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 Item
Male (Male)
C46109 (NCI Thesaurus)
C0086582 (UMLS CUI-1)
CL Item
Female (Female)
C46110 (NCI Thesaurus)
C0015780 (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)
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)
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
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
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)
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
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
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)
Code List
Lab Unit of Measure (circle unit used)
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
Code List
Patient, if female, is not pregnant or breast feeding.
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
Code List
Post-operative radiotherapy
CL Item
Not Given (Not given)
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
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)
PrimarySurgeryDate
Item
Primary Surgery Date (yyyy mmm dd)
date
Item
N Stage, Pathologic (check _ one)
text
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
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
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
Code List
Histologic Grade (WHO)
CL Item
Well Differentiated (Grade I)
C14171 (NCI Thesaurus)
C0205615 (UMLS 2011AA)
CL Item
Moderate (Grade II)
Item
Is there vascular invasion?
text
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
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
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
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
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
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
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
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
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
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)
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
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
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
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
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)
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
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
Code List
CTG Adverse Event Category (* Code/grade according to NCI Common Toxicity Criteria, Version 2.0)
CL Item
Gastrointestinal (Gastrointestinal)
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
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)