ID

6643

Description

ADVL0212: Reporting Period Worksheet (Leukemia) FR901228 in Treating Children With Refractory or Recurrent Solid Tumors or Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=C0F387DC-C9D3-5664-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=C0F387DC-C9D3-5664-E034-0003BA12F5E7

Keywords

  1. 8/26/12 8/26/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 1/9/15 1/9/15 - Martin Dugas
  5. 3/12/15 3/12/15 - Martin Dugas
Uploaded on

January 8, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Brain and Central Nervous System Tumors NCT00053963 Treatment - ADVL0212: Reporting Period Worksheet (Leukemia) - 2172521v3.0

No Instruction available.

  1. StudyEvent: ADVL0212: Reporting Period Worksheet (Leukemia)
    1. No Instruction available.
Header
Description

Header

Institution Name
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
COG Study Number
Description

ProtocolCOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
COG Study Number
Description

ProtocolCOGIdentifierNumber

Data type

text

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

PatientCOGIdentifierNumber

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-2
C39353
UMLS 2011AA Property-2
C1516477
Patient's Initials
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Unnamed2
Description

Unnamed2

Reporting Period Number
Description

TreatmentReportingPeriodNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25651
UMLS 2011AA Property-2
C0700287
Reporting Period start date
Description

Reporting Period Start Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25616
UMLS CUI-1
C2361257
NCI Thesaurus Property-2
C25651
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
Reporting Period End date
Description

Reporting Period End Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2361259
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25651
Height
Description

Patient Height

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0489786
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
cm
Weight
Description

Patient Weight

Data type

float

Measurement units
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
Unnamed3
Description

Unnamed3

Was patient's bone marrow status evaluated during this reporting interval?
Description

BoneMarrowEvaluationInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus ObjectClass
C12431
UMLS 2011AA ObjectClass
C0005953
what was the date of exam?
Description

BoneMarrowEvaluationDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus ObjectClass
C12431
UMLS 2011AA ObjectClass
C0005953
does patient have bone marrow involvement?
Description

BoneMarrowInvolvementInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12431
UMLS 2011AA ObjectClass
C0005953
NCI Thesaurus Property
C25548
UMLS 2011AA Property
C1314939
Was patients shortening fraction determined by echocardiogram?
Description

ShorteningFractionEchocardiogramAssessedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25217
UMLS 2011AA Property
C1516048
what is the percentage?
Description

ShorteningFractionResultPercentageValue

Data type

float

Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C38020
UMLS 2011AA ObjectClass
C1335957
Was patient's ejection fraction as determined by MUGA?
Description

EjectionFractionRadionuclideVentriculogramScanAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25217
UMLS 2011AA Property
C1516048
NCI Thesaurus Property-2
C38073
UMLS 2011AA Property-2
C0521317
NCI Thesaurus ObjectClass
C37946
UMLS 2011AA ObjectClass
C2700377
what is the percentage?
Description

EjectionFractionResultPercentageValue

Data type

float

Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
Is patient off protocol therapy at the end of this reporting period?
Description

PatientOff-treatmentInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25601
UMLS 2011AA Property
C1518544
date of last dose for this reporting period
Description

Date Last Dose

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1762893
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25509
NCI Thesaurus Property-2
C25256
reason treatment ended
Description

Off Treatment Reason

Data type

text

Alias
NCI Thesaurus ObjectClass
C25601
UMLS CUI-1
C1518544
NCI Thesaurus Property
C25365
UMLS CUI-2
C0566251
Did resting heart rate increase by 35%?
Description

RestingHeartRate

Data type

boolean

Did patient experience any of the following: SVT, atrial fibrillation, or atrial flutter?
Description

CTCAdverseEventArrhythmiaAtrialGrade

Data type

float

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
check all that apply
Description

CTCAdverseEventOtherArrhythmiaSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Did patient experience prolonged QTc compared to baseline?
Description

CTCAdverseEventIntervalGrade

Data type

float

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
check all that apply
Description

ArrhythmiaType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Was there a T wave inversion in leads II, III, AVF (inferior leads) or V4, V5, and V6 (lateral leads)?
Description

TWaveInversionInd

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Was ST segment at the J-point greater than or equal to 2 mm below baseline in leads II, II AVF (inferior leads), V4, V5, V6 (lateral leads)?
Description

STSegmentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Did patient experience ventricular arrhythmia?
Description

CTCAdverseEventArrhythmiaVentricularGrade

Data type

float

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Was there a change in Troponin I?
Description

CTCAdverseEventTroponinIGrade

Data type

float

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Was there a change to LVEF?
Description

Lab,Cardiovascular,LVEF

Data type

text

Unnamed5
Description

Unnamed5

Was patient's bone marrow status evaluated during this reporting interval?
Description

BoneMarrowEvaluationInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus ObjectClass
C12431
UMLS 2011AA ObjectClass
C0005953
What was the patient's bone marrow status at the end of this reporting period?
Description

LaboratoryProcedureBoneMarrowBlastCellOutcomePercentageValue

Data type

float

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C12431
UMLS 2011AA Property
C0005953
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus Property-3
C12918
UMLS 2011AA Property-3
C0368761
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
%
Total mg dose of Depsipeptide received during this reporting period
Description

Agent Total Dose

Data type

float

Alias
NCI Thesaurus ValueDomain
C25304
UMLS CUI-1
C2986497
NCI Thesaurus Property
C25379
NCI Thesaurus ValueDomain-2
C25488
NCI Thesaurus ObjectClass
C1708
Unnamed question (agent name)
Description

Agent

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
Unnamed question (agent name)
Description

Agent

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
Were any of the infusions of Depsipeptide interrupted for any reason?
Description

DoseInterruptionInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus Property
C25542
UMLS 2011AA Property
C1512900
please state the time point of the interruption
Description

TreatmentInterruptionDayDuration

Data type

float

Alias
NCI Thesaurus ValueDomain
C25301
UMLS 2011AA ValueDomain
C0439228
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain-2
C25330
UMLS 2011AA ValueDomain-2
C0449238
NCI Thesaurus Property
C25542
UMLS 2011AA Property
C1512900
Was there a deviation from protocol therapy?
Description

Dose Modification

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25256
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain-2
C25572
Did the patient receive radiation therapy during this reporting period?
Description

RTTreatmentInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus Property
C15368
Specify sites
Description

Radiation Therapy Body Site

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1997599
NCI Thesaurus Property
C25341
NCI Thesaurus ObjectClass
C15313
Was tumor tissue surgically obtained for biology studies (e.g. biopsy, resection, fine needle aspiration)?
Description

TissueBiologicalSourceSurgicalInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C12801
UMLS 2011AA ObjectClass
C0040300
NCI Thesaurus Property
C25683
UMLS 2011AA Property
C0449416
Unnamed6
Description

Unnamed6

please describe.
Description

DoseModificationText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25256
UMLS 2011AA ObjectClass
C1265611
NCI Thesaurus Property
C25572
Was there a deviation from protocol therapy?
Description

Dose Modification

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25256
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain-2
C25572
Unnamed7
Description

Unnamed7

Did patient receive concomitant medications while on protocol therapy?
Description

ConcomitantMedicationReceivedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
Unnamed8
Description

Unnamed8

Type
Description

ConcomitantMedicationReceivedType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
please list type
Description

ConcomitantMedicationUseSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ObjectClass-2
C25730
UMLS 2011AA ObjectClass-2
C0521115
NCI Thesaurus Property
C25340
UMLS 2011AA Property
C0457083
Start Date
Description

Treatment Begin Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25431
UMLS CUI-1
C3173309
NCI Thesaurus Property-2
C25275
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
End Date
Description

Treatment End Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1531784
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25275
Description
Description

ConcomitantMedicationReceivedText

Data type

text

Alias
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
Reason for Administration
Description

Concomitant Medication Use Indication

Data type

text

Alias
NCI Thesaurus ObjectClass
C459
UMLS CUI-1
C2826696
NCI Thesaurus ObjectClass-2
C25730
NCI Thesaurus Property
C25382
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ValueDomain-2
C25638
Unnamed9
Description

Unnamed9

Has a new primary cancer of MDS been diagnosed that has not been previously reported?
Description

NewCancerDiagnosisInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
New Cancer Diagnosis Date
Description

NewCancerDiagnosisDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Unnamed10
Description

Unnamed10

Vital Status
Description

PatientVitalStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C18003
UMLS 2011AA ValueDomain
C0442732
NCI Thesaurus ValueDomain-2
C25688
UMLS 2011AA ValueDomain-2
C0449438
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Was the patient unable to be contacted for current scheduled follow-up?
Description

PatientLostFollow-upInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25560
UMLS 2011AA Property
C0745777
NCI Thesaurus Property-2
C16033
UMLS 2011AA Property-2
C1522577
Was patient enrolled on another COG therapeutic study at the end of this reporting period?
Description

PatientOtherEnrollmentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
Was patient's consent withdrawn?
Description

PatientWithdrawFollow-upConsentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16033
UMLS 2011AA Property
C1522577
NCI Thesaurus Property-2
C25460
UMLS 2011AA Property-2
C1511481
NCI Thesaurus Property-3
C38061
UMLS 2011AA Property-3
C2349954
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Did patient relapse or experience disease progression during this reporting period?
Description

DiseaseProgressionInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25331
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
date of relapse or progression
Description

DiseaseProgressionDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C25331
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
Unnamed11
Description

Unnamed11

Category
Description

CTCAdverseEventCategory

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25161
UMLS 2011AA Property
C0008902
Other, specify [unnamed category]
Description

CTCAdverseEventClassificationSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25161
UMLS 2011AA Property
C0008902
Type
Description

CTCAdverseEventTermType

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25703
UMLS 2011AA Property
C1515273
Other, specify [unnamed type]
Description

CTCAdverseEventTermSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25703
UMLS 2011AA Property
C1515273
Code
Description

CommonTerminologyCriteriaAdverseEventTermCOGCode

Data type

text

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
Other, specify [unnamed code]
Description

CTCAdverseEventCOGCodeSpecify

Data type

float

Alias
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
Grade
Description

CTCAdverseEventGrade2

Data type

float

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Attribution
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
Adverse Drug Experience?
Description

ADRFiledInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25410
UMLS 2011AA ObjectClass
C1521800
NCI Thesaurus Property
C25175
UMLS 2011AA Property
C1522646
Dose Limiting Toxicity?
Description

ToxicityReportInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C27990
UMLS 2011AA ObjectClass
C0600688
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
Date Onset
Description

CTCAdverseEventOnsetDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25279
UMLS 2011AA Property
C0332162
Date of test or evaluation showing toxicity resolved to eligibility requirements or baseline
Description

CTCAdverseEventResolutionDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25655
UMLS 2011AA Property
C1514893
check box if not resolved [toxicity]
Description

CTCAdverseEventResolutionInd

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25655
UMLS 2011AA Property
C1514893
Unnamed12
Description

Unnamed12

Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Ccrr Module For Advl0212: Reporting Period Worksheet (leukemia)
Description

Ccrr Module For Advl0212: Reporting Period Worksheet (leukemia)

Similar models

No Instruction available.

  1. StudyEvent: ADVL0212: Reporting Period Worksheet (Leukemia)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Institution Name
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
ProtocolCOGIdentifierNumber
Item
COG Study Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
ProtocolCOGIdentifierNumber
Item
COG Study Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientCOGIdentifierNumber
Item
COG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C39353 (NCI Thesaurus Property-2)
C1516477 (UMLS 2011AA Property-2)
Patient Initials
Item
Patient's Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Item Group
Unnamed2
TreatmentReportingPeriodNumber
Item
Reporting Period Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
C0700287 (UMLS 2011AA Property-2)
Reporting Period Start Date
Item
Reporting Period start date
date
C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C2361257 (UMLS CUI-1)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Reporting Period End Date
Item
Reporting Period End date
date
C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
Patient Height
Item
Height
float
C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
Patient Weight
Item
Weight
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Item Group
Unnamed3
BoneMarrowEvaluationInd-3
Item
Was patient's bone marrow status evaluated during this reporting interval?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
BoneMarrowEvaluationDate
Item
what was the date of exam?
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
BoneMarrowInvolvementInd-3
Item
does patient have bone marrow involvement?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
ShorteningFractionEchocardiogramAssessedInd-2
Item
Was patients shortening fraction determined by echocardiogram?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25217 (NCI Thesaurus Property)
C1516048 (UMLS 2011AA Property)
ShorteningFractionResultPercentageValue
Item
what is the percentage?
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38020 (NCI Thesaurus ObjectClass)
C1335957 (UMLS 2011AA ObjectClass)
EjectionFractionRadionuclideVentriculogramScanAssessmentInd-2
Item
Was patient's ejection fraction as determined by MUGA?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25217 (NCI Thesaurus Property)
C1516048 (UMLS 2011AA Property)
C38073 (NCI Thesaurus Property-2)
C0521317 (UMLS 2011AA Property-2)
C37946 (NCI Thesaurus ObjectClass)
C2700377 (UMLS 2011AA ObjectClass)
EjectionFractionResultPercentageValue
Item
what is the percentage?
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
PatientOff-treatmentInd-3
Item
Is patient off protocol therapy at the end of this reporting period?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25601 (NCI Thesaurus Property)
C1518544 (UMLS 2011AA Property)
Date Last Dose
Item
date of last dose for this reporting period
date
C25164 (NCI Thesaurus ValueDomain)
C1762893 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus Property)
C25256 (NCI Thesaurus Property-2)
Item
reason treatment ended
text
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS CUI-1)
C25365 (NCI Thesaurus Property)
C0566251 (UMLS CUI-2)
Code List
reason treatment ended
CL Item
Progressive disease (Progressive disease)
CL Item
Adverse Event/side Effects/complications (Irreversible dose-limiting toxicity)
CL Item
Patient withdrawal from protocol (Patient withdrawal from protocol)
CL Item
Off Study (Off Study)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Lost To Follow-up (Lost to follow-up)
CL310949 (NCI Metathesaurus)
CL Item
Death On Study (Death on study)
CL Item
Cytogenetic Resistance (Cytogenetic Resistance)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Disease Progression Before Active Treatment (Disease Progression before Active Treatment)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal or refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Before Beginning Protocol Therapy (Patient withdrawal or refusal prior to beginning protocol therapy)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
RestingHeartRate
Item
Did resting heart rate increase by 35%?
boolean
CTCAdverseEventArrhythmiaAtrialGrade
Item
Did patient experience any of the following: SVT, atrial fibrillation, or atrial flutter?
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item
check all that apply
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
check all that apply
CL Item
SVT (SVT)
CL Item
Atrial fibrillation (Atrial fibrillation)
CL Item
Atrial flutter (Atrial flutter)
CTCAdverseEventIntervalGrade
Item
Did patient experience prolonged QTc compared to baseline?
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item
check all that apply
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
check all that apply
CL Item
To greater than or equal to 480 msec (To greater than or equal to 480 msec)
CL Item
Increase of greater than or equal to 50 msec (Increase of greater than or equal to 50 msec)
CL Item
Increase by 15 % (Increase by 15 %)
TWaveInversionInd
Item
Was there a T wave inversion in leads II, III, AVF (inferior leads) or V4, V5, and V6 (lateral leads)?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
STSegmentInd-2
Item
Was ST segment at the J-point greater than or equal to 2 mm below baseline in leads II, II AVF (inferior leads), V4, V5, V6 (lateral leads)?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CTCAdverseEventArrhythmiaVentricularGrade
Item
Did patient experience ventricular arrhythmia?
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CTCAdverseEventTroponinIGrade
Item
Was there a change in Troponin I?
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item
Was there a change to LVEF?
text
Code List
Was there a change to LVEF?
CL Item
Yes, decrease to less than or equal to 40% (Yes, decrease to less than or equal to 40%)
CL Item
Yes, decrease by greater than or equal to 25%, but not below 40% (Yes, decrease by greater than or equal to 25%, but not below 40%)
CL Item
No (No)
Item Group
Unnamed5
BoneMarrowEvaluationInd-3
Item
Was patient's bone marrow status evaluated during this reporting interval?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
LaboratoryProcedureBoneMarrowBlastCellOutcomePercentageValue
Item
What was the patient's bone marrow status at the end of this reporting period?
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C12918 (NCI Thesaurus Property-3)
C0368761 (UMLS 2011AA Property-3)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Agent Total Dose
Item
Total mg dose of Depsipeptide received during this reporting period
float
C25304 (NCI Thesaurus ValueDomain)
C2986497 (UMLS CUI-1)
C25379 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
Agent
Item
Unnamed question (agent name)
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Agent
Item
Unnamed question (agent name)
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
DoseInterruptionInd-3
Item
Were any of the infusions of Depsipeptide interrupted for any reason?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25542 (NCI Thesaurus Property)
C1512900 (UMLS 2011AA Property)
TreatmentInterruptionDayDuration
Item
please state the time point of the interruption
float
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25330 (NCI Thesaurus ValueDomain-2)
C0449238 (UMLS 2011AA ValueDomain-2)
C25542 (NCI Thesaurus Property)
C1512900 (UMLS 2011AA Property)
Item
Was there a deviation from protocol therapy?
text
C25180 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25256 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain-2)
Code List
Was there a deviation from protocol therapy?
CL Item
Yes, protocol specified modification for toxicity (Yes, protocol specified modification for toxicity)
CL Item
Yes non-protocol specified modification for toxicity (Yes non-protocol specified modification for toxicity)
CL Item
Yes, other reason for deviation (Yes, other reason for deviation)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, planned)
CL Item
Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)
RTTreatmentInd-3
Item
Did the patient receive radiation therapy during this reporting period?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
Radiation Therapy Body Site
Item
Specify sites
text
C25191 (NCI Thesaurus ValueDomain)
C1997599 (UMLS CUI-1)
C25341 (NCI Thesaurus Property)
C15313 (NCI Thesaurus ObjectClass)
TissueBiologicalSourceSurgicalInd-2
Item
Was tumor tissue surgically obtained for biology studies (e.g. biopsy, resection, fine needle aspiration)?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C25683 (NCI Thesaurus Property)
C0449416 (UMLS 2011AA Property)
Item Group
Unnamed6
DoseModificationText
Item
please describe.
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25256 (NCI Thesaurus ObjectClass)
C1265611 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
Item
Was there a deviation from protocol therapy?
text
C25180 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25256 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain-2)
Code List
Was there a deviation from protocol therapy?
CL Item
Yes, protocol specified modification for toxicity (Yes, protocol specified modification for toxicity)
CL Item
Yes non-protocol specified modification for toxicity (Yes non-protocol specified modification for toxicity)
CL Item
Yes, other reason for deviation (Yes, other reason for deviation)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, planned)
CL Item
Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)
Item Group
Unnamed7
ConcomitantMedicationReceivedInd-2
Item
Did patient receive concomitant medications while on protocol therapy?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
Item Group
Unnamed8
Item
Type
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
Code List
Type
CL Item
Corticosteroid (Corticosteroid)
C2322 (NCI Thesaurus)
C0001617 (UMLS 2011AA)
CL Item
Anti-convulsant (Anti-Convulsant)
CL Item
Anti-fungal (Anti-Fungal)
C0718566 (NCI Metathesaurus)
CL Item
Growth Factor (Growth factor)
C20424 (NCI Thesaurus)
C0018284 (UMLS 2011AA)
CL Item
Other Specify (Other, specify)
ConcomitantMedicationUseSpecify
Item
please list type
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
Treatment Begin Date
Item
Start Date
date
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus Property)
C3173309 (UMLS CUI-1)
C25275 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Treatment End Date
Item
End Date
date
C25164 (NCI Thesaurus ValueDomain)
C1531784 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
ConcomitantMedicationReceivedText
Item
Description
text
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
Concomitant Medication Use Indication
Item
Reason for Administration
text
C459 (NCI Thesaurus ObjectClass)
C2826696 (UMLS CUI-1)
C25730 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C25704 (NCI Thesaurus ValueDomain)
C25638 (NCI Thesaurus ValueDomain-2)
Item Group
Unnamed9
NewCancerDiagnosisInd-3
Item
Has a new primary cancer of MDS been diagnosed that has not been previously reported?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
NewCancerDiagnosisDate
Item
New Cancer Diagnosis Date
date
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Unnamed10
Item
Vital Status
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C18003 (NCI Thesaurus ValueDomain)
C0442732 (UMLS 2011AA ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C0449438 (UMLS 2011AA ValueDomain-2)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
Vital Status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
PatientLostFollow-upInd-2
Item
Was the patient unable to be contacted for current scheduled follow-up?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25560 (NCI Thesaurus Property)
C0745777 (UMLS 2011AA Property)
C16033 (NCI Thesaurus Property-2)
C1522577 (UMLS 2011AA Property-2)
PatientOtherEnrollmentInd-2
Item
Was patient enrolled on another COG therapeutic study at the end of this reporting period?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
PatientWithdrawFollow-upConsentInd-2
Item
Was patient's consent withdrawn?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property-2)
C38061 (NCI Thesaurus Property-3)
C2349954 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
DiseaseProgressionInd-3
Item
Did patient relapse or experience disease progression during this reporting period?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
DiseaseProgressionDate
Item
date of relapse or progression
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
Item Group
Unnamed11
Item
Category
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
Code List
Category
CL Item
Gastrointestinal (Gastrointestinal)
C13359 (NCI Thesaurus)
C0521362 (UMLS 2011AA)
CL Item
Infection Febrile Neutropenia (Infection/Febrile Neutropenia)
CL Item
Blood/bone Marrow (Blood/Bone Marrow)
CL324677 (NCI Metathesaurus)
CL Item
Hepatic (Hepatic)
C13308 (NCI Thesaurus)
C0205054 (UMLS 2011AA)
CL Item
Renal/genitourinary (Renal/Genitourinary)
CL328688 (NCI Metathesaurus)
CL Item
Cardiovascular (arrhythmia) (Cardiovascular (Arrhythmia))
CL Item
Constitutional Symptoms (Constitutional Symptoms)
CL Item
Metabolic/laboratory (Metabolic/Laboratory)
CL Item
Other, specify [unnamed category] (Other, specify [unnamed category])
CTCAdverseEventClassificationSpecify
Item
Other, specify [unnamed category]
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
Item
Type
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25703 (NCI Thesaurus Property)
C1515273 (UMLS 2011AA Property)
Code List
Type
CL Item
Nausea (Nausea)
CL Item
Vomiting Nos (Vomiting)
CL Item
Not Available (Febrile Neutropenia)
CL Item
Neutropenia (Neutrophils/Granulocytes (ANC/AGC))
CL Item
Aspartate Aminotransferase Increased (SGOT (AST))
C26947 (NCI Thesaurus)
C0151904 (UMLS 2011AA)
CL Item
Alanine Aminotransferase Increased (SGPT (ALT))
C26948 (NCI Thesaurus)
C0151905 (UMLS 2011AA)
CL Item
Blood Creatinine Increased (Creatinine)
C0235431 (NCI Metathesaurus)
CL Item
Platelet Count Decreased (Platelets)
CL Item
Ventricular Arrhythmia Nos (Ventricular Arrhythmia)
CL Item
Fatigue (Fatigue)
C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)
CL Item
Blood Creatine Phosphokinase Increased (CPK)
CL038686 (NCI Metathesaurus)
CL Item
Other, specify [unnamed type] (Other, specify [unnamed type])
CTCAdverseEventTermSpecify
Item
Other, specify [unnamed type]
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25703 (NCI Thesaurus Property)
C1515273 (UMLS 2011AA Property)
Item
Code
text
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
Code List
Code
CL Item
Nausea (408)
C3258 (NCI Thesaurus)
C0027497 (UMLS 2011AA)
CL Item
Vomiting (426)
C3442 (NCI Thesaurus)
C0042963 (UMLS 2011AA)
CL Item
Febrile Neutropenia (494)
C0746883 (NCI Metathesaurus)
CL Item
Neutrophils/granulocytes (anc/agc) (146)
CL Item
Sgot (ast) (481)
CL Item
Sgpt (alt) (482)
CL Item
Creatinine (784)
CL Item
Platelets (148)
CL Item
Ventricular Arrhythmia Nos (181)
CL Item
Fatigue (262)
C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)
CL Item
Creatinine Phosphokinase (cpk) (532)
CL Item
Other, Specify (Other, specify [unnamed code])
CTCAdverseEventCOGCodeSpecify
Item
Other, specify [unnamed code]
float
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
CTCAdverseEventGrade2
Item
Grade
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item
Attribution
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
Code List
Attribution
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (Unlikely)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Definite (Definite)
CL209464 (NCI Metathesaurus)
ADRFiledInd-3
Item
Adverse Drug Experience?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25410 (NCI Thesaurus ObjectClass)
C1521800 (UMLS 2011AA ObjectClass)
C25175 (NCI Thesaurus Property)
C1522646 (UMLS 2011AA Property)
ToxicityReportInd-2
Item
Dose Limiting Toxicity?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C27990 (NCI Thesaurus ObjectClass)
C0600688 (UMLS 2011AA ObjectClass)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
CTCAdverseEventOnsetDate
Item
Date Onset
date
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25279 (NCI Thesaurus Property)
C0332162 (UMLS 2011AA Property)
CTCAdverseEventResolutionDate
Item
Date of test or evaluation showing toxicity resolved to eligibility requirements or baseline
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25655 (NCI Thesaurus Property)
C1514893 (UMLS 2011AA Property)
Item
check box if not resolved [toxicity]
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25655 (NCI Thesaurus Property)
C1514893 (UMLS 2011AA Property)
Code List
check box if not resolved [toxicity]
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Not Applicable (Not applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
Item Group
Unnamed12
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Item Group
Ccrr Module For Advl0212: Reporting Period Worksheet (leukemia)

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