ID

2645

Description

RTOG 0815 F0: Radiation Therapy Oncology Group Phase III Randomized Study of Dose- Escalated Radiotherapy With/Without STAD for Intermediate-Risk Prostate Cancer Initial Follow-up Form Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=655253E9-5F19-860D-E040-BB89AD434872

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=655253E9-5F19-860D-E040-BB89AD434872

Mots-clés

Téléchargé le

19 septembre 2012

DOI

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Creative Commons BY-NC 3.0 Legacy

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NCT00936390 Treatment - RTOG 0815 F0: Radiation Therapy Oncology Group Phase III Randomized Study of Dose- Escalated Radiotherapy With/Without STAD for Intermediate-Risk Prostate Cancer Initial Follow-up Form - 2850896v1.0

model
Détails

INSTRUCTIONS: Submit this form at the appropriate followup interval. Use -1 for unknown or not applicable unless otherwise specified in codetable. All dates to be reported mm-dd-yyyy unless otherwise indicated.

1 Formulaires

StudyEvent: RTOG 0815 F0: Radiation Therapy Oncology Group Phase III Randomized Study of Dose- Escalated Radiotherapy With/Without STAD for Intermediate-Risk Prostate Cancer Initial Follow-up Form
1. INSTRUCTIONS: Submit this form at the appropriate followup interval. Use -1 for unknown or not applicable unless otherwise specified in codetable. All dates to be reported mm-dd-yyyy unless otherwise indicated.

Name

Type

Description | Question | Decode (Coded Value)

Type de données

Alias

Unnamed1

Item Group

Unnamed2

ProtocolRTOGIdentifierNumber

Item

RTOG Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C19778 (NCI Thesaurus Property)
C1514695 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

RadiationTherapyOncologyGroupPatientCaseIdentifierNumber

Item

Case #

text

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

InstitutionName

Item

Institution Name

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

InstitutionIdentifierNumber

Item

Institution No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

PatientInitialsName

Item

Patient Initials

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)

PatientRadiationTherapyOncologyGroupIdentifierNumber

Item

RTOG Patient ID

text

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

Unnamed2

Item Group

Unnamed1

DataAmendedInd-3

Item

Amended Data

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)

CL.1

Code List

Amended Data

CL Item

Yes (yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

Unnamed3

Item Group

Unnamed 3

PatientVitalStatus

Item

Patient's Vital Status

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C18003 (NCI Thesaurus ValueDomain)
C0442732 (UMLS 2011AA ValueDomain)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25717 (NCI Thesaurus Property)
C1148433 (UMLS 2011AA Property)

CL.2

Code List

Patient's Vital Status

CL Item

Alive (Alive)

CL Item

Dead (Dead)

PatientLastContactDate

Item

Date of Last Contact or Death

date

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25461 (NCI Thesaurus Property)
C0337611 (UMLS 2011AA Property)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

PatientDeathPatientDeathPrimaryReason

Item

Primary Cause of Death

text

C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)
C25251 (NCI Thesaurus ValueDomain)
C0205225 (UMLS 2011AA ValueDomain)

CL.3

Code List

Primary Cause of Death

CL Item

Due To Other Cause (Due to other cause)

CL Item

Due To Protocol Treatment (Due to protocol treatment)

CL Item

Due To This Disease (Due to this disease)

CL Item

Not Applicable (Not applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PrimaryCauseDeathOtherReasonSpecify

Item

Due to other cause, specify

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C0007465 (NCI Metathesaurus ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

CancerFollow-upStatusInd-3

Item

Has the patient had a documented clinical assessment for this cancer (SINCE SUBMISSION OF THE PREVIOUS FOLLOW-UP FORM)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CL.4

Code List

Has the patient had a documented clinical assessment for this cancer (SINCE SUBMISSION OF THE PREVIOUS FOLLOW-UP FORM)

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)

AssessmentPerformedDate

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Item

Performance Status

text

C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain)
C1512162 (UMLS 2011AA ValueDomain)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)

CL.5

Code List

Performance Status

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)

CL Item

Dead (5)

Unnamed4

Item Group

Unnamed Module 6

ProstateGlandBiopsyPerformedStatus

Item

Has the patient had a prostate biopsy (SINCE SUBMISSION OF THE LAST FOLLOW-UP FORM)

text

C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.6

Code List

Has the patient had a prostate biopsy (SINCE SUBMISSION OF THE LAST FOLLOW-UP FORM)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes, Negative (Yes, negative)

CL Item

Yes, Positive (Yes, positive)

CL Item

Yes, Results Unknown (Yes, results unknown)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

BiopsyDate

Item

Biopsy Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)

PalpableTumorPresentIndicator

Item

Is the tumor palpable

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25606 (NCI Thesaurus ObjectClass)
C0522499 (UMLS 2011AA ObjectClass)

CL.7

Code List

Is the tumor palpable

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Equivocal (Equivocal)

C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)

CL Item

Not Evaluated (Not evaluated)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Unnamed5

Item Group

Unnamed Module 5

BiochemicalProgressionPresentInd-3

Item

Has the patient been diagnosed with biochemical recurrence since submission of the last follow-up form

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25331 (NCI Thesaurus ObjectClass)
C25434 (NCI Thesaurus ObjectClass)
C0205474 (UMLS 2011AA ObjectClass)

CL.8

Code List

Has the patient been diagnosed with biochemical recurrence since submission of the last follow-up form

CL Item

No (NO)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (YES)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CancerProgressionFirstLocalDiagnosisInd-3

Item

Has the patient been diagnosed with a first local recurrence (SINCE SUBMISSION OF LAST FOLLOW-UP FORM See Protocol Section 11)

text

C19987 (NCI Thesaurus ObjectClass)
C0242656 (UMLS 2011AA ObjectClass)
C67263 (NCI Thesaurus Property)
C0205276 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.9

Code List

Has the patient been diagnosed with a first local recurrence (SINCE SUBMISSION OF LAST FOLLOW-UP FORM See Protocol Section 11)

CL Item

No (NO)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (YES)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

LocalRecurrenceFirstDiagnosisDate

Item

Date

date

C3352 (NCI Thesaurus ObjectClass)
C0034897 (UMLS 2011AA ObjectClass)
C25388 (NCI Thesaurus ObjectClass)
C1947913 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

AssessmentMethodSpecify

Item

Other Specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)

AssessmentMethodSpecify

Item

Other Specify

text

CancerProgressionDistantFirstDistantDiagnosisInd

Item

Has the patient been diagnosed with first distant progression (SINCE SUBMISSION OF THE LAST FOLLOW-UP FORM)

text

C19987 (NCI Thesaurus ObjectClass)
C0242656 (UMLS 2011AA ObjectClass)
C25321 (NCI Thesaurus Property)
C0443203 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

CL.11

Code List

Has the patient been diagnosed with first distant progression (SINCE SUBMISSION OF THE LAST FOLLOW-UP FORM)

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)

DistantProgressionFirstDate

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus ValueDomain)
C1279901 (UMLS 2011AA ValueDomain)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)

ProgressionSiteText

Item

Sites of Progression (First distant)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25331 (NCI Thesaurus ObjectClass)

AssessmentMethodType

Item

Method of Evaluation (DISTANT PROGRESSION)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)

CL.12

Code List

Method of Evaluation (DISTANT PROGRESSION)

CL Item

Mri (MRI (NMR))

CL Item

Not Applicable (Not applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Pathologic (Pathologic)

C25610 (NCI Thesaurus)
C1521733 (UMLS 2011AA)

CL Item

Physical Exam (Physical exam)

CL Item

Radiographic (Radiographic)

AssessmentMethodType

Item

Method of Evaluation (DISTANT PROGRESSION)

text

CL.12

Code List

Method of Evaluation (DISTANT PROGRESSION)

CL Item

Mri (MRI (NMR))

CL Item

Not Applicable (Not applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Pathologic (Pathologic)

C25610 (NCI Thesaurus)
C1521733 (UMLS 2011AA)

CL Item

Physical Exam (Physical exam)

CL Item

Radiographic (Radiographic)

PROSTATE: PSA MEASUREMENTS

Item Group

Unnamed Module 4a

LaboratoryProcedureProstate-SpecificAntigenTumorMarkerResultDate

Item

PSA Date

date

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17220 (NCI Thesaurus Property)
C0041365 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

LaboratoryProcedureProstate-SpecificAntigenTumorMarkerResultValue

Item

PSA Value

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17220 (NCI Thesaurus Property)
C0041365 (UMLS 2011AA Property)
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.24

Code List

Units

CL Item

Nanograms Per Deciliter (ng/dL)

CL Item

Nanograms Per Milliliter (ng/mL)

CL Item

Nanomoles Per Liter (nmol/l)

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)
C0947322 (UMLS 2011AA Property)

CL.14

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)

Treatment Schedule (LHRH Agonist)

Item Group

Treatment Schedule (lhrh Agonist)

ProtocolHormoneTherapyPatientCurrentReceivedInd-3

Item

Is patient on protocol hormone (ORAL ANTIANDROGEN)

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.18

Code List

Is patient on protocol hormone (ORAL ANTIANDROGEN)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationName

Item

LHRH agonist

text

C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
C1910 (NCI Thesaurus Property)
C1518041 (UMLS 2011AA Property)

CL.16

Code List

LHRH agonist

CL Item

Eligard (Eligard)

CL Item

Lupron (Lupron)

C0701459 (NCI Metathesaurus)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Viadur (Viadur)

CL Item

Zoladex (Zoladex)

HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationSpecify

Item

Other, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C1910 (NCI Thesaurus Property)
C1518041 (UMLS 2011AA Property)

HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationBeginDate

Item

LHRH agonist start date (IF STARTED IN THIS FOLLOW-UP PERIOD)

date

C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C1910 (NCI Thesaurus Property)
C1518041 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)

HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationEndDate

Item

LHRH agonist end date (IF TERMINATED IN THIS FOLLOW-UP PERIOD)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C1910 (NCI Thesaurus Property)
C1518041 (UMLS 2011AA Property)

Off-treatmentReason

Item

Reason Treatment Ended

text

C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CL.20

Code List

Reason Treatment Ended

CL Item

Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)

CL Item

Alternative Therapy (Alternative therapy)

CL Item

Death On Study (Death on study)

CL Item

Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)

CL Item

Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)

CL Item

Patient Withdrawal Or Refusal Before Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)

CL Item

Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)

Off-treatmentAlternativeReasonSpecify

Item

Alternative Therapy, Specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25415 (NCI Thesaurus Property)
C1523987 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

Off-TreatmentConditionSpecify

Item

Patient off-treatment for other complicating disease, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25457 (NCI Thesaurus Property)
C0348080 (UMLS 2011AA Property)

Off-treatmentReasonSpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CumulativeAgentTotalDose

Item

Total Dose (TO DATE)

double

C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25470 (NCI Thesaurus ObjectClass)
C1511559 (UMLS 2011AA ObjectClass)
C25304 (NCI Thesaurus Property)
C0439810 (UMLS 2011AA Property)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)

TREATMENT SCHEDULE (ORAL ANTIANDROGEN)

Item Group

Treatment Schedule (oral Antiandrogen)

ProtocolHormoneTherapyPatientCurrentReceivedInd-3

Item

Is patient on protocol hormone (ORAL ANTIANDROGEN)

text

CL.18

Code List

Is patient on protocol hormone (ORAL ANTIANDROGEN)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

OralAntiandrogenTherapyAgentAdministeredName

Item

Oral antiandrogen taken

text

C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25311 (NCI Thesaurus ObjectClass)
C0442027 (UMLS 2011AA ObjectClass)
C15481 (NCI Thesaurus ObjectClass)
C0279492 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)

CL.19

Code List

Oral antiandrogen taken

CL Item

Casodex (Casodex)

C0591237 (NCI Metathesaurus)

CL Item

Eulexin (Eulexin)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

OralAntiandrogenTherapyAgentAdministeredSpecify

Item

Other, specify

text

C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25311 (NCI Thesaurus ObjectClass)
C0442027 (UMLS 2011AA ObjectClass)
C15481 (NCI Thesaurus ObjectClass)
C0279492 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

OralAntiandrogenTherapyAgentAdministeredBeginDate

Item

Oral Antiandrogen Start Date (IF STARTED IN THIS FOLLOW-UP PERIOD)

date

C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25311 (NCI Thesaurus ObjectClass)
C0442027 (UMLS 2011AA ObjectClass)
C15481 (NCI Thesaurus ObjectClass)
C0279492 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)

OralAntiandrogenTherapyAgentAdministeredEndDate

Item

Oral Antiandrogen End Date (IF TERMINATED IN THIS FOLLOW-UP PERIOD)

date

C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25311 (NCI Thesaurus ObjectClass)
C0442027 (UMLS 2011AA ObjectClass)
C15481 (NCI Thesaurus ObjectClass)
C0279492 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

Off-treatmentReason

Item

Reason Treatment Ended

text

CL.20

Code List

Reason Treatment Ended

CL Item

Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)

CL Item

Alternative Therapy (Alternative therapy)

CL Item

Death On Study (Death on study)

CL Item

Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)

CL Item

Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)

CL Item

Patient Withdrawal Or Refusal Before Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)

CL Item

Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)

Off-treatmentAlternativeReasonSpecify

Item

Alternative Therapy, Specify

text

Off-TreatmentConditionSpecify

Item

Patient off-treatment for other complicating disease, specify

text

Off-treatmentReasonSpecify

Item

Other specify

text

CumulativeAgentTotalDose

Item

Total Dose (TO DATE)

double

Lab Values

Item Group

Lab Values

LaboratoryProcedureResultStatus

Item

Lab Values (Month 3)

text

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.31

Code List

Lab Values (Month 3)

CL Item

Abnormal (Abnormal)

C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)
C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)

CL Item

Normal (Normal)

C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)

CL Item

Not Done (Not done)

CL281691 (NCI Metathesaurus)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

LaboratoryProcedureTestosteroneResultSpecifiedValue

Item

Testosterone

double

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

TestosteroneAssessmentDate

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C2299 (NCI Thesaurus ObjectClass)
C0039601 (UMLS 2011AA ObjectClass)

AssessmentLabUOM

Item

Units

text

CL.24

Code List

Units

CL Item

Nanograms Per Deciliter (ng/dL)

CL Item

Nanograms Per Milliliter (ng/mL)

CL Item

Nanomoles Per Liter (nmol/l)

CL Item

Not Otherwise Specified (NOS)

CL006269 (NCI Metathesaurus)

LaboratoryProcedureTestosteroneResultLowerLimitofNormalValue

Item

Testosterone Lower Limit Normal

double

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

LaboratoryProcedureTestosteroneResultUpperLimitofNormalValue

Item

Testosterone Upper Limit Normal

text

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

Lab Values

Item Group

Lab Values

LaboratoryProcedureResultStatus

Item

Lab Values (Month 3)

text

CL.31

Code List

Lab Values (Month 3)

CL Item

Abnormal (Abnormal)

C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)
C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)

CL Item

Normal (Normal)

C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)

CL Item

Not Done (Not done)

CL281691 (NCI Metathesaurus)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

LaboratoryProcedureTestosteroneResultSpecifiedValue

Item

Testosterone

double

TestosteroneAssessmentDate

Item

Date

date

AssessmentLabUOM

Item

Units

text

CL.24

Code List

Units

CL Item

Nanograms Per Deciliter (ng/dL)

CL Item

Nanograms Per Milliliter (ng/mL)

CL Item

Nanomoles Per Liter (nmol/l)

CL Item

Not Otherwise Specified (NOS)

CL006269 (NCI Metathesaurus)

LaboratoryProcedureTestosteroneResultLowerLimitofNormalValue

Item

Testosterone Lower Limit Normal

double

LaboratoryProcedureTestosteroneResultUpperLimitofNormalValue

Item

Testosterone Upper Limit Normal

text

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

CBC/diff

Item Group

Baseline Lab Values (hematologic)

LaboratoryProcedureResultStatus

Item

Lab Values (Month 3)

text

CL.31

Code List

Lab Values (Month 3)

CL Item

Abnormal (Abnormal)

C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)
C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)

CL Item

Normal (Normal)

C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)

CL Item

Not Done (Not done)

CL281691 (NCI Metathesaurus)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

LaboratoryProcedureLeukocyteResultUnspecifiedValue

Item

WBC (mm^3)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12529 (NCI Thesaurus Property)
C0023516 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureHemoglobinResultSpecifiedValue

Item

Hemoglobin (g/dL)

double

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

LaboratoryProcedurePlateletResultSpecifiedValue

Item

Peripheral Platelet Count (x 10^3 U/L)

double

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

LaboratoryProcedureNeutrophilResultTotalValue

Item

ANC (mm^3)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12533 (NCI Thesaurus Property)
C0027950 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureEvaluationPerformedDate

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

SGPT (ALT) or SGOT (AST)

Item Group

Baseline Lab Values (hematologic)

LaboratoryProcedureResultStatus

Item

Lab Values (Month 3)

text

CL.31

Code List

Lab Values (Month 3)

CL Item

Abnormal (Abnormal)

C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)
C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)

CL Item

Normal (Normal)

C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)

CL Item

Not Done (Not done)

CL281691 (NCI Metathesaurus)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

LaboratoryProcedureResultStatus

Item

Lab Values (Month 3)

text

CL.31

Code List

Lab Values (Month 3)

CL Item

Abnormal (Abnormal)

C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)
C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)

CL Item

Normal (Normal)

C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)

CL Item

Not Done (Not done)

CL281691 (NCI Metathesaurus)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

LaboratoryProcedureResultStatus

Item

Lab Values (Month 3)

text

CL.31

Code List

Lab Values (Month 3)

CL Item

Abnormal (Abnormal)

C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)
C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)

CL Item

Normal (Normal)

C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)

CL Item

Not Done (Not done)

CL281691 (NCI Metathesaurus)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

LaboratoryTestName

Item

Test (Month 3)

text

C38470 (NCI Thesaurus ObjectClass)
C25294 (NCI Thesaurus ValueDomain)
C0022885 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus Property)
C0027365 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)

LaboratoryTestName

Item

Test (Month 3)

text

LaboratoryTestName

Item

Test (Month 3)

text

LabTestLabsStandardValue

Item

Value

double

C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LabTestLabsStandardValue

Item

Value

double

C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LabTestLabsStandardValue

Item

Value

double

C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureEvaluationPerformedDate

Item

Date

date

LaboratoryProcedureEvaluationPerformedDate

Item

Date

date

LaboratoryProcedureEvaluationPerformedDate

Item

Date

date

Alkaline Phosphatase

Item Group

Baseline Lab Values (hematologic)

LaboratoryProcedureResultStatus

Item

Lab Values (Month 3)

text

CL.31

Code List

Lab Values (Month 3)

CL Item

Abnormal (Abnormal)

C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)
C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)

CL Item

Normal (Normal)

C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)

CL Item

Not Done (Not done)

CL281691 (NCI Metathesaurus)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

LaboratoryProcedureResultStatus

Item

Lab Values (Month 3)

text

CL.31

Code List

Lab Values (Month 3)

CL Item

Abnormal (Abnormal)

C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)
C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)

CL Item

Normal (Normal)

C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)

CL Item

Not Done (Not done)

CL281691 (NCI Metathesaurus)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

LaboratoryProcedureResultStatus

Item

Lab Values (Month 3)

text

CL.31

Code List

Lab Values (Month 3)

CL Item

Abnormal (Abnormal)

C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)
C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)

CL Item

Normal (Normal)

C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)

CL Item

Not Done (Not done)

CL281691 (NCI Metathesaurus)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

LabTestLabsStandardValue

Item

Value

double

C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LabTestLabsStandardValue

Item

Value

double

C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LabTestLabsStandardValue

Item

Value

double

C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureEvaluationPerformedDate

Item

Date

date

LaboratoryProcedureEvaluationPerformedDate

Item

Date

date

LaboratoryProcedureEvaluationPerformedDate

Item

Date

date

Unnamed6

Item Group

Non-protocol Therapy

Non-protocolTherapyAdministeredInd-3

Item

Is the patient receiving any non-protocol cancer therapy not previously reported (PROSTATE If yes, enter therapy type and date for each therapy delivered during the follow-up period.)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.32

Code List

Is the patient receiving any non-protocol cancer therapy not previously reported (PROSTATE If yes, enter therapy type and date for each therapy delivered during the follow-up period.)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

Non-ProtocolTherapyAdministeredType

Item

Non-Protocol Therapy Type

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.33

Code List

Non-Protocol Therapy Type

CL Item

Chemotherapy (Chemotherapy)

C15632 (NCI Thesaurus)
C0392920 (UMLS 2011AA)

CL Item

Hormones (Hormones)

CL Item

Other Specify (Other, specify)

CL Item

Radiation To Other Sites, Specify (Radiation to other sites, specify)

CL Item

Radiation To Pelvis (Radiation to pelvis)

CL Item

Surgery (Surgery)

C17173 (NCI Thesaurus)
C0038894 (UMLS 2011AA)

CL Item

None (None)

C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)

Non-ProtocolTherapyFirstAdministeredDate

Item

Date of First Non-Protocol Therapy

date

C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

Non-ProtocolTreatmentFirstAdministeredSpecify

Item

Specify

text

C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

Unnamed7

Item Group

Unnamed Module 7

NewCancerDiagnosisInd

Item

Has a new primary cancer or MDS been diagnosed that has not been previously reported

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)

CL.34

Code List

Has a new primary cancer or MDS been diagnosed that has not been previously reported

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

SecondTumorSite

Item

Second Primary Tumor Site

text

C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25666 (NCI Thesaurus ObjectClass)
C0205436 (UMLS 2011AA ObjectClass)

CL.35

Code List

Second Primary Tumor 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

Other Hematologic (Other hematologic)

CL Item

Other Solid (Other solid)

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

Unknown Primary (Unknown primary)

SecondPrimaryNeoplasmDiagnosisDate

Item

Second Primary Cancer Date

date

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C25666 (NCI Thesaurus ObjectClass)
C0205436 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

PrimaryDiseaseSiteSpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)

Adverse Events

Item Group

Protocol Specific Adverse Event Evaluation

TreatmentRelatedAdverseEventReportInd-3

Item

Any Treatment Related Adverse Events

text

C25648 (NCI Thesaurus ObjectClass)
C0439849 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C0684224 (NCI Metathesaurus Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.36

Code List

Any Treatment Related Adverse Events

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

MedDRACode

Item

MedDRA disease code

double

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)

CommonToxicityCriteriaAdverseEventShortNameType

Item

CTC Adverse Event Term

text

C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C0332307 (NCI Metathesaurus ValueDomain)
C25249 (NCI Thesaurus Property)
C1806781 (UMLS 2011AA Property)

CL.37

Code List

CTC Adverse Event Term

CL Item

Retinoic Acid Syndrome ("Retinoic acid syndrome")

CL Item

Acidosis Nos (Acidosis)

C0001122 (NCI Metathesaurus)

CL Item

Rash: Acne/acneiform (Acne)

CL Item

Neuroendocrine: Acth Deficiency (ACTH)

CL Item

Capillary Leak Syndrome (Acute vascular leak syndrome)

C0343084 (NCI Metathesaurus)

CL Item

Inappropriate Adh Secretion (ADH)

CL Item

Adrenal Insufficiency (Adrenal insufficiency)

CL Item

Obstruction/stenosis Of Airway (Airway obstruction - Select)

CL Item

Alcohol Intolerance Syndrome (antabuse-like Syndrome) (Alcohol intolerance syndrome)

CL Item

Blood Alkaline Phosphatase Nos Increased (Alkaline phosphatase)

CL Item

Alkalosis Nos (Alkalosis)

C0002063 (NCI Metathesaurus)

CL Item

Hypersensitivity Nos (Allergic reaction)

CL Item

Allergy/immunology Other (Allergy-Other (Specify))

CL Item

Alopecia (Alopecia)

C2865 (NCI Thesaurus)

CL Item

Alanine Aminotransferase Increased (ALT)

C26948 (NCI Thesaurus)
C0151905 (UMLS 2011AA)

CL Item

Blood Amylase Increased (Amylase)

CL038581 (NCI Metathesaurus)

CL Item

Anorexia (Anorexia)

C2875 (NCI Thesaurus)
C0003123 (UMLS 2011AA)

CL Item

Apnoea (Apnea)

CL Item

Arachnoiditis (Arachnoiditis)

C37913 (NCI Thesaurus)
C0003708 (UMLS 2011AA)

CL Item

Adult Respiratory Distress Syndrome (ARDS)

C3353 (NCI Thesaurus)
C0035222 (UMLS 2011AA)

CL Item

Vessel Injury-artery (Artery injury - Select)

CL Item

Arthritis Nos (Arthritis)

CL Item

Ascites (Ascites)

C2885 (NCI Thesaurus)
C0003962 (UMLS 2011AA)

CL Item

Aspiration (Aspiration)

CL Item

Aspartate Aminotransferase Increased (AST)

C26947 (NCI Thesaurus)
C0151904 (UMLS 2011AA)

CL Item

Ataxia Nec (Ataxia)

CL Item

Atelectasis (Atelectasis)

CL Item

Atrophy, Skin (Atrophy, skin)

CL Item

Atrophy, Subcutaneous Fat (Atrophy, subcutaneous fat)

CL Item

Auditory/ear Other (Auditory/Ear-Other (Specify))

CL Item

Autoimmune Disorder Nos (Autoimmune reaction)

CL Item

Blood Bicarbonate Decreased (Bicarbonate, serum-low)

CL038577 (NCI Metathesaurus)

CL Item

Blood Bilirubin Increased (Bilirubin)

CL039714 (NCI Metathesaurus)

CL Item

Bladder Disorder Nos (Bladder spasms)

CL Item

Blood/bone Marrow Other (Blood-Other (Specify))

CL Item

Vision Blurred (Blurred vision)

CL Item

Bone Age (alteration In Bone Age) (Bone age)

CL Item

Bone Marrow Depression Nos (Bone marrow cellularity)

CL Item

Brachial Plexopathy (Brachial plexopathy)

CL Item

Breast Volume/hypoplasia (Breast)

CL Item

Breast Function/lactation (Breast function)

CL Item

Bronchospasm, Wheezing (Bronchospasm)

CL Item

Ecchymosis (Bruising)

C26758 (NCI Thesaurus)
C0013491 (UMLS 2011AA)

CL Item

Burn (Burn)

CL Item

Arrhythmia Nos (Cardiac Arrhythmia-Other (Specify))

CL Item

Cardiac General Other (Cardiac General-Other (Specify))

CL Item

Myocardial Ischaemia (Cardiac ischemia/infarction)

C0151744 (NCI Metathesaurus)

CL Item

Cardiopulmonary Arrest, Cause Unknown (non-fatal) (Cardiopulmonary arrest)

CL Item

Cataract Nec (Cataract)

CL Item

Cd4 Lymphocytes Decreased (CD4 count)

CL038783 (NCI Metathesaurus)

CL Item

Cervical Spine-range Of Motion (Cervical spine ROM)

CL Item

Cheilitis (Cheilitis)

CL Item

Prolonged Chest Tube Drainage Or Air Leak After Pulmonary Resection (Chest tube drainage or leak)

CL Item

Cholecystitis (Cholecystitis)

CL Item

Hypercholesterolaemia (Cholesterol)

C0020443 (NCI Metathesaurus)

CL Item

Chyle Or Lymph Leakage (Chyle or lymph leakage)

CL Item

Chylothorax (Chylothorax)

CL Item

Haemorrhagic Stroke (CNS Hemorrhage)

CL036983 (NCI Metathesaurus)

CL Item

Cerebral Ischaemia (CNS ischemia)

C0917798 (NCI Metathesaurus)

CL Item

Cns Necrosis/cystic Progression (CNS necrosis)

CL Item

Coagulation Disorder Nos (Coagulation-Other (Specify))

CL Item

Learning Disorder Nos (Cognitive disturbance)

C0023186 (NCI Metathesaurus)

CL Item

Colitis Nos (Colitis)

CL Item

Colitis, Infectious (e.g., Clostridium Difficile) (Colitis, infectious)

CL Item

Conduction Abnormality/atrioventricular Heart Block (Conduction abnormality - Select)

CL Item

Confusion (Confusion)

C37928 (NCI Thesaurus)
C0009676 (UMLS 2011AA)

CL Item

Constipation (Constipation)

C37930 (NCI Thesaurus)
C0009806 (UMLS 2011AA)

CL Item

Constitutional Symptoms Other (Constitutional Symptoms-Other (Specify))

CL Item

Cough (Cough)

C37935 (NCI Thesaurus)
C0010200 (UMLS 2011AA)

CL Item

Blood Creatine Phosphokinase Increased (CPK)

CL038686 (NCI Metathesaurus)

CL Item

Blood Creatinine Increased (Creatinine)

C0235431 (NCI Metathesaurus)

CL Item

Leak, Cerebrospinal Fluid (csf) (CSF leak)

CL Item

Cardiac Troponin I Increased (cTnI)

CL038402 (NCI Metathesaurus)

CL Item

Cardiac Troponin T Increased (cTnT)

CL038393 (NCI Metathesaurus)

CL Item

Cushingoid (Cushingoid)

C37938 (NCI Thesaurus)
C0878661 (UMLS 2011AA)

CL Item

Cystitis (Cystitis)

CL Item

Cytokine Release Syndrome/acute Infusion Reaction (Cytokine release syndrome)

CL Item

Death Not Associated With Ctcae Term (Death not associated with CTCAE term - Select)

CL Item

Skin Breakdown/decubitus Ulcer (Decubitus)

CL Item

Dehydration (Dehydration)

C26740 (NCI Thesaurus)
C0011175 (UMLS 2011AA)

CL Item

Puberty (delayed) (Delayed puberty)

CL Item

Dental: Dentures Or Prosthesis (Dentures)

CL Item

Dermal Change Lymphedema, Phlebolymphedema (Dermal change)

CL Item

Dermatitis (Dermatitis - Select)

CL Item

Dermatology/skin Other (Dermatology-Other (Specify))

CL Item

Local Complication - Device/prosthesis-related (Device/prosthesis)

CL Item

Pancreatic Endocrine: Glucose Intolerance (Diabetes)

CL Item

Diarrhoea Nos (Diarrhea)

CL Item

Disseminated Intravascular Coagulation (DIC)

C2992 (NCI Thesaurus)
C0012739 (UMLS 2011AA)

CL Item

Diplopia (Diplopia)

C37941 (NCI Thesaurus)
C0012569 (UMLS 2011AA)

CL Item

Distention/bloating, Abdominal (Distention)

CL Item

Dizziness (exc Vertigo) (Dizziness)

CL Item

Pulmonary Function Test Nos Decreased (DL(co))

CL040958 (NCI Metathesaurus)

CL Item

Dry Eye Nec (Dry eye)

CL Item

Dry Mouth (Dry mouth)

CL Item

Dry Skin (Dry skin)

C0151908 (NCI Metathesaurus)

CL Item

Dysphagia (Dysphagia)

C2980 (NCI Thesaurus)
C0011168 (UMLS 2011AA)

CL Item

Dyspnoea Nos (Dyspnea)

CL Item

Edema, Larynx (Edema, larynx)

CL Item

Edema: Head And Neck (Edema: head and neck)

CL Item

Oedema Nos (Edema: limb)

CL Item

Edema: Trunk/genital (Edema: trunk/genital)

CL Item

Edema: Viscera (Edema: viscera)

CL Item

Ejaculatory Dysfunction (Ejaculatory dysfunction)

CL Item

Encephalopathy (Encephalopathy)

CL Item

Endocrine Other (Endocrine-Other (Specify))

CL Item

Enteritis (inflammation Of The Small Bowel) (Enteritis)

CL Item

Impotence (Erectile dysfunction)

C3133 (NCI Thesaurus)
C0242350 (UMLS 2011AA)

CL Item

Erythema Multiforme (Erythema multiforme)

C3024 (NCI Thesaurus)
C0014742 (UMLS 2011AA)

CL Item

Oesophagitis Nos (Esophagitis)

CL Item

Exostosis (Exostosis)

CL Item

Extremity-upper (function) (Extremity-upper (function))

CL Item

Eyelid Dysfunction (Eyelid dysfunction)

CL Item

Fatigue (Fatigue)

C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)

CL Item

Febrile Neutropenia (fever Of Unknown Origin Without Clinically Or Microbiologically Documented Infection) (anc <1.0 X 10^9/l, Fever >=38.5 Degrees C) (Febrile neutropenia)

CL Item

Feminization (Feminization of male)

C26773 (NCI Thesaurus)
C0015799 (UMLS 2011AA)

CL Item

Bone Growth: Femoral Head; Slipped Capital Femoral Epiphysis (Femoral head growth)

CL Item

Forced Expiratory Volume Decreased (FEV(1))

CL036765 (NCI Metathesaurus)

CL Item

Pyrexia (Fever)

CL Item

Blood Fibrinogen Decreased (Fibrinogen)

CL039651 (NCI Metathesaurus)

CL Item

Fibrosis-cosmesis (Fibrosis-cosmesis)

CL Item

Fibrosis-deep Connective Tissue (Fibrosis-deep connective tissue)

CL Item

Fistula, Gi (Fistula, GI - Select)

CL Item

Fistula, Gu (Fistula, GU - Select)

CL Item

Fistula, Pulmonary/upper Respiratory (Fistula, pulmonary - Select)

CL Item

Photopsia (Flashing lights)

C0085635 (NCI Metathesaurus)

CL Item

Flatulence (Flatulence)

CL Item

Flu-like Syndrome (Flu-like syndrome)

CL Item

Flushing (Flushing)

C26775 (NCI Thesaurus)
C0016382 (UMLS 2011AA)

CL Item

Fracture (Fracture)

CL Item

Extremity-lower (gait/walking) (Gait/walking)

CL Item

Gastritis Nos (Gastritis)

CL Item

Glomerular Filtration Rate (GFR)

CL Item

Gamma-glutamyltransferase Increased (GGT)

C26943 (NCI Thesaurus)
C0151662 (UMLS 2011AA)

CL Item

Gastrointestinal Other (GI-Other (Specify))

CL Item

Glaucoma Nos (Glaucoma)

CL Item

Neuroendocrine: Gonadotropin Secretion Abnormality (Gonadotropin)

CL Item

Growth And Development Other (Growth and Development-Other (Specify))

CL Item

Neuroendocrine: Growth Hormone Secretion Abnormality (Growth hormone)

CL Item

Gynaecomastia (Gynecomastia)

CL Item

Localised Exfoliation (Hand-foot)

CL Item

Haptoglobin Decreased (Haptoglobin)

C0236062 (NCI Metathesaurus)

CL Item

Hearing: Patients With/without Baseline Audiogram And Enrolled In A Monitoring Program (Hearing (monitoring program))

CL Item

Hearing: Patients Without Baseline Audiogram And Not Enrolled In A Monitoring Program (Hearing (without monitoring program))

CL Item

Dyspepsia (Heartburn)

C26756 (NCI Thesaurus)
C0013395 (UMLS 2011AA)

CL Item

Hematoma (Hematoma)

CL Item

Haemoglobin Decreased (Hemoglobin)

C0162119 (NCI Metathesaurus)

CL Item

Haemoglobinuria Present (Hemoglobinuria)

CL Item

Hemolysis Nos (Hemolysis)

C0019054 (NCI Metathesaurus)

CL Item

Hemorrhage, Pulmonary/upper Respiratory (Hemorrhage pulmonary - Select)

CL Item

Post-operative Haemorrhage (Hemorrhage with surgery)

CL Item

Hemorrhage, Gi (Hemorrhage, GI - Select)

CL Item

Hemorrhage, Gu (Hemorrhage, GU - Select)

CL Item

Hemorrhage/bleeding Other (Hemorrhage-Other (Specify))

CL Item

Hemorrhoids (Hemorrhoids)

CL Item

Hepatobiliary/pancreas Other (Hepatobiliary-Other (Specify))

CL Item

Hiccups (Hiccoughs)

C0019521 (NCI Metathesaurus)

CL Item

Menopausal Symptoms (Hot flashes)

CL Item

Hydrocephalus (Hydrocephalus)

CL Item

Hypercalcaemia (Hypercalcemia)

CL Item

Hyperglycaemia Nos (Hyperglycemia)

CL Item

Hyperkalaemia (Hyperkalemia)

C0020461 (NCI Metathesaurus)

CL Item

Hypermagnesaemia (Hypermagnesemia)

C0151714 (NCI Metathesaurus)

CL Item

Hypernatraemia (Hypernatremia)

C0020488 (NCI Metathesaurus)

CL Item

Skin Discolouration (Hyperpigmentation)

CL Item

Hypertension Nos (Hypertension)

CL Item

Thyroid Function, High (hyperthyroidism, Thyrotoxicosis) (Hyperthyroidism)

CL Item

Hypertriglyceridaemia (Hypertriglyceridemia)

C0020557 (NCI Metathesaurus)

CL Item

Hyperuricaemia (Hyperuricemia)

C0740394 (NCI Metathesaurus)

CL Item

Blood Albumin Decreased (Hypoalbuminemia)

CL039392 (NCI Metathesaurus)

CL Item

Hypocalcaemia (Hypocalcemia)

CL Item

Hypoglycaemia Nos (Hypoglycemia)

CL Item

Hypokalaemia (Hypokalemia)

CL Item

Blood Magnesium Decreased (Hypomagnesemia)

CL Item

Hyponatraemia (Hyponatremia)

CL Item

Parathyroid Function, Low (hypoparathyroidism) (Hypoparathyroidism)

CL Item

Hypophosphataemia (Hypophosphatemia)

CL Item

Hypopigmentation (Hypopigmentation)

CL Item

Hypotension Nos (Hypotension)

CL Item

Hypothermia (Hypothermia)

CL Item

Hypothyroidism (Hypothyroidism)

C26800 (NCI Thesaurus)
C0020676 (UMLS 2011AA)

CL Item

Hypoxia (Hypoxia)

C3890 (NCI Thesaurus)
C0242184 (UMLS 2011AA)

CL Item

Ileus (Ileus)

CL Item

Urinary Incontinence (Incontinence)

C3429 (NCI Thesaurus)
C0021167 (UMLS 2011AA)

CL Item

Incontinence, Anal (Incontinence, anal)

CL Item

Induration/fibrosis (skin And Subcutaneous Tissue) (Induration)

CL Item

Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically) - Select)

CL Item

Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC - Select)

CL Item

Infection With Unknown Anc (Infection with unknown ANC - Select)

CL Item

Infection Nos (Infection-Other (Specify))

CL Item

Infertility/sterility (Infertility/sterility)

CL Item

Injection Site Reaction Nos (Injection site reaction)

CL Item

Prothrombin Time Prolonged (INR)

CL Item

Insomnia Nec (Insomnia)

CL Item

Intra-operative Injury (Intraop injury - Select)

CL Item

Intra-operative Injury Other (Intraop Injury-Other (Specify))

CL Item

Extrapyramidal Disorder Nec (Involuntary movement)

CL Item

Iron Overload (Iron overload)

CL Item

Menstruation Irregular (Irregular menses)

CL Item

Irritability (Irritability)

CL Item

Joint-effusion (Joint-effusion)

CL Item

Joint-function (Joint-function)

CL Item

Keratitis Nec (Keratitis)

CL Item

Bone Growth: Spine Kyphosis/lordosis (Kyphosis/lordosis)

CL Item

Laryngeal Nerve Dysfunction (Laryngeal nerve)

CL Item

Leak (including Anastomotic), Gi (Leak, GI - Select)

CL Item

Leak (including Anastomotic), Gu (Leak, GU - Select)

CL Item

Left Ventricular Diastolic Dysfunction (Left ventricular diastolic dysfunction)

CL Item

Left Ventricular Failure (Left ventricular systolic dysfunction)

C0023212 (NCI Metathesaurus)

CL Item

Leucopenia Nos (Leukocytes)

CL Item

Encephalopathy Nos (Leukoencephalopathy)

CL Item

Libido Decreased (Libido)

C0011124 (NCI Metathesaurus)

CL Item

Bone Growth: Limb Length Discrepancy (Limb length)

CL Item

Lipase Increased (Lipase)

CL Item

Hepatic Failure (Liver dysfunction)

C26922 (NCI Thesaurus)
C0085605 (UMLS 2011AA)

CL Item

Lumbar Spine-range Of Motion (Lumbar spine ROM)

CL Item

Lymphatics Other (Lymphatics-Other (Specify))

CL Item

Lymphedema-related Fibrosis (Lymphedema-related fibrosis)

CL Item

Lymphocele (Lymphocele)

C0024248 (NCI Metathesaurus)

CL Item

Lymphopenia (Lymphopenia)

C26823 (NCI Thesaurus)
C0024312 (UMLS 2011AA)

CL Item

Malabsorption (Malabsorption)

CL Item

Virilism (Masculinization of female)

C26914 (NCI Thesaurus)

CL Item

Amnesia Nec (Memory impairment)

CL Item

Mental Status (Mental status)

C0278060 (NCI Metathesaurus)

CL Item

Metabolic/laboratory Other (Metabolic-Other (Specify))

CL Item

Mood Alteration (Mood alteration - Select)

CL Item

Mucositis/stomatitis (clinical Exam) (Mucositis (clinical exam) - Select)

CL Item

Mucositis/stomatitis (functional/symptomatic) (Mucositis (functional/symptomatic) - Select)

CL Item

Muscle Weakness, Generalized Or Specific Area (not Due To Neuropathy) (Muscle weakness - Select)

CL Item

Muscular/skeletal Hypoplasia (Muscular/skeletal hypoplasia)

CL Item

Musculoskeletal/soft Tissue Other (Musculoskeletal-Other (Specify))

CL Item

Myelitis (Myelitis)

C26832 (NCI Thesaurus)
C0026975 (UMLS 2011AA)

CL Item

Myelodysplasia (Myelodysplasia)

CL Item

Myocarditis Nos (Myocarditis)

CL Item

Myositis (Myositis)

C27578 (NCI Thesaurus)
C0027121 (UMLS 2011AA)

CL Item

Nail Abnormality Nos (Nail changes)

CL038732 (NCI Metathesaurus)

CL Item

Nasal Cavity/paranasal Sinus Reactions (Nasal/paranasal reactions)

CL Item

Nausea (Nausea)

CL Item

Necrosis, Gi (Necrosis, GI - Select)

CL Item

Neurology Other (Neurology-Other (Specify))

CL Item

Peripheral Motor Neuropathy (Neuropathy-motor)

CL Item

Peripheral Sensory Neuropathy (Neuropathy-sensory)

CL Item

Neuropathy: Cranial (Neuropathy: cranial - Select)

CL Item

Neutropenia (Neutrophils)

C3277 (NCI Thesaurus)

CL Item

Breast Nipple/areolar Deformity (Nipple/areolar)

CL Item

Blindness Night (Nyctalopia)

CL Item

Nystagmus Nos (Nystagmus)

CL Item

Obesity (Obesity)

C3283 (NCI Thesaurus)
C0028754 (UMLS 2011AA)

CL Item

Obstruction, Gi (Obstruction, GI - Select)

CL Item

Obstruction, Gu (Obstruction, GU - Select)

CL Item

Conjunctivitis Nec (Ocular surface disease)

CL Item

Ocular/visual Other (Ocular-Other (Specify))

CL Item

Opportunistic Infection Associated With >=grade 2 Lymphopenia (Opportunistic infection)

CL Item

Optic Disc Edema (Optic disc edema)

CL Item

Orgasmic Dysfunction (Orgasmic dysfunction)

CL Item

Osteonecrosis (Osteonecrosis)

CL Item

Osteoporosis (Osteoporosis)

C3298 (NCI Thesaurus)
C0029456 (UMLS 2011AA)

CL Item

Otitis Externa (exc Boil Of Meatus) Nos (Otitis, external)

CL Item

Otitis Media Serous Nos (Otitis, middle)

C0271453 (NCI Metathesaurus)

CL Item

Pain (Pain - Select)

CL Item

Pain Other (Pain-Other (Specify))

CL Item

Palpitations (Palpitations)

C0030252 (NCI Metathesaurus)

CL Item

Pancreas, Exocrine Enzyme Deficiency (Pancreas, exocrine enzyme deficiency)

CL Item

Pancreatitis Nos (Pancreatitis)

CL Item

Odor (patient Odor) (Patient odor)

CL Item

Perforation, Gi (Perforation, GI - Select)

CL Item

Perforation, Gu (Perforation, GU - Select)

CL Item

Pericardial Effusion (Pericardial effusion)

C3319 (NCI Thesaurus)
C0031039 (UMLS 2011AA)

CL Item

Pericarditis (Pericarditis)

CL Item

Dental: Periodontal Disease (Periodontal)

CL Item

Peripheral Ischaemia Nos (Peripheral arterial ischemia)

CL Item

Personality Change (Personality)

CL Item

Petechiae (Petechiae)

CL Item

Phlebitis Superficial (Phlebitis)

C0750876 (NCI Metathesaurus)

CL Item

Phlebolymphatic Cording (Phlebolymphatic cording)

CL Item

Photophobia (Photophobia)

C28210 (NCI Thesaurus)
C0085636 (UMLS 2011AA)

CL Item

Photosensitivity Reaction Nos (Photosensitivity)

CL Item

Phrenic Nerve Dysfunction (Phrenic nerve)

CL Item

Platelet Count Decreased (Platelets)

C0392386 (NCI Metathesaurus)

CL Item

Pleural Effusion (Pleural effusion)

C3331 (NCI Thesaurus)
C0021071 (UMLS 2011AA)

CL Item

Pneumonitis Nos (Pneumonitis)

CL Item

Pneumothorax Nos (Pneumothorax)

C0032326 (NCI Metathesaurus)

CL Item

Portal Hypertension (Portal flow)

C3119 (NCI Thesaurus)
C0020541 (UMLS 2011AA)

CL Item

Puberty (precocious) (Precocious puberty)

CL Item

Proctitis Nos (Proctitis)

CL Item

Neuroendocrine: Prolactin Hormone Secretion Abnormality (Prolactin)

CL Item

Prolapse Of Stoma, Gi (Prolapse of stoma, GI)

CL Item

Prolapse Of Stoma, Gu (Prolapse of stoma, GU)

CL Item

Prolonged Intubation After Pulmonary Resection (>24 Hrs After Surgery) (Prolonged intubation)

CL Item

Electrocardiogram Qt Prolonged (Prolonged QTc)

C0151878 (NCI Metathesaurus)

CL Item

Proptosis/enophthalmos (Proptosis/enophthalmos)

CL Item

Proteinuria Present (Proteinuria)

CL Item

Pruritus Nos (Pruritus)

CL Item

Delusion Nos (Psychosis)

CL Item

Activated Partial Thromboplastin Time Prolonged (PTT)

CL038857 (NCI Metathesaurus)

CL Item

Pulmonary Fibrosis (Pulmonary fibrosis)

C26869 (NCI Thesaurus)
C0034069 (UMLS 2011AA)

CL Item

Pulmonary Hypertension (Pulmonary hypertension)

CL Item

Pulmonary/upper Respiratory Other (Pulmonary-Other (Specify))

CL Item

Upper Motor Neurone Lesion (Pyramidal tract dysfunction)

CL Item

Dermatitis Exfoliative Nos (Rash)

CL Item

Growth Velocity (reduction In Growth Velocity) (Reduction in growth velocity)

CL Item

Renal Failure Nos (Renal failure)

CL Item

Renal/genitourinary Other (Renal-Other (Specify))

CL Item

Restrictive Cardiomyopathy (Restrictive cardiomyopathy)

CL Item

Retinal Detachment (Retinal detachment)

CL Item

Retinopathy (Retinopathy)

CL Item

Rhinitis Allergic Nos (Rhinitis)

C0002103 (NCI Metathesaurus)

CL Item

Right Ventricular Dysfunction (cor Pulmonale) (Right ventricular dysfunction)

CL Item

Rigors (Rigors/chills)

C0424790 (NCI Metathesaurus)

CL Item

Salivary Gland Disorder Nos (Salivary gland changes)

CL Item

Scleral Necrosis/melt (Scleral necrosis)

CL Item

Bone: Spine-scoliosis (Scoliosis)

CL Item

Secondary Malignancy Possibly Related To Cancer Treatment (Secondary Malignancy (possibly related to cancer treatment))

CL Item

Convulsions Nos (Seizure)

CL Item

Seroma (Seroma)

CL Item

Serum Sickness (Serum sickness)

C0036830 (NCI Metathesaurus)

CL Item

Sexual/reproductive Function Other (Sexual-Other (Specify))

CL Item

Short Stature (Short stature)

CL Item

Soft Tissue Necrosis (Soft tissue necrosis - Select)

CL Item

Depressed Level Of Consciousness (Somnolence)

C0549249 (NCI Metathesaurus)

CL Item

Speech Disorder Nec (Speech impairment)

CL Item

Splenic Function (Splenic function)

CL Item

Striae (Striae)

CL Item

Stricture/stenosis (including Anastomotic), Gu (Stricture, anastomotic, GU - Select)

CL Item

Stricture/stenosis (including Anastomotic), Gi (Stricture, GI - Select)

CL Item

Supraventricular And Nodal Arrhythmia (Supraventricular arrhythmia - Select)

CL Item

Sweating Increased (Sweating)

C0700590 (NCI Metathesaurus)

CL Item

Syncope (Syncope (fainting))

CL Item

Syndromes Other (Syndromes-Other (Specify))

CL Item

Taste Disturbance (Taste alteration)

CL Item

Dental: Teeth (Teeth)

CL Item

Dental: Teeth Development (Teeth development)

CL Item

Telangiectasia (Telangiectasia)

CL Item

Thrombosis/embolism (vascular Access-related) (Thrombosis/embolism (vascular access))

CL Item

Thrombosis Nos (Thrombosis/thrombus/embolism)

CL Item

Thrombotic Microangiopathy (e.g., Thrombotic Thrombocytopenic Purpura[ttp] Or Hemolytic Uremic Syndrome[hus]) (Thrombotic microangiopathy)

CL Item

Tinnitus (Tinnitus)

CL Item

Tremor Nec (Tremor)

CL Item

Trismus (difficulty, Restriction Or Pain When Opening Mouth) (Trismus)

CL Item

Tumour Flare (Tumor flare)

CL039490 (NCI Metathesaurus)

CL Item

Tumour Lysis Syndrome (Tumor lysis syndrome)

CL Item

Caecitis (Typhlitis)

CL Item

Ulcer, Gi (Ulcer, GI - Select)

CL Item

Ulceration (Ulceration)

CL Item

Fanconi Syndrome (Urinary electrolyte wasting)

C0015624 (NCI Metathesaurus)

CL Item

Urinary Frequency (Urinary frequency)

C26906 (NCI Thesaurus)
C0677481 (UMLS 2011AA)

CL Item

Urinary Retention (Urinary retention)

C0080274 (NCI Metathesaurus)

CL Item

Urine Discolouration (Urine color change)

CL Item

Urticaria Nos (Urticaria)

CL Item

Uveitis (Uveitis)

CL Item

Vaginal Discharge (non-infectious) (Vaginal discharge)

CL Item

Vulvovaginal Dryness (Vaginal dryness)

CL036720 (NCI Metathesaurus)

CL Item

Vaginal Mucositis (Vaginal mucositis)

CL Item

Vaginal Stenosis/length (Vaginal stenosis)

CL Item

Vaginitis (Vaginitis)

CL Item

Valvular Heart Disease (Valvular heart disease)

CL Item

Vascular Other (Vascular-Other (Specify))

CL Item

Vasculitis Nos (Vasculitis)

CL Item

Vasovagal Attack (Vasovagal episode)

CL Item

Ventricular Arrhythmia (Ventricular arrhythmia - Select)

C26924 (NCI Thesaurus)
C0085612 (UMLS 2011AA)

CL Item

Vessel Injury-vein (Vessel injury - Select)

CL Item

Viral Hepatitis (Viral hepatitis)

CL Item

Visceral Arterial Ischaemia (Visceral arterial ischemia)

CL Item

Vital Capacity (Vital capacity)

CL Item

Vitreous Hemorrhage (Vitreous hemorrhage)

CL Item

Dysphonia (Voice changes)

C0935979 (NCI Metathesaurus)

CL Item

Vomiting Nos (Vomiting)

CL Item

Lacrimation Increased (Watery eye)

C0262476 (NCI Metathesaurus)

CL Item

Weight Increased (Weight gain)

C0043094 (NCI Metathesaurus)

CL Item

Weight Decreased (Weight loss)

CL Item

Culture Wound Negative (Wound complication, non-infectious)

CTCAdverseEventTermSpecify

Item

Other CTC Adverse Event Term not listed

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)

CommonToxicityCriteriaAdverseEventGrade

Item

CTC AE Grade

double

C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CL.38

Code List

CTC AE Grade

CL Item

Severe Adverse Event (3)

C41340 (NCI Thesaurus)
C1519275 (UMLS 2011AA)

CL Item

Life-threatening Or Disabling Adverse Event (4)

CL Item

Death Related To Adverse Event (5)

C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)

CTCAdverseEventReportBeginDate

Item

CTCAE Begin Date (MM DD YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)

CTCAdverseEventAttributionScale

Item

Attribution

text

C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)

CL.39

Code List

Attribution

CL Item

Definite (Definite)

CL209464 (NCI Metathesaurus)

CL Item

Possible (Possible)

C0332149 (NCI Metathesaurus)

CL Item

Probable (Probable)

C0332148 (NCI Metathesaurus)

CL Item

Unlikely (Unlikely)

CL Item

Unrelated (Unrelated)

C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)

SeriousAdverseEventReportInd-3

Item

SAE report submitted

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C54035 (NCI Thesaurus ObjectClass)
C0205404 (UMLS 2011AA ObjectClass)

CL.40

Code List

SAE report submitted

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

Comments

Item Group

Footer

ResearchCommentsText

Item

Comments

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)

ResponsiblePersonSignatureText

Item

Signature of Person Completing This Form

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)

FormOriginalCompleteDate

Item

Date Form Originally Completed

date

C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25604 (NCI Thesaurus Property)
C0205313 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

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NCT00936390 Treatment - RTOG 0815 F0: Radiation Therapy Oncology Group Phase III Randomized Study of Dose- Escalated Radiotherapy With/Without STAD for Intermediate-Risk Prostate Cancer Initial Follow-up Form - 2850896v1.0

INSTRUCTIONS: Submit this form at the appropriate followup interval. Use -1 for unknown or not applicable unless otherwise specified in codetable. All dates to be reported mm-dd-yyyy unless otherwise indicated.

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