ID

7430

Beschrijving

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

Link

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

Trefwoorden

  1. 19-09-12 19-09-12 -
  2. 09-01-15 09-01-15 - Martin Dugas
  3. 09-01-15 09-01-15 - Martin Dugas
  4. 05-07-15 05-07-15 -
Geüploaded op

9 januari 2015

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy

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

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. StudyEvent: RTOG 0815 F0: Radiation Therapy Oncology Group Phase III Randomized Study of Dose- Escalated Radiotherapy With/Without STAD for Intermediate-Risk Prostate Cancer Initial Follow-up Form
    1. INSTRUCTIONS: Submit this form at the appropriate followup interval. Use -1 for unknown or not applicable unless otherwise specified in codetable. All dates to be reported mm-dd-yyyy unless otherwise indicated.
Unnamed2
Beschrijving

Unnamed2

RTOG Study No.
Beschrijving

Protocol ID RTOG

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1514695
NCI Thesaurus Property
C19778
NCI Thesaurus Property-2
C25364
Case #
Beschrijving

RadiationTherapyOncologyGroupPatientCaseIdentifierNumber

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C19778
UMLS 2011AA ObjectClass-2
C1514695
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C49152
UMLS 2011AA Property-2
C1706256
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
Institution Name
Beschrijving

Institution Name

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Institution No.
Beschrijving

Institution Number

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
UMLS CUI-2
C0805701
NCI Thesaurus Property
C25364
Patient Initials
Beschrijving

Patient Initials

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
RTOG Patient ID
Beschrijving

Trial subject ID RTOG

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1514695
NCI Thesaurus Property
C19778
NCI Thesaurus Property-2
C25364
Header
Beschrijving

Header

Amended Data
Beschrijving

Data amended

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Unnamed 3
Beschrijving

Unnamed 3

Patient's Vital Status
Beschrijving

Patient Status

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C3846084
NCI Thesaurus ValueDomain
C18003
NCI Thesaurus ValueDomain-2
C25688
NCI Thesaurus Property
C25717
Date of Last Contact or Death
Beschrijving

Date last contact

Datatype

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C0805839
NCI Thesaurus Property
C25461
NCI Thesaurus Property-2
C25551
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Primary Cause of Death
Beschrijving

Primary Cause of Death

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C0007465
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C28554
NCI Thesaurus ValueDomain-2
C25251
Due to other cause, specify
Beschrijving

Primary Cause of Death, specify

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C0007465
NCI Thesaurus ObjectClass-2
C25251
NCI Metathesaurus ObjectClass
C0007465
NCI Thesaurus Property
C17649
NCI Thesaurus Property-2
C25365
NCI Thesaurus ValueDomain
C25685
Has the patient had a documented clinical assessment for this cancer (SINCE SUBMISSION OF THE PREVIOUS FOLLOW-UP FORM)
Beschrijving

Documented clinical assessment for this cancer

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1522577
NCI Thesaurus Property
C16033
UMLS CUI-2
C0006826
NCI Thesaurus ObjectClass
C9305
NCI Thesaurus Property-2
C25365
Date
Beschrijving

Assessment Date

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985720
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C38000
Performance Status
Beschrijving

ECOG Performance Status

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1520224
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
Unnamed Module 6
Beschrijving

Unnamed Module 6

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

Prostate Biopsy

Datatype

text

Alias
NCI Thesaurus ObjectClass
C15189
UMLS CUI-1
C0194804
NCI Thesaurus ObjectClass-2
C12410
NCI Thesaurus Property
C38000
NCI Thesaurus ValueDomain
C25688
Biopsy Date
Beschrijving

Biopsy Date

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0005558
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C15189
UMLS CUI-2
C0011008
NCI Thesaurus Property
C25275
Is the tumor palpable
Beschrijving

Palpable Tumor

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C0746412
NCI Thesaurus ObjectClass
C3262
NCI Thesaurus Property
C25626
NCI Thesaurus ObjectClass-2
C25606
Unnamed Module 5
Beschrijving

Unnamed Module 5

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

PSA Failure

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C2985506
NCI Thesaurus Property
C25626
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ObjectClass-2
C25434
Has the patient been diagnosed with a first local recurrence (SINCE SUBMISSION OF LAST FOLLOW-UP FORM See Protocol Section 11)
Beschrijving

Neoplasm recurrence, Local

Datatype

text

Alias
NCI Thesaurus ObjectClass
C19987
UMLS CUI-1
C0027643
NCI Thesaurus Property
C67263
NCI Thesaurus Property-2
C25509
NCI Thesaurus Property-3
C15220
NCI Thesaurus ValueDomain
C38148
Date
Beschrijving

Date of Neoplasm local recurrence

Datatype

date

Alias
NCI Thesaurus ObjectClass
C3352
UMLS CUI-1
C0027643
NCI Thesaurus ObjectClass-2
C25388
UMLS CUI-2
C0011008
NCI Thesaurus Property
C25509
NCI Thesaurus Property-2
C15220
NCI Thesaurus ValueDomain
C25164
Other Specify
Beschrijving

Evaluation method, specify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C2911685
NCI Thesaurus ObjectClass
C20989
UMLS CUI-2
C1521902
NCI Thesaurus Property
C16847
Other Specify
Beschrijving

Evaluation method, specify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C2911685
NCI Thesaurus ObjectClass
C20989
UMLS CUI-2
C1521902
NCI Thesaurus Property
C16847
Has the patient been diagnosed with first distant progression (SINCE SUBMISSION OF THE LAST FOLLOW-UP FORM)
Beschrijving

Neoplasm recurrence, Distal

Datatype

text

Alias
NCI Thesaurus ObjectClass
C19987
UMLS CUI-1
C0027627
NCI Thesaurus Property
C25321
NCI Thesaurus Property-2
C25509
NCI Thesaurus Property-3
C15220
NCI Thesaurus ValueDomain
C25180
Date
Beschrijving

Date of Neoplasm distal recurrence

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0027627
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ValueDomain-2
C25509
UMLS CUI-2
C0011008
NCI Thesaurus Property
C25275
Sites of Progression (First distant)
Beschrijving

Progression Sites

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0280457
NCI Thesaurus Property
C25341
NCI Thesaurus ObjectClass
C25331
Method of Evaluation (DISTANT PROGRESSION)
Beschrijving

Evaluation method

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2911685
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C16847
Method of Evaluation (DISTANT PROGRESSION)
Beschrijving

Evaluation method

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2911685
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C16847
Unnamed Module 4a
Beschrijving

Unnamed Module 4a

PSA Date
Beschrijving

PSA date

Datatype

date

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0138741
NCI Thesaurus Property
C17525
UMLS CUI-2
C0011008
NCI Thesaurus Property-2
C20200
NCI Thesaurus Property-3
C17220
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
PSA Value
Beschrijving

PSA

Datatype

float

Maateenheden
  • ng/ml
Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0138741
NCI Thesaurus Property
C17525
NCI Thesaurus Property-2
C20200
NCI Thesaurus Property-3
C17220
NCI Thesaurus ValueDomain
C25712
ng/ml
Units
Beschrijving

AssessmentLabUOM

Datatype

text

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ValueDomain
C25709
UMLS 2011AA ValueDomain
C1519795
Method of Assay
Beschrijving

PSAManufacturerAssayType

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C17525
UMLS 2011AA ObjectClass
C0138741
NCI Thesaurus Property
C16341
UMLS 2011AA Property
C0005507
NCI Thesaurus Property-2
C25392
UMLS 2011AA Property-2
C0947322
Treatment Schedule (lhrh Agonist)
Beschrijving

Treatment Schedule (lhrh Agonist)

Is patient on protocol hormone (ORAL ANTIANDROGEN)
Beschrijving

ProtocolHormoneTherapyPatientCurrentReceivedInd-3

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C25320
UMLS 2011AA ObjectClass-2
C1507394
NCI Thesaurus ObjectClass-3
C15445
UMLS 2011AA ObjectClass-3
C0279025
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus Property-2
C25639
UMLS 2011AA Property-2
C1514756
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
LHRH agonist
Beschrijving

HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationName

Datatype

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
NCI Thesaurus Property-2
C1910
UMLS 2011AA Property-2
C1518041
Other, specify
Beschrijving

HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationSpecify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus Property-2
C1910
UMLS 2011AA Property-2
C1518041
LHRH agonist start date (IF STARTED IN THIS FOLLOW-UP PERIOD)
Beschrijving

HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationBeginDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus Property-2
C1910
UMLS 2011AA Property-2
C1518041
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
LHRH agonist end date (IF TERMINATED IN THIS FOLLOW-UP PERIOD)
Beschrijving

HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationEndDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus Property-2
C1910
UMLS 2011AA Property-2
C1518041
Reason Treatment Ended
Beschrijving

Off Treatment Reason

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
Alternative Therapy, Specify
Beschrijving

Off-treatmentAlternativeReasonSpecify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
NCI Thesaurus Property
C25415
UMLS 2011AA Property
C1523987
NCI Thesaurus Property-2
C25365
UMLS 2011AA Property-2
C0678257
Patient off-treatment for other complicating disease, specify
Beschrijving

Off-TreatmentConditionSpecify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
NCI Thesaurus Property
C25457
UMLS 2011AA Property
C0348080
Other specify
Beschrijving

Off Treatment Reason, specify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
UMLS CUI-3
C1521902
Total Dose (TO DATE)
Beschrijving

Cumulative Dose Agent

Datatype

float

Alias
NCI Thesaurus ObjectClass
C1708
UMLS CUI-1
C2986497
NCI Thesaurus ObjectClass-2
C25470
UMLS CUI-2
C1521826
NCI Thesaurus Property
C25304
NCI Thesaurus Property-2
C25256
NCI Thesaurus ValueDomain
C25304
NCI Thesaurus ValueDomain-2
C25488
Treatment Schedule (oral Antiandrogen)
Beschrijving

Treatment Schedule (oral Antiandrogen)

Is patient on protocol hormone (ORAL ANTIANDROGEN)
Beschrijving

ProtocolHormoneTherapyPatientCurrentReceivedInd-3

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C25320
UMLS 2011AA ObjectClass-2
C1507394
NCI Thesaurus ObjectClass-3
C15445
UMLS 2011AA ObjectClass-3
C0279025
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus Property-2
C25639
UMLS 2011AA Property-2
C1514756
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Oral antiandrogen taken
Beschrijving

OralAntiandrogenTherapyAgentAdministeredName

Datatype

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass-2
C25311
UMLS 2011AA ObjectClass-2
C0442027
NCI Thesaurus ObjectClass-3
C15481
UMLS 2011AA ObjectClass-3
C0279492
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
Other, specify
Beschrijving

OralAntiandrogenTherapyAgentAdministeredSpecify

Datatype

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass-2
C25311
UMLS 2011AA ObjectClass-2
C0442027
NCI Thesaurus ObjectClass-3
C15481
UMLS 2011AA ObjectClass-3
C0279492
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Oral Antiandrogen Start Date (IF STARTED IN THIS FOLLOW-UP PERIOD)
Beschrijving

OralAntiandrogenTherapyAgentAdministeredBeginDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass-2
C25311
UMLS 2011AA ObjectClass-2
C0442027
NCI Thesaurus ObjectClass-3
C15481
UMLS 2011AA ObjectClass-3
C0279492
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
Oral Antiandrogen End Date (IF TERMINATED IN THIS FOLLOW-UP PERIOD)
Beschrijving

OralAntiandrogenTherapyAgentAdministeredEndDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass-2
C25311
UMLS 2011AA ObjectClass-2
C0442027
NCI Thesaurus ObjectClass-3
C15481
UMLS 2011AA ObjectClass-3
C0279492
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Reason Treatment Ended
Beschrijving

Off Treatment Reason

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
Alternative Therapy, Specify
Beschrijving

Off-treatmentAlternativeReasonSpecify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
NCI Thesaurus Property
C25415
UMLS 2011AA Property
C1523987
NCI Thesaurus Property-2
C25365
UMLS 2011AA Property-2
C0678257
Patient off-treatment for other complicating disease, specify
Beschrijving

Off-TreatmentConditionSpecify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
NCI Thesaurus Property
C25457
UMLS 2011AA Property
C0348080
Other specify
Beschrijving

Off Treatment Reason, specify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
UMLS CUI-3
C1521902
Total Dose (TO DATE)
Beschrijving

Cumulative Dose Agent

Datatype

float

Alias
NCI Thesaurus ObjectClass
C1708
UMLS CUI-1
C2986497
NCI Thesaurus ObjectClass-2
C25470
UMLS CUI-2
C1521826
NCI Thesaurus Property
C25304
NCI Thesaurus Property-2
C25256
NCI Thesaurus ValueDomain
C25304
NCI Thesaurus ValueDomain-2
C25488
Lab Values
Beschrijving

Lab Values

Lab Values (Month 3)
Beschrijving

Laboratory Test Result Status

Datatype

text

Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C2346633
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25688
Testosterone
Beschrijving

LaboratoryProcedureTestosteroneResultSpecifiedValue

Datatype

float

Maateenheden
  • ng/dl
Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C2299
UMLS 2011AA Property-2
C0039601
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
ng/dl
Date
Beschrijving

TestosteroneAssessmentDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C2299
UMLS 2011AA ObjectClass
C0039601
Units
Beschrijving

AssessmentLabUOM

Datatype

text

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ValueDomain
C25709
UMLS 2011AA ValueDomain
C1519795
Testosterone Lower Limit Normal
Beschrijving

LaboratoryProcedureTestosteroneResultLowerLimitofNormalValue

Datatype

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C2299
UMLS 2011AA Property-2
C0039601
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25555
UMLS 2011AA ValueDomain-2
C1518030
Testosterone Upper Limit Normal
Beschrijving

LaboratoryProcedureTestosteroneResultUpperLimitofNormalValue

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C2299
UMLS 2011AA Property-2
C0039601
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
Lab Values
Beschrijving

Lab Values

Lab Values (Month 3)
Beschrijving

Laboratory Test Result Status

Datatype

text

Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C2346633
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25688
Testosterone
Beschrijving

LaboratoryProcedureTestosteroneResultSpecifiedValue

Datatype

float

Maateenheden
  • ng/dl
Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C2299
UMLS 2011AA Property-2
C0039601
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
ng/dl
Date
Beschrijving

TestosteroneAssessmentDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C2299
UMLS 2011AA ObjectClass
C0039601
Units
Beschrijving

AssessmentLabUOM

Datatype

text

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ValueDomain
C25709
UMLS 2011AA ValueDomain
C1519795
Testosterone Lower Limit Normal
Beschrijving

LaboratoryProcedureTestosteroneResultLowerLimitofNormalValue

Datatype

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C2299
UMLS 2011AA Property-2
C0039601
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25555
UMLS 2011AA ValueDomain-2
C1518030
Testosterone Upper Limit Normal
Beschrijving

LaboratoryProcedureTestosteroneResultUpperLimitofNormalValue

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C2299
UMLS 2011AA Property-2
C0039601
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
Baseline Lab Values (hematologic)
Beschrijving

Baseline Lab Values (hematologic)

Lab Values (Month 3)
Beschrijving

Laboratory Test Result Status

Datatype

text

Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C2346633
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25688
WBC (mm^3)
Beschrijving

Leukocytes (WBC)

Datatype

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0023508
NCI Thesaurus Property
C12529
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
Hemoglobin (g/dL)
Beschrijving

LaboratoryProcedureHemoglobinResultSpecifiedValue

Datatype

float

Maateenheden
  • g/dL
Alias
NCI Thesaurus Property
C16676
UMLS 2011AA Property
C0019046
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
g/dL
Peripheral Platelet Count (x 10^3 U/L)
Beschrijving

Platelets

Datatype

float

Maateenheden
  • 1000/uL
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0005821
NCI Thesaurus Property-2
C12520
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
1000/uL
ANC (mm^3)
Beschrijving

Neutrophil count

Datatype

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0200633
NCI Thesaurus Property
C12533
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C25304
NCI Thesaurus ValueDomain-2
C25712
Date
Beschrijving

Laboratory Procedure Date

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0022885
NCI Thesaurus Property
C25214
UMLS CUI-2
C0011008
NCI Thesaurus Property-2
C38000
NCI Thesaurus ObjectClass
C25294
Baseline Lab Values (hematologic)
Beschrijving

Baseline Lab Values (hematologic)

Lab Values (Month 3)
Beschrijving

Laboratory Test Result Status

Datatype

text

Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C2346633
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25688
Lab Values (Month 3)
Beschrijving

Laboratory Test Result Status

Datatype

text

Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C2346633
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25688
Lab Values (Month 3)
Beschrijving

Laboratory Test Result Status

Datatype

text

Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C2346633
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25688
Test (Month 3)
Beschrijving

LaboratoryTestName

Datatype

text

Alias
NCI Thesaurus ObjectClass
C38470
NCI Thesaurus ValueDomain
C25294
UMLS 2011AA ValueDomain
C0022885
NCI Thesaurus Property
C42614
UMLS 2011AA Property
C0027365
NCI Thesaurus ValueDomain-2
C42614
UMLS 2011AA ValueDomain-2
C0027365
Test (Month 3)
Beschrijving

LaboratoryTestName

Datatype

text

Alias
NCI Thesaurus ObjectClass
C38470
NCI Thesaurus ValueDomain
C25294
UMLS 2011AA ValueDomain
C0022885
NCI Thesaurus Property
C42614
UMLS 2011AA Property
C0027365
NCI Thesaurus ValueDomain-2
C42614
UMLS 2011AA ValueDomain-2
C0027365
Test (Month 3)
Beschrijving

LaboratoryTestName

Datatype

text

Alias
NCI Thesaurus ObjectClass
C38470
NCI Thesaurus ValueDomain
C25294
UMLS 2011AA ValueDomain
C0022885
NCI Thesaurus Property
C42614
UMLS 2011AA Property
C0027365
NCI Thesaurus ValueDomain-2
C42614
UMLS 2011AA ValueDomain-2
C0027365
Value
Beschrijving

LabTestLabsStandardValue

Datatype

float

Alias
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Value
Beschrijving

LabTestLabsStandardValue

Datatype

float

Alias
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Value
Beschrijving

LabTestLabsStandardValue

Datatype

float

Alias
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Date
Beschrijving

Laboratory Procedure Date

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0022885
NCI Thesaurus Property
C25214
UMLS CUI-2
C0011008
NCI Thesaurus Property-2
C38000
NCI Thesaurus ObjectClass
C25294
Date
Beschrijving

Laboratory Procedure Date

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0022885
NCI Thesaurus Property
C25214
UMLS CUI-2
C0011008
NCI Thesaurus Property-2
C38000
NCI Thesaurus ObjectClass
C25294
Date
Beschrijving

Laboratory Procedure Date

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0022885
NCI Thesaurus Property
C25214
UMLS CUI-2
C0011008
NCI Thesaurus Property-2
C38000
NCI Thesaurus ObjectClass
C25294
Baseline Lab Values (hematologic)
Beschrijving

Baseline Lab Values (hematologic)

Lab Values (Month 3)
Beschrijving

Laboratory Test Result Status

Datatype

text

Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C2346633
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25688
Lab Values (Month 3)
Beschrijving

Laboratory Test Result Status

Datatype

text

Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C2346633
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25688
Lab Values (Month 3)
Beschrijving

Laboratory Test Result Status

Datatype

text

Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C2346633
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25688
Value
Beschrijving

LabTestLabsStandardValue

Datatype

float

Alias
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Value
Beschrijving

LabTestLabsStandardValue

Datatype

float

Alias
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Value
Beschrijving

LabTestLabsStandardValue

Datatype

float

Alias
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Date
Beschrijving

Laboratory Procedure Date

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0022885
NCI Thesaurus Property
C25214
UMLS CUI-2
C0011008
NCI Thesaurus Property-2
C38000
NCI Thesaurus ObjectClass
C25294
Date
Beschrijving

Laboratory Procedure Date

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0022885
NCI Thesaurus Property
C25214
UMLS CUI-2
C0011008
NCI Thesaurus Property-2
C38000
NCI Thesaurus ObjectClass
C25294
Date
Beschrijving

Laboratory Procedure Date

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0022885
NCI Thesaurus Property
C25214
UMLS CUI-2
C0011008
NCI Thesaurus Property-2
C38000
NCI Thesaurus ObjectClass
C25294
Non-protocol Therapy
Beschrijving

Non-protocol Therapy

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.)
Beschrijving

Non-protocolTherapyAdministeredInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Non-Protocol Therapy Type
Beschrijving

Non-ProtocolTherapyAdministeredType

Datatype

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
Beschrijving

Non-ProtocolTherapyFirstAdministeredDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Specify
Beschrijving

Non-ProtocolTreatmentFirstAdministeredSpecify

Datatype

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Unnamed Module 7
Beschrijving

Unnamed Module 7

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

New primary cancer

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C0751623
NCI Thesaurus ObjectClass
C25586
NCI Thesaurus ObjectClass-2
C9305
NCI Thesaurus Property
C15220
Second Primary Tumor Site
Beschrijving

Second Primary Tumor Site

Datatype

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS CUI-1
C0751623
NCI Thesaurus ObjectClass
C3262
UMLS CUI-2
C1515974
NCI Thesaurus Property
C25341
NCI Thesaurus ObjectClass-2
C25666
Second Primary Cancer Date
Beschrijving

Second Primary Tumor Date

Datatype

date

Alias
NCI Thesaurus ObjectClass
C3262
UMLS CUI-1
C0751623
NCI Thesaurus ObjectClass-2
C25251
UMLS CUI-2
C0011008
NCI Thesaurus ObjectClass-3
C25666
NCI Thesaurus Property
C15220
NCI Thesaurus ValueDomain
C25164
Other specify
Beschrijving

Primary Disease Site

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C0449695
NCI Thesaurus Property
C25341
NCI Thesaurus ObjectClass
C25251
NCI Thesaurus ObjectClass-2
C2991
Protocol Specific Adverse Event Evaluation
Beschrijving

Protocol Specific Adverse Event Evaluation

Any Treatment Related Adverse Events
Beschrijving

Adverse Event

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25648
UMLS CUI-1
C0877248
NCI Thesaurus ObjectClass-2
C41331
NCI Thesaurus ObjectClass-3
C15368
NCI Metathesaurus Property
C0684224
NCI Thesaurus ValueDomain
C38148
MedDRA disease code
Beschrijving

MedDRACode

Datatype

float

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Metathesaurus ObjectClass
CL104089
CTC Adverse Event Term
Beschrijving

CommonToxicityCriteriaAdverseEventShortNameType

Datatype

text

Alias
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Metathesaurus ValueDomain
C0332307
NCI Thesaurus Property-2
C25249
UMLS 2011AA Property-2
C1806781
Other CTC Adverse Event Term not listed
Beschrijving

CTCAdverseEventTermSpecify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
CTC AE Grade
Beschrijving

CommonToxicityCriteriaAdverseEventGrade

Datatype

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
CTCAE Begin Date (MM DD YYYY)
Beschrijving

CTCAdverseEventReportBeginDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
Attribution
Beschrijving

CTCAdverseEventAttributionScale

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
SAE report submitted
Beschrijving

SeriousAdverseEventReportInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus ObjectClass-2
C54035
UMLS 2011AA ObjectClass-2
C0205404
Footer
Beschrijving

Footer

Comments
Beschrijving

Research Comments

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Signature of Person Completing This Form
Beschrijving

Responsible Person Signature

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus ObjectClass-2
C25657
NCI Thesaurus Property
C25678
Date Form Originally Completed
Beschrijving

Form Completion Date

Datatype

date

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

Similar models

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. StudyEvent: RTOG 0815 F0: Radiation Therapy Oncology Group Phase III Randomized Study of Dose- Escalated Radiotherapy With/Without STAD for Intermediate-Risk Prostate Cancer Initial Follow-up Form
    1. INSTRUCTIONS: Submit this form at the appropriate followup interval. Use -1 for unknown or not applicable unless otherwise specified in codetable. All dates to be reported mm-dd-yyyy unless otherwise indicated.
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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)
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)
Item Group
Unnamed 3
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)
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)
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)
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)
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)
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)
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)
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)
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)
Item Group
Unnamed Module 6
Item
Has the patient had a prostate biopsy (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)
Code List
Has the patient had a prostate biopsy (SINCE SUBMISSION OF THE LAST FOLLOW-UP FORM)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Negative (Yes, negative)
CL Item
Yes, Positive (Yes, positive)
CL Item
Yes, Results Unknown (Yes, results unknown)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
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)
Item
Is 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)
Code List
Is the tumor palpable
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Equivocal (Equivocal)
C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)
CL Item
Not Evaluated (Not evaluated)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item Group
Unnamed Module 5
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)
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)
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)
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, 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)
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)
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)
Item
Method of Evaluation (DISTANT PROGRESSION)
text
C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
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)
Item
Method of Evaluation (DISTANT PROGRESSION)
text
C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
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)
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)
Item
Units
text
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS 2011AA ValueDomain)
Code List
Units
CL Item
Nanograms Per Deciliter (ng/dL)
CL Item
Nanograms Per Milliliter (ng/mL)
CL Item
Nanomoles Per Liter (nmol/l)
CL Item
Not Otherwise Specified (NOS)
CL006269 (NCI Metathesaurus)
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)
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)
Item Group
Treatment Schedule (lhrh Agonist)
ProtocolHormoneTherapyPatientCurrentReceivedInd-3
Item
Is patient on protocol hormone (ORAL ANTIANDROGEN)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25320 (NCI Thesaurus ObjectClass-2)
C1507394 (UMLS 2011AA ObjectClass-2)
C15445 (NCI Thesaurus ObjectClass-3)
C0279025 (UMLS 2011AA ObjectClass-3)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C25639 (NCI Thesaurus Property-2)
C1514756 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
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)
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)
Item
Reason Treatment Ended
text
C25638 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
Code List
Reason Treatment Ended
CL Item
Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Death On Study (Death on study)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Before Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Off-treatmentAlternativeReasonSpecify
Item
Alternative Therapy, Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25415 (NCI Thesaurus Property)
C1523987 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-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 (TO DATE)
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)
Item Group
Treatment Schedule (oral Antiandrogen)
ProtocolHormoneTherapyPatientCurrentReceivedInd-3
Item
Is patient on protocol hormone (ORAL ANTIANDROGEN)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25320 (NCI Thesaurus ObjectClass-2)
C1507394 (UMLS 2011AA ObjectClass-2)
C15445 (NCI Thesaurus ObjectClass-3)
C0279025 (UMLS 2011AA ObjectClass-3)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C25639 (NCI Thesaurus Property-2)
C1514756 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Item
Oral antiandrogen taken
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25311 (NCI Thesaurus ObjectClass-2)
C0442027 (UMLS 2011AA ObjectClass-2)
C15481 (NCI Thesaurus ObjectClass-3)
C0279492 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
Code List
Oral antiandrogen taken
CL Item
Casodex (Casodex)
C0591237 (NCI Metathesaurus)
CL Item
Eulexin (Eulexin)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
OralAntiandrogenTherapyAgentAdministeredSpecify
Item
Other, specify
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25311 (NCI Thesaurus ObjectClass-2)
C0442027 (UMLS 2011AA ObjectClass-2)
C15481 (NCI Thesaurus ObjectClass-3)
C0279492 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
OralAntiandrogenTherapyAgentAdministeredBeginDate
Item
Oral Antiandrogen Start Date (IF STARTED IN THIS FOLLOW-UP PERIOD)
date
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25311 (NCI Thesaurus ObjectClass-2)
C0442027 (UMLS 2011AA ObjectClass-2)
C15481 (NCI Thesaurus ObjectClass-3)
C0279492 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
OralAntiandrogenTherapyAgentAdministeredEndDate
Item
Oral Antiandrogen End Date (IF TERMINATED IN THIS FOLLOW-UP PERIOD)
date
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25311 (NCI Thesaurus ObjectClass-2)
C0442027 (UMLS 2011AA ObjectClass-2)
C15481 (NCI Thesaurus ObjectClass-3)
C0279492 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Reason Treatment Ended
text
C25638 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
Code List
Reason Treatment Ended
CL Item
Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Death On Study (Death on study)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Before Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Off-treatmentAlternativeReasonSpecify
Item
Alternative Therapy, Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25415 (NCI Thesaurus Property)
C1523987 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-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 (TO DATE)
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)
Item Group
Lab Values
Item
Lab Values (Month 3)
text
C20200 (NCI Thesaurus Property)
C2346633 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
Code List
Lab Values (Month 3)
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)
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)
TestosteroneAssessmentDate
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C2299 (NCI Thesaurus ObjectClass)
C0039601 (UMLS 2011AA ObjectClass)
Item
Units
text
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS 2011AA ValueDomain)
Code List
Units
CL Item
Nanograms Per Deciliter (ng/dL)
CL Item
Nanograms Per Milliliter (ng/mL)
CL Item
Nanomoles Per Liter (nmol/l)
CL Item
Not Otherwise Specified (NOS)
CL006269 (NCI Metathesaurus)
LaboratoryProcedureTestosteroneResultLowerLimitofNormalValue
Item
Testosterone Lower Limit Normal
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)
Item Group
Lab Values
Item
Lab Values (Month 3)
text
C20200 (NCI Thesaurus Property)
C2346633 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
Code List
Lab Values (Month 3)
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)
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)
TestosteroneAssessmentDate
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C2299 (NCI Thesaurus ObjectClass)
C0039601 (UMLS 2011AA ObjectClass)
Item
Units
text
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS 2011AA ValueDomain)
Code List
Units
CL Item
Nanograms Per Deciliter (ng/dL)
CL Item
Nanograms Per Milliliter (ng/mL)
CL Item
Nanomoles Per Liter (nmol/l)
CL Item
Not Otherwise Specified (NOS)
CL006269 (NCI Metathesaurus)
LaboratoryProcedureTestosteroneResultLowerLimitofNormalValue
Item
Testosterone Lower Limit Normal
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)
Item Group
Baseline Lab Values (hematologic)
Item
Lab Values (Month 3)
text
C20200 (NCI Thesaurus Property)
C2346633 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
Code List
Lab Values (Month 3)
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)
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 (x 10^3 U/L)
float
C20200 (NCI Thesaurus Property)
C0005821 (UMLS CUI-1)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Neutrophil count
Item
ANC (mm^3)
float
C25294 (NCI Thesaurus ObjectClass)
C0200633 (UMLS CUI-1)
C12533 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25304 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Laboratory Procedure Date
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
Item Group
Baseline Lab Values (hematologic)
Item
Lab Values (Month 3)
text
C20200 (NCI Thesaurus Property)
C2346633 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
Code List
Lab Values (Month 3)
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)
Item
Lab Values (Month 3)
text
C20200 (NCI Thesaurus Property)
C2346633 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
Code List
Lab Values (Month 3)
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)
Item
Lab Values (Month 3)
text
C20200 (NCI Thesaurus Property)
C2346633 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
Code List
Lab Values (Month 3)
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)
LaboratoryTestName
Item
Test (Month 3)
text
C38470 (NCI Thesaurus ObjectClass)
C25294 (NCI Thesaurus ValueDomain)
C0022885 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus Property)
C0027365 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain-2)
C0027365 (UMLS 2011AA ValueDomain-2)
LaboratoryTestName
Item
Test (Month 3)
text
C38470 (NCI Thesaurus ObjectClass)
C25294 (NCI Thesaurus ValueDomain)
C0022885 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus Property)
C0027365 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain-2)
C0027365 (UMLS 2011AA ValueDomain-2)
LaboratoryTestName
Item
Test (Month 3)
text
C38470 (NCI Thesaurus ObjectClass)
C25294 (NCI Thesaurus ValueDomain)
C0022885 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus Property)
C0027365 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain-2)
C0027365 (UMLS 2011AA ValueDomain-2)
LabTestLabsStandardValue
Item
Value
float
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LabTestLabsStandardValue
Item
Value
float
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LabTestLabsStandardValue
Item
Value
float
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Laboratory Procedure Date
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
Laboratory Procedure Date
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
Laboratory Procedure Date
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
Item Group
Baseline Lab Values (hematologic)
Item
Lab Values (Month 3)
text
C20200 (NCI Thesaurus Property)
C2346633 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
Code List
Lab Values (Month 3)
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)
Item
Lab Values (Month 3)
text
C20200 (NCI Thesaurus Property)
C2346633 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
Code List
Lab Values (Month 3)
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)
Item
Lab Values (Month 3)
text
C20200 (NCI Thesaurus Property)
C2346633 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
Code List
Lab Values (Month 3)
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)
LabTestLabsStandardValue
Item
Value
float
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LabTestLabsStandardValue
Item
Value
float
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LabTestLabsStandardValue
Item
Value
float
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Laboratory Procedure Date
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
Laboratory Procedure Date
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
Laboratory Procedure Date
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
Item Group
Non-protocol Therapy
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)
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)
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)
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)
Item Group
Unnamed Module 7
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)
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)
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)
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)
Item Group
Protocol Specific Adverse Event Evaluation
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)
Code List
Any Treatment Related Adverse Events
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
MedDRACode
Item
MedDRA disease code
float
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)
Item
CTC Adverse Event Term
text
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C0332307 (NCI Metathesaurus ValueDomain)
C25249 (NCI Thesaurus Property-2)
C1806781 (UMLS 2011AA Property-2)
Code List
CTC Adverse Event Term
CL Item
Retinoic Acid Syndrome ("Retinoic acid syndrome")
CL Item
Acidosis Nos (Acidosis)
C0001122 (NCI Metathesaurus)
CL Item
Rash: Acne/acneiform (Acne)
CL Item
Neuroendocrine: Acth Deficiency (ACTH)
CL Item
Capillary Leak Syndrome (Acute vascular leak syndrome)
C0343084 (NCI Metathesaurus)
CL Item
Inappropriate Adh Secretion (ADH)
CL Item
Adrenal Insufficiency (Adrenal insufficiency)
CL Item
Obstruction/stenosis Of Airway (Airway obstruction - Select)
CL Item
Alcohol Intolerance Syndrome (antabuse-like Syndrome) (Alcohol intolerance syndrome)
CL Item
Blood Alkaline Phosphatase Nos Increased (Alkaline phosphatase)
CL Item
Alkalosis Nos (Alkalosis)
C0002063 (NCI Metathesaurus)
CL Item
Hypersensitivity Nos (Allergic reaction)
CL Item
Allergy/immunology Other (Allergy-Other (Specify))
CL Item
Alopecia (Alopecia)
C2865 (NCI Thesaurus)
CL Item
Alanine Aminotransferase Increased (ALT)
C26948 (NCI Thesaurus)
C0151905 (UMLS 2011AA)
CL Item
Blood Amylase Increased (Amylase)
CL038581 (NCI Metathesaurus)
CL Item
Anorexia (Anorexia)
C2875 (NCI Thesaurus)
C0003123 (UMLS 2011AA)
CL Item
Apnoea (Apnea)
CL Item
Arachnoiditis (Arachnoiditis)
C37913 (NCI Thesaurus)
C0003708 (UMLS 2011AA)
CL Item
Adult Respiratory Distress Syndrome (ARDS)
C3353 (NCI Thesaurus)
C0035222 (UMLS 2011AA)
CL Item
Vessel Injury-artery (Artery injury - Select)
CL Item
Arthritis Nos (Arthritis)
CL Item
Ascites (Ascites)
C2885 (NCI Thesaurus)
C0003962 (UMLS 2011AA)
CL Item
Aspiration (Aspiration)
CL Item
Aspartate Aminotransferase Increased (AST)
C26947 (NCI Thesaurus)
C0151904 (UMLS 2011AA)
CL Item
Ataxia Nec (Ataxia)
CL Item
Atelectasis (Atelectasis)
CL Item
Atrophy, Skin (Atrophy, skin)
CL Item
Atrophy, Subcutaneous Fat (Atrophy, subcutaneous fat)
CL Item
Auditory/ear Other (Auditory/Ear-Other (Specify))
CL Item
Autoimmune Disorder Nos (Autoimmune reaction)
CL Item
Blood Bicarbonate Decreased (Bicarbonate, serum-low)
CL038577 (NCI Metathesaurus)
CL Item
Blood Bilirubin Increased (Bilirubin)
CL039714 (NCI Metathesaurus)
CL Item
Bladder Disorder Nos (Bladder spasms)
CL Item
Blood/bone Marrow Other (Blood-Other (Specify))
CL Item
Vision Blurred (Blurred vision)
CL Item
Bone Age (alteration In Bone Age) (Bone age)
CL Item
Bone Marrow Depression Nos (Bone marrow cellularity)
CL Item
Brachial Plexopathy (Brachial plexopathy)
CL Item
Breast Volume/hypoplasia (Breast)
CL Item
Breast Function/lactation (Breast function)
CL Item
Bronchospasm, Wheezing (Bronchospasm)
CL Item
Ecchymosis (Bruising)
C26758 (NCI Thesaurus)
C0013491 (UMLS 2011AA)
CL Item
Burn (Burn)
CL Item
Arrhythmia Nos (Cardiac Arrhythmia-Other (Specify))
CL Item
Cardiac General Other (Cardiac General-Other (Specify))
CL Item
Myocardial Ischaemia (Cardiac ischemia/infarction)
C0151744 (NCI Metathesaurus)
CL Item
Cardiopulmonary Arrest, Cause Unknown (non-fatal) (Cardiopulmonary arrest)
CL Item
Cataract Nec (Cataract)
CL Item
Cd4 Lymphocytes Decreased (CD4 count)
CL038783 (NCI Metathesaurus)
CL Item
Cervical Spine-range Of Motion (Cervical spine ROM)
CL Item
Cheilitis (Cheilitis)
CL Item
Prolonged Chest Tube Drainage Or Air Leak After Pulmonary Resection (Chest tube drainage or leak)
CL Item
Cholecystitis (Cholecystitis)
CL Item
Hypercholesterolaemia (Cholesterol)
C0020443 (NCI Metathesaurus)
CL Item
Chyle Or Lymph Leakage (Chyle or lymph leakage)
CL Item
Chylothorax (Chylothorax)
CL Item
Haemorrhagic Stroke (CNS Hemorrhage)
CL036983 (NCI Metathesaurus)
CL Item
Cerebral Ischaemia (CNS ischemia)
C0917798 (NCI Metathesaurus)
CL Item
Cns Necrosis/cystic Progression (CNS necrosis)
CL Item
Coagulation Disorder Nos (Coagulation-Other (Specify))
CL Item
Learning Disorder Nos (Cognitive disturbance)
C0023186 (NCI Metathesaurus)
CL Item
Colitis Nos (Colitis)
CL Item
Colitis, Infectious (e.g., Clostridium Difficile) (Colitis, infectious)
CL Item
Conduction Abnormality/atrioventricular Heart Block (Conduction abnormality - Select)
CL Item
Confusion (Confusion)
C37928 (NCI Thesaurus)
C0009676 (UMLS 2011AA)
CL Item
Constipation (Constipation)
C37930 (NCI Thesaurus)
C0009806 (UMLS 2011AA)
CL Item
Constitutional Symptoms Other (Constitutional Symptoms-Other (Specify))
CL Item
Cough (Cough)
C37935 (NCI Thesaurus)
C0010200 (UMLS 2011AA)
CL Item
Blood Creatine Phosphokinase Increased (CPK)
CL038686 (NCI Metathesaurus)
CL Item
Blood Creatinine Increased (Creatinine)
C0235431 (NCI Metathesaurus)
CL Item
Leak, Cerebrospinal Fluid (csf) (CSF leak)
CL Item
Cardiac Troponin I Increased (cTnI)
CL038402 (NCI Metathesaurus)
CL Item
Cardiac Troponin T Increased (cTnT)
CL038393 (NCI Metathesaurus)
CL Item
Cushingoid (Cushingoid)
C37938 (NCI Thesaurus)
C0878661 (UMLS 2011AA)
CL Item
Cystitis (Cystitis)
CL Item
Cytokine Release Syndrome/acute Infusion Reaction (Cytokine release syndrome)
CL Item
Death Not Associated With Ctcae Term (Death not associated with CTCAE term - Select)
CL Item
Skin Breakdown/decubitus Ulcer (Decubitus)
CL Item
Dehydration (Dehydration)
C26740 (NCI Thesaurus)
C0011175 (UMLS 2011AA)
CL Item
Puberty (delayed) (Delayed puberty)
CL Item
Dental: Dentures Or Prosthesis (Dentures)
CL Item
Dermal Change Lymphedema, Phlebolymphedema (Dermal change)
CL Item
Dermatitis (Dermatitis - Select)
CL Item
Dermatology/skin Other (Dermatology-Other (Specify))
CL Item
Local Complication - Device/prosthesis-related (Device/prosthesis)
CL Item
Pancreatic Endocrine: Glucose Intolerance (Diabetes)
CL Item
Diarrhoea Nos (Diarrhea)
CL Item
Disseminated Intravascular Coagulation (DIC)
C2992 (NCI Thesaurus)
C0012739 (UMLS 2011AA)
CL Item
Diplopia (Diplopia)
C37941 (NCI Thesaurus)
C0012569 (UMLS 2011AA)
CL Item
Distention/bloating, Abdominal (Distention)
CL Item
Dizziness (exc Vertigo) (Dizziness)
CL Item
Pulmonary Function Test Nos Decreased (DL(co))
CL040958 (NCI Metathesaurus)
CL Item
Dry Eye Nec (Dry eye)
CL Item
Dry Mouth (Dry mouth)
CL Item
Dry Skin (Dry skin)
C0151908 (NCI Metathesaurus)
CL Item
Dysphagia (Dysphagia)
C2980 (NCI Thesaurus)
C0011168 (UMLS 2011AA)
CL Item
Dyspnoea Nos (Dyspnea)
CL Item
Edema, Larynx (Edema, larynx)
CL Item
Edema: Head And Neck (Edema: head and neck)
CL Item
Oedema Nos (Edema: limb)
CL Item
Edema: Trunk/genital (Edema: trunk/genital)
CL Item
Edema: Viscera (Edema: viscera)
CL Item
Ejaculatory Dysfunction (Ejaculatory dysfunction)
CL Item
Encephalopathy (Encephalopathy)
CL Item
Endocrine Other (Endocrine-Other (Specify))
CL Item
Enteritis (inflammation Of The Small Bowel) (Enteritis)
CL Item
Impotence (Erectile dysfunction)
C3133 (NCI Thesaurus)
C0242350 (UMLS 2011AA)
CL Item
Erythema Multiforme (Erythema multiforme)
C3024 (NCI Thesaurus)
C0014742 (UMLS 2011AA)
CL Item
Oesophagitis Nos (Esophagitis)
CL Item
Exostosis (Exostosis)
CL Item
Extremity-upper (function) (Extremity-upper (function))
CL Item
Eyelid Dysfunction (Eyelid dysfunction)
CL Item
Fatigue (Fatigue)
C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)
CL Item
Febrile Neutropenia (fever Of Unknown Origin Without Clinically Or Microbiologically Documented Infection) (anc <1.0 X 10^9/l, Fever >=38.5 Degrees C) (Febrile neutropenia)
CL Item
Feminization (Feminization of male)
C26773 (NCI Thesaurus)
C0015799 (UMLS 2011AA)
CL Item
Bone Growth: Femoral Head; Slipped Capital Femoral Epiphysis (Femoral head growth)
CL Item
Forced Expiratory Volume Decreased (FEV(1))
CL036765 (NCI Metathesaurus)
CL Item
Pyrexia (Fever)
CL Item
Blood Fibrinogen Decreased (Fibrinogen)
CL039651 (NCI Metathesaurus)
CL Item
Fibrosis-cosmesis (Fibrosis-cosmesis)
CL Item
Fibrosis-deep Connective Tissue (Fibrosis-deep connective tissue)
CL Item
Fistula, Gi (Fistula, GI - Select)
CL Item
Fistula, Gu (Fistula, GU - Select)
CL Item
Fistula, Pulmonary/upper Respiratory (Fistula, pulmonary - Select)
CL Item
Photopsia (Flashing lights)
C0085635 (NCI Metathesaurus)
CL Item
Flatulence (Flatulence)
CL Item
Flu-like Syndrome (Flu-like syndrome)
CL Item
Flushing (Flushing)
C26775 (NCI Thesaurus)
C0016382 (UMLS 2011AA)
CL Item
Fracture (Fracture)
CL Item
Extremity-lower (gait/walking) (Gait/walking)
CL Item
Gastritis Nos (Gastritis)
CL Item
Glomerular Filtration Rate (GFR)
CL Item
Gamma-glutamyltransferase Increased (GGT)
C26943 (NCI Thesaurus)
C0151662 (UMLS 2011AA)
CL Item
Gastrointestinal Other (GI-Other (Specify))
CL Item
Glaucoma Nos (Glaucoma)
CL Item
Neuroendocrine: Gonadotropin Secretion Abnormality (Gonadotropin)
CL Item
Growth And Development Other (Growth and Development-Other (Specify))
CL Item
Neuroendocrine: Growth Hormone Secretion Abnormality (Growth hormone)
CL Item
Gynaecomastia (Gynecomastia)
CL Item
Localised Exfoliation (Hand-foot)
CL Item
Haptoglobin Decreased (Haptoglobin)
C0236062 (NCI Metathesaurus)
CL Item
Hearing: Patients With/without Baseline Audiogram And Enrolled In A Monitoring Program (Hearing (monitoring program))
CL Item
Hearing: Patients Without Baseline Audiogram And Not Enrolled In A Monitoring Program (Hearing (without monitoring program))
CL Item
Dyspepsia (Heartburn)
C26756 (NCI Thesaurus)
C0013395 (UMLS 2011AA)
CL Item
Hematoma (Hematoma)
CL Item
Haemoglobin Decreased (Hemoglobin)
C0162119 (NCI Metathesaurus)
CL Item
Haemoglobinuria Present (Hemoglobinuria)
CL Item
Hemolysis Nos (Hemolysis)
C0019054 (NCI Metathesaurus)
CL Item
Hemorrhage, Pulmonary/upper Respiratory (Hemorrhage pulmonary - Select)
CL Item
Post-operative Haemorrhage (Hemorrhage with surgery)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Select)
CL Item
Hemorrhage, Gu (Hemorrhage, GU - Select)
CL Item
Hemorrhage/bleeding Other (Hemorrhage-Other (Specify))
CL Item
Hemorrhoids (Hemorrhoids)
CL Item
Hepatobiliary/pancreas Other (Hepatobiliary-Other (Specify))
CL Item
Hiccups (Hiccoughs)
C0019521 (NCI Metathesaurus)
CL Item
Menopausal Symptoms (Hot flashes)
CL Item
Hydrocephalus (Hydrocephalus)
CL Item
Hypercalcaemia (Hypercalcemia)
CL Item
Hyperglycaemia Nos (Hyperglycemia)
CL Item
Hyperkalaemia (Hyperkalemia)
C0020461 (NCI Metathesaurus)
CL Item
Hypermagnesaemia (Hypermagnesemia)
C0151714 (NCI Metathesaurus)
CL Item
Hypernatraemia (Hypernatremia)
C0020488 (NCI Metathesaurus)
CL Item
Skin Discolouration (Hyperpigmentation)
CL Item
Hypertension Nos (Hypertension)
CL Item
Thyroid Function, High (hyperthyroidism, Thyrotoxicosis) (Hyperthyroidism)
CL Item
Hypertriglyceridaemia (Hypertriglyceridemia)
C0020557 (NCI Metathesaurus)
CL Item
Hyperuricaemia (Hyperuricemia)
C0740394 (NCI Metathesaurus)
CL Item
Blood Albumin Decreased (Hypoalbuminemia)
CL039392 (NCI Metathesaurus)
CL Item
Hypocalcaemia (Hypocalcemia)
CL Item
Hypoglycaemia Nos (Hypoglycemia)
CL Item
Hypokalaemia (Hypokalemia)
CL Item
Blood Magnesium Decreased (Hypomagnesemia)
CL Item
Hyponatraemia (Hyponatremia)
CL Item
Parathyroid Function, Low (hypoparathyroidism) (Hypoparathyroidism)
CL Item
Hypophosphataemia (Hypophosphatemia)
CL Item
Hypopigmentation (Hypopigmentation)
CL Item
Hypotension Nos (Hypotension)
CL Item
Hypothermia (Hypothermia)
CL Item
Hypothyroidism (Hypothyroidism)
C26800 (NCI Thesaurus)
C0020676 (UMLS 2011AA)
CL Item
Hypoxia (Hypoxia)
C3890 (NCI Thesaurus)
C0242184 (UMLS 2011AA)
CL Item
Ileus (Ileus)
CL Item
Urinary Incontinence (Incontinence)
C3429 (NCI Thesaurus)
C0021167 (UMLS 2011AA)
CL Item
Incontinence, Anal (Incontinence, anal)
CL Item
Induration/fibrosis (skin And Subcutaneous Tissue) (Induration)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically) - Select)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC - Select)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Select)
CL Item
Infection Nos (Infection-Other (Specify))
CL Item
Infertility/sterility (Infertility/sterility)
CL Item
Injection Site Reaction Nos (Injection site reaction)
CL Item
Prothrombin Time Prolonged (INR)
CL Item
Insomnia Nec (Insomnia)
CL Item
Intra-operative Injury (Intraop injury - Select)
CL Item
Intra-operative Injury Other (Intraop Injury-Other (Specify))
CL Item
Extrapyramidal Disorder Nec (Involuntary movement)
CL Item
Iron Overload (Iron overload)
CL Item
Menstruation Irregular (Irregular menses)
CL Item
Irritability (Irritability)
CL Item
Joint-effusion (Joint-effusion)
CL Item
Joint-function (Joint-function)
CL Item
Keratitis Nec (Keratitis)
CL Item
Bone Growth: Spine Kyphosis/lordosis (Kyphosis/lordosis)
CL Item
Laryngeal Nerve Dysfunction (Laryngeal nerve)
CL Item
Leak (including Anastomotic), Gi (Leak, GI - Select)
CL Item
Leak (including Anastomotic), Gu (Leak, GU - Select)
CL Item
Left Ventricular Diastolic Dysfunction (Left ventricular diastolic dysfunction)
CL Item
Left Ventricular Failure (Left ventricular systolic dysfunction)
C0023212 (NCI Metathesaurus)
CL Item
Leucopenia Nos (Leukocytes)
CL Item
Encephalopathy Nos (Leukoencephalopathy)
CL Item
Libido Decreased (Libido)
C0011124 (NCI Metathesaurus)
CL Item
Bone Growth: Limb Length Discrepancy (Limb length)
CL Item
Lipase Increased (Lipase)
CL Item
Hepatic Failure (Liver dysfunction)
C26922 (NCI Thesaurus)
C0085605 (UMLS 2011AA)
CL Item
Lumbar Spine-range Of Motion (Lumbar spine ROM)
CL Item
Lymphatics Other (Lymphatics-Other (Specify))
CL Item
Lymphedema-related Fibrosis (Lymphedema-related fibrosis)
CL Item
Lymphocele (Lymphocele)
C0024248 (NCI Metathesaurus)
CL Item
Lymphopenia (Lymphopenia)
C26823 (NCI Thesaurus)
C0024312 (UMLS 2011AA)
CL Item
Malabsorption (Malabsorption)
CL Item
Virilism (Masculinization of female)
C26914 (NCI Thesaurus)
CL Item
Amnesia Nec (Memory impairment)
CL Item
Mental Status (Mental status)
C0278060 (NCI Metathesaurus)
CL Item
Metabolic/laboratory Other (Metabolic-Other (Specify))
CL Item
Mood Alteration (Mood alteration - Select)
CL Item
Mucositis/stomatitis (clinical Exam) (Mucositis (clinical exam) - Select)
CL Item
Mucositis/stomatitis (functional/symptomatic) (Mucositis (functional/symptomatic) - Select)
CL Item
Muscle Weakness, Generalized Or Specific Area (not Due To Neuropathy) (Muscle weakness - Select)
CL Item
Muscular/skeletal Hypoplasia (Muscular/skeletal hypoplasia)
CL Item
Musculoskeletal/soft Tissue Other (Musculoskeletal-Other (Specify))
CL Item
Myelitis (Myelitis)
C26832 (NCI Thesaurus)
C0026975 (UMLS 2011AA)
CL Item
Myelodysplasia (Myelodysplasia)
CL Item
Myocarditis Nos (Myocarditis)
CL Item
Myositis (Myositis)
C27578 (NCI Thesaurus)
C0027121 (UMLS 2011AA)
CL Item
Nail Abnormality Nos (Nail changes)
CL038732 (NCI Metathesaurus)
CL Item
Nasal Cavity/paranasal Sinus Reactions (Nasal/paranasal reactions)
CL Item
Nausea (Nausea)
CL Item
Necrosis, Gi (Necrosis, GI - Select)
CL Item
Neurology Other (Neurology-Other (Specify))
CL Item
Peripheral Motor Neuropathy (Neuropathy-motor)
CL Item
Peripheral Sensory Neuropathy (Neuropathy-sensory)
CL Item
Neuropathy: Cranial (Neuropathy: cranial - Select)
CL Item
Neutropenia (Neutrophils)
C3277 (NCI Thesaurus)
CL Item
Breast Nipple/areolar Deformity (Nipple/areolar)
CL Item
Blindness Night (Nyctalopia)
CL Item
Nystagmus Nos (Nystagmus)
CL Item
Obesity (Obesity)
C3283 (NCI Thesaurus)
C0028754 (UMLS 2011AA)
CL Item
Obstruction, Gi (Obstruction, GI - Select)
CL Item
Obstruction, Gu (Obstruction, GU - Select)
CL Item
Conjunctivitis Nec (Ocular surface disease)
CL Item
Ocular/visual Other (Ocular-Other (Specify))
CL Item
Opportunistic Infection Associated With >=grade 2 Lymphopenia (Opportunistic infection)
CL Item
Optic Disc Edema (Optic disc edema)
CL Item
Orgasmic Dysfunction (Orgasmic dysfunction)
CL Item
Osteonecrosis (Osteonecrosis)
CL Item
Osteoporosis (Osteoporosis)
C3298 (NCI Thesaurus)
C0029456 (UMLS 2011AA)
CL Item
Otitis Externa (exc Boil Of Meatus) Nos (Otitis, external)
CL Item
Otitis Media Serous Nos (Otitis, middle)
C0271453 (NCI Metathesaurus)
CL Item
Pain (Pain - Select)
CL Item
Pain Other (Pain-Other (Specify))
CL Item
Palpitations (Palpitations)
C0030252 (NCI Metathesaurus)
CL Item
Pancreas, Exocrine Enzyme Deficiency (Pancreas, exocrine enzyme deficiency)
CL Item
Pancreatitis Nos (Pancreatitis)
CL Item
Odor (patient Odor) (Patient odor)
CL Item
Perforation, Gi (Perforation, GI - Select)
CL Item
Perforation, Gu (Perforation, GU - Select)
CL Item
Pericardial Effusion (Pericardial effusion)
C3319 (NCI Thesaurus)
C0031039 (UMLS 2011AA)
CL Item
Pericarditis (Pericarditis)
CL Item
Dental: Periodontal Disease (Periodontal)
CL Item
Peripheral Ischaemia Nos (Peripheral arterial ischemia)
CL Item
Personality Change (Personality)
CL Item
Petechiae (Petechiae)
CL Item
Phlebitis Superficial (Phlebitis)
C0750876 (NCI Metathesaurus)
CL Item
Phlebolymphatic Cording (Phlebolymphatic cording)
CL Item
Photophobia (Photophobia)
C28210 (NCI Thesaurus)
C0085636 (UMLS 2011AA)
CL Item
Photosensitivity Reaction Nos (Photosensitivity)
CL Item
Phrenic Nerve Dysfunction (Phrenic nerve)
CL Item
Platelet Count Decreased (Platelets)
C0392386 (NCI Metathesaurus)
CL Item
Pleural Effusion (Pleural effusion)
C3331 (NCI Thesaurus)
C0021071 (UMLS 2011AA)
CL Item
Pneumonitis Nos (Pneumonitis)
CL Item
Pneumothorax Nos (Pneumothorax)
C0032326 (NCI Metathesaurus)
CL Item
Portal Hypertension (Portal flow)
C3119 (NCI Thesaurus)
C0020541 (UMLS 2011AA)
CL Item
Puberty (precocious) (Precocious puberty)
CL Item
Proctitis Nos (Proctitis)
CL Item
Neuroendocrine: Prolactin Hormone Secretion Abnormality (Prolactin)
CL Item
Prolapse Of Stoma, Gi (Prolapse of stoma, GI)
CL Item
Prolapse Of Stoma, Gu (Prolapse of stoma, GU)
CL Item
Prolonged Intubation After Pulmonary Resection (>24 Hrs After Surgery) (Prolonged intubation)
CL Item
Electrocardiogram Qt Prolonged (Prolonged QTc)
C0151878 (NCI Metathesaurus)
CL Item
Proptosis/enophthalmos (Proptosis/enophthalmos)
CL Item
Proteinuria Present (Proteinuria)
CL Item
Pruritus Nos (Pruritus)
CL Item
Delusion Nos (Psychosis)
CL Item
Activated Partial Thromboplastin Time Prolonged (PTT)
CL038857 (NCI Metathesaurus)
CL Item
Pulmonary Fibrosis (Pulmonary fibrosis)
C26869 (NCI Thesaurus)
C0034069 (UMLS 2011AA)
CL Item
Pulmonary Hypertension (Pulmonary hypertension)
CL Item
Pulmonary/upper Respiratory Other (Pulmonary-Other (Specify))
CL Item
Upper Motor Neurone Lesion (Pyramidal tract dysfunction)
CL Item
Dermatitis Exfoliative Nos (Rash)
CL Item
Growth Velocity (reduction In Growth Velocity) (Reduction in growth velocity)
CL Item
Renal Failure Nos (Renal failure)
CL Item
Renal/genitourinary Other (Renal-Other (Specify))
CL Item
Restrictive Cardiomyopathy (Restrictive cardiomyopathy)
CL Item
Retinal Detachment (Retinal detachment)
CL Item
Retinopathy (Retinopathy)
CL Item
Rhinitis Allergic Nos (Rhinitis)
C0002103 (NCI Metathesaurus)
CL Item
Right Ventricular Dysfunction (cor Pulmonale) (Right ventricular dysfunction)
CL Item
Rigors (Rigors/chills)
C0424790 (NCI Metathesaurus)
CL Item
Salivary Gland Disorder Nos (Salivary gland changes)
CL Item
Scleral Necrosis/melt (Scleral necrosis)
CL Item
Bone: Spine-scoliosis (Scoliosis)
CL Item
Secondary Malignancy Possibly Related To Cancer Treatment (Secondary Malignancy (possibly related to cancer treatment))
CL Item
Convulsions Nos (Seizure)
CL Item
Seroma (Seroma)
CL Item
Serum Sickness (Serum sickness)
C0036830 (NCI Metathesaurus)
CL Item
Sexual/reproductive Function Other (Sexual-Other (Specify))
CL Item
Short Stature (Short stature)
CL Item
Soft Tissue Necrosis (Soft tissue necrosis - Select)
CL Item
Depressed Level Of Consciousness (Somnolence)
C0549249 (NCI Metathesaurus)
CL Item
Speech Disorder Nec (Speech impairment)
CL Item
Splenic Function (Splenic function)
CL Item
Striae (Striae)
CL Item
Stricture/stenosis (including Anastomotic), Gu (Stricture, anastomotic, GU - Select)
CL Item
Stricture/stenosis (including Anastomotic), Gi (Stricture, GI - Select)
CL Item
Supraventricular And Nodal Arrhythmia (Supraventricular arrhythmia - Select)
CL Item
Sweating Increased (Sweating)
C0700590 (NCI Metathesaurus)
CL Item
Syncope (Syncope (fainting))
CL Item
Syndromes Other (Syndromes-Other (Specify))
CL Item
Taste Disturbance (Taste alteration)
CL Item
Dental: Teeth (Teeth)
CL Item
Dental: Teeth Development (Teeth development)
CL Item
Telangiectasia (Telangiectasia)
CL Item
Thrombosis/embolism (vascular Access-related) (Thrombosis/embolism (vascular access))
CL Item
Thrombosis Nos (Thrombosis/thrombus/embolism)
CL Item
Thrombotic Microangiopathy (e.g., Thrombotic Thrombocytopenic Purpura[ttp] Or Hemolytic Uremic Syndrome[hus]) (Thrombotic microangiopathy)
CL Item
Tinnitus (Tinnitus)
CL Item
Tremor Nec (Tremor)
CL Item
Trismus (difficulty, Restriction Or Pain When Opening Mouth) (Trismus)
CL Item
Tumour Flare (Tumor flare)
CL039490 (NCI Metathesaurus)
CL Item
Tumour Lysis Syndrome (Tumor lysis syndrome)
CL Item
Caecitis (Typhlitis)
CL Item
Ulcer, Gi (Ulcer, GI - Select)
CL Item
Ulceration (Ulceration)
CL Item
Fanconi Syndrome (Urinary electrolyte wasting)
C0015624 (NCI Metathesaurus)
CL Item
Urinary Frequency (Urinary frequency)
C26906 (NCI Thesaurus)
C0677481 (UMLS 2011AA)
CL Item
Urinary Retention (Urinary retention)
C0080274 (NCI Metathesaurus)
CL Item
Urine Discolouration (Urine color change)
CL Item
Urticaria Nos (Urticaria)
CL Item
Uveitis (Uveitis)
CL Item
Vaginal Discharge (non-infectious) (Vaginal discharge)
CL Item
Vulvovaginal Dryness (Vaginal dryness)
CL036720 (NCI Metathesaurus)
CL Item
Vaginal Mucositis (Vaginal mucositis)
CL Item
Vaginal Stenosis/length (Vaginal stenosis)
CL Item
Vaginitis (Vaginitis)
CL Item
Valvular Heart Disease (Valvular heart disease)
CL Item
Vascular Other (Vascular-Other (Specify))
CL Item
Vasculitis Nos (Vasculitis)
CL Item
Vasovagal Attack (Vasovagal episode)
CL Item
Ventricular Arrhythmia (Ventricular arrhythmia - Select)
C26924 (NCI Thesaurus)
C0085612 (UMLS 2011AA)
CL Item
Vessel Injury-vein (Vessel injury - Select)
CL Item
Viral Hepatitis (Viral hepatitis)
CL Item
Visceral Arterial Ischaemia (Visceral arterial ischemia)
CL Item
Vital Capacity (Vital capacity)
CL Item
Vitreous Hemorrhage (Vitreous hemorrhage)
CL Item
Dysphonia (Voice changes)
C0935979 (NCI Metathesaurus)
CL Item
Vomiting Nos (Vomiting)
CL Item
Lacrimation Increased (Watery eye)
C0262476 (NCI Metathesaurus)
CL Item
Weight Increased (Weight gain)
C0043094 (NCI Metathesaurus)
CL Item
Weight Decreased (Weight loss)
CL Item
Culture Wound Negative (Wound complication, non-infectious)
CTCAdverseEventTermSpecify
Item
Other CTC Adverse Event Term not listed
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
CommonToxicityCriteriaAdverseEventGrade
Item
CTC AE Grade
float
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CTCAdverseEventReportBeginDate
Item
CTCAE Begin Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
Item
Attribution
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
Code List
Attribution
CL Item
Definite (Definite)
CL209464 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
Item
SAE report submitted
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C54035 (NCI Thesaurus ObjectClass-2)
C0205404 (UMLS 2011AA ObjectClass-2)
Code List
SAE report submitted
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Footer
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)

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