ID

43385

Description

Form 1 - Eligibility Checklist and Initial Evaluation Gefitinib in Treating Patients With Non-Small Cell Lung Cancer That Has Been Surgically Removed NCT00049543 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A7422C05-78BD-5678-E034-0003BA0B1A09

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A7422C05-78BD-5678-E034-0003BA0B1A09

Keywords

Versions (4)
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 3/22/15 3/22/15 - Martin Dugas
  4. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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NSCLC (NCT00049543)

English

No Instruction available.

1 forms  
  1. StudyEvent: Form 1 - Eligibility Checklist and Initial Evaluation
    1. No Instruction available.
Patient Information
Description

Patient Information

Alias
UMLS CUI-1
C1955348
Patient Study ID, Coordinating Group
Description

PatientStudyID,CoordinatingGroup

Data type

text

Patient Initials
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Patient Medical Record Number
Description

PatientMedicalRecordNumber

Data type

text

Institution Name
Description

InstitutionName

Data type

text

Registered Investigator (NCI Investigator #)
Description

RegisteredInvestigator

Data type

text

Patient's Date of Birth (yyyy mmm dd)
Description

PatientBirthDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25275
UMLS CUI-1
C0421451
Patient Gender
Description

Patient Gender

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C17357
UMLS CUI-1
C0683312
UMLS CUI-2
C0030705
UMLS CUI-3
C0079399
Patient Race (check _ all that apply)
Description

PatientRace

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17049
UMLS 2011AA Property
C0034510
Patient Ethnicity (check _ one only)
Description

PatientEthnicity

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17049
UMLS 2011AA Property
C0034510
Payment Method (check _ one USA only)
Description

PaymentMethod

Data type

text

IRB/REB Approval Date (yyyy mmm dd)
Description

IRBApprovalDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25425
UMLS 2011AA Property
C0205540
Projected Start Date of Treatment (yyyy mmm dd)
Description

ProjectedTreatmentBeginDate

Data type

date

Logged
Description

LoggedEntryInitials

Data type

text

Logged Date
Description

Logged Date

Data type

date

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

RegulatoryAffairsReviewInitials

Data type

text

RA Date
Description

RA Date

Data type

date

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

CoordinatorReviewInitials

Data type

text

Coord Date
Description

Coord Date

Data type

date

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

PhysicianReviewInitials

Data type

text

Data Ent'd
Description

DataEntryInitials

Data type

text

Verified
Description

DataVerificationInitials

Data type

text

Eligibility Checklist
Description

Eligibility Checklist

Patient has histological proof of a primary non-small cell lung cancer (bronchoalveolar carcinomas presenting as a discrete radiological mass or node are eligible. Please specify)
Description

LungCancerProofInd

Data type

boolean

Alias
UMLS CUI-1
C0242379
Histologic Type
Description

Histologic Type

Data type

integer

Alias
UMLS CUI-1
C0449574
Post operatively the patient had a pathological stage of
Description

PathologicStagePostoperativeInd

Data type

text

Stage
Description

StageGrouping

Data type

text

Adequate Lymph Node sampling was performed (see section 5.1.1.4 of the protocol)
Description

LymphNodeAdequateSamplingInd

Data type

text

Please specify the extent of lymph node sampling (check _ one only)
Description

LymphNodeSamplingExtent

Data type

text

Nodes >= 1.5 cm were sampled (specify)
Description

LymphNodeSamplingExtentLargeSite

Data type

text

Other (specify)
Description

LymphNodeSamplingOtherExtent

Data type

text

Surgery consisted of lobectomy, sleeve resection, bilobectomy or pneumonectomy. (segmentectomy or wedge resection only is not eligible)
Description

LungCarcinomaSurgicalProcedureTherapyInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C15329
UMLS 2011AA Property
C0543467
NCI Thesaurus ObjectClass
C4878
UMLS 2011AA ObjectClass
C0684249
Patient has had all gross disease surgically removed.
Description

GrossDiseaseRemovedInd

Data type

text

All surgical margins of resection are negative for tumour.
Description

SurgicalResectionNegativeMarginIndicator

Data type

text

No more than 16 weeks may have elapsed between surgical resection and randomization.
Description

MaximumTimePostSurgeryIndicator

Data type

text

Surgery Date
Description

SurgeryDate

Data type

date

Measurement units
  • yyyy mmm dd
Alias
UMLS CUI-1
C1628561
yyyy mmm dd
A representative formalin fixed paraffin block of tumour tissue must be submitted at the request of the central tumour bank in order that specific EGFR correlative marker assays may be conducted.
Description

TumorBlocksSentIndicator

Data type

text

Performance Status is <= 2. (see protocol appendix II)
Description

MinimumPerformanceStatusIndicator

Data type

text

Required hematologic and biochemistry investigations done within 14 days prior to randomization, including:
Description

RequiredHematology14DaysIndicator

Data type

text

Date Hematology (Blood) Sample Obtained (yyyy mmm dd)
Description

Lab,Hematology,SampleCollectionDate

Data type

date

Peripheral WBC Count
Description

Lab,Hematology,WBC

Data type

float

Measurement units
  • 1000/uL
Alias
UMLS CUI-1
C0023508
1000/uL
Peripheral neutrophil count (>= 1.5 x 10 9/L or >= 1500/uL; Value)
Description

Lab,Hematology,NeutrophilCount

Data type

float

Peripheral Platelet Count (1000/uL or x 10 9/L)
Description

Lab,Hematology,Platelets

Data type

float

Lab Unit of Measure (circle unit used)
Description

Lab,UnitsofMeasure

Data type

text

Alias
UMLS CUI-1
C1519795
Required biochemistry investigations done within 14 days prior to randomization, and greater than 8 days following surgical resection, including
Description

RequiredBiochemistry14DaysIndicator

Data type

text

Specimen Collection Date (Biochemistry, yyyy mmm dd)
Description

Specimen Collection Date (Biochemistry, yyyy mmm dd)

Data type

date

Alias
UMLS CUI-1
C1302413
Bilirubin (uL or 10 9/L)
Description

Lab,Hepatic,Bilirubin

Data type

float

Alias
UMLS CUI-1
C1278039
Alkaline Phosphatase (U/L; * If alkaline phosphatase is greater than ULN but <= 2.5 X ULN, ultrasound or CT scan of abdomen and bone scan MUST be done prior to randomization)
Description

Lab,Hepatic,AlkalinePhosphatase

Data type

float

SGOT (AST) (U/L; ** If AST SGOT or ALT SGPT is greater than ULN but <= 2.5 X ULN, ultrasound, CT or MRI of abdomen MUST be done prior to randomization)
Description

Lab,Hepatic,SGOT

Data type

float

Alias
UMLS CUI-1
C0201899
SGPT (ALT) (U/L; ** If AST SGOT or ALT SGPT is greater than ULN but <= 2.5 X ULN, ultrasound, CT or MRI of abdomen MUST be done prior to randomization)
Description

Lab,Hepatic,SGPT

Data type

float

Alias
UMLS CUI-1
C0201836
Creatinine (mg/dl or umol/L)
Description

Lab,Renal,Creatinine

Data type

float

Alias
UMLS CUI-1
C0201976
Bilirubin ULN
Description

HepaticBilirubinLabUpperLimitNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C305
UMLS 2011AA Property-2
C0005437
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
Alkaline Phosphatase ULN
Description

Alkaline Phosphatase ULN

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0151420
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C16276
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
SGOT (AST) ULN
Description

SGOTLabUpperLimitNormalValue

Data type

float

Alias
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
SGPT (ALT) ULN
Description

SGPTLabUpperLimitNormalValue

Data type

float

Alias
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
Creatinine ULN
Description

Creatinine, serum ULN

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201976
NCI Thesaurus Property
C20200
UMLS CUI-2
C1519815
NCI Thesaurus Property-2
C399
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
Patient's age is >= 18 years (lower age limit subject to local policy regarding age at which patient may sign own consent)
Description

PatientAge18YearsIndicator

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0001675
Patient has had a chest x-ray within 14 days of randomization.
Description

PrestudyChestX-RayIndicator

Data type

text

Date of chest x-ray (yyyy mmm dd)
Description

ChestX-RayAssessmentDate

Data type

date

Patient has had a CT or MRI scan of the chest within 42 days prior to surgery.
Description

PrestudyChestCTIndicator

Data type

text

Date of CT or MRI of chest
Description

ChestComputedTomographyMagneticResonanceImagingDiagnosticImagingPerformedDate

Data type

date

Measurement units
  • yyyy mmm dd
Alias
NCI Thesaurus ObjectClass
C16502
NCI Thesaurus ObjectClass-2
C17204
NCI Thesaurus ObjectClass-3
C25389
NCI Thesaurus ObjectClass-4
C16809
NCI Thesaurus Property
C38000
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0011008
UMLS CUI-2
C0040405
UMLS CUI-3
C0024485
UMLS CUI-4
C0817096
yyyy mmm dd
Patient has had an EKG within 14 days prior to randomization.
Description

PrestudyEKGIndicator

Data type

text

Date of EKG (yyyy mmm dd)
Description

DiagnosticElectrocardiogramPerformedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C25482
UMLS 2011AA ObjectClass
C0348026
NCI Metathesaurus ObjectClass
C0013798
Men and women of childbearing age will use adequate contraception.
Description

EligibilityContraceptionIndicator

Data type

text

Patient has received post-operative radiation. (If patient has received post-operative radiation therapy)
Description

PrestudyPostoperativeRadiationTherapyIndicator

Data type

boolean

Radiation therapy has been completed at least three weeks prior to randomization
Description

PrestudyRadiationTherapyCompleteIndicator

Data type

text

The patient has recovered from all radiation therapy related toxicity
Description

RadiationTherapyToxicityRecoveryIndicator

Data type

text

Date Adjuvant Radiation Therapy Ended (yyyy mmm dd)
Description

AdjuvantRTEndDate

Data type

date

Informed consent has been signed and dated by patient.
Description

PatientConsentSignedIndicator

Data type

text

Date informed consent signed (yyyy mmm dd)
Description

InformedConsentDateSigned

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Patient accessible for treatment and follow-up.
Description

PatientTherapeuticProcedureFollow-upEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C16033
NCI Thesaurus Property-2
C49236
NCI Thesaurus Property-3
C25171
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0013893
Initiation of protocol therapy will begin within 10 working days of randomization.
Description

TreatmentRequirementBeginIndicator

Data type

text

No other prior or concurrent malignancies within the last 5 years, except as specified in protocol section 5.2.1.
Description

NoOtherMalignancyIndicator

Data type

text

No combination of small cell and non-small cell carcinomas or a pulmonary carcinoid tumour.
Description

NoCombinationLungCancerIndicator

Data type

text

No more than one discrete area of apparent primary cancer (even if within same lobe, T4, IIIB are ineligible)
Description

OneDiscretePrimaryCancerIndicator

Data type

text

No clinically significant or untreated ophthalmologic or gastrointestinal conditions.
Description

NoOphthalmologicGastrointestinalDiseaseIndicator

Data type

text

No active pathological condition that would render the protocol treatment dangerous. (see protocol section 5.2.5 )
Description

NoPathologicRiskConditionIndicator

Data type

text

No history of psychiatric or neurological disorder that would make the obtainment of informed consent problematic, or that would limit compliance with study requirements.
Description

NoPsychiatricImpairmentHistoryIndicator

Data type

text

Patient, if female, is not pregnant or breast feeding.
Description

FemalePatientNotPregnantIndicator

Data type

text

No prior adjuvant or neoadjuvant chemotherapy or immunotherapy for NSCLC. (limited low dose preoperative radiation therapy or endobronchial brachytherapy or laser therapy for short term control of hemoptysis or lobar obstruction is permitted, however full dose, pre-operative radiotherapy of curative intent is cause for exclusion )
Description

NoPriorLungChemotherapyIndicator

Data type

text

No history of allergic reactions to compounds of similar chemical or biologic composition to IRESSA.
Description

NoAgentAllergyHistoryIndicator

Data type

text

Patient does not take drugs which induce CYP3A4 enzymes, e.g., phenytoin, carbamazepine, barbiturates, rifampicin or St John's Wort.
Description

NoCYP3A4EnzymeMedicationsIndicator

Data type

text

Adequate healing from previous oncologic or other major surgery has occurred.
Description

AdequateSurgicalHealingIndicator

Data type

text

Post-operative radiotherapy
Description

PostoperativeRadiotherapyStatus

Data type

text

Randomization
Description

Randomization

Alias
UMLS CUI-1
C0034656
Randomization Date (yyyy mmm dd)
Description

RandomizationDate

Data type

date

Investigator Signature
Description

InvestigatorSignature

Data type

text

Alias
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Date of Investigator Signature (yyyy mmm dd)
Description

InvestigatorSignatureDate

Data type

date

Person Completing Form, Last Name
Description

PersonCompletingForm,LastName

Data type

text

Person Completing Form, First Name
Description

PersonCompletingForm,FirstName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Form Completion Date, Original (yyyy mmm dd)
Description

FormCompletionDate,Original

Data type

date

History And Physical Exam
Description

History And Physical Exam

Date of evaluation (yyyy mmm dd)
Description

AssessmentDate

Data type

date

Is patient currently smoking?
Description

PatientCurrentSmokerIndicator

Data type

text

Has previously been a smoker?
Description

PatientPreviousSmokerIndicator

Data type

text

Performance Status (check _ one)
Description

PerformanceStatus

Data type

text

Patient Height (cm)
Description

PatientHeight

Data type

float

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25347
UMLS 2011AA Property
C0489786
Patient Weight (kg)
Description

PatientWeight

Data type

float

Investigations
Description

Investigations

Imaging Site
Description

DiagnosticImagingAnatomicSite

Data type

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

Data type

text

Pregnancy test
Description

PregnancyTestResult

Data type

text

Baseline Hematology/biochemistry Values
Description

Baseline Hematology/biochemistry Values

Hemoglobin (g/dl or g/L)
Description

Lab,Hematology,Hemoglobin

Data type

float

Peripheral Neutrophils (%)
Description

Lab,Hematology,Neutrophils,CellPercentage

Data type

float

Lactate Dehydrogenase (LDH) (U/L)
Description

Lab,Chemistry,LactateDehydrogenase

Data type

float

Lactate Dehydrogenase ULN
Description

Lab,Chemistry,LactateDehydrogenase,ULN

Data type

float

BUN (mg/dl or umol/L)
Description

Lab,Renal,BUN

Data type

float

BUN ULN
Description

LaboratoryProcedureBloodUreaNitrogenResultUpperLimitNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C61019
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
UMLS CUI-1
C0005845
UMLS CUI-2
C1519815
Potassium (K) (mEq/L)
Description

Lab,Electrolytes,Potassium

Data type

float

Potassium LLN
Description

LaboratoryProcedurePotassiumElectrolytesOutcomeLowerLimitNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C464
NCI Thesaurus Property-3
C765
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25555
UMLS CUI-1
C0032821
UMLS CUI-2
C1518030
Potassium ULN
Description

LaboratoryProcedurePotassiumElectrolytesOutcomeUpperLimitNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C464
NCI Thesaurus Property-3
C765
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
UMLS CUI-1
C0032821
UMLS CUI-2
C1519815
Sodium (Na) (mmol/L)
Description

Lab,Electrolytes,Sodium

Data type

float

Sodium LLN
Description

LaboratoryProcedureSodiumElectrolytesOutcomeLowerLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C830
NCI Thesaurus Property-3
C464
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25555
UMLS CUI-1
C0037473
UMLS CUI-2
C1518030
Sodium ULN
Description

LaboratoryProcedureSodiumElectrolytesOutcomeUpperLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C830
NCI Thesaurus Property-3
C464
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
UMLS CUI-1
C0037473
UMLS CUI-2
C1519815
Chloride (Cl)
Description

Lab,Electrolytes,Chloride

Data type

float

Measurement units
  • mEq/L
Alias
UMLS CUI-1
C0201952
mEq/L
Chloride LLN
Description

LaboratoryProcedureChlorideIonElectrolytesOutcomeLowerLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C464
NCI Thesaurus Property-3
C1741
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25555
UMLS CUI-1
C0201952
UMLS CUI-2
C1518030
Chloride ULN
Description

LaboratoryProcedureChlorideIonElectrolytesOutcomeUpperLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C464
NCI Thesaurus Property-3
C1741
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
UMLS CUI-1
C0201952
UMLS CUI-2
C1519815
Calcium (Ca) (mg/dL or umol/L)
Description

Lab,Electrolytes,Calcium

Data type

float

Calcium LLN
Description

LaboratoryProcedureCalciumElectrolytesOutcomeLowerLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C331
NCI Thesaurus Property-2
C20200
NCI Thesaurus Property-3
C464
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25555
UMLS CUI-1
C0006675
UMLS CUI-2
C1518030
Calcium ULN
Description

LaboratoryProcedureCalciumElectrolytesOutcomeUpperLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C331
NCI Thesaurus Property-2
C20200
NCI Thesaurus Property-3
C464
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
UMLS CUI-1
C0006675
UMLS CUI-2
C1519815
Albumin (g/dl or g/L)
Description

Chemistry,BloodAlbumin

Data type

float

Albumin LLN
Description

LaboratoryProcedureAlbuminResultLowerLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C214
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25555
UMLS CUI-1
C0001924
UMLS CUI-2
C1518030
Albumin ULN
Description

LaboratoryProcedureAlbuminResultUpperLimitNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C214
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
UMLS CUI-1
C0001924
UMLS CUI-2
C1519815
Disease History/prior Treatment
Description

Disease History/prior Treatment

Primary Surgery Date (yyyy mmm dd)
Description

PrimarySurgeryDate

Data type

date

N Stage, Pathologic (check _ one)
Description

NStage,Pathologic

Data type

text

T Stage, Pathologic (check _ one)
Description

TStage,Pathologic

Data type

text

Stage Grouping, Pathologic
Description

StageGrouping,Pathologic

Data type

text

Specify other histologic type
Description

HistologicType,OtherName

Data type

text

Histologic Grade (WHO)
Description

HistologicGrade

Data type

text

Is there vascular invasion?
Description

VascularInvasionInd

Data type

text

Is the parietal pleural margin involved?
Description

ParietalPleuralMarginInvolvedInd

Data type

text

Was lymph node sampling done?
Description

LymphNodeSamplingInd

Data type

text

Number of Lymph Nodes Examined (If yes,)
Description

LymphNode(s)ExaminedNumber

Data type

float

Alias
NCI Thesaurus Property
C25500
UMLS 2011AA Property
C0332128
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
Number of Positive Lymph Nodes
Description

LymphNode(s)PositiveNumber

Data type

float

Alias
NCI Thesaurus Property
C25246
UMLS 2011AA Property
C1446409
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
Lymph Nodes Type (Station)
Description

LymphNodesType

Data type

text

Lymph Node Involvement (* Indicate Node Involvement: 0= not evaluated; 3= pathologically positive; 4= pathologically negative; 5= equivocal; 6= unknown)
Description

LymphNodeInvolvement

Data type

text

Type of Procedure
Description

SurgicalProcedureType

Data type

text

Tumour Size, Maximum Diameter (cm Record longest or largest diameter of tumour.)
Description

TumorSize,MaximumDiameter

Data type

float

Tumour Location, Side
Description

TumorLocation,Side

Data type

text

Tumour Location, Area (check _ all that apply)
Description

TumorLocation,Area

Data type

text

Other, specify
Description

TumorLocation,AreaOther

Data type

text

Tumour Location, Zone (check _ all that apply)
Description

TumorLocation,Zone

Data type

text

Does the tumour involve the pleura?
Description

PleuraInvolvedInd

Data type

text

Is the tumour at the surgical margin?
Description

TumorMarginInd

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25563
UMLS 2011AA Property
C0205284
Tumour Extension (check _ all that apply)
Description

TumorExtension

Data type

text

Other, specify
Description

TumorExtension,OtherStructures

Data type

text

Prior adjuvant RT? (If yes, record below)
Description

PriorAdjuvantRTInd

Data type

text

Date Adjuvant Radiation Therapy Started (yyyy mmm dd)
Description

AdjuvantRTBeginDate

Data type

date

Total dose of Radiation Therapy (cGy)
Description

RTTotalDose

Data type

float

Prior Adjuvant Chemotherapy?
Description

PriorAdjuvantChemotherapyInd

Data type

text

Adverse event
Description

Adverse event

Alias
UMLS CUI-1
C0877248
CTC Adverse Event Term (* Code/grade according to NCI Common Toxicity Criteria, version 2.0; Include all symptoms/findings including disease related symptoms present at baseline. All symptoms listed here must be reported on subsequent forms.)
Description

CTC Adverse Event Term (* Code/grade according to NCI Common Toxicity Criteria, version 2.0; Include all symptoms/findings including disease related symptoms present at baseline. All symptoms listed here must be reported on subsequent forms.)

Data type

text

Alias
UMLS CUI-1
C1516728
UMLS CUI-2
C2826934
CTC Adverse Event Term, Other
Description

CTCAdverseEventTerm,Other

Data type

text

CTG Adverse Event Category (* Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
Description

CTCAdverseEventCategory

Data type

text

CTC Adverse Event Grade (0=None NA=Not Assessed; * Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
Description

CTC Adverse Event Grade (0=None NA=Not Assessed; * Code/grade according to NCI Common Toxicity Criteria, Version 2.0)

Data type

text

Alias
UMLS CUI-1
C2985911
COMMENTS
Description

Comments

Data type

text

Concomitant Medications
Description

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Agent Name (generic or trade name)
Description

Agent Name (generic or trade name)

Data type

text

Alias
UMLS CUI-1
C0450442
Other Major Medical Problems
Description

Other Major Medical Problems

Date Documented (yyyy mmm dd)
Description

PatientMedicalConditionDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25457
UMLS CUI-1
C0012634
UMLS CUI-2
C0011008
Condition (e.g. diabetes)
Description

PatientMedicalConditionText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25457
UMLS CUI-1
C0012634
Other Relevant Details (e.g. insulin treatment)
Description

PatientHistoryText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C18772
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1 forms
  1. StudyEvent: Form 1 - Eligibility Checklist and Initial Evaluation
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient Information
C1955348 (UMLS CUI-1)
PatientStudyID,CoordinatingGroup
Item
Patient Study ID, Coordinating Group
text
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
PatientMedicalRecordNumber
Item
Patient Medical Record Number
text
InstitutionName
Item
Institution Name
text
RegisteredInvestigator
Item
Registered Investigator (NCI Investigator #)
text
Birth Date
Item
Patient's Date of Birth (yyyy mmm dd)
date
C16960 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C0421451 (UMLS CUI-1)
Item
Patient Gender
text
C25372 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C17357 (NCI Thesaurus Property)
C0683312 (UMLS CUI-1)
C0030705 (UMLS CUI-2)
C0079399 (UMLS CUI-3)
CL.9
Code List
Patient Gender
CL Item
Male (Male)
C46109 (NCI Thesaurus)
C0086582 (UMLS CUI-1)
CL Item
Female (Female)
C46110 (NCI Thesaurus)
C0086287 (UMLS CUI-1)
Item
Patient Race (check _ all that apply)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17049 (NCI Thesaurus Property)
C0034510 (UMLS 2011AA Property)
CL.2
Code List
Patient Race (check _ all that apply)
CL Item
White_cdus (White)
CL Item
Black_cdus (Black or African American)
CL Item
Pacific_islander_cdus (Native Hawaiian or other Pacific Islander)
CL Item
Asian_cdus (Asian)
CL Item
Native_american_cdus (American Indian or Alaska Native)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Patient Ethnicity (check _ one only)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17049 (NCI Thesaurus Property)
C0034510 (UMLS 2011AA Property)
CL.3
Code List
Patient Ethnicity (check _ one only)
CL Item
Hispanic_or_latino (Hispanic or Latino)
CL Item
Non_hispanic (Non-Hispanic)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Payment Method (check _ one USA only)
text
CL.4
Code List
Payment Method (check _ one USA only)
CL Item
Private Insurance (Private Insurance)
CL Item
Medicare (Medicare)
C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)
CL Item
Medicare And Private Insurance (Medicare/Private Insurance)
CL Item
Medicaid (Medicaid)
C0025071 (NCI Metathesaurus)
CL Item
Medicaid And Medicare (Medicaid & Medicare)
CL Item
Military Or Veterans Sponsored Nos (Military or Veterans Sponsored NOS)
CL Item
Military Sponsored (including Champus & Tricare) (Military Sponsored (including CHAMPUS and TRICARE))
CL Item
Veterans Sponsored (Veterans Sponsored)
CL Item
Self Pay (no Insurance) (Self pay (no insurance))
CL Item
No Means Of Payment (no Insurance) (No means of payment (no insurance))
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
IRBApprovalDate
Item
IRB/REB Approval Date (yyyy mmm dd)
date
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25425 (NCI Thesaurus Property)
C0205540 (UMLS 2011AA Property)
ProjectedTreatmentBeginDate
Item
Projected Start Date of Treatment (yyyy mmm dd)
date
LoggedEntryInitials
Item
Logged
text
LoggedEntryDate
Item
Logged Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS CUI-1)
RegulatoryAffairsReviewInitials
Item
RA
text
RegulatoryAffairsReviewDate
Item
RA Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS CUI-1)
CoordinatorReviewInitials
Item
Study Coord
text
CoordinatorReviewDate
Item
Coord 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
Eligibility Checklist
Lung neoplasm
Item
Patient has histological proof of a primary non-small cell lung cancer (bronchoalveolar carcinomas presenting as a discrete radiological mass or node are eligible. Please specify)
boolean
C0242379 (UMLS CUI-1)
Item
Histologic Type
integer
C0449574 (UMLS CUI-1)
CL.27
Code List
Histologic Type
CL Item
Squamous cell carcinoma (1)
C0007137 (UMLS CUI-1)
CL Item
Adenocarcinoma (2)
C0001418 (UMLS CUI-1)
CL Item
Adenosquamous carcinoma (3)
C0206623 (UMLS CUI-1)
CL Item
Large cell undifferentiated (4)
C0345958 (UMLS CUI-1)
CL Item
Other, Specify (5)
C1299220 (UMLS CUI-1)
PathologicStagePostoperativeInd
Item
Post operatively the patient had a pathological stage of
text
Item
Stage
text
CL.11
Code List
Stage
CL Item
Refer To Figo Staging For Specific Gynecologic Cancer (IB)
CL Item
Refer To Figo Staging For Specific Gynecologic Cancer (II)
CL Item
Refer To Figo Staging For Specific Gynecologic Cancer (IIIA)
LymphNodeAdequateSamplingInd
Item
Adequate Lymph Node sampling was performed (see section 5.1.1.4 of the protocol)
text
Item
Please specify the extent of lymph node sampling (check _ one only)
text
CL.7
Code List
Please specify the extent of lymph node sampling (check _ one only)
CL Item
Complete Mediastinal Resection (Complete mediastinal resection)
CL Item
Partial Mediastinal Resection (Partial mediastinal resection)
CL Item
Nodes >= 1.5 Cm Were Sampled (Nodes >= 1.5 cm were sampled)
CL Item
No Enlarged Lymph Nodes On Ct Chest, No Mediastinal Sampling Done (No enlarged lymph nodes on CT chest, no mediastinal sampling done)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
LymphNodeSamplingExtentLargeSite
Item
Nodes >= 1.5 cm were sampled (specify)
text
LymphNodeSamplingOtherExtent
Item
Other (specify)
text
LungCarcinomaSurgicalProcedureTherapyInd-3
Item
Surgery consisted of lobectomy, sleeve resection, bilobectomy or pneumonectomy. (segmentectomy or wedge resection only is not eligible)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15329 (NCI Thesaurus Property)
C0543467 (UMLS 2011AA Property)
C4878 (NCI Thesaurus ObjectClass)
C0684249 (UMLS 2011AA ObjectClass)
GrossDiseaseRemovedInd
Item
Patient has had all gross disease surgically removed.
text
SurgicalResectionNegativeMarginIndicator
Item
All surgical margins of resection are negative for tumour.
text
MaximumTimePostSurgeryIndicator
Item
No more than 16 weeks may have elapsed between surgical resection and randomization.
text
SurgeryDate
Item
Surgery Date
date
C1628561 (UMLS CUI-1)
TumorBlocksSentIndicator
Item
A representative formalin fixed paraffin block of tumour tissue must be submitted at the request of the central tumour bank in order that specific EGFR correlative marker assays may be conducted.
text
MinimumPerformanceStatusIndicator
Item
Performance Status is <= 2. (see protocol appendix II)
text
RequiredHematology14DaysIndicator
Item
Required hematologic and biochemistry investigations done within 14 days prior to randomization, including:
text
Lab,Hematology,SampleCollectionDate
Item
Date Hematology (Blood) Sample Obtained (yyyy mmm dd)
date
WBC
Item
Peripheral WBC Count
float
C0023508 (UMLS CUI-1)
Lab,Hematology,NeutrophilCount
Item
Peripheral neutrophil count (>= 1.5 x 10 9/L or >= 1500/uL; Value)
float
Lab,Hematology,Platelets
Item
Peripheral Platelet Count (1000/uL or x 10 9/L)
float
Item
Lab Unit of Measure (circle unit used)
text
C1519795 (UMLS CUI-1)
CL.23
Code List
Lab Unit of Measure (circle unit used)
CL Item
Ul (uL)
CL Item
X10^9/l (10 9/L)
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)
RequiredBiochemistry14DaysIndicator
Item
Required biochemistry investigations done within 14 days prior to randomization, and greater than 8 days following surgical resection, including
text
SpecimenCollectionDate
Item
Specimen Collection Date (Biochemistry, yyyy mmm dd)
date
C1302413 (UMLS CUI-1)
Bilirubin
Item
Bilirubin (uL or 10 9/L)
float
C1278039 (UMLS CUI-1)
Lab,Hepatic,AlkalinePhosphatase
Item
Alkaline Phosphatase (U/L; * If alkaline phosphatase is greater than ULN but <= 2.5 X ULN, ultrasound or CT scan of abdomen and bone scan MUST be done prior to randomization)
float
SGOT (AST)
Item
SGOT (AST) (U/L; ** If AST SGOT or ALT SGPT is greater than ULN but <= 2.5 X ULN, ultrasound, CT or MRI of abdomen MUST be done prior to randomization)
float
C0201899 (UMLS CUI-1)
SGPT
Item
SGPT (ALT) (U/L; ** If AST SGOT or ALT SGPT is greater than ULN but <= 2.5 X ULN, ultrasound, CT or MRI of abdomen MUST be done prior to randomization)
float
C0201836 (UMLS CUI-1)
Creatinine
Item
Creatinine (mg/dl or umol/L)
float
C0201976 (UMLS CUI-1)
HepaticBilirubinLabUpperLimitNormalValue
Item
Bilirubin ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property-2)
C0005437 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
Alkaline Phosphatase ULN
Item
Alkaline Phosphatase ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0151420 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C16276 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
SGOTLabUpperLimitNormalValue
Item
SGOT (AST) ULN
float
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
SGPTLabUpperLimitNormalValue
Item
SGPT (ALT) ULN
float
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
Creatinine, serum ULN
Item
Creatinine ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C399 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
Adult
Item
Patient's age is >= 18 years (lower age limit subject to local policy regarding age at which patient may sign own consent)
boolean
C38147 (NCI Thesaurus ValueDomain)
C0001675 (UMLS CUI-1)
PrestudyChestX-RayIndicator
Item
Patient has had a chest x-ray within 14 days of randomization.
text
ChestX-RayAssessmentDate
Item
Date of chest x-ray (yyyy mmm dd)
date
PrestudyChestCTIndicator
Item
Patient has had a CT or MRI scan of the chest within 42 days prior to surgery.
text
Date CT or MR chest
Item
Date of CT or MRI of chest
date
C16502 (NCI Thesaurus ObjectClass)
C17204 (NCI Thesaurus ObjectClass-2)
C25389 (NCI Thesaurus ObjectClass-3)
C16809 (NCI Thesaurus ObjectClass-4)
C38000 (NCI Thesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS CUI-1)
C0040405 (UMLS CUI-2)
C0024485 (UMLS CUI-3)
C0817096 (UMLS CUI-4)
PrestudyEKGIndicator
Item
Patient has had an EKG within 14 days prior to randomization.
text
DiagnosticElectrocardiogramPerformedDate
Item
Date of EKG (yyyy mmm dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25482 (NCI Thesaurus ObjectClass)
C0348026 (UMLS 2011AA ObjectClass)
C0013798 (NCI Metathesaurus ObjectClass)
EligibilityContraceptionIndicator
Item
Men and women of childbearing age will use adequate contraception.
text
PrestudyPostoperativeRadiationTherapyIndicator
Item
Patient has received post-operative radiation. (If patient has received post-operative radiation therapy)
boolean
PrestudyRadiationTherapyCompleteIndicator
Item
Radiation therapy has been completed at least three weeks prior to randomization
text
RadiationTherapyToxicityRecoveryIndicator
Item
The patient has recovered from all radiation therapy related toxicity
text
AdjuvantRTEndDate
Item
Date Adjuvant Radiation Therapy Ended (yyyy mmm dd)
date
PatientConsentSignedIndicator
Item
Informed consent has been signed and dated by patient.
text
InformedConsentDateSigned
Item
Date informed consent signed (yyyy mmm dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Patient accessible for treatment and follow-up
Item
Patient accessible for treatment and follow-up.
boolean
C16960 (NCI Thesaurus ObjectClass)
C16033 (NCI Thesaurus Property)
C49236 (NCI Thesaurus Property-2)
C25171 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C0013893 (UMLS CUI-1)
TreatmentRequirementBeginIndicator
Item
Initiation of protocol therapy will begin within 10 working days of randomization.
text
NoOtherMalignancyIndicator
Item
No other prior or concurrent malignancies within the last 5 years, except as specified in protocol section 5.2.1.
text
NoCombinationLungCancerIndicator
Item
No combination of small cell and non-small cell carcinomas or a pulmonary carcinoid tumour.
text
OneDiscretePrimaryCancerIndicator
Item
No more than one discrete area of apparent primary cancer (even if within same lobe, T4, IIIB are ineligible)
text
NoOphthalmologicGastrointestinalDiseaseIndicator
Item
No clinically significant or untreated ophthalmologic or gastrointestinal conditions.
text
NoPathologicRiskConditionIndicator
Item
No active pathological condition that would render the protocol treatment dangerous. (see protocol section 5.2.5 )
text
NoPsychiatricImpairmentHistoryIndicator
Item
No history of psychiatric or neurological disorder that would make the obtainment of informed consent problematic, or that would limit compliance with study requirements.
text
Item
Patient, if female, is not pregnant or breast feeding.
text
CL.15
Code List
Patient, if female, is not pregnant or breast feeding.
CL Item
Na (NA)
NoPriorLungChemotherapyIndicator
Item
No prior adjuvant or neoadjuvant chemotherapy or immunotherapy for NSCLC. (limited low dose preoperative radiation therapy or endobronchial brachytherapy or laser therapy for short term control of hemoptysis or lobar obstruction is permitted, however full dose, pre-operative radiotherapy of curative intent is cause for exclusion )
text
NoAgentAllergyHistoryIndicator
Item
No history of allergic reactions to compounds of similar chemical or biologic composition to IRESSA.
text
NoCYP3A4EnzymeMedicationsIndicator
Item
Patient does not take drugs which induce CYP3A4 enzymes, e.g., phenytoin, carbamazepine, barbiturates, rifampicin or St John's Wort.
text
AdequateSurgicalHealingIndicator
Item
Adequate healing from previous oncologic or other major surgery has occurred.
text
Item
Post-operative radiotherapy
text
CL.14
Code List
Post-operative radiotherapy
CL Item
Given (Given)
CL Item
Not Given (Not given)
Item Group
Randomization
C0034656 (UMLS CUI-1)
RandomizationDate
Item
Randomization Date (yyyy mmm dd)
date
InvestigatorSignature
Item
Investigator Signature
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignatureDate
Item
Date of Investigator Signature (yyyy mmm dd)
date
PersonCompletingForm,LastName
Item
Person Completing Form, Last Name
text
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)
FormCompletionDate,Original
Item
Form Completion Date, Original (yyyy mmm dd)
date
Item Group
History And Physical Exam
AssessmentDate
Item
Date of evaluation (yyyy mmm dd)
date
Item
Is patient currently smoking?
text
CL.16
Code List
Is patient currently smoking?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Has previously been a smoker?
text
CL.17
Code List
Has previously been a smoker?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Performance Status (check _ one)
text
CL.18
Code List
Performance Status (check _ one)
CL Item
0 (0 = Fully active, able to carry on all pre-disease performance without restriction (Karnofsky 90-100))
C0919414 (NCI Metathesaurus)
CL Item
1 (1 = Restricted in physically strenuous activity but ambulatory (K 70-80))
CL Item
2 (2 = Ambulatory and capable of all self-care but unable to carry out any work activities (K 50-60))
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
3 (3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours (K 30-40))
CL Item
4 (4 = Completely disabled, cannot carry on any self-care. Totally confined to bed or chair (K 10-20))
PatientHeight
Item
Patient Height (cm)
float
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS 2011AA Property)
PatientWeight
Item
Patient Weight (kg)
float
Item Group
Investigations
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.19
Code List
Imaging Site
CL Item
Chest (Chest)
C25389 (NCI Thesaurus)
C0817096 (UMLS 2011AA)
CL Item
Brain (Brain)
C12439 (NCI Thesaurus)
C0006104 (UMLS 2011AA)
CL Item
Abdomen (Abdomen)
C12664 (NCI Thesaurus)
C0230168 (UMLS 2011AA)
CL Item
Bone (Bone)
C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)
CL Item
Cardiac (Cardiac)
C13306 (NCI Thesaurus)
C1522601 (UMLS 2011AA)
Item
Method of Evaluation
text
CL.20
Code List
Method of Evaluation
CL Item
Chest X-ray (Chest x-ray)
CL Item
Ct Scan (CT Scan)
CL Item
Mri (MRI (NMR))
CL Item
Ultrasound (Ultrasound)
C64384 (NCI Thesaurus)
C1456803 (UMLS 2011AA)
CL Item
Bone Scan (Bone scan)
C17646 (NCI Thesaurus)
C0203668 (UMLS 2011AA)
CL Item
Ekg (EKG)
CL Item
Not Evaluated (Not evaluated)
Item
Pregnancy test
text
CL.21
Code List
Pregnancy test
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Not Evaluated (Not evaluated)
Item Group
Baseline Hematology/biochemistry Values
Lab,Hematology,Hemoglobin
Item
Hemoglobin (g/dl or g/L)
float
Lab,Hematology,Neutrophils,CellPercentage
Item
Peripheral Neutrophils (%)
float
Lab,Chemistry,LactateDehydrogenase
Item
Lactate Dehydrogenase (LDH) (U/L)
float
Lab,Chemistry,LactateDehydrogenase,ULN
Item
Lactate Dehydrogenase ULN
float
Lab,Renal,BUN
Item
BUN (mg/dl or umol/L)
float
BUN ULN
Item
BUN ULN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C61019 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0005845 (UMLS CUI-1)
C1519815 (UMLS CUI-2)
Lab,Electrolytes,Potassium
Item
Potassium (K) (mEq/L)
float
Potassium LLN
Item
Potassium LLN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C464 (NCI Thesaurus Property-2)
C765 (NCI Thesaurus Property-3)
C25712 (NCI Thesaurus ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C0032821 (UMLS CUI-1)
C1518030 (UMLS CUI-2)
Potassium ULN
Item
Potassium ULN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C464 (NCI Thesaurus Property-2)
C765 (NCI Thesaurus Property-3)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0032821 (UMLS CUI-1)
C1519815 (UMLS CUI-2)
Lab,Electrolytes,Sodium
Item
Sodium (Na) (mmol/L)
float
Sodium LLN
Item
Sodium LLN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C830 (NCI Thesaurus Property-2)
C464 (NCI Thesaurus Property-3)
C25712 (NCI Thesaurus ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C0037473 (UMLS CUI-1)
C1518030 (UMLS CUI-2)
Sodium ULN
Item
Sodium ULN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C830 (NCI Thesaurus Property-2)
C464 (NCI Thesaurus Property-3)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0037473 (UMLS CUI-1)
C1519815 (UMLS CUI-2)
Chloride
Item
Chloride (Cl)
float
C0201952 (UMLS CUI-1)
Chloride LLN
Item
Chloride LLN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C464 (NCI Thesaurus Property-2)
C1741 (NCI Thesaurus Property-3)
C25712 (NCI Thesaurus ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C0201952 (UMLS CUI-1)
C1518030 (UMLS CUI-2)
Chloride ULN
Item
Chloride ULN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C464 (NCI Thesaurus Property-2)
C1741 (NCI Thesaurus Property-3)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0201952 (UMLS CUI-1)
C1519815 (UMLS CUI-2)
Lab,Electrolytes,Calcium
Item
Calcium (Ca) (mg/dL or umol/L)
float
Calcium LLN
Item
Calcium LLN
float
C25294 (NCI Thesaurus ObjectClass)
C331 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C464 (NCI Thesaurus Property-3)
C25712 (NCI Thesaurus ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C0006675 (UMLS CUI-1)
C1518030 (UMLS CUI-2)
Calcium ULN
Item
Calcium ULN
float
C25294 (NCI Thesaurus ObjectClass)
C331 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C464 (NCI Thesaurus Property-3)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0006675 (UMLS CUI-1)
C1519815 (UMLS CUI-2)
Chemistry,BloodAlbumin
Item
Albumin (g/dl or g/L)
float
Albumin LLN
Item
Albumin LLN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C214 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C0001924 (UMLS CUI-1)
C1518030 (UMLS CUI-2)
Albumin ULN
Item
Albumin ULN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C214 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0001924 (UMLS CUI-1)
C1519815 (UMLS CUI-2)
Item Group
Disease History/prior Treatment
PrimarySurgeryDate
Item
Primary Surgery Date (yyyy mmm dd)
date
Item
N Stage, Pathologic (check _ one)
text
CL.24
Code List
N Stage, Pathologic (check _ one)
CL Item
N0, According To Ajcc Criteria (N0)
CL Item
N1, According To Ajcc Criteria (N1)
CL Item
N2, According To Ajcc Criteria (N2)
CL Item
N3, According To Ajcc Criteria (N3)
CL Item
Nx, According To Ajcc Criteria (Nx)
Item
T Stage, Pathologic (check _ one)
text
CL.25
Code List
T Stage, Pathologic (check _ one)
CL Item
Tumor 2 Cm Or Less In Greatest Dimension (T1)
CL Item
Tumor More Than 2 Cm But Not More Than 5 Cm In Greatest Dimension (T2)
CL Item
Tumor More Than 5 Cm In Greatest Dimension (T3)
CL Item
Tumor Of Any Size With Direct (T4)
Item
Stage Grouping, Pathologic
text
CL.26
Code List
Stage Grouping, Pathologic
CL Item
Ib, According To Current Ajcc Guidelines (IB)
CL Item
Iia, According To Current Ajcc Guidelines (IIA)
CL Item
Iib, According To Current Ajcc Guidelines (IIB)
CL Item
Iiia, According To Current Ajcc Guidelines (IIIA)
HistologicType,OtherName
Item
Specify other histologic type
text
Item
Histologic Grade (WHO)
text
CL.28
Code List
Histologic Grade (WHO)
CL Item
Well Differentiated (Grade I)
C14171 (NCI Thesaurus)
C0205615 (UMLS 2011AA)
CL Item
Moderate (Grade II)
CL Item
Poor (Grade III)
Item
Is there vascular invasion?
text
CL.29
Code List
Is there vascular invasion?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Is the parietal pleural margin involved?
text
CL.30
Code List
Is the parietal pleural margin involved?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Was lymph node sampling done?
text
CL.31
Code List
Was lymph node sampling done?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
LymphNode(s)ExaminedNumber
Item
Number of Lymph Nodes Examined (If yes,)
float
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
LymphNode(s)PositiveNumber
Item
Number of Positive Lymph Nodes
float
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
Item
Lymph Nodes Type (Station)
text
CL.32
Code List
Lymph Nodes Type (Station)
CL Item
Highest Mediastinal Node (Highest mediastinal (1))
CL Item
Right Upper Paratracheal Node (Right upper paratracheal (2R))
CL Item
Left Upper Paratracheal Node (Left upper paratracheal (2L))
CL Item
Pre- And Retro Paratracheal Node (Pre- and retro paratracheal (3))
CL Item
Right Lower Paratracheal Node (Right lower paratracheal (4R))
CL Item
Left Lower Paratracheal Node (Left lower paratracheal (4L))
CL Item
Subaortic Node (Subaortic (5))
CL Item
Para-aortic Node (Para-aortic (6))
CL Item
Subcarinal Node (Subcarinal (7))
CL Item
Paraesophageal (Paraesophageal (8))
C25344 (NCI Thesaurus)
C0475302 (UMLS 2011AA)
CL Item
Pulmonary Ligament (Pulmonary ligament (9))
C0225794 (NCI Metathesaurus)
CL Item
Right Hilar Node (Right hilar (10R))
CL Item
Left Hilar Node (Left hilar (10L))
CL Item
Interlobar Node (Interlobar (11))
CL Item
Right Lobar Node (Right lobar (12R))
CL Item
Left Lobar Node (Left lobar (12L))
CL Item
Right Segmental Node (Right segmental (13R))
CL Item
Left Segmental Node (Left segmental (13L))
CL Item
Right Subsegmental Node (Right subsegmental (14R))
CL Item
Left Subsegmental Node (Left subsegmental (14L))
Item
Lymph Node Involvement (* Indicate Node Involvement: 0= not evaluated; 3= pathologically positive; 4= pathologically negative; 5= equivocal; 6= unknown)
text
CL.33
Code List
Lymph Node Involvement (* Indicate Node Involvement: 0= not evaluated; 3= pathologically positive; 4= pathologically negative; 5= equivocal; 6= unknown)
CL Item
Not Evaluated (not evaluated)
CL Item
The Node Is Considered To Be Positive Based Upon Histological Evaluation. (pathologically positive)
CL Item
The Node Is Considered To Be Negative Based Upon Histological Evaluation. (pathologically negative)
CL Item
Equivocal (equivocal)
C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Type of Procedure
text
CL.34
Code List
Type of Procedure
CL Item
Lobectomy (Lobectomy)
C15272 (NCI Thesaurus)
C0023928 (UMLS 2011AA)
CL Item
Pneumonectomy (Pneumonectomy)
C15305 (NCI Thesaurus)
C0032284 (UMLS 2011AA)
CL Item
Bilobectomy (Bilobectomy)
CL Item
Bronchial Sleeve Resection (Bronchial sleeve resection)
TumorSize,MaximumDiameter
Item
Tumour Size, Maximum Diameter (cm Record longest or largest diameter of tumour.)
float
Item
Tumour Location, Side
text
CL.35
Code List
Tumour Location, Side
CL Item
Left (Left)
C25229 (NCI Thesaurus)
C0205091 (UMLS 2011AA)
CL Item
Right (Right)
C25228 (NCI Thesaurus)
C0205090 (UMLS 2011AA)
Item
Tumour Location, Area (check _ all that apply)
text
CL.36
Code List
Tumour Location, Area (check _ all that apply)
CL Item
Upper Lobe (Upper lobe)
CL Item
Middle Lobe (Middle lobe)
CL Item
Lower Lobe (Lower lobe)
CL Item
Mainstem Bronchus (Mainstem bronchus)
CL Item
Carina (Carina)
C25264 (NCI Thesaurus)
C0225594 (UMLS 2011AA)
CL Item
Other, Specify (Other, specify)
TumorLocation,AreaOther
Item
Other, specify
text
Item
Tumour Location, Zone (check _ all that apply)
text
CL.37
Code List
Tumour Location, Zone (check _ all that apply)
CL Item
Predominantly Central (Predominantly central)
CL Item
Predominantly Peripheral (Predominantly peripheral)
CL Item
Indeterminate (Indeterminate)
C48658 (NCI Thesaurus)
C0205258 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Does the tumour involve the pleura?
text
CL.38
Code List
Does the tumour involve the pleura?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Is the tumour at the surgical margin?
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25563 (NCI Thesaurus Property)
C0205284 (UMLS 2011AA Property)
CL.39
Code List
Is the tumour at the surgical margin?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Tumour Extension (check _ all that apply)
text
CL.40
Code List
Tumour Extension (check _ all that apply)
CL Item
Chest Wall (Chest Wall)
CL035093 (NCI Metathesaurus)
C62484 (NCI Thesaurus)
C0205076 (UMLS 2011AA)
CL Item
Pericardium (Pericardium)
C13005 (NCI Thesaurus)
C0031050 (UMLS 2011AA)
CL Item
Mediastinum (Mediastinum)
C12748 (NCI Thesaurus)
C0025066 (UMLS 2011AA)
CL Item
Diaphragm (Diaphragm)
C12702 (NCI Thesaurus)
C0011980 (UMLS 2011AA)
CL Item
Esophagus (Esophagus)
C12389 (NCI Thesaurus)
C0014876 (UMLS 2011AA)
CL Item
Other, Specify (Other, specify)
TumorExtension,OtherStructures
Item
Other, specify
text
Item
Prior adjuvant RT? (If yes, record below)
text
CL.41
Code List
Prior adjuvant RT? (If yes, record below)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
AdjuvantRTBeginDate
Item
Date Adjuvant Radiation Therapy Started (yyyy mmm dd)
date
RTTotalDose
Item
Total dose of Radiation Therapy (cGy)
float
Item
Prior Adjuvant Chemotherapy?
text
CL.42
Code List
Prior Adjuvant Chemotherapy?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item Group
Adverse event
C0877248 (UMLS CUI-1)
Item
CTC Adverse Event Term (* Code/grade according to NCI Common Toxicity Criteria, version 2.0; Include all symptoms/findings including disease related symptoms present at baseline. All symptoms listed here must be reported on subsequent forms.)
text
C1516728 (UMLS CUI-1)
C2826934 (UMLS CUI-2)
CL.43
Code List
CTC Adverse Event Term (* Code/grade according to NCI Common Toxicity Criteria, version 2.0; Include all symptoms/findings including disease related symptoms present at baseline. All symptoms listed here must be reported on subsequent forms.)
CL Item
Anorexia (anorexia)
CL Item
Chest Pain (chest pain (non-cardiac and non-pleuritic))
CL Item
Constipation (constipation)
CL Item
Diarrhea For Patients Without Colostomy (diarrhea (patients without colostomy))
CL Item
Dry Skin (dry skin)
CL Item
Dyspnea (dyspnea (shortness of breath))
CL Item
Fatigue (fatigue (lethargy, malaise, asthenia))
CL Item
Infection Without Neutropenia (infection (without neutropenia))
CL Item
Nausea (nausea)
CL Item
Pruritus (pruritus)
CL Item
Rash/desquamation (rash / desquamation)
CL Item
Vomiting (vomiting)
CTCAdverseEventTerm,Other
Item
CTC Adverse Event Term, Other
text
Item
CTG Adverse Event Category (* Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
text
CL.44
Code List
CTG Adverse Event Category (* Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
CL Item
Gastrointestinal (Gastrointestinal)
CL Item
Pain (Pain)
CL Item
Dermatology/skin (Dermatology/Skin)
CL Item
Pulmonary (Pulmonary)
CL Item
Constitutional Symptoms (Constitutional Symptoms)
CL Item
Infection (Infection)
CTCAdverseEventGrade
Item
CTC Adverse Event Grade (0=None NA=Not Assessed; * Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
text
C2985911 (UMLS CUI-1)
Comments
Item
COMMENTS
text
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
AgentName
Item
Agent Name (generic or trade name)
text
C0450442 (UMLS CUI-1)
Item Group
Other Major Medical Problems
Medical condition date
Item
Date Documented (yyyy mmm dd)
date
C25164 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25457 (NCI Thesaurus Property-2)
C0012634 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
Medical condition
Item
Condition (e.g. diabetes)
text
C25704 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25457 (NCI Thesaurus Property-2)
C0012634 (UMLS CUI-1)
Patient History Text
Item
Other Relevant Details (e.g. insulin treatment)
text
C25704 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C18772 (NCI Thesaurus Property)
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