ID

10078

Beschreibung

RTOG 0521 FS: Radiation Therapy Oncology Group Phase III Randomized Study of Localized, High-Risk Prostate Cancer Interim Follow-up Form Hormone Therapy and Radiation Therapy or Hormone Therapy and Radiation Therapy Followed by Docetaxel and Prednisone in Treating Patients With Localized Prostate Cancer NCT00288080 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F6C17FD2-E3B5-62CA-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F6C17FD2-E3B5-62CA-E034-0003BA3F9857

Stichworte

Klinische Studie [Dokumenttyp]

Prostatatumoren

Verlaufsstudien

19.09.12 19.09.12 -
09.01.15 09.01.15 - Martin Dugas
23.03.15 23.03.15 - Martin Dugas

Hochgeladen am

23. März 2015

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy

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Prostate Cancer NCT00288080

Modell
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 Formulare

StudyEvent: RTOG 0521 FS: Radiation Therapy Oncology Group Phase III Randomized Study of Localized, High-Risk Prostate Cancer Interim 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

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Header

Item Group

Header

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)

RTOG ID

Item

Case #

text

C16960 (NCI Thesaurus ObjectClass)
C19778 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C49152 (NCI Thesaurus Property-2)
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C1514695 (UMLS CUI-2)

Institution Name

Item

Institution Name

text

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

Institution Number

Item

Institution No.

text

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

Patient Initials

Item

Patient Initials

text

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

Trial subject ID RTOG

Item

RTOG Patient ID

text

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

Data amended

Item

Amended Data

boolean

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

Research Comments

Item

Comments

text

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

Responsible Person Signature

Item

Signature of Person Completing This Form

text

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

Form Completion Date

Item

Date Form Originally Completed

date

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

Patient data

Item Group

Patient data

C2707520 (UMLS CUI-1)

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

boolean

C38148 (NCI Thesaurus ValueDomain)
C16033 (NCI Thesaurus Property)
C9305 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property-2)
C1522577 (UMLS CUI-1)
C0006826 (UMLS CUI-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)

ECOG Performance Status

Item

Performance Status

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

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)

Prostate Biopsy

Item

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

text

C15189 (NCI Thesaurus ObjectClass)
C0194804 (UMLS CUI-1)
C12410 (NCI Thesaurus ObjectClass-2)
C38000 (NCI Thesaurus Property)
C25688 (NCI Thesaurus ValueDomain)

CL.6

Code List

Has the patient has a prostate biospy (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)

Biopsy Date

Item

Biopsy Date

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)

Palpable Tumor

Item

Was the tumor palpable

text

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

CL.7

Code List

Was 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)

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.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-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 LAST FOLLOW-UP FORM See Protocol Section 11)

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.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-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)

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.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)

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 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.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)

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)

Progression Sites

Item

Sites of Progression (First distant)

text

C25704 (NCI Thesaurus ValueDomain)
C0280457 (UMLS CUI-1)
C25341 (NCI Thesaurus Property)
C25331 (NCI Thesaurus ObjectClass)

New primary cancer

Item

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

text

C25180 (NCI Thesaurus ValueDomain)
C0751623 (UMLS CUI-1)
C25586 (NCI Thesaurus ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C15220 (NCI Thesaurus Property)

CL.21

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)

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.22

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)

Adverse Event

Item

New or continuing adverse events (IF PATIENT EXPERIENCED ANY TREATMENT RELATED ADVERSE EVENTS DURING THIS REPORT PERIOD, SUBMIT ADVERSE EVENT FORM AE)

text

C38148 (NCI Thesaurus ValueDomain)
C0877248 (UMLS CUI-1)
C25586 (NCI Thesaurus ObjectClass)
C41331 (NCI Thesaurus ObjectClass-2)
C25275 (NCI Thesaurus Property)

CL.23

Code List

New or continuing adverse events (IF PATIENT EXPERIENCED ANY TREATMENT RELATED ADVERSE EVENTS DURING THIS REPORT PERIOD, SUBMIT ADVERSE EVENT FORM AE)

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)

PROSTATE: 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)

AssessmentLabUOM

Item

Units 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.15

Code List

Units of Measure

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)

LaboratoryProcedureTestosteroneResultSpecifiedValue

Item

Testosterone

float

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

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.14

Code List

Testosterone

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)

Testosterone LLN

Item

Testosterone Lower Limit Normal

float

C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C2299 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C0039601 (UMLS CUI-1)
C1518030 (UMLS CUI-2)

Testosterone ULN

Item

Testosterone Upper Limit Normal

float

C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C2299 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0039601 (UMLS CUI-1)
C1519815 (UMLS CUI-2)

Treatment Schedule (LHRH Agonist)

Item Group

Treatment Schedule (lhrh Agonist)

LHRH Agonist

Item

Is patient on protocol hormone (LHRH Agonist)

boolean

C16960 (NCI Thesaurus ObjectClass)
C25320 (NCI Thesaurus ObjectClass-2)
C15445 (NCI Thesaurus ObjectClass-3)
C25471 (NCI Thesaurus Property)
C25639 (NCI Thesaurus Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1518041 (UMLS CUI-1)

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-2)
C1518041 (UMLS 2011AA Property-2)

CL.17

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-2)
C1518041 (UMLS 2011AA Property-2)

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-2)
C1518041 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)

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-2)
C1518041 (UMLS 2011AA Property-2)

Off Treatment Reason

Item

Reason Treatment Ended (LHRH Agonist)

text

C25638 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)

CL.18

Code List

Reason Treatment Ended (LHRH Agonist)

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-2)
C0678257 (UMLS 2011AA Property-2)

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 Treatment Reason, specify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
C1521902 (UMLS CUI-3)

Cumulative Dose Agent

Item

Total Dose

float

C1708 (NCI Thesaurus ObjectClass)
C2986497 (UMLS CUI-1)
C25470 (NCI Thesaurus ObjectClass-2)
C1521826 (UMLS CUI-2)
C25304 (NCI Thesaurus Property)
C25256 (NCI Thesaurus Property-2)
C25304 (NCI Thesaurus ValueDomain)
C25488 (NCI Thesaurus ValueDomain-2)

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.19

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.20

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-Protocol Treatment, Specify

Item

Specify

text

C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C25509 (NCI Thesaurus Property)
C25382 (NCI Thesaurus Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1518384 (UMLS CUI-1)
C1521902 (UMLS CUI-2)

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Item Kommentare für :

Prostate Cancer NCT00288080

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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