ID

8701

Beschreibung

RTOG 1115 I1: Phase III RT + Standard ADT vs RT + Enhanced ADT + TAK-700 Initial Evaluation Form Hormone Therapy, Radiation Therapy, and Steroid 17alpha-monooxygenase TAK-700 in Treating Patients With High-Risk Prostate Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AEA3B793-58EB-AE06-E040-BB89AD431781

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AEA3B793-58EB-AE06-E040-BB89AD431781

Stichworte

Baseline

Prostatatumoren

Hochgeladen am

9. Januar 2015

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy

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Prostate Cancer NCT01546987 Pre-Study - RTOG 1115 I1: Phase III RT + Standard ADT vs RT + Enhanced ADT + TAK-700 Initial Evaluation Form - 3290738v1.0

Modell
Details

INSTRUCTIONS: Submit this form at time of patient's entry on study. All dates to be reported mm-dd-yyyy unless otherwise indicated

1 Formulare

StudyEvent: RTOG 1115 I1: Phase III RT + Standard ADT vs RT + Enhanced ADT + TAK-700 Initial Evaluation Form
1. INSTRUCTIONS: Submit this form at time of patient's entry on study. All dates to be reported mm-dd-yyyy unless otherwise indicated

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Header Module

Item Group

Unnamed Module 1

Protocol ID RTOG

Item

RTOG Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1514695 (UMLS CUI-2)
C19778 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

RadiationTherapyOncologyGroupPatientCaseIdentifierNumber

Item

Case #

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19778 (NCI Thesaurus ObjectClass-2)
C1514695 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C49152 (NCI Thesaurus Property-2)
C1706256 (UMLS 2011AA Property-2)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)

Institution Name

Item

Institution Name

text

C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)

Institution Number

Item

Institution No.

text

C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)

Patient Initials

Item

Patient Initials

text

C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)

Trial subject ID RTOG

Item

RTOG Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1514695 (UMLS CUI-2)
C19778 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Data amended

Item

Amended Data

boolean

C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)

Patient Information

Item Group

Unnamed Module 2

ECOG Performance Status

Item

Performance Status (ECOG 0-4)

text

C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)

CL.2

Code List

Performance Status (ECOG 0-4)

CL Item

Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)

CL Item

Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)

CL Item

Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)

CL Item

Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)

CL Item

Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)

DiagnosticProcedurePersonalMedicalHistoryPhysicalExaminationDigitalRectalExaminationPerformedInd-2

Item

History and physical/digital rectal

boolean

C18020 (NCI Thesaurus ObjectClass)
C0430022 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C17631 (NCI Thesaurus Property-2)
C1384593 (UMLS 2011AA Property-2)
C38000 (NCI Thesaurus Property-3)
C0884358 (UMLS 2011AA Property-3)
C18772 (NCI Thesaurus Property-4)
C0262926 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

DigitalRectalExaminationAssessmentDate

Item

Date Performed

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C17631 (NCI Thesaurus ObjectClass)
C1384593 (UMLS 2011AA ObjectClass)

PriorCancerDiagnosisInd-3

Item

Has the patient had any prior cancer diagnosed (invasive other than study site)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)

PriorMalignantNeoplasmSite

Item

Prior malignancy site

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C14143 (NCI Thesaurus ObjectClass-3)
C0205282 (UMLS 2011AA ObjectClass-3)
CL111053 (NCI Metathesaurus Property)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)

CL.5

Code List

Prior malignancy site

CL Item

Aml/mds (AML/MDS)

C9441 (NCI Thesaurus)

CL Item

Bcc (BCC)

CL Item

Bladder Is The Site Of Second Primary Or Recurrent Tumor (bladder)

CL Item

Brain Is The Site Of Second Primary Or Recurrent Tumor (brain)

CL Item

Colorectal (Colorectal)

C13363 (NCI Thesaurus)
C0555952 (UMLS 2011AA)

CL Item

Esophageal (Esophageal)

C37950 (NCI Thesaurus)
C1522619 (UMLS 2011AA)

CL Item

Gastric (Gastric)

C13307 (NCI Thesaurus)
C1704242 (UMLS 2011AA)

CL Item

Liver Is The Site Of Second Primary Or Recurrent Tumor (liver)

CL Item

Lung Is The Site Of Second Primary Or Recurrent Tumor (lung)

CL Item

Melanoma (Melanoma)

C3224 (NCI Thesaurus)
C0025202 (UMLS 2011AA)

CL Item

Nhl (NHL)

CL Item

Pancreatic (Pancreatic)

C25726 (NCI Thesaurus)
C0030274 (UMLS 2011AA)

CL Item

Renal (Renal)

C25225 (NCI Thesaurus)
C0022646 (UMLS 2011AA)

CL Item

Squamous-skin (Squamous-skin)

CL Item

Other Hematologic (Other hematologic)

CL Item

Other Solid (Other solid)

CL Item

Unknown Primary (Unknown primary)

PriorMalignantNeoplasmSpecify

Item

Specify

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C14143 (NCI Thesaurus ObjectClass-3)
C0205282 (UMLS 2011AA ObjectClass-3)
CL111053 (NCI Metathesaurus Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

CancerAblationDate

Item

Date Eradicated (mm-yyyy)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C20985 (NCI Thesaurus Property)
C0547070 (UMLS 2011AA Property)

OTHER PATIENT DISEASE TYPE

Item Group

Other Patient Disease Type

CongestiveHeartFailureHistoryInd-2

Item

Heart problems (unstable angina and/or Congestive heart failure requiring hospitalization Within the last 6 months)

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3080 (NCI Thesaurus ObjectClass)
C0018802 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)

TransmuralMyocardialInfarctionPatientPersonalMedicalHistoryInd-3

Item

Heart problems (transmural myocardial infarction within the last 6 months)

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C27996 (NCI Thesaurus ObjectClass-2)
C0027051 (UMLS 2011AA ObjectClass-2)
CL233186 (NCI Metathesaurus ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

ChronicDiseaseInfectionInd-2

Item

Infection (acute bacterial or fungal infection Requiring intravenous antibiotics at the time of Registration)

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C14141 (NCI Thesaurus ObjectClass-2)
C0205191 (UMLS 2011AA ObjectClass-2)

ChronicObstructiveAirwaysDiseaseRespiratoryEventHospitalizationInd-2

Item

COPD exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at registration ([within 30 days of registration])

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25179 (NCI Thesaurus Property)
C0019993 (UMLS 2011AA Property)
C3199 (NCI Thesaurus ObjectClass)
C0024117 (UMLS 2011AA ObjectClass)
CL316903 (NCI Metathesaurus ObjectClass)

ChronicDiseaseHepaticInsufficiencyInd-2

Item

Hepatic Insufficiency (resulting in clinical Jaundice and/or coagulation defects)

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C14141 (NCI Thesaurus ObjectClass-2)
C0205191 (UMLS 2011AA ObjectClass-2)
C1306571 (NCI Metathesaurus Property)

PatientAcquiredImmunodeficiencySyndromeAssessmentInd-3

Item

Does the patient have AIDS (based upon Current CDC definition)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C2851 (NCI Thesaurus Property-2)
C0001175 (UMLS 2011AA Property-2)

CushingSyndromeDiagnosisInd-2

Item

Cushing Syndrome

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C2969 (NCI Thesaurus ObjectClass)
C0010481 (UMLS 2011AA ObjectClass)

ChronicSevereRenalDiseaseorDisorderPresentInd-2

Item

Severe chronic renal disease (per study criteria)

boolean

C25225 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
C70667 (NCI Thesaurus ObjectClass-3)
C0205082 (UMLS 2011AA ObjectClass-3)
C14141 (NCI Thesaurus ObjectClass-4)
C0205191 (UMLS 2011AA ObjectClass-4)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

ChronicLiverDiseaseorDisorderPresentInd-2

Item

Chronic liver disease (per study criteria)

boolean

C12392 (NCI Thesaurus ObjectClass)
C0023884 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
C14141 (NCI Thesaurus ObjectClass-3)
C0205191 (UMLS 2011AA ObjectClass-3)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

UncontrolledHypertensionPresentInd-3

Item

Uncontrolled hypertension (per study criteria)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C3117 (NCI Thesaurus ObjectClass)
C0020538 (UMLS 2011AA ObjectClass)
C48932 (NCI Thesaurus ObjectClass-2)
C0205318 (UMLS 2011AA ObjectClass-2)

Prostate: Prior Treatment

Item Group

Prostate: Prior Treatment

PatientProstateCarcinomaSurgicalProcedurePersonalMedicalHistoryInd-2

Item

Prior surgery (RADICAL PROSTATECTOMY, CRYOSURGERY [OR HIGH-INTENSITY FOCUSED ULTRASOUND HIFU])

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus Property)
C0543467 (UMLS 2011AA Property)
C4863 (NCI Thesaurus Property-2)
C0600139 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientPelvicExternalBeamRadiationTherapyBrachytherapyPersonalMedicalHistoryInd-2

Item

Prior radiation therapy ([RT INCLUDING BRACHYTHERAPY, TO THE REGION OF STUDY THAT WOULD RESULT IN OVERLAP OF RT FIELDS])

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15751 (NCI Thesaurus Property)
C1517033 (UMLS 2011AA Property)
C15195 (NCI Thesaurus Property-2)
C0006098 (UMLS 2011AA Property-2)
C25399 (NCI Thesaurus Property-3)
C0030797 (UMLS 2011AA Property-3)
C18772 (NCI Thesaurus Property-4)
C0262926 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientChemotherapyPersonalMedicalHistoryInd-2

Item

Prior chemotherapy

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus Property)
C0392920 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)

PriorHormonalTherapyAdministeredInd-3

Item

Prior Hormonal Therapy (LHRH AGONIST, ANTI-ANDROGEN THERAPY, ESTOGEN, TESTOSTERONE OR BILATERAL ORCHIECTOMY)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus ObjectClass-2)
C0279025 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

HormoneTherapyPriorTestosteroneAdministeredInd-3

Item

Prior testosterone therapy (If yes, administered)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C2299 (NCI Thesaurus Property-2)
C0039601 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)

HormoneTherapyPriorTestosteroneAdministeredEndDate

Item

Prior testosterone therapy end date

date

C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C2299 (NCI Thesaurus Property-2)
C0039601 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

Prostate: Initial Diagnosis

Item Group

Prostate: Initial Diagnosis

ProstateTumorHistologicCategory

Item

Histologic Type

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus ObjectClass-2)
C0033572 (UMLS 2011AA ObjectClass-2)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property-2)
C0008902 (UMLS 2011AA Property-2)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C25526 (NCI Thesaurus ValueDomain-2)
C0205462 (UMLS 2011AA ValueDomain-2)

CL.21

Code List

Histologic Type

CL Item

Adenocarcinoma, Conventional, Not Otherwise Specified (Adenocarcinoma, conventional NOS)

CL Item

Other Specify (Other)

TumorHistologicVariationSpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25713 (NCI Thesaurus Property-2)
C0205419 (UMLS 2011AA Property-2)

Diagnosis Date

Item

Diagnosis Date

date

C25164 (NCI Thesaurus ValueDomain)
C2316983 (UMLS CUI-1)
C25626 (NCI Thesaurus Property)
C15220 (NCI Thesaurus ObjectClass)

CoreBiopsyProstateGlandNeoplasmPerformedCount

Item

Total number of core biopsies taken

float

C15680 (NCI Thesaurus ObjectClass)
C1318309 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus Property)
C0027651 (UMLS 2011AA Property)
C12410 (NCI Thesaurus Property-2)
C0033572 (UMLS 2011AA Property-2)
C38000 (NCI Thesaurus Property-3)
C0884358 (UMLS 2011AA Property-3)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

CoreBiopsyProstateGlandMalignantNeoplasmPerformedCount

Item

Number of positive core biopsies

float

C15680 (NCI Thesaurus ObjectClass)
C1318309 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus Property)
C0033572 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C9305 (NCI Thesaurus Property-3)
C0006826 (UMLS 2011AA Property-3)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

CoreBiopsyProstateGlandMalignantNeoplasmPerformedPercentageValue

Item

Total % of positive core biopsies taken

float

C15680 (NCI Thesaurus ObjectClass)
C1318309 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus Property)
C0033572 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C9305 (NCI Thesaurus Property-3)
C0006826 (UMLS 2011AA Property-3)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

GleasonScorePrimaryPatternValue

Item

Gleason Score, Primary Pattern ([most frequently seen] 1-5, 9=unknown)

float

C25251 (NCI Thesaurus Property)
C0205225 (UMLS 2011AA Property)
C28084 (NCI Thesaurus ObjectClass)
C0332326 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25336 (NCI Thesaurus Property-2)
C0449774 (UMLS 2011AA Property-2)

GleasonScoreSecondaryPatternValue

Item

Gleason Score, Secondary Pattern ([second most frequently seen] 1-5, 9=unknown)

float

C25667 (NCI Thesaurus Property)
C0175668 (UMLS 2011AA Property)
C28084 (NCI Thesaurus ObjectClass)
C0332326 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25336 (NCI Thesaurus Property-2)
C0449774 (UMLS 2011AA Property-2)

GleasonScoreWorstPatternValue

Item

Gleason Score, Worst Pattern ([worst pathological grade seen in any specimen] 1-5, 9=unknown)

float

C28084 (NCI Thesaurus ObjectClass)
C0332326 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25719 (NCI Thesaurus Property)
C1522166 (UMLS 2011AA Property)
C25336 (NCI Thesaurus Property-2)
C0449774 (UMLS 2011AA Property-2)

GleasonScoreCombinedPatternValue

Item

Gleason Score, Combined

float

C25454 (NCI Thesaurus Property)
C0205195 (UMLS 2011AA Property)
C28084 (NCI Thesaurus ObjectClass)
C0332326 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25336 (NCI Thesaurus Property-2)
C0449774 (UMLS 2011AA Property-2)

STUDY ENTRY PSA MEASUREMENTS

Item Group

Study Entry Psa Measurements

BaselinePSADate

Item

Baseline PSA Date

date

C17525 (NCI Thesaurus ObjectClass)
C0138741 (UMLS 2011AA ObjectClass)
C25213 (NCI Thesaurus ObjectClass-2)
C1442488 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

LaboratoryProcedureBaselineProstate-SpecificAntigenOutcomeValue

Item

Baseline PSA Value

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C25213 (NCI Thesaurus Property-2)
C1442488 (UMLS 2011AA Property-2)
C20200 (NCI Thesaurus Property-3)
C1274040 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

AssessmentLabUOM

Item

Units

text

C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS 2011AA ValueDomain)

CL.38

Code List

Units

CL Item

Nanograms Per Deciliter (ng/dL)

CL Item

Nanograms Per Milliliter (ng/mL)

CL Item

Not Otherwise Specified (NOS)

CL006269 (NCI Metathesaurus)

PSAManufacturerAssayType

Item

Method of Assay

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17525 (NCI Thesaurus ObjectClass)
C0138741 (UMLS 2011AA ObjectClass)
C16341 (NCI Thesaurus Property)
C0005507 (UMLS 2011AA Property)
C25392 (NCI Thesaurus Property-2)
C0947322 (UMLS 2011AA Property-2)

CL.30

Code List

Method of Assay

CL Item

Abbott Labs (Abbott)

CL Item

Bayer (Bayer)

CL Item

Dpc (DPC)

CL Item

Hybritech (Hybritech)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Unknown (Unknown)

Addtitional PSA Measurements

Item Group

Unnamed Module 4a

LaboratoryProcedureFirstDiagnosisProstate-SpecificAntigenOutcomeInd-2

Item

Pre-diagnostic PSA measurements (Additional PSA's obtained within 1 year prior to diagnosis if available)

boolean

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C20200 (NCI Thesaurus Property-3)
C1274040 (UMLS 2011AA Property-3)
C15220 (NCI Thesaurus Property-4)
C0011900 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PSA date

Item

PSA Date (s)

date

C25294 (NCI Thesaurus ObjectClass)
C0138741 (UMLS CUI-1)
C17525 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C20200 (NCI Thesaurus Property-2)
C17220 (NCI Thesaurus Property-3)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

PSA

Item

PSA Value (s)

float

C25294 (NCI Thesaurus ObjectClass)
C0138741 (UMLS CUI-1)
C17525 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C17220 (NCI Thesaurus Property-3)
C25712 (NCI Thesaurus ValueDomain)

AssessmentLabUOM

Item

Units

text

CL.38

Code List

Units

CL Item

Nanograms Per Deciliter (ng/dL)

CL Item

Nanograms Per Milliliter (ng/mL)

CL Item

Not Otherwise Specified (NOS)

CL006269 (NCI Metathesaurus)

PSAManufacturerAssayType

Item

Method of Assay

text

CL.30

Code List

Method of Assay

CL Item

Abbott Labs (Abbott)

CL Item

Bayer (Bayer)

CL Item

Dpc (DPC)

CL Item

Hybritech (Hybritech)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Unknown (Unknown)

Disease Information

Item Group

Unnamed Module 3

Palpable Tumor

Item

Was the tumor palpable? (at study entry)

text

C25180 (NCI Thesaurus ValueDomain)
C0746412 (UMLS CUI-1)
C3262 (NCI Thesaurus ObjectClass)
C25626 (NCI Thesaurus Property)
C25606 (NCI Thesaurus ObjectClass-2)

CL.31

Code List

Was the tumor palpable? (at study entry)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes, <= 1/2 Of One Lobe (Yes, <= 1/2 of one lobe)

CL Item

Yes, > 1/2 Of One Lobe (Yes, > 1/2 of one lobe)

CL Item

Yes, Both Lobes (Yes, both lobes)

CL Item

Yes, Nos (Yes, NOS)

DiseaseExtracapsularExtensionInd-3

Item

Extracapsular Extension? (by clinical examination)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25270 (NCI Thesaurus Property)
C0231448 (UMLS 2011AA Property)

ProstateTumorSeventhClinicalTStage

Item

T Stage, Clinical (AJCC 7TH EDITION)

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus ObjectClass-2)
C0033572 (UMLS 2011AA ObjectClass-2)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property-2)
C0475455 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.33

Code List

T Stage, Clinical (AJCC 7TH EDITION)

CL Item

Tumor Incidental Histologic Finding In 5% Or Less Of Tissue Resected (T1a)

CL Item

Tumor Incidental Histologic Finding In More Than 5% Of Tissue Resected (T1b)

CL Item

Tumor Identified By Needle Biopsy (eg, Because Of Elevated Psa) (T1c)

CL Item

Tumor Confined Within The Prostate (T2)

CL Item

Tumor Involves One-half Of One Lobe Or Less (T2a)

CL Item

Tumor Involves More Than One-half Of One Lobe But Not Both Lobes (T2b)

CL Item

Tumor Involves Both Lobes (T2c)

CL Item

Tumor Extends Through The Prostate Capule (T3)

CL Item

Extracapsular Extension (unilateral Or Bilateral) (T3a)

CL Item

Tumor Invades Seminal Vesicle(s) (T3b)

CL Item

Tumor Is Fixed Or Invades Adjacent Structures Other Than Seminal Vesicles: Such As External Sphincter, Rectum, Bladder, Levator Muscles, And/or Pelvic Wall (T4)

CL Item

Primary Tumor Cannot Be Assessed (TX)

ProstateTumorSeventhPathologicNStage

Item

N Stage, Pathologic

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus ObjectClass-2)
C0033572 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property-2)
C0456532 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.34

Code List

N Stage, Pathologic

CL Item

No Positive Regional Nodes (pN0)

CL Item

Metastases In Regional Node(s) (pN1)

CL Item

Regional Nodes Not Sampled (pNX)

ProstateTumorSeventhClinicalNStage

Item

N Stage, Clinical (RADIOGRAPHIC)

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus ObjectClass-2)
C0033572 (UMLS 2011AA ObjectClass-2)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property-2)
C0456532 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.35

Code List

N Stage, Clinical (RADIOGRAPHIC)

CL Item

No Regional Lymph Node Metastasis (N0)

CL Item

Metastasis In Regional Lymph Node(s) (N1)

CL Item

Regional Lymph Nodes Were Not Assessed (NX)

ProstateTumorSeventhClinicalMStage

Item

M Stage, Clinical

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus ObjectClass-2)
C0033572 (UMLS 2011AA ObjectClass-2)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25727 (NCI Thesaurus Property-2)
C0456533 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.36

Code List

M Stage, Clinical

CL Item

No Distant Metastasis (M0)

CL Item

Distant Metastasis (M1)

C18206 (NCI Thesaurus)
C1269798 (UMLS 2011AA)

CL Item

Nonregional Lymph Node(s) (M1a)

CL Item

Bone(s) (M1b)

CL Item

Other Site(s) With Or Without Bone Disease (M1c)

SurgicalResectionRegionalLymphNodePerformedInd-3

Item

Regional lymph node dissection (OR SAMPLING)

boolean

C25698 (NCI Thesaurus ObjectClass)
C15232 (NCI Thesaurus ObjectClass-2)
C0728940 (UMLS 2011AA ObjectClass)
C12745 (NCI Thesaurus Property)
C0024204 (UMLS 2011AA Property)
C25643 (NCI Thesaurus Property-2)
C0205147 (UMLS 2011AA Property-2)
C38000 (NCI Thesaurus Property-3)
C0884358 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

Chemistry Panel

Item Group

Baseline Lab Values (hematologic)

Laboratory Procedure Date

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)

LaboratoryProcedureSodiumElectrolytesOutcomeSpecifiedValue

Item

Sodium (mEq/L)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C830 (NCI Thesaurus Property-2)
C0037473 (UMLS 2011AA Property-2)
C464 (NCI Thesaurus Property-3)
C0013832 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureSodiumElectrolytesOutcomeLowerLimitofNormalValue

Item

Sodium LLN

float

LaboratoryProcedureSodiumElectrolytesOutcomeUpperLimitofNormalValue

Item

Sodium ULN

float

LaboratoryProcedurePotassiumElectrolytesOutcomeSpecifiedValue

Item

Potassium (mEq/L)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C464 (NCI Thesaurus Property-2)
C0013832 (UMLS 2011AA Property-2)
C765 (NCI Thesaurus Property-3)
C0032821 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedurePotassiumElectrolytesOutcomeLowerLimitNormalValue

Item

Potassium LLN

float

LaboratoryProcedurePotassiumElectrolytesOutcomeUpperLimitNormalValue

Item

Potassium ULN

float

LaboratoryProcedureChlorideIonElectrolytesOutcomeSpecifiedValue

Item

Chloride (mmol/L)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C464 (NCI Thesaurus Property-2)
C0013832 (UMLS 2011AA Property-2)
C1741 (NCI Thesaurus Property-3)
C0596019 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureChlorideIonElectrolytesOutcomeLowerLimitofNormalValue

Item

Chloride LLN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C464 (NCI Thesaurus Property-2)
C0013832 (UMLS 2011AA Property-2)
C1741 (NCI Thesaurus Property-3)
C0596019 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureChlorideIonElectrolytesOutcomeUpperLimitofNormalValue

Item

Chloride ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C464 (NCI Thesaurus Property-2)
C0013832 (UMLS 2011AA Property-2)
C1741 (NCI Thesaurus Property-3)
C0596019 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureBicarbonateOutcomeSpecifiedValue

Item

Bicarbonate (mEq/L) (mmol/L)

float

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C37918 (NCI Thesaurus Property-2)
C0005367 (UMLS 2011AA Property-2)

LaboratoryProcedureBicarbonateOutcomeUnspecifiedLowerLimitofNormalValue

Item

Bicarbonate, LLN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C37918 (NCI Thesaurus Property-2)
C0005367 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)
C1518030 (UMLS 2011AA ValueDomain-3)

LaboratoryProcedureBicarbonateOutcomeUpperLimitofNormalValue

Item

Bicarbonate ULN

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C37918 (NCI Thesaurus Property-2)
C0005367 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureBloodUreaNitrogenResultMgdLValue

Item

BUN (mg/dL)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C61019 (NCI Thesaurus Property-2)
C0005845 (UMLS 2011AA Property-2)
C28253 (NCI Thesaurus ValueDomain)
C0439210 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus ValueDomain-2)
C1274040 (UMLS 2011AA ValueDomain-2)
C37984 (NCI Thesaurus ValueDomain-3)
C0022877 (UMLS 2011AA ValueDomain-3)
C25712 (NCI Thesaurus ValueDomain-4)
C1522609 (UMLS 2011AA ValueDomain-4)

LaboratoryProcedureBloodUreaNitrogenResultLowerLimitofNormalValue

Item

BUN LNL

float

LaboratoryProcedureBloodUreaNitrogenResultUpperLimitNormalValue

Item

BUN ULN

float

Creatinine, Serum

Item

Creatinine (mg/dL)

float

C20200 (NCI Thesaurus Property)
C0201976 (UMLS CUI-1)
C399 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)

LaboratoryProcedureCreatinineResultUnspecifiedLowerLimitofNormalValue

Item

Creatinine LLN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property-2)
C0010294 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)
C1518030 (UMLS 2011AA ValueDomain-3)

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)

LaboratoryProcedureFastingPlasmaGlucoseMeasurementOutcomeValue

Item

Fasting glucose (mg/dL)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C41376 (NCI Thesaurus Property-2)
C0202042 (UMLS 2011AA Property-2)
C63663 (NCI Thesaurus Property-3)
C0015663 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureFastingPlasmaGlucoseMeasurementOutcomeLowerLimitofNormalValue

Item

Fasting glucose, LLN

float

LaboratoryProcedureFastingPlasmaGlucoseMeasurementOutcomeLabUpperLimitNormalValue

Item

Fasting glucose, ULN

float

LaboratoryProcedureMagnesiumResultSpecifiedValue

Item

Magnesium (mg/dL)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C29239 (NCI Thesaurus Property-2)
C0024467 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C0205369 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureMagnesiumResultUnspecifiedLowerLimitofNormalValue

Item

Magnesium, LLN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C29239 (NCI Thesaurus Property-2)
C0024467 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)
C1518030 (UMLS 2011AA ValueDomain-3)

LaboratoryProcedureMagnesiumResultUpperLimitofNormalValue

Item

Magnesium, ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C29239 (NCI Thesaurus Property-2)
C0024467 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)
C1518030 (UMLS 2011AA ValueDomain-3)

LaboratoryProcedurePhosphorusResultUnspecifiedValue

Item

Phosphorus

float

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C47934 (NCI Thesaurus Property-2)
C0031705 (UMLS 2011AA Property-2)

LaboratoryProcedurePhosphorusResultLowerLimitofNormalValue

Item

Phosphorus LLN

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C47934 (NCI Thesaurus Property-2)
C0031705 (UMLS 2011AA Property-2)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)
C49100 (NCI Thesaurus ValueDomain-2)
C1704610 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedurePhosphorusResultUpperLimitofNormalValue

Item

Phosphorus ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C47934 (NCI Thesaurus Property-2)
C0031705 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

Liver Panel

Item Group

Baseline Lab Values (hematologic)

Laboratory Procedure Date

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)

Albumin

Item

Albumin (g/dL)

float

C20200 (NCI Thesaurus Property)
C0201838 (UMLS CUI-1)
C214 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)

LaboratoryProcedureAlbuminResultLowerLimitofNormalValue

Item

Albumin LLN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C214 (NCI Thesaurus Property-2)
C0001924 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureAlbuminResultUpperLimitNormalValue

Item

Albumin ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C214 (NCI Thesaurus Property-2)
C0001924 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

SGOT (AST)

Item

AST (IU/L)

float

C25294 (NCI Thesaurus ObjectClass)
C0201899 (UMLS CUI-1)
C25202 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

Item

AST ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultLowerLimitofNormalValue

Item

AST LLN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)
C1518030 (UMLS 2011AA ValueDomain-3)

SGPT (ALT)

Item

ALT (U/L)

float

C25294 (NCI Thesaurus ObjectClass)
C0201836 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C25293 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultLowerLimitofNormalValue

Item

ALT LLN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property-2)
C0376147 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)
C1518030 (UMLS 2011AA ValueDomain-3)

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue

Item

ALT ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property-2)
C0376147 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

Alkaline Phosphatase

Item

Alkaline Phosphatase (IU/L)

float

C20200 (NCI Thesaurus Property)
C0201850 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C16276 (NCI Thesaurus Property-2)

LaboratoryProcedureAlkalinePhosphataseResultLowerLimitNormalValue

Item

Alkaline Phosphatase LLN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C16276 (NCI Thesaurus Property-2)
C0002059 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (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)

LaboratoryProcedureTotalBilirubinResultSpecifiedValue

Item

Total Bilirubin (mg/dL)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property-2)
C0201913 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C0205369 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureTotalBilirubinResultLowerLimitofNormalValue

Item

Total bilirubin LLN

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property-2)
C0201913 (UMLS 2011AA Property-2)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)
C49100 (NCI Thesaurus ValueDomain-2)
C1704610 (UMLS 2011AA ValueDomain-2)

Bilirubin, Total ULN

Item

Total bilirubin ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0201913 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C38037 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C25706 (NCI Thesaurus ValueDomain-3)

LaboratoryProcedureDirectBilirubinMeasurementResultUnspecifiedValue

Item

Direct Bilirubin (mg/dL)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C64481 (NCI Thesaurus Property-2)
C0201916 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureDirectBilirubinMeasurementResultLowerLimitofNormalValue

Item

Direct Bilirubin LLN

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C64481 (NCI Thesaurus Property-2)
C0201916 (UMLS 2011AA Property-2)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)
C49100 (NCI Thesaurus ValueDomain-2)
C1704610 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureDirectBilirubinMeasurementResultUpperLimitNormalValue

Item

Direct Bilirubin ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C64481 (NCI Thesaurus Property-2)
C0201916 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

Fasting Lipid Panel

Item Group

Fasting Lipid Panel

Laboratory Procedure Date

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)

LaboratoryProcedureFastingSerumTotalCholesterolMeasurementOutcomeValue

Item

Cholesterol (mg/dL)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C63663 (NCI Thesaurus Property-2)
C0015663 (UMLS 2011AA Property-2)
C61032 (NCI Thesaurus Property-3)
C1445957 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureFastingSerumTotalCholesterolMeasurementOutcomeLowerLimitofNormalValue

Item

Cholesterol LLN

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C63663 (NCI Thesaurus Property-2)
C0015663 (UMLS 2011AA Property-2)
C61032 (NCI Thesaurus Property-3)
C1445957 (UMLS 2011AA Property-3)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)
C49100 (NCI Thesaurus ValueDomain-2)
C1704610 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureFastingSerumTotalCholesterolMeasurementOutcomeUpperLimitNormalValue

Item

Cholesterol ULN

float

HematologySerumHighDensityLipoprotein(HDL)CholesterolLaboratoryResultValueinmg/dL

Item

HDL (mg/dL)

float

C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C13325 (NCI Thesaurus Property)
C0229671 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C25186 (NCI Thesaurus Property-3)
C0023821 (UMLS 2011AA Property-3)
C369 (NCI Thesaurus Property-4)
C0008377 (UMLS 2011AA Property-4)
C28253 (NCI Thesaurus ValueDomain)
C0439210 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus ValueDomain-2)
C1274040 (UMLS 2011AA ValueDomain-2)
C37984 (NCI Thesaurus ValueDomain-3)
C0022877 (UMLS 2011AA ValueDomain-3)
C25712 (NCI Thesaurus ValueDomain-4)
C1522609 (UMLS 2011AA ValueDomain-4)

HematologySerumHighDensityLipoprotein(HDL)CholesterolLaboratoryProcedureLowerLimitofNormalValue

Item

HDL LLN

text

C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C13325 (NCI Thesaurus Property)
C0229671 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C25186 (NCI Thesaurus Property-3)
C0023821 (UMLS 2011AA Property-3)
C369 (NCI Thesaurus Property-4)
C0008377 (UMLS 2011AA Property-4)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)
C49100 (NCI Thesaurus ValueDomain-2)
C1704610 (UMLS 2011AA ValueDomain-2)

HematologySerumHighDensityLipoprotein(HDL)CholesterolLaboratoryProcedureUpperLimitofNormalValue

Item

HDL ULN

float

C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C13325 (NCI Thesaurus Property)
C0229671 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C25186 (NCI Thesaurus Property-3)
C0023821 (UMLS 2011AA Property-3)
C369 (NCI Thesaurus Property-4)
C0008377 (UMLS 2011AA Property-4)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

HematologySerumLowDensityLipoprotein(LDL)CholesterolLaboratoryResultValueinmg/dL

Item

LDL (mg/dL)

float

C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C13325 (NCI Thesaurus Property)
C0229671 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C25187 (NCI Thesaurus Property-3)
C0023823 (UMLS 2011AA Property-3)
C369 (NCI Thesaurus Property-4)
C0008377 (UMLS 2011AA Property-4)
C28253 (NCI Thesaurus ValueDomain)
C0439210 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus ValueDomain-2)
C1274040 (UMLS 2011AA ValueDomain-2)
C37984 (NCI Thesaurus ValueDomain-3)
C0022877 (UMLS 2011AA ValueDomain-3)
C25712 (NCI Thesaurus ValueDomain-4)
C1522609 (UMLS 2011AA ValueDomain-4)

HematologySerumLowDensityLipoprotein(LDL)CholesterolLaboratoryProcedureLowerLimitofNormalValue

Item

LDL LLN

text

C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C13325 (NCI Thesaurus Property)
C0229671 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C25187 (NCI Thesaurus Property-3)
C0023823 (UMLS 2011AA Property-3)
C369 (NCI Thesaurus Property-4)
C0008377 (UMLS 2011AA Property-4)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)
C49100 (NCI Thesaurus ValueDomain-2)
C1704610 (UMLS 2011AA ValueDomain-2)

HematologySerumLowDensityLipoprotein(LDL)CholesterolLaboratoryProcedureUpperLimitofNormalValue

Item

LDL ULN

float

C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C13325 (NCI Thesaurus Property)
C0229671 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C25187 (NCI Thesaurus Property-3)
C0023823 (UMLS 2011AA Property-3)
C369 (NCI Thesaurus Property-4)
C0008377 (UMLS 2011AA Property-4)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureFastingTriglycerideMeasurementOutcomeValue

Item

Triglycerides (mg/dL)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C63663 (NCI Thesaurus Property-2)
C0015663 (UMLS 2011AA Property-2)
C64812 (NCI Thesaurus Property-3)
C0202236 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureFastingTriglycerideMeasurementOutcomeLowerLimitofNormalValue

Item

Triglycerides LLN

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C63663 (NCI Thesaurus Property-2)
C0015663 (UMLS 2011AA Property-2)
C64812 (NCI Thesaurus Property-3)
C0202236 (UMLS 2011AA Property-3)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)
C49100 (NCI Thesaurus ValueDomain-2)
C1704610 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureFastingTriglycerideMeasurementOutcomeUpperLimitNormalValue

Item

Triglycerides ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C63663 (NCI Thesaurus Property-2)
C0015663 (UMLS 2011AA Property-2)
C64812 (NCI Thesaurus Property-3)
C0202236 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

CBC with Differential

Item Group

Baseline Lab Values (hematologic)

Laboratory Procedure Date

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)

Hemoglobin

Item

Hemoglobin (gm/dL)

float

C16676 (NCI Thesaurus Property)
C0019046 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)

Hemoglobin LLN

Item

Hemoglobin, LLN

float

C25294 (NCI Thesaurus ObjectClass)
C0019046 (UMLS CUI-1)
C16676 (NCI Thesaurus Property)
C1518030 (UMLS CUI-2)
C20200 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)

LaboratoryProcedureHemoglobinResultUpperLimitofNormalValue

Item

Hemoglobin, ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

Leukocytes (WBC)

Item

WBC (cells/mcL)

float

C25294 (NCI Thesaurus ObjectClass)
C0023508 (UMLS CUI-1)
C12529 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

LaboratoryProcedureLeukocyteResultLowerLimitofNormalValue

Item

WBC LLN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12529 (NCI Thesaurus Property)
C0023516 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureLeukocyteResultUpperLimitofNormalValue

Item

WBC ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12529 (NCI Thesaurus Property)
C0023516 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

Platelets

Item

Platelets (mcL)

float

C20200 (NCI Thesaurus Property)
C0005821 (UMLS CUI-1)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)

Platelets LLN

Item

Platelets LLN

float

C25294 (NCI Thesaurus ObjectClass)
C0005821 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1518030 (UMLS CUI-2)
C12520 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)

LaboratoryProcedurePlateletResultUpperLimitofNormalValue

Item

Platelets ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12520 (NCI Thesaurus Property-2)
C0005821 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

Neutrophil count

Item

ANC ([cells/mm^3])

float

C25294 (NCI Thesaurus ObjectClass)
C0200633 (UMLS CUI-1)
C12533 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25304 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

LaboratoryProcedureNeutrophilResultLowerLimitofNormalValue

Item

Absolute neutrophil count LLN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12533 (NCI Thesaurus Property)
C0027950 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureNeutrophilResultUpperLimitofNormalValue

Item

ANC ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12533 (NCI Thesaurus Property)
C0027950 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

Hemoglobin A1C (%)

Item Group

Hemoglobin A1 C (%)

HematologyGlycosylatedHemoglobinMeasurementLabPercentageValue

Item

Hemogloblin A1C

float

C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C64849 (NCI Thesaurus Property)
C0202054 (UMLS 2011AA Property)

LaboratoryProcedureGlycosylatedHemoglobinMeasurementOutcomeLowerLimitofNormalValue

Item

Hemoglobin A1C LLN

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C64849 (NCI Thesaurus Property-2)
C0202054 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureGlycosylatedHemoglobinMeasurementOutcomeUpperLimitofNormalValue

Item

Hemoglobin A1C ULN

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C64849 (NCI Thesaurus Property-2)
C0202054 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

Serum Testosterone

Item Group

Serum Testosterone

Laboratory Procedure Date

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)

LaboratoryProcedureTestosteroneResultSpecifiedValue

Item

Testosterone

float

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C2299 (NCI Thesaurus Property-2)
C0039601 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureTestosteroneResultLowerLimitofNormalValue

Item

Testosterone LLN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C2299 (NCI Thesaurus Property-2)
C0039601 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureTestosteroneResultUpperLimitofNormalValue

Item

Testosterone ULN

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C2299 (NCI Thesaurus Property-2)
C0039601 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

AssessmentLabUOM

Item

Units

text

CL.38

Code List

Units

CL Item

Nanograms Per Deciliter (ng/dL)

CL Item

Nanograms Per Milliliter (ng/mL)

CL Item

Not Otherwise Specified (NOS)

CL006269 (NCI Metathesaurus)

Header

Item Group

Unnamed

BrachytherapyAdministeredInd-3

Item

Is patient receiving brachytherapy (LDR/HDR)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15195 (NCI Thesaurus ObjectClass)
C0006098 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

TransrectalUltrasoundProstateAssessmentIndicator

Item

Transrectal Ultrasound (Brachytherapy only)

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C18315 (NCI Thesaurus ObjectClass)
C0373345 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus Property-2)
C0033572 (UMLS 2011AA Property-2)

CL.40

Code List

Transrectal Ultrasound (Brachytherapy only)

CL Item

Not Applicable (Not Applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

Laboratory Procedure Date

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)

TransrectalUltrasoundProstateAssessmentVolumeMeasurement

Item

Prostate volume

float

C18315 (NCI Thesaurus ObjectClass)
C0373345 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C12410 (NCI Thesaurus Property-2)
C0033572 (UMLS 2011AA Property-2)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25335 (NCI Thesaurus ValueDomain-2)
C0449468 (UMLS 2011AA ValueDomain-2)

TransrectalUltrasoundProstateAssessmentDate

Item

Date performed

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C18315 (NCI Thesaurus ObjectClass)
C0373345 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus Property-2)
C0033572 (UMLS 2011AA Property-2)

MagneticResonanceImagingComputedTomographyDiagnosticImagingAbdominalCavityPelvisPhysicalExaminationInd-2

Item

CT/MRI abdomen/pelvis

boolean

C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C17204 (NCI Thesaurus ObjectClass-2)
C0040405 (UMLS 2011AA ObjectClass-2)
C16809 (NCI Thesaurus ObjectClass-3)
C0024485 (UMLS 2011AA ObjectClass-3)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C12664 (NCI Thesaurus Property-2)
C0230168 (UMLS 2011AA Property-2)
C12767 (NCI Thesaurus Property-3)
C0030797 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

AbdominalPelvisScanPerformedDate

Item

Date Performed

date

C12767 (NCI Thesaurus ObjectClass)
C0030797 (UMLS 2011AA ObjectClass)
C0000726 (NCI Metathesaurus ObjectClass)
C17999 (NCI Thesaurus ObjectClass-2)
C0441633 (UMLS 2011AA ObjectClass-2)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

BoneScanMedicalImagingAssessmentInd-3

Item

Bone scan

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C17646 (NCI Thesaurus ObjectClass)
C0203668 (UMLS 2011AA ObjectClass)
C16831 (NCI Thesaurus ObjectClass-2)

Patient Evaluations

Item Group

Patient Evaluations

Patient Height

Item

Height

float

C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)

Laboratory Procedure Date

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)

Patient Weight

Item

Weight

float

C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)

HeartMUGATestInd-3

Item

MUGA Scan

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C38073 (NCI Thesaurus Property)
C0521317 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)

HeartMUGATestDate

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C38073 (NCI Thesaurus Property)
C0521317 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)

HeartEchocardiogramTestInd-3

Item

Echocardiogram

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C37945 (NCI Thesaurus Property)
C2243117 (UMLS 2011AA Property)
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)

EchocardiogramDate

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C37945 (NCI Thesaurus ObjectClass)
C2243117 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)

HeartLVEFTestPercentageValue

Item

Resting ejection fraction

float

C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property-2)
C2700377 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

Survivorship

Item Group

Survivorship

DiabetesMellitusDiseasePresentInd-2

Item

Diabetes

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C2985 (NCI Thesaurus ObjectClass-2)
C0011849 (UMLS 2011AA ObjectClass-2)

ChronicDiseaseCoronaryArteryInd-3

Item

Coronary Artery Disease

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C14141 (NCI Thesaurus ObjectClass-2)
C0205191 (UMLS 2011AA ObjectClass-2)
C0205042 (NCI Metathesaurus Property)

PatientPriorMyocardialInfarctionInd-3

Item

Myocardial infarction

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C27996 (NCI Thesaurus Property)
C0027051 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)

PatientCerebrovascularAccidentHistoryInd-3

Item

Stroke

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3390 (NCI Thesaurus Property)
C0038454 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)

PersonPulmonaryEmbolismIndicator

Item

Pulmonary embolism

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C50713 (NCI Thesaurus Property)
C0034065 (UMLS 2011AA Property)

PersonDeepVeinThrombosisPersonalMedicalHistoryInd-2

Item

Deep vein thrombosis

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C49343 (NCI Thesaurus Property)
C0149871 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)

PersonOsteoporosisFracturePersonalMedicalHistoryInd-2

Item

Osteoporotic fracture

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C3298 (NCI Thesaurus Property)
C0029456 (UMLS 2011AA Property)
C3046 (NCI Thesaurus Property-2)
C0016658 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

Concomitant Medications

Item Group

Concomitant Medications

ConcomitantMedicationUseInd-3

Item

Concomitant medications

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)

Concomitant Medication

Item

Medication

text

C25704 (NCI Thesaurus ValueDomain)
C2347852 (UMLS CUI-1)
C459 (NCI Thesaurus ObjectClass)
C25639 (NCI Thesaurus Property)
C25730 (NCI Thesaurus ObjectClass-2)

ConcomitantMedicationAdministeredDose

Item

Dose

float

C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

Comments

Item Group

Footer

Research Comments

Item

Comments

text

C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)

Responsible Person Signature

Item

Signature of Person Completing This Form

text

C25704 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C25657 (NCI Thesaurus ObjectClass-2)
C25678 (NCI Thesaurus Property)

Form Completion Date

Item

Date Form Originally Completed

date

C19464 (NCI Thesaurus ObjectClass)
C1549507 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C25604 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

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Prostate Cancer NCT01546987 Pre-Study - RTOG 1115 I1: Phase III RT + Standard ADT vs RT + Enhanced ADT + TAK-700 Initial Evaluation Form - 3290738v1.0

INSTRUCTIONS: Submit this form at time of patient's entry on study. All dates to be reported mm-dd-yyyy unless otherwise indicated

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