ID

6053

Description

NCIC OV 21 Treatment Report Form Comparing Three Combination Chemotherapy Regimens in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=69B8C40D-B835-E610-E040-BB89AD43211A

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=69B8C40D-B835-E610-E040-BB89AD43211A

Keywords

Versions (6)
  1. 9/19/12 9/19/12 -
  2. 11/26/14 11/26/14 - Martin Dugas
  3. 11/26/14 11/26/14 - Martin Dugas
  4. 1/9/15 1/9/15 - Martin Dugas
  5. 1/9/15 1/9/15 - Martin Dugas
  6. 9/20/21 9/20/21 -
Uploaded on

November 26, 2014

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Ovarian Cancer NCT00993655 Treatment - NCIC OV 21 Treatment Report Form - 2874225v1.0

English

The purpose of the "Treatment Report" is to document drug administration, adverse events and response for one reporting period. For this study a reporting period is defined as one cycle (i.e. 1 cycle = 3 weeks or 21 days). Cycle length will be increased in cases where the start of the next cycle of treatment is delayed and will be decreased if the patient goes off protocol treatment before the end of the cycle. The "Treatment Report" should be completed within 2 weeks of the end of each reporting period.

1 forms  
Patient Information
Description

Patient Information

NCIC Patient ID (NCIC CTG Patient Serial Number issued at the time of randomization)
Description

PatientNationalCancerInstituteofCanadaIdentifierNumber

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
C25582
UMLS 2011AA Property
C1513884
Patient Initials (first-middle-last)
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
Patient Hospital No. (if permitted by REB)
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
Investigator No.
Description

PhysicianInvestigatorIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C25741
UMLS 2011AA ObjectClass
C0031831
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Investigator First Name
Description

InvestigatorFirstName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Investigator Middle Name
Description

TreatingPhysicianMiddleName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25741
UMLS 2011AA ObjectClass
C0031831
NCI Thesaurus ObjectClass
C25705
UMLS 2011AA ObjectClass
C1522326
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25569
UMLS 2011AA Property
C0444598
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
Investigator Last Name
Description

InvestigatorLastName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
NCI Thesaurus Property
C25551
UMLS 2011AA Property
C1517741
Timing Of Report
Description

Timing Of Report

Cycle Number
Description

TherapyCourseAdministeredCount

Data type

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Other, specify
Description

TreatmentEvaluationPeriodCycleSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ValueDomain
C25472
UMLS 2011AA ValueDomain
C1511572
NCI Thesaurus ValueDomain
C25275
UMLS 2011AA ValueDomain
C2745955
Day 1 of this cycle (yyyy-mmm-dd)
Description

AssessmentFirstDayDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C25301
UMLS 2011AA Property
C0439228
Physical Exam
Description

Physical Exam

Date of Physical Exam (yyyy-mmm-dd)
Description

PatientPhysicalExaminationDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
Weight (kg)
Description

PatientWeightMeasurement

Data type

double

Measurement units
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25208
UMLS 2011AA Property
C0043100
Kg
ECOG Performance Status
Description

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain
C25491
UMLS 2011AA ValueDomain
C1512162
NCI Thesaurus ObjectClass
C20641
UMLS 2011AA ObjectClass
C1518965
Systemic Therapy Report
Description

Systemic Therapy Report

Was the agent Paclitaxel administered during this reporting period
Description

PaclitaxelAgentDuringReportingPeriodAdministeredInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C1411
UMLS 2011AA ObjectClass
C0144576
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus Property
C25490
UMLS 2011AA Property
C0347984
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Was the agent Carboplatin administered during this reporting period
Description

CarboplatinAgentDuringReportingPeriodAdministeredInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C1282
UMLS 2011AA ObjectClass
C0079083
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus Property
C25490
UMLS 2011AA Property
C0347984
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Was the agent Cisplatin administered during this reporting period
Description

CisplatinAgentDuringReportingPeriodAdministeredInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C376
UMLS 2011AA ObjectClass
C0008838
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus Property
C25490
UMLS 2011AA Property
C0347984
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Study Drug Administration - Paclitaxel
Description

Study Drug Administration - Paclitaxel

Day of cycle
Description

AdministeredAgentDayCourseType

Data type

text

Alias
NCI Thesaurus ObjectClass
C41161
UMLS 2011AA ObjectClass
C1521826
NCI Thesaurus ObjectClass
C25382
UMLS 2011AA ObjectClass
C1521801
NCI Thesaurus Property
C25301
UMLS 2011AA Property
C0439228
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Other, specify
Description

TreatmentEvaluationPeriodCycleSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ValueDomain
C25472
UMLS 2011AA ValueDomain
C1511572
NCI Thesaurus ValueDomain
C25275
UMLS 2011AA ValueDomain
C2745955
Date (yyyy-mmm-dd)
Description

AgentAdministeredDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Route
Description

Drug Administration Route

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C0013153
NCI Thesaurus ObjectClass
C459
NCI Thesaurus ObjectClass
C25409
NCI Thesaurus Property
C25169
Total Actual Dose of Agents/Drugs for this cycle (mg)
Description

TotalAgentActualCourseDose

Data type

double

Alias
NCI Thesaurus ObjectClass
C25304
UMLS 2011AA ObjectClass
C0439810
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus Property
C25274
UMLS 2011AA Property
C0237400
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ValueDomain
C25274
UMLS 2011AA ValueDomain
C0237400
Was dose modified due to weight loss (from the previous cycle due to a change in weight BSA during this reporting period)
Description

AgentWeightLossDoseModificationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C3445
UMLS 2011AA Property
C0043096
NCI Thesaurus Property
C25488
UMLS 2011AA Property
C0178602
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Dose Modification Table - Paclitaxel
Description

Dose Modification Table - Paclitaxel

Date of dose modifications (yyyy-mmm-dd)
Description

DoseModificationDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus Property
C25572
Dose modification (Type of)
Description

DoseModificationStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
NCI Thesaurus Property
C25572
Other, specify
Description

DoseAdverseEventModificationSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C41331
UMLS 2011AA Property
C0877248
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus Property
C25572
Protocol mandated
Description

ProtocolAgentNotCompleteAdministrationAdverseEventInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C41161
UMLS 2011AA ObjectClass
C1521826
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ValueDomain
C41331
UMLS 2011AA ValueDomain
C0877248
Gfr For Carboplatin Dose Calculation
Description

Gfr For Carboplatin Dose Calculation

Date
Description

AssessmentPerformedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
Units
Description

AssessmentLabUOM

Data type

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
Study Drug Administration - Paclitaxel
Description

Study Drug Administration - Paclitaxel

Day of cycle
Description

AdministeredAgentDayCourseType

Data type

text

Alias
NCI Thesaurus ObjectClass
C41161
UMLS 2011AA ObjectClass
C1521826
NCI Thesaurus ObjectClass
C25382
UMLS 2011AA ObjectClass
C1521801
NCI Thesaurus Property
C25301
UMLS 2011AA Property
C0439228
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Other, specify
Description

TreatmentEvaluationPeriodCycleSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ValueDomain
C25472
UMLS 2011AA ValueDomain
C1511572
NCI Thesaurus ValueDomain
C25275
UMLS 2011AA ValueDomain
C2745955
Date (yyyy-mmm-dd)
Description

AgentAdministeredDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Route
Description

Drug Administration Route

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C0013153
NCI Thesaurus ObjectClass
C459
NCI Thesaurus ObjectClass
C25409
NCI Thesaurus Property
C25169
Total Actual Dose of Agents/Drugs for this cycle (mg)
Description

TotalAgentActualCourseDose

Data type

double

Alias
NCI Thesaurus ObjectClass
C25304
UMLS 2011AA ObjectClass
C0439810
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus Property
C25274
UMLS 2011AA Property
C0237400
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ValueDomain
C25274
UMLS 2011AA ValueDomain
C0237400
Was dose modified due to weight loss (from the previous cycle due to a change in weight BSA during this reporting period)
Description

AgentWeightLossDoseModificationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C3445
UMLS 2011AA Property
C0043096
NCI Thesaurus Property
C25488
UMLS 2011AA Property
C0178602
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Dose Modification Table - Paclitaxel
Description

Dose Modification Table - Paclitaxel

Date of dose modifications (yyyy-mmm-dd)
Description

DoseModificationDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus Property
C25572
Dose modification (Type of)
Description

DoseModificationStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
NCI Thesaurus Property
C25572
Other, specify
Description

DoseAdverseEventModificationSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C41331
UMLS 2011AA Property
C0877248
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus Property
C25572
Protocol mandated
Description

ProtocolAgentNotCompleteAdministrationAdverseEventInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C41161
UMLS 2011AA ObjectClass
C1521826
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ValueDomain
C41331
UMLS 2011AA ValueDomain
C0877248
Study Drug Administration - Paclitaxel
Description

Study Drug Administration - Paclitaxel

Day of cycle
Description

AdministeredAgentDayCourseType

Data type

text

Alias
NCI Thesaurus ObjectClass
C41161
UMLS 2011AA ObjectClass
C1521826
NCI Thesaurus ObjectClass
C25382
UMLS 2011AA ObjectClass
C1521801
NCI Thesaurus Property
C25301
UMLS 2011AA Property
C0439228
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Other, specify
Description

TreatmentEvaluationPeriodCycleSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ValueDomain
C25472
UMLS 2011AA ValueDomain
C1511572
NCI Thesaurus ValueDomain
C25275
UMLS 2011AA ValueDomain
C2745955
Date (yyyy-mmm-dd)
Description

AgentAdministeredDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Route
Description

Drug Administration Route

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C0013153
NCI Thesaurus ObjectClass
C459
NCI Thesaurus ObjectClass
C25409
NCI Thesaurus Property
C25169
Total Actual Dose of Agents/Drugs for this cycle (mg)
Description

TotalAgentActualCourseDose

Data type

double

Alias
NCI Thesaurus ObjectClass
C25304
UMLS 2011AA ObjectClass
C0439810
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus Property
C25274
UMLS 2011AA Property
C0237400
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ValueDomain
C25274
UMLS 2011AA ValueDomain
C0237400
Was dose modified due to weight loss (from the previous cycle due to a change in weight BSA during this reporting period)
Description

AgentWeightLossDoseModificationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C3445
UMLS 2011AA Property
C0043096
NCI Thesaurus Property
C25488
UMLS 2011AA Property
C0178602
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Dose Modification Table - Paclitaxel
Description

Dose Modification Table - Paclitaxel

Date of dose modifications (yyyy-mmm-dd)
Description

DoseModificationDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus Property
C25572
Dose modification (Type of)
Description

DoseModificationStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
NCI Thesaurus Property
C25572
Other, specify
Description

DoseAdverseEventModificationSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C41331
UMLS 2011AA Property
C0877248
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus Property
C25572
Protocol mandated
Description

ProtocolAgentNotCompleteAdministrationAdverseEventInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C41161
UMLS 2011AA ObjectClass
C1521826
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ValueDomain
C41331
UMLS 2011AA ValueDomain
C0877248
Hospitalization
Description

Hospitalization

Reason for hospitalization
Description

PatientHospitalizationSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25179
UMLS 2011AA Property
C0019993
Admission Date (yyyy-mmm-dd)
Description

InpatientHospitalAdmissionDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16696
UMLS 2011AA ObjectClass
C0019994
NCI Thesaurus ObjectClass
C25182
UMLS 2011AA ObjectClass
C0021562
NCI Thesaurus Property
C25385
UMLS 2011AA Property
C0809949
Discharge Date (yyyy-mmm-dd)
Description

InpatientHospitalDischargeDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16696
UMLS 2011AA ObjectClass
C0019994
NCI Thesaurus ObjectClass
C25182
UMLS 2011AA ObjectClass
C0021562
NCI Thesaurus Property
C25166
UMLS 2011AA Property
C0030685
Growth Factors
Description

Growth Factors

Was growth factor administered? (e.g. GCSF, erythropoietin, etc. during this reporting period)
Description

GrowthFactorAdministeredInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C20424
UMLS 2011AA ObjectClass
C0018284
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Growth factor
Description

GrowthFactorAgentCurrentReportPeriodAdministeredType

Data type

text

Alias
NCI Thesaurus ObjectClass
C20424
UMLS 2011AA ObjectClass
C0018284
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Other, specify (If)
Description

GrowthFactorAgentCurrentReportPeriodAdministeredSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C20424
UMLS 2011AA ObjectClass
C0018284
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Start Date (yyyy-mmm-dd)
Description

GrowthFactorAgentCurrentReportPeriodAdministeredBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C20424
UMLS 2011AA ObjectClass
C0018284
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
Stop Date (yyyy-mmm-dd)
Description

GrowthFactorAgentCurrentReportPeriodAdministeredEndDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C20424
UMLS 2011AA ObjectClass
C0018284
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Surgery
Description

Surgery

Surgery Date (dd-mmm-yyyy)
Description

SurgeryDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Anti-cancer Treatment
Description

Anti-cancer Treatment

Non-Protocol Therapy Type
Description

Non-ProtocolTherapyAdministeredType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Other, specify
Description

Non-ProtocolTherapyAdministeredSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Name of non-protocol cancer therapy (eg. 2nd look surgery, tamoxifen)
Description

Non-protocolTherapyAdministeredText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Ongoing from previous reporting period
Description

PriorAdverseEventContinuedInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Metathesaurus Property
C0750536
Treatment Start Date (yyyy-mmm-dd)
Description

Non-protocolTherapyBeginDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Continuing at end of this reporting period
Description

Medication continued

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0013227
NCI Thesaurus ObjectClass
C459
UMLS CUI-2
C0549178
NCI Thesaurus Property
C25409
NCI Metathesaurus Property
C0750536
Treatment Stop Date (yyyy-mmm-dd)
Description

Non-protocolTherapyAdministeredEndDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Hematology
Description

Hematology

Date Specimen collected (for biochemical investigations)
Description

SpecimenCollectedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C25452
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Date
Description

AssessmentPerformedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
Lab ID
Description

PathologyCoreFacilityLaboratoryIdentifierNumber

Data type

text

Alias
NCI Thesaurus ObjectClass
C37984
UMLS 2011AA ObjectClass
C0022877
NCI Thesaurus ObjectClass
C18189
UMLS 2011AA ObjectClass
C0030664
NCI Thesaurus ObjectClass
C15896
UMLS 2011AA ObjectClass
C1511521
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
Hemoglobin
Description

LaboratoryProcedureHemoglobinResultUnspecifiedValue

Data type

double

Alias
NCI Thesaurus Property
C16676
UMLS 2011AA Property
C0019046
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Peripheral Platelet Count
Description

LaboratoryProcedurePlateletResultUnspecifiedValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C12520
UMLS 2011AA Property
C0005821
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
WBC
Description

LaboratoryProcedureLeukocyteResultUnspecifiedValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C12529
UMLS 2011AA Property
C0023516
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Absolute neutrophil count
Description

LaboratoryProcedureAbsoluteNeutrophilCountResultUnspecifiedValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C63321
UMLS 2011AA Property
C0948762
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Other
Description

LaboratoryProcedurePerformedSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Biochemistry
Description

Biochemistry

Date Specimen collected (for biochemical investigations)
Description

SpecimenCollectedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C25452
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Date
Description

AssessmentPerformedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
Lab ID
Description

PathologyCoreFacilityLaboratoryIdentifierNumber

Data type

text

Alias
NCI Thesaurus ObjectClass
C37984
UMLS 2011AA ObjectClass
C0022877
NCI Thesaurus ObjectClass
C18189
UMLS 2011AA ObjectClass
C0030664
NCI Thesaurus ObjectClass
C15896
UMLS 2011AA ObjectClass
C1511521
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
Serum Creatinine
Description

LaboratoryProcedureCreatinineResultUnspecifiedValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Total Bilirubin
Description

LaboratoryProcedureTotalBilirubinResultUnspecifiedValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C38037
UMLS 2011AA Property
C0201913
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
SGOT (AST)
Description

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
SGPT (ALT)
Description

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUnspecifiedValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C25293
UMLS 2011AA Property
C0376147
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
CA125
Description

LaboratoryProcedureCA-125AntigenTumorMarkerResultValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C325
UMLS 2011AA Property
C0006610
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C17220
UMLS 2011AA Property
C0041365
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Other
Description

LaboratoryProcedurePerformedSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Magnesium
Description

LaboratoryProcedureMagnesiumResultUnspecifiedValue

Data type

double

Measurement units
  • mmol/L
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C29239
UMLS 2011AA Property
C0024467
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mmol/L
Calcium
Description

LaboratoryProcedureCalciumElectrolytesOutcomeValue

Data type

double

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C331
UMLS 2011AA Property
C0006675
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C464
UMLS 2011AA Property
C0013832
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mg/dL
Response Assessment - Question 2
Description

Response Assessment - Question 2

Were disease assessment results obtained this report period?
Description

DiseaseAssessmentResultInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
Reason evaluation not done
Description

EvaluationNotDoneReasonType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C25214
UMLS 2011AA ObjectClass
C0220825
NCI Thesaurus Property
C49484
UMLS 2011AA Property
C1272696
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Specify
Description

EvaluationNotDoneReasonSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C25214
UMLS 2011AA ObjectClass
C0220825
NCI Thesaurus Property
C49484
UMLS 2011AA Property
C1272696
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Was there evidence of objective disease progression at this assessment
Description

DiseaseProgressionInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25331
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
Target Lesions
Description

Target Lesions

Did the patient have any target lesions by imaging or clinical exam on post-op baseline report
Description

DiseasePost-OperativeStatusType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25623
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Date
Description

AssessmentPerformedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
Target Lesion Site (e.g. pelvis)
Description

LesionTargetSite

Data type

text

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property
C25702
UMLS 2011AA Property
C1521840
NCI Thesaurus ValueDomain
C37901
UMLS 2011AA ValueDomain
C0205145
Method of Evaluation
Description

AssessmentMethodType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
Other Specify
Description

AssessmentMethodSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
Dimension 1 (End of Reporting Period Measurements)
Description

TumorLargestDimensionMeasurement

Data type

double

Measurement units
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25550
UMLS 2011AA Property
C0443228
NCI Thesaurus Property
C25483
UMLS 2011AA Property
C0439534
cm
Dimension 2 (End of Reporting Period Measurements)
Description

TumorSecondDimensionMeasurement

Data type

double

Measurement units
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25666
UMLS 2011AA Property
C0205436
NCI Thesaurus Property
C25483
UMLS 2011AA Property
C0439534
cm
Sum of Longest Diameters of All Target Lesions
Description

LongestLesionSumDiameterMeasurement

Data type

double

Alias
NCI Thesaurus ObjectClass
C25558
UMLS 2011AA ObjectClass
C1522425
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25285
UMLS 2011AA Property
C1301886
NCI Thesaurus Property
C25697
UMLS 2011AA Property
C1515051
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
Non- Target Lesions During Treatment
Description

Non- Target Lesions During Treatment

Were there any non-target lesions reported at baseline
Description

LesionNontargetBaselineLocationInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25592
UMLS 2011AA Property
C1518389
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property
C25213
UMLS 2011AA Property
C1442488
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ValueDomain
C9305
UMLS 2011AA ValueDomain
C0006826
Date
Description

AssessmentPerformedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
Nontarget Lesion Site (e.g. pelvis)
Description

LesionNontargetSite

Data type

text

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25592
UMLS 2011AA Property
C1518389
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus ValueDomain
C37901
UMLS 2011AA ValueDomain
C0205145
Method of Evaluation
Description

AssessmentMethodType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
Other Specify
Description

AssessmentMethodSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
Follow-up status of nontarget lesion (End of Reporting Period )
Description

Non-TargetLesionFollow-upStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass
C25592
UMLS 2011AA ObjectClass
C1518389
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
New Lesions
Description

New Lesions

Was the appearance of any new lesions documented (since baseline i.e. previously or current reporting periods Note: New Lesions constitute objective disease progression)
Description

NewLesionAppearanceInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus Property
C25377
UMLS 2011AA Property
C0700364
Date
Description

AssessmentPerformedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
New Lesion Site (e.g. pelvis)
Description

LesionNewSite

Data type

text

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25586
UMLS 2011AA Property
C0205314
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus ValueDomain
C37901
UMLS 2011AA ValueDomain
C0205145
Method of Evaluation
Description

AssessmentMethodType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
Other Specify
Description

AssessmentMethodSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
Other Radiology
Description

Other Radiology

Date
Description

AssessmentPerformedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
Adverse Events / Intercurrent Illness
Description

Adverse Events / Intercurrent Illness

Has the patient experienced any symptoms or adverse events since the last report
Description

AdverseEventNewPeriodicReportInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25586
UMLS 2011AA Property
C0205314
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Metathesaurus Property
CL158136
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
CTC Adverse Event Short Name
Description

CommonToxicityCriteriaAdverseEventShortNameType

Data type

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
C25249
UMLS 2011AA Property
C1806781
CTC Select AE
Description

CTCAdverseEventSpecifiedTermType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C38024
UMLS 2011AA Property
C0205369
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
CTC AE Attribution Code
Description

CTCAdverseEventAttributionScale

Data type

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
Seriousness Attributed to Adverse Event
Description

AdverseEventSeriousnessAttributionScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
Ip Administration -- Questions
Description

Ip Administration -- Questions

Day 1 Ip Administration
Description

Day 1 Ip Administration

Concomitant Measures/medications
Description

Concomitant Measures/medications

Name of treatment
Description

ConcomitantTherapeuticProcedurePerformedText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C49236
UMLS 2011AA ObjectClass
C0087111
NCI Thesaurus ObjectClass
C25730
UMLS 2011AA ObjectClass
C0521115
Reason for Administration
Description

ConcomitantMedicationAdministeredReasonText

Data type

text

Alias
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ObjectClass
C25730
UMLS 2011AA ObjectClass
C0521115
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Ongoing? (from previous)
Description

ConcomitantMedicationAdministrationCurrentInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ObjectClass
C25730
UMLS 2011AA ObjectClass
C0521115
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ValueDomain
C25471
UMLS 2011AA ValueDomain
C0521116
Start date
Description

AgentBeginDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Stop date
Description

AgentEndDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Major Medical Problems
Description

Major Medical Problems

Date Documented (first)
Description

PatientMedicalConditionDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25261
UMLS 2011AA Property
C0205476
NCI Thesaurus Property
C25457
UMLS 2011AA Property
C0348080
Medical condition
Description

PatientMedicalConditionText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25261
UMLS 2011AA Property
C0205476
NCI Thesaurus Property
C25457
UMLS 2011AA Property
C0348080
Other Relevant Details
Description

PatientHistoryText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
Quality Of Life Questionnaire
Description

Quality Of Life Questionnaire

Was QoL Questionnaire completed?
Description

QualityofLifeCompleteAssessmentInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C17047
UMLS 2011AA ObjectClass
C0518214
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property
C25367
Date Questionnaire Completed
Description

QualityofLifeCompleteAssessmentDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C17047
UMLS 2011AA ObjectClass
C0518214
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property
C25367
Specify the reason the questionnaire was not completed
Description

QOLNotAdministeredReason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C17047
UMLS 2011AA ObjectClass
C0518214
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
Specify other reason
Description

Quality-of-LifeAssessmentOtherIncompleteSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property
C49160
UMLS 2011AA Property
C0205257
NCI Thesaurus ObjectClass
C15584
UMLS 2011AA ObjectClass
C0281588
Comments
Description

Comments

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
Contact Information
Description

Contact Information

CRA Name
Description

CRAName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C25465
UMLS 2011AA ObjectClass
C1516627
Phone number
Description

ClinicalResearchAssociatePersonTelephoneNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25395
UMLS 2011AA Property
C0039457
NCI Thesaurus ObjectClass
C25465
UMLS 2011AA ObjectClass
C1516627
Fax Number
Description

ClinicalResearchAssociatePersonFaxNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass
C25465
UMLS 2011AA ObjectClass
C1516627
NCI Thesaurus Property
C25210
UMLS 2011AA Property
C0085205
Institution Name
Description

InstitutionName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus ValueDomain
C21541
UMLS 2011AA ValueDomain
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
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Similar models

The purpose of the "Treatment Report" is to document drug administration, adverse events and response for one reporting period. For this study a reporting period is defined as one cycle (i.e. 1 cycle = 3 weeks or 21 days). Cycle length will be increased in cases where the start of the next cycle of treatment is delayed and will be decreased if the patient goes off protocol treatment before the end of the cycle. The "Treatment Report" should be completed within 2 weeks of the end of each reporting period.

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient Information
PatientNationalCancerInstituteofCanadaIdentifierNumber
Item
NCIC Patient ID (NCIC CTG Patient Serial Number issued at the time of randomization)
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)
C25582 (NCI Thesaurus Property)
C1513884 (UMLS 2011AA Property)
PatientInitialsName
Item
Patient Initials (first-middle-last)
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)
PatientMedicalRecordNumber
Item
Patient Hospital No. (if permitted by REB)
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)
PhysicianInvestigatorIdentifierNumber
Item
Investigator No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorFirstName
Item
Investigator First Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
TreatingPhysicianMiddleName
Item
Investigator Middle Name
text
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass)
C1522326 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25569 (NCI Thesaurus Property)
C0444598 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
InvestigatorLastName
Item
Investigator Last Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
Item Group
Timing Of Report
Item
Cycle Number
text
C15368 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.1
Code List
Cycle Number
CL Item
1 (1)
CL Item
2 (2)
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
3 (3)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
TreatmentEvaluationPeriodCycleSpecify
Item
Other, specify
text
C15368 (NCI Thesaurus ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25472 (NCI Thesaurus ValueDomain)
C1511572 (UMLS 2011AA ValueDomain)
C25275 (NCI Thesaurus ValueDomain)
C2745955 (UMLS 2011AA ValueDomain)
AssessmentFirstDayDate
Item
Day 1 of this cycle (yyyy-mmm-dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25301 (NCI Thesaurus Property)
C0439228 (UMLS 2011AA Property)
Item Group
Physical Exam
PatientPhysicalExaminationDate
Item
Date of Physical Exam (yyyy-mmm-dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
PatientWeightMeasurement
Item
Weight (kg)
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25208 (NCI Thesaurus Property)
C0043100 (UMLS 2011AA Property)
Item
ECOG Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain)
C1512162 (UMLS 2011AA ValueDomain)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
CL.2
Code List
ECOG 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)
Item Group
Systemic Therapy Report
Item
Was the agent Paclitaxel administered during this reporting period
text
C1411 (NCI Thesaurus ObjectClass)
C0144576 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25490 (NCI Thesaurus Property)
C0347984 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.3
Code List
Was the agent Paclitaxel administered during this reporting period
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Was the agent Carboplatin administered during this reporting period
text
C1282 (NCI Thesaurus ObjectClass)
C0079083 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25490 (NCI Thesaurus Property)
C0347984 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.4
Code List
Was the agent Carboplatin administered during this reporting period
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Was the agent Cisplatin administered during this reporting period
text
C376 (NCI Thesaurus ObjectClass)
C0008838 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25490 (NCI Thesaurus Property)
C0347984 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.5
Code List
Was the agent Cisplatin administered during this reporting period
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Study Drug Administration - Paclitaxel
Item
Day of cycle
text
C41161 (NCI Thesaurus ObjectClass)
C1521826 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus ObjectClass)
C1521801 (UMLS 2011AA ObjectClass)
C25301 (NCI Thesaurus Property)
C0439228 (UMLS 2011AA Property)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.17
Code List
Day of cycle
CL Item
Day 1 (Day 1)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
TreatmentEvaluationPeriodCycleSpecify
Item
Other, specify
text
C15368 (NCI Thesaurus ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25472 (NCI Thesaurus ValueDomain)
C1511572 (UMLS 2011AA ValueDomain)
C25275 (NCI Thesaurus ValueDomain)
C2745955 (UMLS 2011AA ValueDomain)
AgentAdministeredDate
Item
Date (yyyy-mmm-dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Route
text
C25284 (NCI Thesaurus ValueDomain)
C0013153 (UMLS CUI-1)
C459 (NCI Thesaurus ObjectClass)
C25409 (NCI Thesaurus ObjectClass)
C25169 (NCI Thesaurus Property)
CL.18
Code List
Route
CL Item
Intravenous (IV)
X-MO-6794 (MGED)
X-MO-6794 (MGED)
CL Item
Intraperitoneal Route Of Administration (IP)
C38258 (NCI Thesaurus)
C1522583 (UMLS 2011AA)
TotalAgentActualCourseDose
Item
Total Actual Dose of Agents/Drugs for this cycle (mg)
double
C25304 (NCI Thesaurus ObjectClass)
C0439810 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25274 (NCI Thesaurus Property)
C0237400 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C25274 (NCI Thesaurus ValueDomain)
C0237400 (UMLS 2011AA ValueDomain)
Item
Was dose modified due to weight loss (from the previous cycle due to a change in weight BSA during this reporting period)
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C3445 (NCI Thesaurus Property)
C0043096 (UMLS 2011AA Property)
C25488 (NCI Thesaurus Property)
C0178602 (UMLS 2011AA Property)
C25572 (NCI Thesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.19
Code List
Was dose modified due to weight loss (from the previous cycle due to a change in weight BSA during this reporting period)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Dose Modification Table - Paclitaxel
DoseModificationDate
Item
Date of dose modifications (yyyy-mmm-dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
Item
Dose modification (Type of)
text
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25572 (NCI Thesaurus Property)
CL.20
Code List
Dose modification (Type of)
CL Item
Dose Reduced (Dose reduced)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
CL Item
Dose Omitted (Dose omitted)
CL Item
Dose Delayed (Dose delayed)
CL Item
Change Of Route (Change of route)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
DoseAdverseEventModificationSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
Item
Protocol mandated
text
C41161 (NCI Thesaurus ObjectClass)
C1521826 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
CL.21
Code List
Protocol mandated
CL Item
No: C0028423 (No)
C0028423 (NCI Metathesaurus)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Gfr For Carboplatin Dose Calculation
AssessmentPerformedDate
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
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)
CL.11
Code List
Units
CL Item
Milliliters Per Minute (ml/min)
CL Item
Milliliters Per Second (ml/sec)
Item Group
Study Drug Administration - Paclitaxel
Item
Day of cycle
text
C41161 (NCI Thesaurus ObjectClass)
C1521826 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus ObjectClass)
C1521801 (UMLS 2011AA ObjectClass)
C25301 (NCI Thesaurus Property)
C0439228 (UMLS 2011AA Property)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.17
Code List
Day of cycle
CL Item
Day 1 (Day 1)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
TreatmentEvaluationPeriodCycleSpecify
Item
Other, specify
text
C15368 (NCI Thesaurus ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25472 (NCI Thesaurus ValueDomain)
C1511572 (UMLS 2011AA ValueDomain)
C25275 (NCI Thesaurus ValueDomain)
C2745955 (UMLS 2011AA ValueDomain)
AgentAdministeredDate
Item
Date (yyyy-mmm-dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Route
text
C25284 (NCI Thesaurus ValueDomain)
C0013153 (UMLS CUI-1)
C459 (NCI Thesaurus ObjectClass)
C25409 (NCI Thesaurus ObjectClass)
C25169 (NCI Thesaurus Property)
CL.18
Code List
Route
CL Item
Intravenous (IV)
X-MO-6794 (MGED)
X-MO-6794 (MGED)
CL Item
Intraperitoneal Route Of Administration (IP)
C38258 (NCI Thesaurus)
C1522583 (UMLS 2011AA)
TotalAgentActualCourseDose
Item
Total Actual Dose of Agents/Drugs for this cycle (mg)
double
C25304 (NCI Thesaurus ObjectClass)
C0439810 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25274 (NCI Thesaurus Property)
C0237400 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C25274 (NCI Thesaurus ValueDomain)
C0237400 (UMLS 2011AA ValueDomain)
Item
Was dose modified due to weight loss (from the previous cycle due to a change in weight BSA during this reporting period)
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C3445 (NCI Thesaurus Property)
C0043096 (UMLS 2011AA Property)
C25488 (NCI Thesaurus Property)
C0178602 (UMLS 2011AA Property)
C25572 (NCI Thesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.19
Code List
Was dose modified due to weight loss (from the previous cycle due to a change in weight BSA during this reporting period)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Dose Modification Table - Paclitaxel
DoseModificationDate
Item
Date of dose modifications (yyyy-mmm-dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
Item
Dose modification (Type of)
text
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25572 (NCI Thesaurus Property)
CL.20
Code List
Dose modification (Type of)
CL Item
Dose Reduced (Dose reduced)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
CL Item
Dose Omitted (Dose omitted)
CL Item
Dose Delayed (Dose delayed)
CL Item
Change Of Route (Change of route)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
DoseAdverseEventModificationSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
Item
Protocol mandated
text
C41161 (NCI Thesaurus ObjectClass)
C1521826 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
CL.21
Code List
Protocol mandated
CL Item
No: C0028423 (No)
C0028423 (NCI Metathesaurus)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Study Drug Administration - Paclitaxel
Item
Day of cycle
text
C41161 (NCI Thesaurus ObjectClass)
C1521826 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus ObjectClass)
C1521801 (UMLS 2011AA ObjectClass)
C25301 (NCI Thesaurus Property)
C0439228 (UMLS 2011AA Property)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.17
Code List
Day of cycle
CL Item
Day 1 (Day 1)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
TreatmentEvaluationPeriodCycleSpecify
Item
Other, specify
text
C15368 (NCI Thesaurus ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25472 (NCI Thesaurus ValueDomain)
C1511572 (UMLS 2011AA ValueDomain)
C25275 (NCI Thesaurus ValueDomain)
C2745955 (UMLS 2011AA ValueDomain)
AgentAdministeredDate
Item
Date (yyyy-mmm-dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Route
text
C25284 (NCI Thesaurus ValueDomain)
C0013153 (UMLS CUI-1)
C459 (NCI Thesaurus ObjectClass)
C25409 (NCI Thesaurus ObjectClass)
C25169 (NCI Thesaurus Property)
CL.18
Code List
Route
CL Item
Intravenous (IV)
X-MO-6794 (MGED)
X-MO-6794 (MGED)
CL Item
Intraperitoneal Route Of Administration (IP)
C38258 (NCI Thesaurus)
C1522583 (UMLS 2011AA)
TotalAgentActualCourseDose
Item
Total Actual Dose of Agents/Drugs for this cycle (mg)
double
C25304 (NCI Thesaurus ObjectClass)
C0439810 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25274 (NCI Thesaurus Property)
C0237400 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C25274 (NCI Thesaurus ValueDomain)
C0237400 (UMLS 2011AA ValueDomain)
Item
Was dose modified due to weight loss (from the previous cycle due to a change in weight BSA during this reporting period)
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C3445 (NCI Thesaurus Property)
C0043096 (UMLS 2011AA Property)
C25488 (NCI Thesaurus Property)
C0178602 (UMLS 2011AA Property)
C25572 (NCI Thesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.19
Code List
Was dose modified due to weight loss (from the previous cycle due to a change in weight BSA during this reporting period)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Dose Modification Table - Paclitaxel
DoseModificationDate
Item
Date of dose modifications (yyyy-mmm-dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
Item
Dose modification (Type of)
text
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25572 (NCI Thesaurus Property)
CL.20
Code List
Dose modification (Type of)
CL Item
Dose Reduced (Dose reduced)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
CL Item
Dose Omitted (Dose omitted)
CL Item
Dose Delayed (Dose delayed)
CL Item
Change Of Route (Change of route)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
DoseAdverseEventModificationSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
Item
Protocol mandated
text
C41161 (NCI Thesaurus ObjectClass)
C1521826 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
CL.21
Code List
Protocol mandated
CL Item
No: C0028423 (No)
C0028423 (NCI Metathesaurus)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Hospitalization
PatientHospitalizationSpecify
Item
Reason for hospitalization
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25179 (NCI Thesaurus Property)
C0019993 (UMLS 2011AA Property)
InpatientHospitalAdmissionDate
Item
Admission Date (yyyy-mmm-dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16696 (NCI Thesaurus ObjectClass)
C0019994 (UMLS 2011AA ObjectClass)
C25182 (NCI Thesaurus ObjectClass)
C0021562 (UMLS 2011AA ObjectClass)
C25385 (NCI Thesaurus Property)
C0809949 (UMLS 2011AA Property)
InpatientHospitalDischargeDate
Item
Discharge Date (yyyy-mmm-dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16696 (NCI Thesaurus ObjectClass)
C0019994 (UMLS 2011AA ObjectClass)
C25182 (NCI Thesaurus ObjectClass)
C0021562 (UMLS 2011AA ObjectClass)
C25166 (NCI Thesaurus Property)
C0030685 (UMLS 2011AA Property)
Item Group
Growth Factors
Item
Was growth factor administered? (e.g. GCSF, erythropoietin, etc. during this reporting period)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C20424 (NCI Thesaurus ObjectClass)
C0018284 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.22
Code List
Was growth factor administered? (e.g. GCSF, erythropoietin, etc. during this reporting period)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Growth factor
text
C20424 (NCI Thesaurus ObjectClass)
C0018284 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.23
Code List
Growth factor
CL Item
Epoetin Alfa (Epoetin)
C2695 (NCI Thesaurus)
C0357126 (UMLS 2011AA)
CL Item
Granulocyte-macrophage Colony-stimulating Factor (G-CSF)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
GrowthFactorAgentCurrentReportPeriodAdministeredSpecify
Item
Other, specify (If)
text
C20424 (NCI Thesaurus ObjectClass)
C0018284 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
GrowthFactorAgentCurrentReportPeriodAdministeredBeginDate
Item
Start Date (yyyy-mmm-dd)
date
C20424 (NCI Thesaurus ObjectClass)
C0018284 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
GrowthFactorAgentCurrentReportPeriodAdministeredEndDate
Item
Stop Date (yyyy-mmm-dd)
date
C20424 (NCI Thesaurus ObjectClass)
C0018284 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Surgery
SurgeryDate
Item
Surgery Date (dd-mmm-yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Item Group
Anti-cancer Treatment
Item
Non-Protocol Therapy Type
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.24
Code List
Non-Protocol Therapy Type
CL Item
Chemotherapy (Chemotherapy)
C15632 (NCI Thesaurus)
C0392920 (UMLS 2011AA)
CL Item
Radiation Therapy (Radiation therapy)
C15313 (NCI Thesaurus)
C1522449 (UMLS 2011AA)
CL Item
Hormonal Therapy (Hormonal Therapy)
CL025695 (NCI Metathesaurus)
CL Item
Immunotherapy (Immunotherapy)
C15262 (NCI Thesaurus)
C0021083 (UMLS 2011AA)
CL Item
Other Specify (Other)
Non-ProtocolTherapyAdministeredSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Non-protocolTherapyAdministeredText
Item
Name of non-protocol cancer therapy (eg. 2nd look surgery, tamoxifen)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Ongoing from previous reporting period
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C0750536 (NCI Metathesaurus Property)
CL.25
Code List
Ongoing from previous reporting period
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Non-protocolTherapyBeginDate
Item
Treatment Start Date (yyyy-mmm-dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Item
Continuing at end of this reporting period
text
C38147 (NCI Thesaurus ValueDomain)
C0013227 (UMLS CUI-1)
C459 (NCI Thesaurus ObjectClass)
C0549178 (UMLS CUI-2)
C25409 (NCI Thesaurus Property)
C0750536 (NCI Metathesaurus Property)
CL.26
Code List
Continuing at end of this reporting period
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Non-protocolTherapyAdministeredEndDate
Item
Treatment Stop Date (yyyy-mmm-dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item Group
Hematology
SpecimenCollectedDate
Item
Date Specimen collected (for biochemical investigations)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
AssessmentPerformedDate
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
PathologyCoreFacilityLaboratoryIdentifierNumber
Item
Lab ID
text
C37984 (NCI Thesaurus ObjectClass)
C0022877 (UMLS 2011AA ObjectClass)
C18189 (NCI Thesaurus ObjectClass)
C0030664 (UMLS 2011AA ObjectClass)
C15896 (NCI Thesaurus ObjectClass)
C1511521 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
LaboratoryProcedureHemoglobinResultUnspecifiedValue
Item
Hemoglobin
double
C16676 (NCI Thesaurus Property)
C0019046 (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)
LaboratoryProcedurePlateletResultUnspecifiedValue
Item
Peripheral Platelet Count
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12520 (NCI Thesaurus Property)
C0005821 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureLeukocyteResultUnspecifiedValue
Item
WBC
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12529 (NCI Thesaurus Property)
C0023516 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureAbsoluteNeutrophilCountResultUnspecifiedValue
Item
Absolute neutrophil count
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C63321 (NCI Thesaurus Property)
C0948762 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedurePerformedSpecify
Item
Other
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Item Group
Biochemistry
SpecimenCollectedDate
Item
Date Specimen collected (for biochemical investigations)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
AssessmentPerformedDate
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
PathologyCoreFacilityLaboratoryIdentifierNumber
Item
Lab ID
text
C37984 (NCI Thesaurus ObjectClass)
C0022877 (UMLS 2011AA ObjectClass)
C18189 (NCI Thesaurus ObjectClass)
C0030664 (UMLS 2011AA ObjectClass)
C15896 (NCI Thesaurus ObjectClass)
C1511521 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
LaboratoryProcedureCreatinineResultUnspecifiedValue
Item
Serum Creatinine
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureTotalBilirubinResultUnspecifiedValue
Item
Total Bilirubin
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property)
C0201913 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedValue
Item
SGOT (AST)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUnspecifiedValue
Item
SGPT (ALT)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property)
C0376147 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureCA-125AntigenTumorMarkerResultValue
Item
CA125
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C325 (NCI Thesaurus Property)
C0006610 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17220 (NCI Thesaurus Property)
C0041365 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedurePerformedSpecify
Item
Other
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
LaboratoryProcedureMagnesiumResultUnspecifiedValue
Item
Magnesium
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C29239 (NCI Thesaurus Property)
C0024467 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureCalciumElectrolytesOutcomeValue
Item
Calcium
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C331 (NCI Thesaurus Property)
C0006675 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C464 (NCI Thesaurus Property)
C0013832 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item Group
Response Assessment - Question 2
Item
Were disease assessment results obtained this report period?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
CL.27
Code List
Were disease assessment results obtained this report period?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Reason evaluation not done
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus ObjectClass)
C0220825 (UMLS 2011AA ObjectClass)
C49484 (NCI Thesaurus Property)
C1272696 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.28
Code List
Reason evaluation not done
CL Item
Not Required Per Protocol (Not required per protocol)
CL Item
Institution Error (Institution error)
CL Item
Patient Noncompliance (Patient noncompliance)
C0376405 (NCI Metathesaurus)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
EvaluationNotDoneReasonSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus ObjectClass)
C0220825 (UMLS 2011AA ObjectClass)
C49484 (NCI Thesaurus Property)
C1272696 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item
Was there evidence of objective disease progression at this assessment
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
CL.29
Code List
Was there evidence of objective disease progression at this assessment
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Target Lesions
Item
Did the patient have any target lesions by imaging or clinical exam on post-op baseline report
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25623 (NCI Thesaurus Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.30
Code List
Did the patient have any target lesions by imaging or clinical exam on post-op baseline report
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
AssessmentPerformedDate
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
LesionTargetSite
Item
Target Lesion Site (e.g. pelvis)
text
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25702 (NCI Thesaurus Property)
C1521840 (UMLS 2011AA Property)
C37901 (NCI Thesaurus ValueDomain)
C0205145 (UMLS 2011AA ValueDomain)
AssessmentMethodType
Item
Method of Evaluation
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
AssessmentMethodSpecify
Item
Other Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
TumorLargestDimensionMeasurement
Item
Dimension 1 (End of Reporting Period Measurements)
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25550 (NCI Thesaurus Property)
C0443228 (UMLS 2011AA Property)
C25483 (NCI Thesaurus Property)
C0439534 (UMLS 2011AA Property)
TumorSecondDimensionMeasurement
Item
Dimension 2 (End of Reporting Period Measurements)
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25666 (NCI Thesaurus Property)
C0205436 (UMLS 2011AA Property)
C25483 (NCI Thesaurus Property)
C0439534 (UMLS 2011AA Property)
LongestLesionSumDiameterMeasurement
Item
Sum of Longest Diameters of All Target Lesions
double
C25558 (NCI Thesaurus ObjectClass)
C1522425 (UMLS 2011AA ObjectClass)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25697 (NCI Thesaurus Property)
C1515051 (UMLS 2011AA Property)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
Item Group
Non- Target Lesions During Treatment
Item
Were there any non-target lesions reported at baseline
text
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25592 (NCI Thesaurus Property)
C1518389 (UMLS 2011AA Property)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ValueDomain)
C0006826 (UMLS 2011AA ValueDomain)
CL.31
Code List
Were there any non-target lesions reported at baseline
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
AssessmentPerformedDate
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
LesionNontargetSite
Item
Nontarget Lesion Site (e.g. pelvis)
text
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25592 (NCI Thesaurus Property)
C1518389 (UMLS 2011AA Property)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C37901 (NCI Thesaurus ValueDomain)
C0205145 (UMLS 2011AA ValueDomain)
AssessmentMethodType
Item
Method of Evaluation
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
AssessmentMethodSpecify
Item
Other Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
Item
Follow-up status of nontarget lesion (End of Reporting Period )
text
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25592 (NCI Thesaurus ObjectClass)
C1518389 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.32
Code List
Follow-up status of nontarget lesion (End of Reporting Period )
CL Item
Absent (Absent)
C48190 (NCI Thesaurus)
C0332197 (UMLS 2011AA)
CL Item
Present-no Change (Present-no change)
CL Item
Increase (Increase)
CL Item
Increased To Pd (Increased to PD)
CL Item
Unevaluable (Unevaluable)
C62222 (NCI Thesaurus)
C1883425 (UMLS 2011AA)
Item Group
New Lesions
Item
Was the appearance of any new lesions documented (since baseline i.e. previously or current reporting periods Note: New Lesions constitute objective disease progression)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C25377 (NCI Thesaurus Property)
C0700364 (UMLS 2011AA Property)
CL.33
Code List
Was the appearance of any new lesions documented (since baseline i.e. previously or current reporting periods Note: New Lesions constitute objective disease progression)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
AssessmentPerformedDate
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
LesionNewSite
Item
New Lesion Site (e.g. pelvis)
text
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C37901 (NCI Thesaurus ValueDomain)
C0205145 (UMLS 2011AA ValueDomain)
AssessmentMethodType
Item
Method of Evaluation
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
AssessmentMethodSpecify
Item
Other Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
Item Group
Other Radiology
AssessmentPerformedDate
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
Item Group
Adverse Events / Intercurrent Illness
Item
Has the patient experienced any symptoms or adverse events since the last report
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
CL158136 (NCI Metathesaurus Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.34
Code List
Has the patient experienced any symptoms or adverse events since the last report
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Not Assessed (Not assessed)
CommonToxicityCriteriaAdverseEventShortNameType
Item
CTC Adverse Event Short Name
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)
C1806781 (UMLS 2011AA Property)
CTCAdverseEventSpecifiedTermType
Item
CTC Select AE
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C38024 (NCI Thesaurus Property)
C0205369 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
Item
CTC AE Attribution Code
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)
CL.35
Code List
CTC AE Attribution Code
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
Seriousness Attributed to Adverse Event
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
CL.36
Code List
Seriousness Attributed to Adverse Event
CL Item
Not Serious (Not serious)
CL Item
Death (Death)
C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)
CL Item
Life Threatening (Life threatening)
CL Item
Hospitalized (Hospitalization, initial or prolonged)
CL Item
Disability (Disability/incapacity)
C21007 (NCI Thesaurus)
C0231170 (UMLS 2011AA)
CL Item
Congenital Anomaly (Congenital anomaly)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Item Group
Ip Administration -- Questions
Item Group
Day 1 Ip Administration
Item Group
Concomitant Measures/medications
ConcomitantTherapeuticProcedurePerformedText
Item
Name of treatment
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C49236 (NCI Thesaurus ObjectClass)
C0087111 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass)
C0521115 (UMLS 2011AA ObjectClass)
ConcomitantMedicationAdministeredReasonText
Item
Reason for Administration
text
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass)
C0521115 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
Item
Ongoing? (from previous)
text
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass)
C0521115 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25471 (NCI Thesaurus ValueDomain)
C0521116 (UMLS 2011AA ValueDomain)
CL.37
Code List
Ongoing? (from previous)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
AgentBeginDate
Item
Start date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
AgentEndDate
Item
Stop date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Item Group
Major Medical Problems
PatientMedicalConditionDate
Item
Date Documented (first)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25457 (NCI Thesaurus Property)
C0348080 (UMLS 2011AA Property)
PatientMedicalConditionText
Item
Medical condition
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25457 (NCI Thesaurus Property)
C0348080 (UMLS 2011AA Property)
PatientHistoryText
Item
Other Relevant Details
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
Item Group
Quality Of Life Questionnaire
Item
Was QoL Questionnaire completed?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ObjectClass)
C0518214 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus Property)
CL.38
Code List
Was QoL Questionnaire completed?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
QualityofLifeCompleteAssessmentDate
Item
Date Questionnaire Completed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ObjectClass)
C0518214 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus Property)
Item
Specify the reason the questionnaire was not completed
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ObjectClass)
C0518214 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
CL.39
Code List
Specify the reason the questionnaire was not completed
CL Item
Patient Kept Appointment For Examination, But Could Not Complete Questionnaire Due To Illness (Patient kept appointment for examination, but could not complete questionnaire due to illness)
CL Item
Patient Kept Appointment For Examination, But Refused To Complete Questionnaire For Reasons Other Than Illness (Patient kept appointment for examination, but refused to complete questionnaire for reasons other)
CL Item
Patient Did Not Keep Appointment (Patient did not keep appointment)
CL Item
Patient Could Not Be Contacted (Patient could not be contacted)
CL Item
Test Omitted Due To Institution/investigator Error (Questionnaire not administered due to institutional error)
CL Item
Other Reason (Other reason)
Quality-of-LifeAssessmentOtherIncompleteSpecify
Item
Specify other reason
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C49160 (NCI Thesaurus Property)
C0205257 (UMLS 2011AA Property)
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
Item Group
Comments
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
Item Group
Contact Information
CRAName
Item
CRA Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25465 (NCI Thesaurus ObjectClass)
C1516627 (UMLS 2011AA ObjectClass)
ClinicalResearchAssociatePersonTelephoneNumber
Item
Phone number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25395 (NCI Thesaurus Property)
C0039457 (UMLS 2011AA Property)
C25465 (NCI Thesaurus ObjectClass)
C1516627 (UMLS 2011AA ObjectClass)
ClinicalResearchAssociatePersonFaxNumber
Item
Fax Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25465 (NCI Thesaurus ObjectClass)
C1516627 (UMLS 2011AA ObjectClass)
C25210 (NCI Thesaurus Property)
C0085205 (UMLS 2011AA Property)
InstitutionName
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
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