ID

530

Description

CALGB: 90104 Treatment and Follow-up Form Combination Chemotherapy in Treating Patients With Bladder Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BE1B6072-F2CE-7116-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BE1B6072-F2CE-7116-E034-0003BA12F5E7

Keywords

  1. 8/26/12 8/26/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

August 26, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Bladder Cancer NCT00014534 Treatment - CALGB: 90104 Treatment and Follow-up Form - 2169531v3.0

No Instruction available.

  1. StudyEvent: CALGB: 90104 Treatment and Follow-up Form
    1. No Instruction available.
Ccrr Module For Calgb: 90104 Treatment And Follow-up Form
Description

Ccrr Module For Calgb: 90104 Treatment And Follow-up Form

CALGB Form
Description

CALGBForm

Data type

text

CALGB Study No
Description

ProtocolCALGBIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25442
UMLS 2011AA Property
C1516238
CALGB Patient ID
Description

PatientCALGBIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25442
UMLS 2011AA Property
C1516238
From
Description

TreatmentReportingPeriodBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
To
Description

TreatmentReportingPeriodEndDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
Amended data?
Description

DataAmendedInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Patient Initials
Description

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Participating Group
Description

ParticipatingGroupName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25608
UMLS 2011AA ObjectClass
C0679823
NCI Thesaurus ObjectClass
C17005
UMLS 2011AA ObjectClass
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Patient Medical Record Number
Description

PatientMedicalRecordNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25261
UMLS 2011AA Property
C0205476
NCI Thesaurus Property
C25198
UMLS 2011AA Property
C0034869
Participating Group Protocol Number
Description

ProtocolParticipatingIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Institute/Affiliate
Description

CombinedInstitutionName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS 2011AA ObjectClass
C0205195
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ValueDomain
C21541
UMLS 2011AA ValueDomain
C0018704
Patient's vital status
Description

PatientVitalStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C18003
UMLS 2011AA ValueDomain
C0442732
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Primary cause of death
Description

PatientDeathPrimaryReason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C28554
UMLS 2011AA Property
C0011065
NCI Thesaurus ValueDomain
C28554
UMLS 2011AA ValueDomain
C0011065
Due to other cause, specify
Description

PatientDeathSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C28554
UMLS 2011AA Property
C0011065
Date of last contact or death
Description

PatientLastContactDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C25461
UMLS 2011AA Property
C0337611
GCSF administered?
Description

RecombinantGranulocyteColonyStimulatingFactorReceivedInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ObjectClass
C1287
UMLS 2011AA ObjectClass
C0376562
If yes, specify why (GCSF administered)
Description

Ifyes,specifywhy(GCSFadministered)

Data type

text

Treatment
Description

TreatmentArmNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C32141
UMLS 2011AA Property
C1140618
NCI Thesaurus ObjectClass
C15368
Reason treatment ended
Description

TreatmentDiscontinuedType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
Other, specify (off treatment reason)
Description

OffTreatmentReason,Other

Data type

text

Were there any dose modifications or additions/omissions to protocol treatment?
Description

DoseModificationInd

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C25256
UMLS 2011AA ObjectClass
C1265611
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain
C25572
If yes, specify (modification)
Description

DoseModificationText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25256
UMLS 2011AA ObjectClass
C1265611
NCI Thesaurus Property
C25572
Calculated creatinine clearance
Description

Lab,Renal,CreatinineClearance

Data type

double

WBC
Description

Lab,Hematology,WBC

Data type

double

ANC
Description

LaboratoryProcedureNeutrophilResultSpecifiedValue

Data type

double

Measurement units
  • 1000/uL
Alias
NCI Thesaurus Property
C12533
UMLS 2011AA Property
C0027950
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
1000/uL
AST
Description

HepaticSGOT(AST)LabUnspecifiedValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C13308
UMLS 2011AA ObjectClass
C0205054
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Platelet count
Description

LaboratoryProcedurePlateletResultSpecifiedValue

Data type

double

Measurement units
  • 1000/uL
Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C12520
UMLS 2011AA Property
C0005821
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
1000/uL
BUN
Description

LaboratoryProcedureBloodUreaNitrogenResultUnspecifiedValue

Data type

double

Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C61019
UMLS 2011AA Property
C0005845
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
BUN, ULN
Description

LaboratoryProcedureBloodUreaNitrogenResultUpperLimitNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C61019
UMLS 2011AA Property
C0005845
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Bilirubin
Description

Lab,Hepatic,Bilirubin

Data type

double

Bilirubin, ULN
Description

HepaticBilirubinLabUpperLimitNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C305
UMLS 2011AA Property
C0005437
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Serum creatinine
Description

RenalCreatinineLabSpecifiedValue

Data type

double

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25225
UMLS 2011AA ObjectClass
C0022646
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mg/dL
alkaline phosphatase
Description

Lab,Hepatic,AlkalinePhosphatase

Data type

double

Alkaline phlosphatase, ULN
Description

LaboratoryProcedureAlkalinePhosphataseResultUpperLimitNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C16276
UMLS 2011AA Property
C0002059
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Has the patient had a documented clinical assessment for this cancer?
Description

CancerFollow-upStatusInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Date of last clinical assessment
Description

CancerFollow-UpStatusDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
chest x-ray assessment date
Description

ChestX-RayAssessmentDate

Data type

date

Chest x-ray result
Description

ChestX-RayResult

Data type

text

abdominal/pelvic CT assessment date
Description

Abdominal/PelvicCTAssessmentDate

Data type

text

Abdominal/pelvic CT result
Description

Abdominal/pelvicCTresult

Data type

text

Has the patient been diagnosed with a local recurrence that has not been previously reported?
Description

DiseaseAdvancedProgressionInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25331
NCI Thesaurus Property
C25411
UMLS 2011AA Property
C0205179
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
Date of first local progression
Description

ProgressionDate,FirstLocal

Data type

date

Site(s) of first local progression
Description

ProgressionSite,FirstLocal

Data type

text

Has the patient been diagnosed with a local-regional lymph node recurrence that has not been previously reported?
Description

LocalLymphNodeProgressionInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25331
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
NCI Thesaurus ObjectClass
C25388
UMLS 2011AA ObjectClass
C1947913
Date of first local-regional lymph node progression
Description

ProgressionDate,FirstLocalNode

Data type

date

Site(s) of first local-regional lymph node progression
Description

ProgressionSite,FirstLocalNode

Data type

text

Has the patient been diagnosed with a distant metastatic progression that has not been previously reported?
Description

DistantMetastasisProgressionInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25331
NCI Thesaurus ObjectClass
C25321
UMLS 2011AA ObjectClass
C0443203
NCI Thesaurus ObjectClass
C19151
UMLS 2011AA ObjectClass
C0027627
Date of first distant progression
Description

ProgressionDate,FirstDistant

Data type

date

Site(s) of first local (distant) progression
Description

ProgressionSite,FirstDistant

Data type

text

distant nodes, specify
Description

LymphNodes,DistantLocation

Data type

text

other, specify
Description

MetastaticSite,Other

Data type

text

Has a new primary cancer or myelodysplatsic syndrome been diagnosed that has not been previously reported?
Description

NewCancerDiagnosisInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Date of first local progression (new primary)
Description

NewCancerDiagnosisDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Site(s) of new primary
Description

NewCancerSiteText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
Has the patient experienced any severe, long-term toxicity that has not been previously reported?
Description

LateAdverseEventInd

Data type

text

late adverse event term
Description

RTOGAdverseEventTermText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C19778
UMLS 2011AA ObjectClass
C1514695
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
late adverse event grade
Description

RTOGAdverseEventGrade

Data type

double

Alias
NCI Thesaurus ObjectClass
C19778
UMLS 2011AA ObjectClass
C1514695
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
date of onset of long-term toxicity
Description

LateAdverseEventOnsetDate

Data type

date

comments
Description

ResearchCommentsText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411
completed by
Description

ResponsiblePersonName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
date form completed
Description

FormCompleteDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C40988
UMLS 2011AA ObjectClass
C1516308
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus ValueDomain
C25367

Similar models

No Instruction available.

  1. StudyEvent: CALGB: 90104 Treatment and Follow-up Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Ccrr Module For Calgb: 90104 Treatment And Follow-up Form
CALGBForm
Item
CALGB Form
text
ProtocolCALGBIdentifierNumber
Item
CALGB Study No
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)
PatientCALGBIdentifierNumber
Item
CALGB Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)
TreatmentReportingPeriodBeginDate
Item
From
date
C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
TreatmentReportingPeriodEndDate
Item
To
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
Item
Amended data?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
Code List
Amended data?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
PatientInitialsName
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
ParticipatingGroupName
Item
Participating Group
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientMedicalRecordNumber
Item
Patient Medical Record Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25198 (NCI Thesaurus Property)
C0034869 (UMLS 2011AA Property)
ProtocolParticipatingIdentifierNumber
Item
Participating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CombinedInstitutionName
Item
Institute/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
Item
Patient's vital status
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C18003 (NCI Thesaurus ValueDomain)
C0442732 (UMLS 2011AA ValueDomain)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
Patient's vital status
CL Item
Alive (Alive-NED)
CL Item
Alive (Alive with disease)
CL Item
Dead (Dead)
Item
Primary cause of death
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)
C28554 (NCI Thesaurus ValueDomain)
C0011065 (UMLS 2011AA ValueDomain)
Code List
Primary cause of death
CL Item
Due To This Disease (due to this disease)
CL Item
Due To Protocol Treatment (due to protocol treatment)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Due To Other Cause, Specify (due to other cause)
PatientDeathSpecify
Item
Due to other cause, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)
PatientLastContactDate
Item
Date of last contact or death
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C25461 (NCI Thesaurus Property)
C0337611 (UMLS 2011AA Property)
Item
GCSF administered?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C1287 (NCI Thesaurus ObjectClass)
C0376562 (UMLS 2011AA ObjectClass)
Code List
GCSF administered?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Ifyes,specifywhy(GCSFadministered)
Item
If yes, specify why (GCSF administered)
text
Item
Treatment
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C32141 (NCI Thesaurus Property)
C1140618 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
Code List
Treatment
CL Item
Arm A (Arm A)
CL Item
Arm B (Arm B)
Item
Reason treatment ended
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
Code List
Reason treatment ended
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Disease Progression, Relapse Prior To Beginning Protocol Therapy (Disease progression, relapse prior to beginning protocol therapy)
CL Item
Toxicity/side Effects/complications (Toxicity/side effects/complications)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal or refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal or refusal prior to beginning protocol therapy)
CL Item
disease recurrence (disease recurrence)
CL Item
Death After Beginning Protocol Therapy (death after beginning protocol therapy)
CL Item
Death Prior To Beginning Protocol Therapy (death prior to beginning protocol therapy)
CL Item
Alternative Therapy (alternative therapy)
CL Item
Other (other complicating disease)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Other (Other, specify)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
OffTreatmentReason,Other
Item
Other, specify (off treatment reason)
text
Item
Were there any dose modifications or additions/omissions to protocol treatment?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25256 (NCI Thesaurus ObjectClass)
C1265611 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain)
Code List
Were there any dose modifications or additions/omissions to protocol treatment?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (yes, planned)
CL Item
Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (yes, unplanned)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
DoseModificationText
Item
If yes, specify (modification)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25256 (NCI Thesaurus ObjectClass)
C1265611 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
Lab,Renal,CreatinineClearance
Item
Calculated creatinine clearance
double
Lab,Hematology,WBC
Item
WBC
double
LaboratoryProcedureNeutrophilResultSpecifiedValue
Item
ANC
double
C12533 (NCI Thesaurus Property)
C0027950 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
HepaticSGOT(AST)LabUnspecifiedValue
Item
AST
double
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedurePlateletResultSpecifiedValue
Item
Platelet count
double
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12520 (NCI Thesaurus Property)
C0005821 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureBloodUreaNitrogenResultUnspecifiedValue
Item
BUN
double
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C61019 (NCI Thesaurus Property)
C0005845 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureBloodUreaNitrogenResultUpperLimitNormalValue
Item
BUN, ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C61019 (NCI Thesaurus Property)
C0005845 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Lab,Hepatic,Bilirubin
Item
Bilirubin
double
HepaticBilirubinLabUpperLimitNormalValue
Item
Bilirubin, ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property)
C0005437 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
RenalCreatinineLabSpecifiedValue
Item
Serum creatinine
double
C25225 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Lab,Hepatic,AlkalinePhosphatase
Item
alkaline phosphatase
double
LaboratoryProcedureAlkalinePhosphataseResultUpperLimitNormalValue
Item
Alkaline phlosphatase, ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C16276 (NCI Thesaurus Property)
C0002059 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Item
Has the patient had a documented clinical assessment for this cancer?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
Has the patient had a documented clinical assessment for this cancer?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CancerFollow-UpStatusDate
Item
Date of last clinical assessment
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
ChestX-RayAssessmentDate
Item
chest x-ray assessment date
date
Item
Chest x-ray result
text
Code List
Chest x-ray result
CL Item
Negative (negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Equivocal (equivocal)
C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)
Abdominal/PelvicCTAssessmentDate
Item
abdominal/pelvic CT assessment date
text
Item
Abdominal/pelvic CT result
text
Code List
Abdominal/pelvic CT result
CL Item
Not Done (not done)
CL281691 (NCI Metathesaurus)
CL Item
Normal (normal)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
CL Item
Equivocal (equivocal)
C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)
CL Item
Abnormal-disease Related (abnormal-disease related)
CL Item
Abnormal-not Disease Related (abnormal-not disease related)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Has the patient been diagnosed with a local recurrence that has not been previously reported?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C25411 (NCI Thesaurus Property)
C0205179 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
Code List
Has the patient been diagnosed with a local recurrence that has not been previously reported?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
ProgressionDate,FirstLocal
Item
Date of first local progression
date
Item
Site(s) of first local progression
text
Code List
Site(s) of first local progression
CL Item
Local Progression To The Abdominal Wall (abdominal wall)
CL Item
Local Progression To The Pelvic Wall (pelvic wall)
CL Item
Local Spread To Peritoneal Tissue (peritoneum)
CL Item
Spread Of Cancer To Skin Or Subcutaneous Tissue Near To The Bladder (skin)
CL Item
Local Spread To The Vagina (vagina)
CL Item
Local Spread To The Urethra (urethra)
CL Item
Progression To Another Site, Specify Site (other, specify)
CL Item
Progression To Another Site, Specify Site (Other, specify)
Item
Has the patient been diagnosed with a local-regional lymph node recurrence that has not been previously reported?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25388 (NCI Thesaurus ObjectClass)
C1947913 (UMLS 2011AA ObjectClass)
Code List
Has the patient been diagnosed with a local-regional lymph node recurrence that has not been previously reported?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
ProgressionDate,FirstLocalNode
Item
Date of first local-regional lymph node progression
date
Item
Site(s) of first local-regional lymph node progression
text
Code List
Site(s) of first local-regional lymph node progression
CL Item
Disease Is Present In The Internal Iliac Lymph Nodes (internal iliac)
CL Item
Disease Is Present In The External Iliac Lymph Nodes (external iliac)
CL Item
Disease Is Present In The Common Iliac Lymph Nodes (common iliac)
CL Item
Disease Is Present In The Hypogastric Lymph Nodes (hypogastric)
CL Item
Disease Is Present In The Para-aortic Lymph Nodes (para-aortic)
CL Item
Disease Is Present In Another Local-regional Lymph Nodes, Specify (other, specify)
CL Item
Disease Is Present In Another Local-regional Lymph Nodes, Specify (Other, specify)
Item
Has the patient been diagnosed with a distant metastatic progression that has not been previously reported?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C25321 (NCI Thesaurus ObjectClass)
C0443203 (UMLS 2011AA ObjectClass)
C19151 (NCI Thesaurus ObjectClass)
C0027627 (UMLS 2011AA ObjectClass)
Code List
Has the patient been diagnosed with a distant metastatic progression that has not been previously reported?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
ProgressionDate,FirstDistant
Item
Date of first distant progression
date
Item
Site(s) of first local (distant) progression
text
Code List
Site(s) of first local (distant) progression
CL Item
Bone (bone)
C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)
CL Item
Liver (liver)
C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)
CL Item
Lung (lung)
C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)
CL Item
Peritoneum (peritoneum)
C12770 (NCI Thesaurus)
C0031153 (UMLS 2011AA)
CL Item
Pleura (pleura)
C12469 (NCI Thesaurus)
C0032225 (UMLS 2011AA)
CL Item
Skin (skin)
C12470 (NCI Thesaurus)
C1123023 (UMLS 2011AA)
CL Item
Central Nervous System Or Brain (central nervous system/brain)
CL Item
Distant Lymph Nodes (distant nodes)
CL Item
Other, Specify (other)
LymphNodes,DistantLocation
Item
distant nodes, specify
text
MetastaticSite,Other
Item
other, specify
text
Item
Has a new primary cancer or myelodysplatsic syndrome been diagnosed that has not been previously reported?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
Code List
Has a new primary cancer or myelodysplatsic syndrome been diagnosed that has not been previously reported?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
NewCancerDiagnosisDate
Item
Date of first local progression (new primary)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
NewCancerSiteText
Item
Site(s) of new primary
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
Item
Has the patient experienced any severe, long-term toxicity that has not been previously reported?
text
Code List
Has the patient experienced any severe, long-term toxicity that has not been previously reported?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
RTOGAdverseEventTermText
Item
late adverse event term
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C19778 (NCI Thesaurus ObjectClass)
C1514695 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
RTOGAdverseEventGrade
Item
late adverse event grade
double
C19778 (NCI Thesaurus ObjectClass)
C1514695 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
LateAdverseEventOnsetDate
Item
date of onset of long-term toxicity
date
ResearchCommentsText
Item
comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
ResponsiblePersonName
Item
completed by
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
FormCompleteDate
Item
date form completed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)

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