ID

34792

Description

RTOG 0534 F1: Phase III STAD with Pelvic LN or Prostate only RT for Rising PSA after Radical Prostatectomy Follow-up Form Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising PSA After Surgery for Prostate Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=2A1468A9-C541-1202-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=2A1468A9-C541-1202-E044-0003BA3F9857

Keywords

Clinical Trial

Prostatic Neoplasms

Follow-Up Studies

Copyright Holder

NCI

Uploaded on

January 29, 2019

DOI

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License

Creative Commons BY-NC 3.0

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Prostate Cancer NCT00567580 Follow-Up - RTOG 0534 F1: Phase III STAD with Pelvic LN or Prostate only RT for Rising PSA after Radical Prostatectomy Follow-up Form - 2600005v1.0

model
Details

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 forms

StudyEvent: RTOG 0534 F1: Phase III STAD with Pelvic LN or Prostate only RT for Rising PSA after Radical Prostatectomy 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)

Data type

Alias

Header

Item Group

Unnamed2

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)

Unnamed2

Item Group

Header

Data amended

Item

Amended Data

boolean

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

Unnamed 3

Item Group

Unnamed 3

Patient Status

Item

Patient's Vital Status

text

C16960 (NCI Thesaurus ObjectClass)
C3846084 (UMLS CUI-1)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25717 (NCI Thesaurus Property)

CL.2

Code List

Patient's Vital Status

CL Item

Alive (Alive)

CL Item

Dead (Dead)

Date last contact

Item

Date of Last Contact or Death

date

C16960 (NCI Thesaurus ObjectClass)
C0805839 (UMLS CUI-1)
C25461 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

Primary Cause of Death

Item

Primary Cause of Death

text

C25638 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C28554 (NCI Thesaurus Property)
C25251 (NCI Thesaurus ValueDomain-2)

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)

Primary Cause of Death, specify

Item

Due to other cause, specify

text

C16960 (NCI Thesaurus ObjectClass)
C0007465 (UMLS CUI-1)
C25251 (NCI Thesaurus ObjectClass-2)
C0007465 (NCI Metathesaurus ObjectClass)
C17649 (NCI Thesaurus Property)
C25365 (NCI Thesaurus Property-2)
C25685 (NCI Thesaurus ValueDomain)

Documented clinical assessment for this cancer

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)
C1522577 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C0006826 (UMLS CUI-2)
C9305 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property-2)

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)

ECOG Performance Status

Item

Performance Status (ZUBROD 0-5)

text

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

CL.5

Code List

Performance Status (ZUBROD 0-5)

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)

Assessment Date

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)

Unnamed5

Item Group

Unnamed Module 5

PSA Failure

Item

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

text

C38148 (NCI Thesaurus ValueDomain)
C2985506 (UMLS CUI-1)
C25626 (NCI Thesaurus Property)
C25331 (NCI Thesaurus ObjectClass)
C25434 (NCI Thesaurus ObjectClass-2)

CL.6

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-3)
C1298908 (UMLS 2011AA-4)

CL Item

Yes (YES)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus-3)
C1705108 (UMLS 2011AA-4)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Neoplasm recurrence, Local

Item

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

text

C19987 (NCI Thesaurus ObjectClass)
C0027643 (UMLS CUI-1)
C67263 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C15220 (NCI Thesaurus Property-3)
C38148 (NCI Thesaurus ValueDomain)

CL.7

Code List

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

CL Item

No (NO)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus-3)
C1298908 (UMLS 2011AA-4)

CL Item

Yes (YES)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus-3)
C1705108 (UMLS 2011AA-4)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Date of Neoplasm local recurrence

Item

Date

date

C3352 (NCI Thesaurus ObjectClass)
C0027643 (UMLS CUI-1)
C25388 (NCI Thesaurus ObjectClass-2)
C0011008 (UMLS CUI-2)
C25509 (NCI Thesaurus Property)
C15220 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)

Neoplasm Recurrence, locoregional

Item

Has the patient been diagnosed with a first local-regional progression (pelvic node - recurrence or - SINCE SUBMISSION OF THE LAST FOLLOW-UP FORM)

text

C19987 (NCI Thesaurus ObjectClass)
C0027643 (UMLS CUI-1)
C25388 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C15220 (NCI Thesaurus Property-3)
C38148 (NCI Thesaurus ValueDomain)

CL.9

Code List

Has the patient been diagnosed with a first local-regional progression (pelvic node - recurrence or - SINCE SUBMISSION OF THE LAST FOLLOW-UP FORM)

CL Item

No (NO)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus-3)
C1298908 (UMLS 2011AA-4)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Yes (YES)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus-3)
C1705108 (UMLS 2011AA-4)

Local-RegionalProgressionFirstDate

Item

Date

date

C25331 (NCI Thesaurus ObjectClass)
C25388 (NCI Thesaurus ObjectClass-2)
C1947913 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25509 (NCI Thesaurus ValueDomain-2)
C1279901 (UMLS 2011AA ValueDomain-2)

RecurrentProstateCancerFirstRegionalDiagnosisAnatomicSite

Item

Site of first regional recurrence

text

C7902 (NCI Thesaurus ObjectClass)
C0278838 (UMLS 2011AA ObjectClass)
C25643 (NCI Thesaurus Property)
C0205147 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)

CL.10

Code List

Site of first regional recurrence

CL Item

External Iliac (External iliac)

CL Item

Hypogastric (Hypogastric)

CL Item

Internal Iliac (Internal iliac)

CL Item

Other Specify (Other)

RecurrentProstateCancerFirstRegionalDiagnosisSpecify

Item

Other, specify

text

C7902 (NCI Thesaurus ObjectClass)
C0278838 (UMLS 2011AA ObjectClass)
C25643 (NCI Thesaurus Property)
C0205147 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

Evaluation method

Item

Method of Evaluation (DISTANT PROGRESSION)

text

C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)

CL.14

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)

Evaluation method

Item

Method of Evaluation (DISTANT PROGRESSION)

text

C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)

CL.14

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)

Evaluation method

Item

Method of Evaluation (DISTANT PROGRESSION)

text

C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)

CL.14

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)

Evaluation method, specify

Item

Other Specify

text

C25685 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C16847 (NCI Thesaurus Property)

Evaluation method, specify

Item

Other Specify

text

C25685 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C16847 (NCI Thesaurus Property)

Evaluation method, specify

Item

Other Specify

text

C25685 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C16847 (NCI Thesaurus Property)

Neoplasm recurrence, Distal

Item

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

text

C19987 (NCI Thesaurus ObjectClass)
C0027627 (UMLS CUI-1)
C25321 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C15220 (NCI Thesaurus Property-3)
C25180 (NCI Thesaurus ValueDomain)

CL.12

Code List

Has the patient been diagnosed with first distant recurrence/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)

Date of Neoplasm distal recurrence

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0027627 (UMLS CUI-1)
C25331 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus ValueDomain-2)
C0011008 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)

RecurrentProstateCancerFirstDistantCancerProgressionDiagnosisAnatomicSite

Item

Site of first distant progression

text

C7902 (NCI Thesaurus ObjectClass)
C0278838 (UMLS 2011AA ObjectClass)
C25321 (NCI Thesaurus Property)
C0443203 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C19987 (NCI Thesaurus Property-4)
C0242656 (UMLS 2011AA Property-4)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)

CL.13

Code List

Site of first distant progression

CL Item

Bone (Bone)

C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)

CL Item

Brain (Brain)

C12439 (NCI Thesaurus)
C0006104 (UMLS 2011AA)

CL Item

Liver (Liver)

C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)

CL Item

Lung (Lung)

C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)

CL Item

Lymph Node (Lymph Node (outside pelvis))

C12745 (NCI Thesaurus)
C0024204 (UMLS 2011AA)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

RecurrentProstateCancerFirstDistantCancerProgressionDiagnosisSpecify

Item

Other, specify

text

C7902 (NCI Thesaurus ObjectClass)
C0278838 (UMLS 2011AA ObjectClass)
C25321 (NCI Thesaurus Property)
C0443203 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C19987 (NCI Thesaurus Property-4)
C0242656 (UMLS 2011AA Property-4)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

PSA MEASUREMENTS

Item Group

Unnamed Module 4a

PSA date

Item

PSA Date

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

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)

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.16

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)

ProstaticFossaBiopsyPerformedStatus

Item

Has the patient had a prostatic fossa biopsy

text

C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C27959 (NCI Thesaurus ObjectClass-2)
C1522721 (UMLS 2011AA ObjectClass-2)
C34007 (NCI Thesaurus ObjectClass-3)
C0836913 (UMLS 2011AA ObjectClass-3)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.17

Code List

Has the patient had a prostatic fossa biopsy

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Not Done (Not done)

CL281691 (NCI Metathesaurus)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Yes, Negative (Yes, negative)

CL Item

Yes, Positive (Yes, positive)

CL Item

Yes, Results Unknown (Yes, results unknown)

Biopsy Date

Item

Date of Biopsy (If yes,)

date

C25164 (NCI Thesaurus ValueDomain)
C0005558 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C15189 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)

PalpableProstaticFossaTumorPresentIndicator

Item

Palpable prostatic fossa mass

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25606 (NCI Thesaurus ObjectClass-2)
C0522499 (UMLS 2011AA ObjectClass-2)
C27959 (NCI Thesaurus ObjectClass-3)
C1522721 (UMLS 2011AA ObjectClass-3)
C34007 (NCI Thesaurus ObjectClass-4)
C0836913 (UMLS 2011AA ObjectClass-4)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

CL.18

Code List

Palpable prostatic fossa mass

CL Item

Equivocal (Equivocal)

C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Not Evaluated (Not evaluated)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

LaboratoryProcedureTestosteroneOutcomeStatus

Item

Testosterone

text

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)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.19

Code List

Testosterone

CL Item

Normal (Normal)

C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
C14165 (NCI Thesaurus-3)
C0205307 (UMLS 2011AA-4)

CL Item

Not Done (Not done)

CL281691 (NCI Metathesaurus)

CL Item

Abnormal (Abnormal)

C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)
C25401 (NCI Thesaurus-3)
C0205161 (UMLS 2011AA-4)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

LaboratoryProcedureTestosteroneResultSpecifiedValue

Item

Testosterone (Monthly assessment)

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 Lower Limit Normal

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 Upper Limit Normal

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

Unit of Measure

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.22

Code List

Unit of Measure

CL Item

Nanograms Per Deciliter (ng/dL)

CL Item

Nanograms Per Milliliter (ng/mL)

CL Item

Millimole Per Liter (mmol/L)

CL Item

Not Otherwise Specified (NOS)

CL006269 (NCI Metathesaurus)

AssessmentLabUOM

Item

Unit of Measure

text

CL.22

Code List

Unit of Measure

CL Item

Nanograms Per Deciliter (ng/dL)

CL Item

Nanograms Per Milliliter (ng/mL)

CL Item

Millimole Per Liter (mmol/L)

CL Item

Not Otherwise Specified (NOS)

CL006269 (NCI Metathesaurus)

Assessment Date

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)

Lab Values

Item Group

Baseline Lab Values (hematologic)

LaboratoryProcedureTestosteroneResultSpecifiedValue

Item

Testosterone (Monthly assessment)

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)

LaboratoryProcedureTestosteroneResultSpecifiedValue

Item

Testosterone (Monthly assessment)

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)

LaboratoryProcedureAlanineAminotransferaseMeasurementAspartateAminotransferaseMeasurementOutcomeStatus

Item

SGPT (ALT) or SGOT (AST)

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C64467 (NCI Thesaurus Property-2)
C0201899 (UMLS 2011AA Property-2)
C64433 (NCI Thesaurus Property-3)
C0201836 (UMLS 2011AA Property-3)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.23

Code List

SGPT (ALT) or SGOT (AST)

CL Item

Abnormal (Abnormal)

C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)
C25401 (NCI Thesaurus-3)
C0205161 (UMLS 2011AA-4)

CL Item

Normal (Normal)

C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
C14165 (NCI Thesaurus-3)
C0205307 (UMLS 2011AA-4)

CL Item

Not Done (Not done)

CL281691 (NCI Metathesaurus)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

LaboratoryProcedureTestosteroneResultLowerLimitofNormalValue

Item

Testosterone Lower Limit Normal

float

LaboratoryProcedureTestosteroneResultLowerLimitofNormalValue

Item

Testosterone Lower Limit Normal

float

LaboratoryTestName

Item

Test

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-2)
C0027365 (UMLS 2011AA ValueDomain-2)

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-2)
C0039601 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

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-2)
C0039601 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

LaboratoryTestStandardValue

Item

Value

float

C37984 (NCI Thesaurus ObjectClass)
C0022877 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

AssessmentLabUOM

Item

Unit of Measure

text

CL.22

Code List

Unit of Measure

CL Item

Nanograms Per Deciliter (ng/dL)

CL Item

Nanograms Per Milliliter (ng/mL)

CL Item

Millimole Per Liter (mmol/L)

CL Item

Not Otherwise Specified (NOS)

CL006269 (NCI Metathesaurus)

AssessmentLabUOM

Item

Unit of Measure

text

CL.22

Code List

Unit of Measure

CL Item

Nanograms Per Deciliter (ng/dL)

CL Item

Nanograms Per Milliliter (ng/mL)

CL Item

Millimole Per Liter (mmol/L)

CL Item

Not Otherwise Specified (NOS)

CL006269 (NCI Metathesaurus)

LaboratoryProcedureBloodCellCountResultStatus

Item

CBC

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)
C28133 (NCI Thesaurus Property-2)
C0009555 (UMLS 2011AA Property-2)

CL.24

Code List

CBC

CL Item

Abnormal (Abnormal)

C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)
C25401 (NCI Thesaurus-3)
C0205161 (UMLS 2011AA-4)

CL Item

Normal (Normal)

C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
C14165 (NCI Thesaurus-3)
C0205307 (UMLS 2011AA-4)

CL Item

Not Done (Not done)

CL281691 (NCI Metathesaurus)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Leukocytes (WBC)

Item

WBC (mm^3)

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)

Assessment Date

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)

LaboratoryProcedureHemoglobinResultSpecifiedValue

Item

Hemoglobin (g/dL)

float

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

Platelets

Item

Peripheral Platelet Count (mm^3)

float

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

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-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.25

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-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.26

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-2)
C1518384 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

Non-ProtocolTreatmentFirstAdministeredSpecify

Item

Specify

text

C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

Unnamed7

Item Group

Unnamed Module 7

NewCancerDiagnosisInd-3

Item

Has a new primary cancer or MDS been diagnosed that has not been previously reported? (MYELODYSPLASTIC SYNDROME)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)

CL.27

Code List

Has a new primary cancer or MDS been diagnosed that has not been previously reported? (MYELODYSPLASTIC SYNDROME)

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)

Second Primary Tumor Site

Item

Second Primary Tumor Site

text

C13717 (NCI Thesaurus ValueDomain)
C0751623 (UMLS CUI-1)
C3262 (NCI Thesaurus ObjectClass)
C1515974 (UMLS CUI-2)
C25341 (NCI Thesaurus Property)
C25666 (NCI Thesaurus ObjectClass-2)

CL.28

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)

Second Primary Tumor Date

Item

Second Primary Cancer Date

date

C3262 (NCI Thesaurus ObjectClass)
C0751623 (UMLS CUI-1)
C25251 (NCI Thesaurus ObjectClass-2)
C0011008 (UMLS CUI-2)
C25666 (NCI Thesaurus ObjectClass-3)
C15220 (NCI Thesaurus Property)
C25164 (NCI Thesaurus ValueDomain)

Primary Disease Site

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C0449695 (UMLS CUI-1)
C25341 (NCI Thesaurus Property)
C25251 (NCI Thesaurus ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)

Unnamed8

Item Group

Report All Continuing Or New Adverse Events

Adverse Event

Item

Any Treatment Related Adverse Events

text

C25648 (NCI Thesaurus ObjectClass)
C0877248 (UMLS CUI-1)
C41331 (NCI Thesaurus ObjectClass-2)
C15368 (NCI Thesaurus ObjectClass-3)
C0684224 (NCI Metathesaurus Property)
C38148 (NCI Thesaurus ValueDomain)

CL.29

Code List

Any Treatment Related Adverse Events

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)

MedDRACode

Item

MedDRA Code (BASED ON CTC AE TERM)

float

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

CommonToxicityCriteriaAdverseEventTermType

Item

CTC Adverse Event Term

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)

CL.30

Code List

CTC Adverse Event Term

CL Item

Acidosis Nos (Acidosis (metabolic or respiratory))

C0001122 (NCI Metathesaurus)

CL Item

Capillary Leak Syndrome (Acute vascular leak syndrome)

C0343084 (NCI Metathesaurus)

CL Item

Adrenal Insufficiency (Adrenal insufficiency)

CL Item

Adult Respiratory Distress Syndrome (Adult respiratory distress syndrome (ARDS))

C3353 (NCI Thesaurus)
C0035222 (UMLS 2011AA)

CL Item

Blood Albumin Decreased (Albumin, serum-low (hypoalbuminemia))

CL039392 (NCI Metathesaurus)

CL Item

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

CL Item

Blood Alkaline Phosphatase Nos Increased (Alkaline phosphatase)

CL Item

Alkalosis Nos (Alkalosis (metabolic or respiratory))

C0002063 (NCI Metathesaurus)

CL Item

Hypersensitivity Nos (Allergic reaction/hypersensitivity (including drug fever))

CL Item

Rhinitis Allergic Nos (Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip))

C0002103 (NCI Metathesaurus)

CL Item

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

CL Item

Alanine Aminotransferase Increased (ALT, SGPT (serum glutamic pyruvic transaminase))

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 (Arachn

ID

Description

Link

Keywords

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Item comments for :

Prostate Cancer NCT00567580 Follow-Up - RTOG 0534 F1: Phase III STAD with Pelvic LN or Prostate only RT for Rising PSA after Radical Prostatectomy Follow-up Form - 2600005v1.0

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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