is the first On Treatment Follow-up, give date study medication was first taken
date
Item Group
Ncic Ctg Use Only
LoggedEntryInitials
Item
Logged
text
LoggedEntryDate
Item
Entry date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS CUI-1)
CoordinatorReviewInitials
Item
Study Coord
text
CoordinatorReviewDate
Item
Coordinator Review Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS CUI-1)
PhysicianReviewInitials
Item
Phy
text
DataEntryInitials
Item
Data Ent'd
text
DataVerificationInitials
Item
Verified
text
Item Group
Header
Item Group
6. Notice Of New Primary
NewPrimaryCancerInd
Item
Have any other malignancies or myelodysplastic syndrome been diagnosed?
boolean
NewPrimaryCancerDate
Item
date of diagnosis
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
NewPrimarySite
Item
Site of new primary
text
NewPrimaryDetail
Item
Describe (An Adverse Event Report must be sent to NCIC CTG within 15 working days that diagnosis is known to the investigator. See protocol section 11.0 for details.)
text
Item Group
Ncic Ctg Use
NewPrimaryMalignancyType
Item
Malignancy Type
text
Item Group
7. Hematology
Item
Units (Note: please circle one)
text
CL.9
Code List
Units (Note: please circle one)
CL Item
X10^9/l (10^9/L)
CL Item
S/i (SI Units)
CL Item
Imperial (US Imperial Units)
CL Item
1000/mm3 (1000/mm3)
CL Item
Ul (ul)
CL Item
U/l (U/L)
CL Item
Mg/dl (mg/dL)
CL Item
Umol/l (umol/L)
CL Item
Meq/l (mEq/L)
CL Item
Mmol/l (mmol/L)
CL Item
G/dl (g/dl)
CL Item
G/l (g/L)
Lab,Hematology,SampleCollectionDate
Item
Date
date
Lab,Hematology,Hemoglobin
Item
Hemoglobin
float
Lab,Hematology,Platelets
Item
Platelets
float
Lab,Hematology,WBC
Item
WBC
float
Lab,Hematology,Neutrophils,CellPercentage
Item
Neutrophils %
float
Lab,Hematology,NeutrophilCount
Item
Neutrophils x 109/L
float
Bands*x109/L
Item
Bands* x 109/L
text
Item Group
8. Biochemistry
SpecimenCollectionDate
Item
Date
date
Lab,Hepatic,Bilirubin
Item
total bilirubin
float
Item
U/L
text
CL.15
Code List
U/L
CL Item
U/l (U/L)
Lab,Hepatic,SGOT
Item
AST (SGOT)
float
Lab,Hepatic,AlkalinePhosphatase
Item
Alkaline Phosphatase
float
UNL
Item
UNL
text
Item Group
9. Treatment Given Since Last Report To Ncic Ctg
Non-ProtocolTherapyInd
Item
Is the patient receiving any non-protocol cancer therapy not previously reported? (if yes, specify below)
boolean
Non-ProtocolHormonalTherapyInd
Item
Non-Protocol Hormonal Therapy? (include medical and surgical)
boolean
Non-ProtocolChemotherapyInd
Item
Non-Protocol Chemotherapy?
boolean
Non-ProtocolImmunotherapyInd
Item
Non-Protocol Immunotherapy?
boolean
Non-ProtocolBRMInd
Item
Non-Protocol Biologic Response Modifier?
boolean
Non-ProtocolHDC/ASCTInd
Item
Non-Protocol High Dose Chemotherapy/ Autologous Stem Cell Transplant?
boolean
Non-ProtocolRTInd
Item
Non-Protocol Radiation Therapy?
boolean
Non-protocolSurgeryPerformedInd-3
Item
Non-Protocol Surgery?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass-2)
OtherTherapyInd
Item
Other Non-Protocol Therapy?
boolean
OtherNon-ProtocolTherapyName
Item
(specify)
text
Non-ProtocolFirstChemotherapyAgentName
Item
First ever chemotherapy or EGFR inhibitor given: (specify)
text
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C2167 (NCI Thesaurus ObjectClass-2)
C1443775 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Non-ProtocolFirstChemotherapyBeginDate
Item
Date started
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
Non-ProtocolSecondChemotherapyAgentName
Item
Second ever chemotherapy or EGFR inhibitor given: (specify)
text
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C2167 (NCI Thesaurus ObjectClass-2)
C1443775 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Non-ProtocolSecondChemotherapyBeginDate
Item
Date started(2nd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Ncic Ctg Use2
TypeofSecondLineChemotherapy
Item
1st line
text
Secondlinetherapy
Item
2nd line
text
Item Group
10. On Treatment Long Term Toxicity
Item
NCIC CTG Use only
text
CL.25
Code List
NCIC CTG Use only
CL Item
Acute Toxicity Database (Acute toxicity database)
CL Item
Delayed Toxicity Database (Delayed toxicity database)
Didthepatientexperienceanytoxicitiesduringthetimeframeofthisreport?
Item
Did the patient experience any toxicities during the timeframe of this report? (if yes, please complete form below)
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Item
Toxicity Term
text
CL.27
Code List
Toxicity Term
CL Item
diarrhea (diarrhea)
CL Item
Chest Pain (CHEST PAIN (NON-CARDIAC AND NON-PLEURITIC))
C38665 (NCI Thesaurus)
C0008031 (UMLS 2011AA)
CL Item
Infection Without Neutropenia (INFECTION (WITHOUT NEUTROPENIA))
CL Item
Fatigue (FATIGUE (LETHARGY, MALAISE, ASTHENIA))
C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)
CL Item
Dyspnea (DYSPNEA (SHORTNESS OF BREATH))
C2998 (NCI Thesaurus)
C0013404 (UMLS 2011AA)
CL Item
Rash/desquamation (RASH/DESQUAMATION)
CL Item
Dry Skin (DRY SKIN)
C0151908 (NCI Metathesaurus)
CL Item
Anorexia (ANOREXIA)
C2875 (NCI Thesaurus)
C0003123 (UMLS 2011AA)
CL Item
Pruritus (PRURITUS)
C3344 (NCI Thesaurus)
C0033774 (UMLS 2011AA)
CL Item
Constipation (CONSTIPATION)
C37930 (NCI Thesaurus)
C0009806 (UMLS 2011AA)
CL Item
Diarrhea For Patients Without Colostomy (DIARRHEA (PATIENTS WITHOUT COLOSTOMY))
CL Item
Nausea (nausea)
C3258 (NCI Thesaurus)
C0027497 (UMLS 2011AA)
CL Item
Vomiting (vomiting)
C3442 (NCI Thesaurus)
C0042963 (UMLS 2011AA)
CL Item
fatigue (fatigue)
CL Item
uveitis/keratitis (uveitis/keratitis)
CL Item
rash / acne (rash / acne)
CL Item
Unnamed2 (Unnamed2)
Item
rash / acne (please circle)
text
CL.28
Code List
rash / acne (please circle)
CL Item
Rash (rash)
CL Item
Acne (acne)
CTCAdverseEventTerm,Other
Item
CTC Adverse Event Term, Other
text
Item
Category Code*
text
CL.29
Code List
Category Code*
CL Item
GI (GI)
CL Item
Gastrointestinal (Gastrointestinal)
C13359 (NCI Thesaurus)
C0521362 (UMLS 2011AA)
CL Item
Dermatology/skin (Dermatology/Skin)
CL Item
Infection (Infection)
C0021311 (NCI Metathesaurus)
CL Item
Pulmonary (Pulmonary)
C13304 (NCI Thesaurus)
C2709248 (UMLS 2011AA)
CL Item
Constitutional Symptoms (Constitutional Symptoms)
CL Item
Pain (Pain)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
CL Item
FL (FL)
CL Item
OC (OC)
CL Item
SK (SK)
Item
NCIC CTG use only Tox Code
text
CL.30
Code List
NCIC CTG use only Tox Code
CL Item
Dia (DIA)
CL Item
Nau (NAU)
CL Item
Vom (VOM)
CL Item
Let (LET)
CL Item
Ker (KER)
CL Item
Ras (RAS)
CTCAdverseEventGrade
Item
Worst Severity/Grade* (0=None NA=Not Assessed * Code/grade according to Common Toxicity Criteria, Version 2.0)
text
Item
Relation to Protocol Therapy
text
CL.31
Code List
Relation to Protocol Therapy
CL Item
Unrelated (1=unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (2=unlikely)
CL Item
Possibly (3=possible)
CL Item
Probably (4=probable)
CL Item
Definitely (5=definite)
Comments
Item
COMMENTS
text
Item Group
11. Comments
Item Group
12. Have You Attached Copies Of
Item
12. HAVE YOU ATTACHED COPIES OF
text
CL.32
Code List
12. HAVE YOU ATTACHED COPIES OF
CL Item
Supporting documentation (Supporting documentation)
Item Group
13. Investigator Signature
InvestigatorSignature
Item
Date
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
PersonCompletingForm,LastName
Item
Name of Clinical Research Associate
text
Item Group
Ccrr Module For Form 5 - On & Off Treatment Follow-up Report
VisitReportMonthSpecify
Item
Other
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C29846 (NCI Thesaurus Property)
C0439231 (UMLS 2011AA Property)
C25375 (NCI Thesaurus ObjectClass)
C0684224 (UMLS 2011AA ObjectClass)
C25716 (NCI Thesaurus ObjectClass-2)
C0545082 (UMLS 2011AA ObjectClass-2)
PersonCompletingForm,FirstName
Item
Person Completing Form, First Name
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Lab,Hepatic,SGPT
Item
SGPT
float
Lab,Chemistry,LactateDehydrogenase
Item
Lactate Dehydrogenase (LDH)
float
Lab,Renal,Creatinine
Item
Creatinine
float
Lab,Renal,BUN
Item
BUN
float
Lab,Electrolytes,Potassium
Item
Potassium (K)
float
Lab,Electrolytes,Sodium
Item
Sodium (Na)
float
Lab,Electrolytes,Chloride
Item
Chloride (Cl)
float
Lab,Electrolytes,Calcium
Item
Calcium (Ca)
float
Lab,Chemistry,Albumin
Item
Albumin
float
Item
Imaging Site
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C25421 (NCI Thesaurus Property-2)
C0002808 (UMLS 2011AA Property-2)
CL.33
Code List
Imaging Site
CL Item
Chest (Chest)
C25389 (NCI Thesaurus)
C0817096 (UMLS 2011AA)
Item
Method of Evaluation
text
CL.34
Code List
Method of Evaluation
CL Item
Chest X-ray (Chest X-Ray)
CL Item
Not Evaluated (Not evaluated)
CL Item
Mri (MRI (NMR))
CL Item
Ct Scan (CT Scan)
AssessmentDate
Item
Date of Evaluation
date
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