ID

10042

Beschrijving

FS Radiation Therapy Oncology Group Phase III Randomized Study of Adjuvant Therapy for High Risk pT3NO Prostate Cancer Initial Follow-up Form Adjuvant Radiation Therapy Plus Hormone Therapy Compared With Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer NCT00023829 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A56DC7B3-8145-10C4-E034-080020C9C0E0

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A56DC7B3-8145-10C4-E034-080020C9C0E0

Trefwoorden

Versies (2)
  1. 19-09-12 19-09-12 -
  2. 21-03-15 21-03-15 - Martin Dugas
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21 maart 2015

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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Prostate Cancer adjuvant therapy (FS RTOG Phase III Study NCT00023829)

Engels

INSTRUCTIONS: Submit this form at patient's entry on study. Use -1 for unknown or not applicable unless otherwise specified in codetable. All dates to be reported mm-dd-yyyy unless otherwise indicated.

1 Formulieren  
  1. StudyEvent: FS Radiation Therapy Oncology Group Phase III Randomized Study of Adjuvant Therapy for High Risk pT3NO Prostate Cancer Initial Follow-up Form
    1. INSTRUCTIONS: Submit this form at patient's entry on study. Use -1 for unknown or not applicable unless otherwise specified in codetable. All dates to be reported mm-dd-yyyy unless otherwise indicated.
Header
Beschrijving

Header

RTOG Study
Beschrijving

RTOGStudy

Datatype

text

Case #
Beschrijving

Case#

Datatype

text

Institution Name
Beschrijving

InstitutionName

Datatype

text

Institution No.
Beschrijving

InstitutionNo.

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
Patient Name, Last
Beschrijving

PatientName,Last

Datatype

text

Patient Name, First (13)
Beschrijving

PatientName,First

Datatype

text

AMENDED DATA
Beschrijving

AmendedData

Datatype

text

DATE from (Q2)
Beschrijving

DATEfrom

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
COMMENTS
Beschrijving

Comments

Datatype

text

SIGNATURE
Beschrijving

Signature

Datatype

text

DATE
Beschrijving

Date

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Patient characteristics
Beschrijving

Patient characteristics

Alias
UMLS CUI-1
C0815172
PATIENT'S VITAL STATUS (2)
Beschrijving

Patient'sVitalStatus

Datatype

text

DATE OF LAST CONTACT OR DEATH (3)
Beschrijving

DeathDate/LastContactDate

Datatype

date

CAUSE OF DEATH (IF DEAD)
Beschrijving

Causeofdeath

Datatype

text

Due to other cause, specify (cause of death) (4)
Beschrijving

PrimaryCauseDeathOtherReasonSpecify

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C25251
UMLS 2011AA ObjectClass-2
C0205225
NCI Metathesaurus ObjectClass
C0007465
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C25365
UMLS 2011AA Property-2
C0678257
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
HAS THE PATIENT HAD A DOCUMENTED CLINICAL ASSESSMENT FOR PROSTATE CANCER SINCE SUBMISSION OF THE PREVIOUS FOLLOWUP FORM?
Beschrijving

HASTHEPATIENTHADADOCUMENTEDCLINICALASSESSMENTFORPROSTATECANCERSINCESUBMISSIONOFTHEPREVIOUSFOLLOWUPFORM?

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ValueDomain-2
C25180
DATE OF LAST CLINICAL ASSESSMENT (5)
Beschrijving

CancerFollow-upStatusDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
PERFORMANCE STATUS (ZUBROD 0-4)
Beschrijving

PERFORMANCESTATUS

Datatype

text

Follow-up PSA Value(s)
Beschrijving

Follow-upPSAValue(s)

Datatype

text

Date of PSA Assessment(s) (7)
Beschrijving

DateofPSAAssessment(s)

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
HAS THE PATIENT HAD A PROSTATE BIOPSY SINCE SUBMISSION OF THE LAST FOLLOWUP FORM?
Beschrijving

HASTHEPATIENTHADAPROSTATEBIOPSYSINCESUBMISSIONOFTHELASTFOLLOWUPFORM?

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ValueDomain-2
C25180
UMLS CUI-1
C0194804
Biopsy Date (8)
Beschrijving

BiopsyDate

Datatype

date

HAS THE PATIENT DEVELOPED A FIRST PROGRESSION THAT HAS NOT BEEN PREVIOUSLY REPORTED? (A)
Beschrijving

HASTHEPATIENTDEVELOPEDAFIRSTPROGRESSIONTHATHASNOTBEENPREVIOUSLYREPORTED?

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ValueDomain-2
C25180
UMLS CUI-1
C0242656
HAS THE PATIENT BEEN DIAGNOSED WITH BIOCHEMICAL RECURRENCE SINCE SUBMISSION OF LAST FOLLOW-UP FORM? (See Protocol Section 11)
Beschrijving

ProgressionInd,Biochemical

Datatype

text

DATE OF FIRST BIOCHEMICAL PROGRESSION
Beschrijving

ProgressionDate,FirstBiochemical

Datatype

date

PSA Value at progression (B)
Beschrijving

ProgressionPSAValue

Datatype

float

HAS THE PATIENT BEEN DIAGNOSED WITH FIRST LOCAL-REGIONAL RECURRENCE SINCE SUBMISSION OF LAST FOLLOW-UP FORM? (See Protocol Section 11)
Beschrijving

HASTHEPATIENTBEENDIAGNOSEDWITHFIRSTLOCAL-REGIONALRECURRENCESINCESUBMISSIONOFLASTFOLLOW-UPFORM?

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ValueDomain-2
C25180
UMLS CUI-1
C0027643
DATE OF FIRST LOCAL-REGIONAL PROGRESSION
Beschrijving

ProgressionDate,FirstLocal-Regional

Datatype

date

Alias
UMLS CUI-1
C0011008
UMLS CUI-2
C0027643
SITE(S) OF LOCAL/REGIONAL PROGRESSION
Beschrijving

SITE(S)OFLOCAL/REGIONALPROGRESSION

Datatype

text

WHAT WAS THE METHOD USED TO DETERMINE local/regional PROGRESSION
Beschrijving

WHATWASTHEMETHODUSEDTODETERMINElocal/regionalPROGRESSION

Datatype

text

Other, specify (method used to determine local/regional progression) (C)
Beschrijving

Other,specify(methodusedtodeterminelocal/regionalprogression)

Datatype

text

HAS THE PATIENT BEEN DIAGNOSED WITH FIRST DISTANT RECURRENCE SINCE SUBMISSION OF THE LAST FOLLOW-UP FORM?
Beschrijving

HASTHEPATIENTBEENDIAGNOSEDWITHFIRSTDISTANTRECURRENCESINCESUBMISSIONOFTHELASTFOLLOW-UPFORM?

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ValueDomain-2
C25180
DATE OF FIRST DISTANT PROGRESSION
Beschrijving

ProgressionDate,FirstDistant

Datatype

date

SITE(S) OF FIRST DISTANT PROGRESSION
Beschrijving

Site(s)ofFirstDistantProgression

Datatype

text

WHAT WAS THE METHOD USED TO DETERMINE distant PROGRESSION
Beschrijving

WHATWASTHEMETHODUSEDTODETERMINEdistantPROGRESSION

Datatype

text

Other, specify (method used to determine distant progression)
Beschrijving

Other,specify(methodusedtodeterminedistantprogression)

Datatype

text

New Primary Site
Beschrijving

NewCancerDiagnosisAnatomicSite

Datatype

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
New Primary Cancer Date
Beschrijving

NewPrimaryCancerDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Specify (new primary site)
Beschrijving

Specify(newprimarysite)

Datatype

text

HQ Use (14 HAS A NEW PRIMARY CANCER OR MDS MYELODYSPLASTIC SYNDROME BEEN DIAGNOSED THAT HAS NOT BEEN PREVIOUSLY REPORTED?)
Beschrijving

HQUse

Datatype

text

PROTOCOL HORMONES CONTINUING (11)
Beschrijving

PROTOCOLHORMONESCONTINUING

Datatype

text

DID THE PATIENT RECEIVE ANY NON-PROTOCOL PROSTATE CANCER THERAPY SINCE THE LAST FOLLOW-UP (If yes, enter therapy type and date for each therapy delivered during the follow-up period.)
Beschrijving

DIDTHEPATIENTRECEIVEANYNON-PROTOCOLPROSTATECANCERTHERAPYSINCETHELASTFOLLOW-UP

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ValueDomain-2
C25180
UMLS CUI-1
C1518384
UMLS CUI-2
C0087111
Non-Protocol Therapy Type
Beschrijving

Non-ProtocolTherapyAdministeredType

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25590
NCI Thesaurus Property
C25382
UMLS CUI-1
C1518384
UMLS CUI-2
C0087111
Date of first non-protocol therapy
Beschrijving

Non-ProtocolTherapyDate,First

Datatype

date

Specify (non-protocol prostate cancer therapy) (12)
Beschrijving

Specify(non-protocolprostatecancertherapy)

Datatype

text

Radiation therapy
Beschrijving

Radiation therapy

Alias
UMLS CUI-1
C1522449
TOTAL DOSE TO PROSTATE
Beschrijving

TOTALDOSETOPROSTATE

Datatype

float

Maateenheden
  • Gy
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C2169193
UMLS CUI-2
C0033572
Gy
TOTAL DOSE TO PELVIS
Beschrijving

TOTALDOSETOPELVIS

Datatype

float

Maateenheden
  • Gy
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C2169193
UMLS CUI-2
C0030797
Gy
RADIATION THERAPY START DATE
Beschrijving

RTBeginDate

Datatype

date

Alias
UMLS CUI-1
C1522449
UMLS CUI-2
C0808070
RADIATION THERAPY END DATE
Beschrijving

RTEndDate

Datatype

date

Alias
UMLS CUI-1
C1522449
UMLS CUI-2
C0806020
WERE THERE ANY UNSCHEDULED INTERRUPTIONS IN RADIATION THERAPY?
Beschrijving

RTInterruptionsInd

Datatype

text

Specify RT interruption reason
Beschrijving

RadiationTherapyUnscheduledInterruptionSpecify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
NCI Thesaurus ObjectClass
C15313
NCI Thesaurus Property
C25594
NCI Thesaurus Property-2
C25211
NCI Thesaurus Property-3
C25542
UMLS CUI-1
C0392360
UMLS CUI-2
C1522449
UMLS CUI-3
C1512900
REASON RADIATION THERAPY TREATMENT ENDED
Beschrijving

REASONRADIATIONTHERAPYTREATMENTENDED

Datatype

text

Alias
UMLS CUI-1
C3166257
UMLS CUI-2
C1522449
Alternative therapy, specify (reason radiation therapy ended)
Beschrijving

Alternativetherapy,specify(reasonradiationtherapyended)

Datatype

text

Other complicating disease, specify (reason radiation therapy ended)
Beschrijving

Othercomplicatingdisease,specify(reasonradiationtherapyended)

Datatype

text

Other, specify (reason radiation therapy ended) (10)
Beschrijving

Other,specify(reasonradiationtherapyended)

Datatype

text

Adverse event
Beschrijving

Adverse event

Alias
UMLS CUI-1
C0877248
NEW OR CONTINUING TOXICITY (>= Severity Grade 3) SINCE THE LAST REPORT? (Report impotence, urinary incontinence, urinary frequency in Q12)
Beschrijving

NEWORCONTINUINGTOXICITY(>=SeverityGrade3)SINCETHELASTREPORT?

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ValueDomain-2
C25180
UMLS CUI-1
C1519275
UMLS CUI-2
C3537125
IMT CODE ADVERSE EVENT BASED ON CTEP TOXICITY TERM
Beschrijving

IMTCODEADVERSEEVENTBASEDONCTEPTOXICITYTERM

Datatype

text

CTC ADVERSE EVENT TERM
Beschrijving

CTC ADVERSE EVENT TERM

Datatype

text

Alias
UMLS CUI-1
C1516728
UMLS CUI-2
C2826934
COMMON TOXICITY GENERAL CATEGORY
Beschrijving

COMMONTOXICITYGENERALCATEGORY

Datatype

text

Alias
UMLS CUI-1
C1516728
UMLS CUI-2
C0683312
CTC ADVERSE EVENT GRADE
Beschrijving

CTC ADVERSE EVENT GRADE

Datatype

integer

Alias
UMLS CUI-1
C2985911
CTC ADVERSE EVENT ONSET DATE (GRADE >=3)
Beschrijving

CTC ADVERSE EVENT ONSET DATE (GRADE >=3)

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0011008
UMLS CUI-2
C0877248
UMLS CUI-3
C0332162
CTC ADVERSE EVENT ATTRIBUTION CODE
Beschrijving

CTCADVERSEEVENTATTRIBUTIONCODE

Datatype

text

Alias
UMLS CUI-1
C1706735
Other cause, specify (adverse event attribution)
Beschrijving

Othercause,specify(adverseeventattribution)

Datatype

text

SPECIFY (adverse event)
Beschrijving

Specify(adverseevent)

Datatype

text

RENAL/GENITOURINARY TOXICITY ADVERSE EVENT REPORTS (AER) (Use CTC 2.0 to code severity)
Beschrijving

RENAL/GENITOURINARYTOXICITYADVERSEEVENTREPORTS(AER)

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ValueDomain-2
C25180
UMLS CUI-1
C1527021
UMLS CUI-2
C1522602
URINARY INCONTINENCE, Severity Grade (0-3)
Beschrijving

URINARYINCONTINENCE,SeverityGrade

Datatype

text

Alias
UMLS CUI-1
C0042024
UMLS CUI-2
C0392364
URINARY INCONTINENCE, Attribution (see table below)
Beschrijving

URINARYINCONTINENCE,Attribution

Datatype

text

Specify if other cause (urinary incontinence, attribution)
Beschrijving

Specifyifothercause(urinaryincontinence,attribution)

Datatype

text

URINARY INCONTINENCE, AER Begin Date
Beschrijving

URINARYINCONTINENCE,AERBeginDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
URINARY FREQUENCY/URGENCY, Severity Grade (0-3)
Beschrijving

URINARYFREQUENCY/URGENCY,SeverityGrade

Datatype

text

URINARY FREQUENCY/URGENCY, Attribution (see table below)
Beschrijving

URINARYFREQUENCY/URGENCY,Attribution

Datatype

text

Specify if other cause (urinary frequency/urgency, attribution)
Beschrijving

Specifyifothercause(urinaryfrequency/urgency,attribution)

Datatype

text

URINARY FREQUENCY/URGENCY, AER Begin Date
Beschrijving

URINARYFREQUENCY/URGENCY,AERBeginDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
ERECTILE IMPOTENCE, Severity Grade (0-3)
Beschrijving

ERECTILE IMPOTENCE, Severity Grade (0-3)

Datatype

text

ERECTILE IMPOTENCE, Attribution (Attribution)
Beschrijving

ERECTILEIMPOTENCE,Attribution

Datatype

text

Specify if other cause (erectile impotence, attribution)
Beschrijving

Specifyifothercause(erectileimpotence,attribution)

Datatype

text

ERECTILE IMPOTENCE, AER Begin Date
Beschrijving

ERECTILEIMPOTENCE,AERBeginDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
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Similar models

INSTRUCTIONS: Submit this form at patient's entry on study. Use -1 for unknown or not applicable unless otherwise specified in codetable. All dates to be reported mm-dd-yyyy unless otherwise indicated.

1 Formulieren
  1. StudyEvent: FS Radiation Therapy Oncology Group Phase III Randomized Study of Adjuvant Therapy for High Risk pT3NO Prostate Cancer Initial Follow-up Form
    1. INSTRUCTIONS: Submit this form at patient's entry on study. 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)
Datatype
Alias
Item Group
Header
RTOGStudy
Item
RTOG Study
text
Case#
Item
Case #
text
InstitutionName
Item
Institution Name
text
InstitutionNo.
Item
Institution No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
PatientName,Last
Item
Patient Name, Last
text
PatientName,First
Item
Patient Name, First (13)
text
AmendedData
Item
AMENDED DATA
text
DATEfrom
Item
DATE from (Q2)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Comments
Item
COMMENTS
text
Signature
Item
SIGNATURE
text
Date
Item
DATE
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Patient characteristics
C0815172 (UMLS CUI-1)
Item
PATIENT'S VITAL STATUS (2)
text
CL.1
Code List
PATIENT'S VITAL STATUS (2)
CL Item
Alive (Alive)
CL Item
Dead (Dead)
CL Item
Unknown or not applicable (Unknown or not applicable)
DeathDate/LastContactDate
Item
DATE OF LAST CONTACT OR DEATH (3)
date
Item
CAUSE OF DEATH (IF DEAD)
text
CL.2
Code List
CAUSE OF DEATH (IF DEAD)
CL Item
Due To This Disease (Due to this disease)
CL Item
Due To Protocol Treatment (Due to protocol treatment)
CL Item
Due to other cause, specify (Due to other cause, specify)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
PrimaryCauseDeathOtherReasonSpecify
Item
Due to other cause, specify (cause of death) (4)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C0007465 (NCI Metathesaurus ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Assessment for prostate cancer since previous follow-up
Item
HAS THE PATIENT HAD A DOCUMENTED CLINICAL ASSESSMENT FOR PROSTATE CANCER SINCE SUBMISSION OF THE PREVIOUS FOLLOWUP FORM?
boolean
C25704 (NCI Thesaurus ValueDomain)
C25180 (NCI Thesaurus ValueDomain-2)
CancerFollow-upStatusDate
Item
DATE OF LAST CLINICAL ASSESSMENT (5)
date
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item
PERFORMANCE STATUS (ZUBROD 0-4)
text
CL.4
Code List
PERFORMANCE STATUS (ZUBROD 0-4)
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
CL Item
1 (1)
CL Item
2 (2)
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
3 (3)
CL Item
4 (4)
CL Item
-1 (-1)
Follow-upPSAValue(s)
Item
Follow-up PSA Value(s)
text
DateofPSAAssessment(s)
Item
Date of PSA Assessment(s) (7)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Prostate biopsy
Item
HAS THE PATIENT HAD A PROSTATE BIOPSY SINCE SUBMISSION OF THE LAST FOLLOWUP FORM?
boolean
C25704 (NCI Thesaurus ValueDomain)
C25180 (NCI Thesaurus ValueDomain-2)
C0194804 (UMLS CUI-1)
BiopsyDate
Item
Biopsy Date (8)
date
First progression
Item
HAS THE PATIENT DEVELOPED A FIRST PROGRESSION THAT HAS NOT BEEN PREVIOUSLY REPORTED? (A)
boolean
C25704 (NCI Thesaurus ValueDomain)
C25180 (NCI Thesaurus ValueDomain-2)
C0242656 (UMLS CUI-1)
Item
HAS THE PATIENT BEEN DIAGNOSED WITH BIOCHEMICAL RECURRENCE SINCE SUBMISSION OF LAST FOLLOW-UP FORM? (See Protocol Section 11)
text
CL.7
Code List
HAS THE PATIENT BEEN DIAGNOSED WITH BIOCHEMICAL RECURRENCE SINCE SUBMISSION OF LAST FOLLOW-UP FORM? (See Protocol Section 11)
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)
ProgressionDate,FirstBiochemical
Item
DATE OF FIRST BIOCHEMICAL PROGRESSION
date
ProgressionPSAValue
Item
PSA Value at progression (B)
float
First local-regional recurrence
Item
HAS THE PATIENT BEEN DIAGNOSED WITH FIRST LOCAL-REGIONAL RECURRENCE SINCE SUBMISSION OF LAST FOLLOW-UP FORM? (See Protocol Section 11)
boolean
C25704 (NCI Thesaurus ValueDomain)
C25180 (NCI Thesaurus ValueDomain-2)
C0027643 (UMLS CUI-1)
DATE OF FIRST LOCAL-REGIONAL PROGRESSION
Item
DATE OF FIRST LOCAL-REGIONAL PROGRESSION
date
C0011008 (UMLS CUI-1)
C0027643 (UMLS CUI-2)
SITE(S)OFLOCAL/REGIONALPROGRESSION
Item
SITE(S) OF LOCAL/REGIONAL PROGRESSION
text
Item
WHAT WAS THE METHOD USED TO DETERMINE local/regional PROGRESSION
text
CL.9
Code List
WHAT WAS THE METHOD USED TO DETERMINE local/regional PROGRESSION
CL Item
Physical Exam (Physical exam)
CL Item
Pathologic (Pathologic)
C25610 (NCI Thesaurus)
C1521733 (UMLS 2011AA)
CL Item
Radiographic (Radiographic)
CL Item
Nuclear Scan (Nuclear scan)
CL Item
Other, Specify (Other, specify)
Other method, specify
Item
Other, specify (method used to determine local/regional progression) (C)
text
First distant recurrence
Item
HAS THE PATIENT BEEN DIAGNOSED WITH FIRST DISTANT RECURRENCE SINCE SUBMISSION OF THE LAST FOLLOW-UP FORM?
boolean
C25704 (NCI Thesaurus ValueDomain)
C25180 (NCI Thesaurus ValueDomain-2)
ProgressionDate,FirstDistant
Item
DATE OF FIRST DISTANT PROGRESSION
date
Site(s)ofFirstDistantProgression
Item
SITE(S) OF FIRST DISTANT PROGRESSION
text
Item
WHAT WAS THE METHOD USED TO DETERMINE distant PROGRESSION
text
CL.11
Code List
WHAT WAS THE METHOD USED TO DETERMINE distant PROGRESSION
CL Item
Physical Exam (Physical exam)
CL Item
Pathologic (Pathologic)
C25610 (NCI Thesaurus)
C1521733 (UMLS 2011AA)
CL Item
Radiographic (Radiographic)
CL Item
Nuclear Scan (Nuclear scan)
CL Item
Other, Specify (Other, specify)
Other,specify(methodusedtodeterminedistantprogression)
Item
Other, specify (method used to determine distant progression)
text
Item
New Primary Site
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (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.28
Code List
New Primary Site
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Aml/mds (AML/MDS)
C9441 (NCI Thesaurus)
CL Item
Bcc (BCC)
CL Item
Bladder (Bladder)
C12414 (NCI Thesaurus)
C0005682 (UMLS 2011AA)
CL Item
Brain (Brain)
C12439 (NCI Thesaurus)
C0006104 (UMLS 2011AA)
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 (Liver)
C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)
CL Item
Lung (Lung)
C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)
CL Item
Melanoma (Melanoma)
C3224 (NCI Thesaurus)
C0025202 (UMLS 2011AA)
CL Item
Nhl (NHL)
CL Item
Pancreatic (Pancreatic)
C25726 (NCI Thesaurus)
C0030274 (UMLS 2011AA)
CL Item
Renal (Renal)
C25225 (NCI Thesaurus)
C0022646 (UMLS 2011AA)
CL Item
Squamous-skin (Squamous-Skin)
CL Item
Other Hematologic, Specify (Other Hematologic, specify)
CL Item
Other Solid, Specify (Other solid, specify)
CL Item
Unknown Primary (Unknown primary)
NewPrimaryCancerDate
Item
New Primary Cancer Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Specify(newprimarysite)
Item
Specify (new primary site)
text
HQUse
Item
HQ Use (14 HAS A NEW PRIMARY CANCER OR MDS MYELODYSPLASTIC SYNDROME BEEN DIAGNOSED THAT HAS NOT BEEN PREVIOUSLY REPORTED?)
text
Item
PROTOCOL HORMONES CONTINUING (11)
text
CL.14
Code List
PROTOCOL HORMONES CONTINUING (11)
CL Item
N/a - Arm 2 - No Hormones (N/A - Arm 2 - No hormones)
CL Item
No, terminated since last report period (No, terminated since last report period)
CL Item
No, Previously Reported (No, previously reported)
CL Item
Yes, Per Protocol (Yes, per protocol)
CL Item
Other, Explain (Other (explain in comments))
Non-protocol Therapy
Item
DID THE PATIENT RECEIVE ANY NON-PROTOCOL PROSTATE CANCER THERAPY SINCE THE LAST FOLLOW-UP (If yes, enter therapy type and date for each therapy delivered during the follow-up period.)
boolean
C25704 (NCI Thesaurus ValueDomain)
C25180 (NCI Thesaurus ValueDomain-2)
C1518384 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
Item
Non-Protocol Therapy Type
text
C25284 (NCI Thesaurus ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1518384 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
CL.16
Code List
Non-Protocol Therapy Type
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Radiation To Pelvis (Radiation to pelvis)
CL Item
Radiation To Other Sites, Specify (Radiation to other sites, specify)
CL Item
Surgery (Surgery)
C17173 (NCI Thesaurus)
C0038894 (UMLS 2011AA)
CL Item
Chemotherapy (Chemotherapy)
C15632 (NCI Thesaurus)
C0392920 (UMLS 2011AA)
CL Item
Hormones (Hormones)
CL Item
Other Specify (Other, specify)
CL Item
Surgical Procedure Related To Previous Rt, Specify (Surgical procedure related to previous RT, specify)
CL Item
Complementary Alternative Medicine, Specify (Complementary Alternative Medicine, specify)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Non-ProtocolTherapyDate,First
Item
Date of first non-protocol therapy
date
Specify(non-protocolprostatecancertherapy)
Item
Specify (non-protocol prostate cancer therapy) (12)
text
Item Group
Radiation therapy
C1522449 (UMLS CUI-1)
Total dose prostate
Item
TOTAL DOSE TO PROSTATE
float
C25209 (NCI Thesaurus ValueDomain)
C2169193 (UMLS CUI-1)
C0033572 (UMLS CUI-2)
Total dose pelvis
Item
TOTAL DOSE TO PELVIS
float
C25209 (NCI Thesaurus ValueDomain)
C2169193 (UMLS CUI-1)
C0030797 (UMLS CUI-2)
RTBeginDate
Item
RADIATION THERAPY START DATE
date
C1522449 (UMLS CUI-1)
C0808070 (UMLS CUI-2)
RTEndDate
Item
RADIATION THERAPY END DATE
date
C1522449 (UMLS CUI-1)
C0806020 (UMLS CUI-2)
Item
WERE THERE ANY UNSCHEDULED INTERRUPTIONS IN RADIATION THERAPY?
text
CL.12
Code List
WERE THERE ANY UNSCHEDULED INTERRUPTIONS IN RADIATION THERAPY?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Due To Toxicity (Yes, due to toxicity)
CL Item
Yes, due to other reason (Yes, due to other reason)
RT interruption reason
Item
Specify RT interruption reason
text
C25685 (NCI Thesaurus ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C25594 (NCI Thesaurus Property)
C25211 (NCI Thesaurus Property-2)
C25542 (NCI Thesaurus Property-3)
C0392360 (UMLS CUI-1)
C1522449 (UMLS CUI-2)
C1512900 (UMLS CUI-3)
Item
REASON RADIATION THERAPY TREATMENT ENDED
text
C3166257 (UMLS CUI-1)
C1522449 (UMLS CUI-2)
CL.13
Code List
REASON RADIATION THERAPY TREATMENT ENDED
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
CL Item
Disease Progression/relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Toxicity/side Effects/complications (Toxicity/side effects/complications)
CL Item
Death On Study (Death on study)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal or refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal or refusal prior to beginning protocol therapy)
CL Item
Alternative Therapy (Alternative therapy, specify)
CL Item
Other Complicating Disease (Other complicating disease, specify)
CL Item
Other, Specify: (Other, specify)
Alternativetherapy,specify(reasonradiationtherapyended)
Item
Alternative therapy, specify (reason radiation therapy ended)
text
Othercomplicatingdisease,specify(reasonradiationtherapyended)
Item
Other complicating disease, specify (reason radiation therapy ended)
text
Other,specify(reasonradiationtherapyended)
Item
Other, specify (reason radiation therapy ended) (10)
text
Item Group
Adverse event
C0877248 (UMLS CUI-1)
Toxicity grade 3 or more
Item
NEW OR CONTINUING TOXICITY (>= Severity Grade 3) SINCE THE LAST REPORT? (Report impotence, urinary incontinence, urinary frequency in Q12)
boolean
C25704 (NCI Thesaurus ValueDomain)
C25180 (NCI Thesaurus ValueDomain-2)
C1519275 (UMLS CUI-1)
C3537125 (UMLS CUI-2)
IMT code adverse event
Item
IMT CODE ADVERSE EVENT BASED ON CTEP TOXICITY TERM
text
CTCAdverseEventTerm
Item
CTC ADVERSE EVENT TERM
text
C1516728 (UMLS CUI-1)
C2826934 (UMLS CUI-2)
Item
COMMON TOXICITY GENERAL CATEGORY
text
C1516728 (UMLS CUI-1)
C0683312 (UMLS CUI-2)
CL.25
Code List
COMMON TOXICITY GENERAL CATEGORY
CL Item
Allergy / Immunology (Allergy / Immunology)
CL Item
Auditory/hearing (Auditory/Hearing)
CL Item
Blood/bone Marrow (Blood/Bone marrow)
CL324677 (NCI Metathesaurus)
CL Item
Cardiovascular (arrhythmia) (Cardiovascular (Arrhythmia))
CL Item
Cardiovascular (general) (Cardiovascular (General))
CL Item
Coagulation (Coagulation)
C20812 (NCI Thesaurus)
C0005778 (UMLS 2011AA)
CL Item
Constitutional Symptoms (Constitutional Symptoms)
CL Item
Dermatology/skin (Dermatology/Skin)
CL Item
Endocrine (Endocrine)
C0521425 (NCI Metathesaurus)
CL Item
Gastrointestinal (Gastrointestinal)
C13359 (NCI Thesaurus)
C0521362 (UMLS 2011AA)
CL Item
Hemorrhage (Hemorrhage)
C26791 (NCI Thesaurus)
C0019080 (UMLS 2011AA)
CL Item
Hepatic (Hepatic)
C13308 (NCI Thesaurus)
C0205054 (UMLS 2011AA)
CL Item
Infection Febrile Neutropenia (Infection Febrile Neutropenia)
CL Item
Lymphatics (Lymphatics)
CL Item
Metabolic/laboratory (Metabolic/Laboratory)
CL Item
Musculoskeletal (Musculoskeletal)
C25348 (NCI Thesaurus)
C0497254 (UMLS 2011AA)
CL Item
Neurology (Neurology)
C16908 (NCI Thesaurus)
C0027855 (UMLS 2011AA)
CL Item
Ocular/visual (Ocular/Visual)
CL Item
Pain (Pain)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
CL Item
Pulmonary (Pulmonary)
C13304 (NCI Thesaurus)
C2709248 (UMLS 2011AA)
CL Item
Renal/genitourinary (Renal/Genitourinary)
CL328688 (NCI Metathesaurus)
CL Item
Second Malignancy (Second Malignancy)
CL Item
Sexual/reproductive Functions (Sexual/Reproductive Functions)
CL Item
Syndromes (Syndromes)
Item
CTC ADVERSE EVENT GRADE
integer
C2985911 (UMLS CUI-1)
CL.26
Code List
CTC ADVERSE EVENT GRADE
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CTCADVERSEEVENTONSETDATE
Item
CTC ADVERSE EVENT ONSET DATE (GRADE >=3)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0332162 (UMLS CUI-3)
Item
CTC ADVERSE EVENT ATTRIBUTION CODE
text
C1706735 (UMLS CUI-1)
CL.27
Code List
CTC ADVERSE EVENT ATTRIBUTION CODE
CL Item
Radiotherapy only (Radiotherapy only)
CL Item
Combined Modality (hormone, Rt) (Combined modality (Hormone, RT))
CL Item
Tumor And Rx (Tumor and Rx)
CL Item
Hormones (Hormones)
CL Item
Other Cause, Specify (Other cause, specify)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Othercause,specify(adverseeventattribution)
Item
Other cause, specify (adverse event attribution)
text
Specify(adverseevent)
Item
SPECIFY (adverse event)
text
Renal or genitourinary toxicity
Item
RENAL/GENITOURINARY TOXICITY ADVERSE EVENT REPORTS (AER) (Use CTC 2.0 to code severity)
boolean
C25704 (NCI Thesaurus ValueDomain)
C25180 (NCI Thesaurus ValueDomain-2)
C1527021 (UMLS CUI-1)
C1522602 (UMLS CUI-2)
Item
URINARY INCONTINENCE, Severity Grade (0-3)
text
C0042024 (UMLS CUI-1)
C0392364 (UMLS CUI-2)
CL.18
Code List
URINARY INCONTINENCE, Severity Grade (0-3)
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
CL Item
1 (1)
CL Item
2 (2)
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
3 (3)
Item
URINARY INCONTINENCE, Attribution (see table below)
text
CL.19
Code List
URINARY INCONTINENCE, Attribution (see table below)
CL Item
Radiotherapy only (Radiotherapy only)
CL Item
Combined Modality (hormone, Rt) (Combined modality (Hormone, RT))
CL Item
Tumor And Rx (Tumor and Rx)
CL Item
Hormones (Hormones)
CL Item
Other Cause, Specify (Other cause, specify)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Specifyifothercause(urinaryincontinence,attribution)
Item
Specify if other cause (urinary incontinence, attribution)
text
URINARYINCONTINENCE,AERBeginDate
Item
URINARY INCONTINENCE, AER Begin Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
URINARY FREQUENCY/URGENCY, Severity Grade (0-3)
text
CL.20
Code List
URINARY FREQUENCY/URGENCY, Severity Grade (0-3)
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
CL Item
1 (1)
CL Item
2 (2)
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
3 (3)
Item
URINARY FREQUENCY/URGENCY, Attribution (see table below)
text
CL.21
Code List
URINARY FREQUENCY/URGENCY, Attribution (see table below)
CL Item
Radiotherapy only (Radiotherapy only)
CL Item
Combined Modality (hormone, Rt) (Combined modality (Hormone, RT))
CL Item
Tumor And Rx (Tumor and Rx)
CL Item
Hormones (Hormones)
CL Item
Other Cause, Specify (Other cause, specify)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Specifyifothercause(urinaryfrequency/urgency,attribution)
Item
Specify if other cause (urinary frequency/urgency, attribution)
text
URINARYFREQUENCY/URGENCY,AERBeginDate
Item
URINARY FREQUENCY/URGENCY, AER Begin Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
ERECTILE IMPOTENCE, Severity Grade (0-3)
text
CL.22
Code List
ERECTILE IMPOTENCE, Severity Grade (0-3)
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
CL Item
1 (1)
CL Item
2 (2)
C66833 (NCI Thesaurus)
CL Item
3 (3)
Item
ERECTILE IMPOTENCE, Attribution (Attribution)
text
CL.23
Code List
ERECTILE IMPOTENCE, Attribution (Attribution)
CL Item
Radiotherapy only (Radiotherapy only)
CL Item
Combined Modality (hormone, Rt) (Combined modality (Hormone, RT))
CL Item
Tumor And Rx (Tumor and Rx)
CL Item
Hormones (Hormones)
CL Item
Other Cause, Specify (Other cause, specify)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Specifyifothercause(erectileimpotence,attribution)
Item
Specify if other cause (erectile impotence, attribution)
text
ERECTILEIMPOTENCE,AERBeginDate
Item
ERECTILE IMPOTENCE, AER Begin Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
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