ID

10026

Descrizione

FS Radiation Therapy Oncology Group Phase III Randomized Study of Adjuvant Therapy for High Risk pT3NO Prostate Cancer Initial Follow-up Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=11CE883A-971B-476A-E044-0003BA3F9857

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=11CE883A-971B-476A-E044-0003BA3F9857

Keywords

versioni (2)
  1. 19/09/12 19/09/12 -
  2. 18/03/15 18/03/15 - Martin Dugas
Caricato su

18 marzo 2015

DOI

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Licenza

Creative Commons BY-NC 3.0 Legacy
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Prostate cancer (FS RTOG) Phase III Randomized Study of Adjuvant Therapy for High Risk pT3NO

Inglese

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 moduli  
  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
Descrizione

Header

RTOG Study
Descrizione

RTOGStudy

Tipo di dati

text

Case #
Descrizione

Case#

Tipo di dati

text

Institution Name
Descrizione

InstitutionName

Tipo di dati

text

Institution No.
Descrizione

InstitutionNo.

Tipo di dati

text

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

PatientName,Last

Tipo di dati

text

Patient Name, First (13)
Descrizione

PatientName,First

Tipo di dati

text

AMENDED DATA
Descrizione

AmendedData

Tipo di dati

text

DATE from (Q2)
Descrizione

DATEfrom

Tipo di dati

date

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

Comments

Tipo di dati

text

SIGNATURE
Descrizione

Signature

Tipo di dati

text

DATE
Descrizione

Date

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Patient data
Descrizione

Patient data

PATIENT'S VITAL STATUS (2)
Descrizione

Patient'sVitalStatus

Tipo di dati

text

DATE OF LAST CONTACT OR DEATH (3)
Descrizione

DeathDate/LastContactDate

Tipo di dati

date

CAUSE OF DEATH (IF DEAD)
Descrizione

Causeofdeath

Tipo di dati

text

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

PrimaryCauseDeathOtherReasonSpecify

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ObjectClass-2
C25251
NCI Metathesaurus ObjectClass
C0007465
NCI Thesaurus Property
C17649
NCI Thesaurus Property-2
C25365
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C0007465
HAS THE PATIENT HAD A DOCUMENTED CLINICAL ASSESSMENT FOR PROSTATE CANCER SINCE SUBMISSION OF THE PREVIOUS FOLLOWUP FORM?
Descrizione

HASTHEPATIENTHADADOCUMENTEDCLINICALASSESSMENTFORPROSTATECANCERSINCESUBMISSIONOFTHEPREVIOUSFOLLOWUPFORM?

Tipo di dati

boolean

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

CancerFollow-upStatusDate

Tipo di dati

date

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

PERFORMANCE STATUS (ZUBROD 0-4)

Tipo di dati

integer

Follow-up PSA Value(s)
Descrizione

Follow-upPSAValue(s)

Tipo di dati

text

Date of PSA Assessment(s) (7)
Descrizione

DateofPSAAssessment(s)

Tipo di dati

date

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

HASTHEPATIENTHADAPROSTATEBIOPSYSINCESUBMISSIONOFTHELASTFOLLOWUPFORM?

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ValueDomain-2
C25180
UMLS CUI-1
C0194804
Biopsy Date
Descrizione

Biopsy Date

Tipo di dati

date

Alias
UMLS CUI-1
C0005558
UMLS CUI-2
C0011008
HAS THE PATIENT DEVELOPED A FIRST PROGRESSION THAT HAS NOT BEEN PREVIOUSLY REPORTED? (A)
Descrizione

HASTHEPATIENTDEVELOPEDAFIRSTPROGRESSIONTHATHASNOTBEENPREVIOUSLYREPORTED?

Tipo di dati

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)
Descrizione

ProgressionInd,Biochemical

Tipo di dati

boolean

DATE OF FIRST BIOCHEMICAL PROGRESSION
Descrizione

ProgressionDate,FirstBiochemical

Tipo di dati

date

PSA Value at progression (B)
Descrizione

ProgressionPSAValue

Tipo di dati

float

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

HASTHEPATIENTBEENDIAGNOSEDWITHFIRSTLOCAL-REGIONALRECURRENCESINCESUBMISSIONOFLASTFOLLOW-UPFORM?

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ValueDomain-2
C25180
DATE OF FIRST LOCAL-REGIONAL PROGRESSION
Descrizione

ProgressionDate,FirstLocal-Regional

Tipo di dati

date

SITE(S) OF LOCAL/REGIONAL PROGRESSION
Descrizione

SITE(S)OFLOCAL/REGIONALPROGRESSION

Tipo di dati

text

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

WHATWASTHEMETHODUSEDTODETERMINElocal/regionalPROGRESSION

Tipo di dati

text

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

Other,specify(methodusedtodeterminelocal/regionalprogression)

Tipo di dati

text

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

HASTHEPATIENTBEENDIAGNOSEDWITHFIRSTDISTANTRECURRENCESINCESUBMISSIONOFTHELASTFOLLOW-UPFORM?

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ValueDomain-2
C25180
UMLS CUI-1
C1269798
DATE OF FIRST DISTANT PROGRESSION
Descrizione

ProgressionDate,FirstDistant

Tipo di dati

date

SITE(S) OF FIRST DISTANT PROGRESSION
Descrizione

Site(s)ofFirstDistantProgression

Tipo di dati

text

WHAT WAS THE METHOD USED TO DETERMINE distant PROGRESSION
Descrizione

WHATWASTHEMETHODUSEDTODETERMINEdistantPROGRESSION

Tipo di dati

text

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

Other,specify(methodusedtodeterminedistantprogression)

Tipo di dati

text

Radiation therapy
Descrizione

Radiation therapy

Alias
UMLS CUI-1
C1522449
TOTAL DOSE TO PROSTATE (Gy)
Descrizione

TOTAL DOSE TO PROSTATE (Gy)

Tipo di dati

float

Unità di misura
  • Gy
Alias
NCI Thesaurus ValueDomain
C25209
Gy
TOTAL DOSE TO PELVIS
Descrizione

TOTALDOSETOPELVIS

Tipo di dati

float

Unità di misura
  • Gy
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0242485
Gy
RADIATION THERAPY START DATE
Descrizione

RTBeginDate

Tipo di dati

date

RADIATION THERAPY END DATE
Descrizione

RTEndDate

Tipo di dati

date

WERE THERE ANY UNSCHEDULED INTERRUPTIONS IN RADIATION THERAPY?
Descrizione

RTInterruptionsInd

Tipo di dati

text

Specify RT interruption reason
Descrizione

RadiationTherapyUnscheduledInterruptionSpecify

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25685
NCI Thesaurus ObjectClass
C15313
NCI Thesaurus Property
C25594
NCI Thesaurus Property-2
C25211
NCI Thesaurus Property-3
C25542
REASON RADIATION THERAPY TREATMENT ENDED
Descrizione

REASONRADIATIONTHERAPYTREATMENTENDED

Tipo di dati

text

Alternative therapy, specify (reason radiation therapy ended)
Descrizione

Alternativetherapy,specify(reasonradiationtherapyended)

Tipo di dati

text

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

Othercomplicatingdisease,specify(reasonradiationtherapyended)

Tipo di dati

text

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

Other,specify(reasonradiationtherapyended)

Tipo di dati

text

PROTOCOL HORMONES CONTINUING (11)
Descrizione

PROTOCOLHORMONESCONTINUING

Tipo di dati

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.)
Descrizione

DIDTHEPATIENTRECEIVEANYNON-PROTOCOLPROSTATECANCERTHERAPYSINCETHELASTFOLLOW-UP

Tipo di dati

boolean

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

Non-ProtocolTherapyAdministeredType

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Date of first non-protocol therapy
Descrizione

Non-ProtocolTherapyDate,First

Tipo di dati

date

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

Specify(non-protocolprostatecancertherapy)

Tipo di dati

text

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

RENAL/GENITOURINARYTOXICITYADVERSEEVENTREPORTS(AER)

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ValueDomain-2
C25180
URINARY INCONTINENCE, Severity Grade (0-3)
Descrizione

URINARYINCONTINENCE,SeverityGrade

Tipo di dati

text

URINARY INCONTINENCE, Attribution (see table below)
Descrizione

URINARYINCONTINENCE,Attribution

Tipo di dati

text

Specify if other cause (urinary incontinence, attribution)
Descrizione

Specifyifothercause(urinaryincontinence,attribution)

Tipo di dati

text

URINARY INCONTINENCE, AER Begin Date
Descrizione

URINARYINCONTINENCE,AERBeginDate

Tipo di dati

date

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

URINARYFREQUENCY/URGENCY,SeverityGrade

Tipo di dati

text

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

URINARYFREQUENCY/URGENCY,Attribution

Tipo di dati

text

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

Specifyifothercause(urinaryfrequency/urgency,attribution)

Tipo di dati

text

URINARY FREQUENCY/URGENCY, AER Begin Date
Descrizione

URINARYFREQUENCY/URGENCY,AERBeginDate

Tipo di dati

date

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

ERECTILEIMPOTENCE,SeverityGrade

Tipo di dati

text

ERECTILE IMPOTENCE, Attribution (see table below)
Descrizione

ERECTILEIMPOTENCE,Attribution

Tipo di dati

text

Specify if other cause (erectile impotence, attribution)
Descrizione

Specifyifothercause(erectileimpotence,attribution)

Tipo di dati

text

ERECTILE IMPOTENCE, AER Begin Date
Descrizione

ERECTILEIMPOTENCE,AERBeginDate

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Adverse event
Descrizione

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)
Descrizione

NEWORCONTINUINGTOXICITY(>=SeverityGrade3)SINCETHELASTREPORT?

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ValueDomain-2
C25180
IMT CODE ADVERSE EVENT BASED ON CTEP TOXICITY TERM
Descrizione

IMTCODEADVERSEEVENTBASEDONCTEPTOXICITYTERM

Tipo di dati

text

CTC ADVERSE EVENT TERM
Descrizione

CTCAdverseEventTerm

Tipo di dati

text

COMMON TOXICITY GENERAL CATEGORY
Descrizione

COMMONTOXICITYGENERALCATEGORY

Tipo di dati

text

CTC ADVERSE EVENT GRADE
Descrizione

CTCADVERSEEVENTGRADE

Tipo di dati

text

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

CTCADVERSEEVENTONSETDATE

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
CTC ADVERSE EVENT ATTRIBUTION CODE
Descrizione

CTCADVERSEEVENTATTRIBUTIONCODE

Tipo di dati

text

Other cause, specify (adverse event attribution)
Descrizione

Othercause,specify(adverseeventattribution)

Tipo di dati

text

SPECIFY (adverse event)
Descrizione

Specify(adverseevent)

Tipo di dati

text

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

HQUse

Tipo di dati

text

New cancer
Descrizione

New cancer

Alias
UMLS CUI-1
C0205314
UMLS CUI-2
C0006826
New Primary Site
Descrizione

NewCancerDiagnosisAnatomicSite

Tipo di dati

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
Descrizione

NewPrimaryCancerDate

Tipo di dati

date

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

Specify(newprimarysite)

Tipo di dati

text

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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 moduli
  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
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
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
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)
Cause of death, specify
Item
Due to other cause, specify (cause of death) (4)
text
C16960 (NCI Thesaurus ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0007465 (NCI Metathesaurus ObjectClass)
C17649 (NCI Thesaurus Property)
C25365 (NCI Thesaurus Property-2)
C25685 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
Documented clinical assessment for prostate cancer
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)
integer
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 since last follow-up
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
date
C0005558 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
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)
Biochemical recurrence
Item
HAS THE PATIENT BEEN DIAGNOSED WITH BIOCHEMICAL RECURRENCE SINCE SUBMISSION OF LAST FOLLOW-UP FORM? (See Protocol Section 11)
boolean
Progression date, biochemical
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)
ProgressionDate,FirstLocal-Regional
Item
DATE OF FIRST LOCAL-REGIONAL PROGRESSION
date
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)
Method to determine progression, specify
Item
Other, specify (method used to determine local/regional progression) (C)
text
Distant metastasis
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)
C1269798 (UMLS CUI-1)
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 Group
C1522449 (UMLS CUI-1)
Total dose prostate
Item
TOTAL DOSE TO PROSTATE (Gy)
float
C25209 (NCI Thesaurus ValueDomain)
Total dose pelvis
Item
TOTAL DOSE TO PELVIS
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS CUI-1)
RTBeginDate
Item
RADIATION THERAPY START DATE
date
RTEndDate
Item
RADIATION THERAPY END DATE
date
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)
Item
REASON RADIATION THERAPY TREATMENT ENDED
text
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
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)
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.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
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)
Item
URINARY INCONTINENCE, Severity Grade (0-3)
text
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)
C0205448 (UMLS 2011AA)
CL Item
3 (3)
Item
ERECTILE IMPOTENCE, Attribution (see table below)
text
CL.23
Code List
ERECTILE IMPOTENCE, 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(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)
Item Group
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)
IMT code adverse event
Item
IMT CODE ADVERSE EVENT BASED ON CTEP TOXICITY TERM
text
CTCAdverseEventTerm
Item
CTC ADVERSE EVENT TERM
text
Item
COMMON TOXICITY GENERAL CATEGORY
text
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
text
C2985911 (UMLS CUI-1)
CL.26
Code List
CTC ADVERSE EVENT GRADE
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
9 (9)
CTCADVERSEEVENTONSETDATE
Item
CTC ADVERSE EVENT ONSET DATE (GRADE >=3)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
CTC ADVERSE EVENT ATTRIBUTION CODE
text
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
HQUse
Item
HQ Use (14 HAS A NEW PRIMARY CANCER OR MDS MYELODYSPLASTIC SYNDROME BEEN DIAGNOSED THAT HAS NOT BEEN PREVIOUSLY REPORTED?)
text
Item Group
C0205314 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
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
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