ID

645

Beschrijving

ADVL0212: Reporting Period Worksheet 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=B1EC15B1-1989-311F-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B1EC15B1-1989-311F-E034-0003BA12F5E7

Trefwoorden

Versies (6)
  1. 26-08-12 26-08-12 -
  2. 08-01-15 08-01-15 - Martin Dugas
  3. 09-01-15 09-01-15 - Martin Dugas
  4. 09-01-15 09-01-15 - Martin Dugas
  5. 22-03-15 22-03-15 - Martin Dugas
  6. 22-03-15 22-03-15 - Martin Dugas
Geüploaded op

26 augustus 2012

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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Brain and Central Nervous System Tumors NCT00053963 Treatment - ADVL0212: Reporting Period Worksheet - 2076231v3.0

Engels

No Instruction available.

1 Formulieren  
  1. StudyEvent: ADVL0212: Reporting Period Worksheet
    1. No Instruction available.
Unnamed1
Beschrijving

Unnamed1

Institution Name
Beschrijving

InstitutionName

Datatype

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
Study Number
Beschrijving

ProtocolCOGIdentifierNumber

Datatype

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
Study Number
Beschrijving

ProtocolCOGIdentifierNumber

Datatype

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 Number
Beschrijving

PatientCOGIdentifierNumber

Datatype

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
C39353
UMLS 2011AA Property
C1516477
Patient's Initials
Beschrijving

PatientInitialsName

Datatype

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
Date worksheet entered into RDE
Beschrijving

DataEnteredDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C37949
UMLS 2011AA Property
C1521975
Unnamed2
Beschrijving

Unnamed2

Reporting Period (1. Required field)
Beschrijving

TreatmentReportingPeriodNumber

Datatype

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
C25651
UMLS 2011AA Property
C0700287
Reporting Period start date (1. Required field)
Beschrijving

TreatmentReportingPeriodBeginDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
Reporting Period end date (MM/DD/YYYY)
Beschrijving

TreatmentReportingPeriodEndDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
Patient's Height (in cm at beginning of Reporting Period)
Beschrijving

PatientHeightMeasurement

Datatype

double

Maateenheden
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25347
UMLS 2011AA Property
C0489786
cm
Patient's Weight (in kg at beginning of Reporting Period)
Beschrijving

PatientWeightMeasurement

Datatype

double

Maateenheden
  • 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
Unnamed3
Beschrijving

Unnamed3

Did patient have a bone marrow evaluation during this reporting interval? (1. Required field)
Beschrijving

BoneMarrowEvaluationInd-3

Datatype

text

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? (MM/DD/YYYY)
Beschrijving

BoneMarrowEvaluationDate

Datatype

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? (Reset)
Beschrijving

BoneMarrowInvolvementInd-3

Datatype

text

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 patient's shortening fraction determined by echocardiogram?
Beschrijving

ShorteningFractionEchocardiogramAssessedInd-2

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25217
UMLS 2011AA Property
C1516048
what is the percentage? (1. Required field)
Beschrijving

ShorteningFractionResultPercentageValue

Datatype

double

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?
Beschrijving

EjectionFractionRadionuclideVentriculogramScanAssessmentInd-2

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25217
UMLS 2011AA Property
C1516048
NCI Thesaurus Property
C38073
UMLS 2011AA Property
C0521317
NCI Thesaurus ObjectClass
C37946
UMLS 2011AA ObjectClass
C2700377
what is the percentage? (1. Required field)
Beschrijving

EjectionFractionResultPercentageValue

Datatype

double

Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Is patient off protocol therapy at the end of this reporting period? (1. Required field)
Beschrijving

PatientOff-treatmentInd-3

Datatype

text

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 last drug or other protocol defined treatment was received (1. Must be between DT1 and DT2 or entry is prevented)
Beschrijving

TreatmentLastDoseEndDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
reason off protocol therapy (Off Study is defined as lost to follow-up, death, entry onto another COG therapeutic protocol)
Beschrijving

Off-treatmentReason

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Unnamed4
Beschrijving

Unnamed4

Was patient's disease status evaluated during this reporting interval? (1. Required field)
Beschrijving

DiseaseExaminedDiseaseResponseInd-2

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25500
UMLS 2011AA Property
C0332128
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
what was the patient's response? (1. If CR or PR, a request for submission of the response assessment form is generated if the form has not been filled out.)
Beschrijving

TumorResponseType

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
Total mg dose of Depsipeptide received during this reporting period (1. Required field)
Beschrijving

AgentCourseTotalDose

Datatype

double

Alias
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
Were any of the infusions of Depsipeptide interrupted for any reason? (1. Required field)
Beschrijving

DoseInterruptionInd-3

Datatype

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 describe. (1. Text field)
Beschrijving

DoseModificationText

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25256
UMLS 2011AA ObjectClass
C1265611
NCI Thesaurus Property
C25572
Was there a deviation from protocol therapy? (1. Required field)
Beschrijving

DoseModificationInd

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C25256
UMLS 2011AA ObjectClass
C1265611
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain
C25572
Did the patient receive radiation therapy during this reporting period? (1. Required field)
Beschrijving

RTTreatmentInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus Property
C15368
Specify sites (1. If the field is reported as "Yes" above, some text must be filled in for the "specify sites" question. If above is no, this question must not be answered.)
Beschrijving

RTSiteName

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
Was tumor tissue surgically obtained for biology studies (e.g. biopsy, resection, fine needle aspiration)? (1. Required field)
Beschrijving

TissueBiologicalSourceSurgicalInd-2

Datatype

text

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
Unnamed5
Beschrijving

Unnamed5

please describe. (1. Text field)
Beschrijving

DoseModificationText

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25256
UMLS 2011AA ObjectClass
C1265611
NCI Thesaurus Property
C25572
Was there a deviation from protocol therapy? (1. Required field)
Beschrijving

DoseModificationInd

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C25256
UMLS 2011AA ObjectClass
C1265611
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain
C25572
Unnamed6
Beschrijving

Unnamed6

Did patient receive concomitant medications while on protocol therapy? (1. Required field)
Beschrijving

ConcomitantMedicationReceivedInd-2

Datatype

text

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
Type (Type of drugs)
Beschrijving

ConcomitantMedicationReceivedType

Datatype

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 (text field)
Beschrijving

ConcomitantMedicationUseSpecify

Datatype

text

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

TreatmentBeginDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25431
UMLS 2011AA Property
C0439659
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
End Date
Beschrijving

TreatmentEndDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Description (agent, dose, etc.)
Beschrijving

ConcomitantMedicationReceivedText

Datatype

text

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

ConcomitantMedicationAdministeredReasonText

Datatype

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
Unnamed7
Beschrijving

Unnamed7

Did a second malignant neoplasm (SMN) occur during this Reporting Period? (If SMN is acute myelogenous leukemia or myelodysplastic syndrome MDS, submit the NCI secondary AML/MDS form, cytogenetics and pathology reports.)
Beschrijving

NewCancerDiagnosisInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Date SMN diagnosed (1. If the answer to SMN is yes, this field must be supplied. The date must be between the start and end date of this reporting period.)
Beschrijving

NewCancerDiagnosisDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Unnamed8
Beschrijving

Unnamed8

Life status at end of this reporting period (1. Required field)
Beschrijving

PatientVitalStatus

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C18003
UMLS 2011AA ValueDomain
C0442732
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Was patient confirmed lost to follow up at the end of this reporting period? (1. Required field)
Beschrijving

PatientLostFollow-upInd-2

Datatype

text

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
C16033
UMLS 2011AA Property
C1522577
Was patient enrolled on another COG therapeutic study at the end of this reporting period? (1. Required field)
Beschrijving

PatientOtherEnrollmentInd-2

Datatype

text

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? (1. Required field)
Beschrijving

PatientWithdrawFollow-upConsentInd-2

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16033
UMLS 2011AA Property
C1522577
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus Property
C38061
UMLS 2011AA Property
C2349954
Did patient relapse or experience disease progression during this reporting period? (1. Required field)
Beschrijving

DiseaseProgressionInd-3

Datatype

text

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 (MM/DD/YYYY)
Beschrijving

DiseaseProgressionDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C25331
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
Unnamed9
Beschrijving

Unnamed9

Category
Beschrijving

CTCAdverseEventCategory

Datatype

text

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

CTCAdverseEventClassificationSpecify

Datatype

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
Beschrijving

CTCAdverseEventTermType

Datatype

text

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

CTCAdverseEventTermSpecify

Datatype

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
Beschrijving

CommonTerminologyCriteriaAdverseEventTermCOGCode

Datatype

text

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

CTCAdverseEventCOGCodeSpecify

Datatype

double

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

CTCAdverseEventGrade2

Datatype

double

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Attribution (Code only for grade 2 or higher or for any toxicity for which an AdEERS Report is filed)
Beschrijving

CTCAdverseEventAttributionScale

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
Adverse Drug Experience? (Code only for grade 2 or higher or for any toxicity for which an AdEERS Report is filed)
Beschrijving

ADRFiledInd-3

Datatype

text

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? (Reset)
Beschrijving

ToxicityReportInd-2

Datatype

text

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
Beschrijving

CTCAdverseEventOnsetDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
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
Beschrijving

CTCAdverseEventResolutionDate

Datatype

date

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

CTCAdverseEventResolutionInd

Datatype

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
Unnamed10
Beschrijving

Unnamed10

Comments
Beschrijving

ResearchCommentsText

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411
Ccrr Module For Advl0212: Reporting Period Worksheet
Beschrijving

Ccrr Module For Advl0212: Reporting Period Worksheet

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  1. StudyEvent: ADVL0212: Reporting Period Worksheet
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Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Unnamed1
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)
ProtocolCOGIdentifierNumber
Item
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
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 Number
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)
C1516477 (UMLS 2011AA Property)
PatientInitialsName
Item
Patient's Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
DataEnteredDate
Item
Date worksheet entered into RDE
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C37949 (NCI Thesaurus Property)
C1521975 (UMLS 2011AA Property)
Item Group
Unnamed2
TreatmentReportingPeriodNumber
Item
Reporting Period (1. Required field)
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)
C0700287 (UMLS 2011AA Property)
TreatmentReportingPeriodBeginDate
Item
Reporting Period start date (1. Required field)
date
C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
TreatmentReportingPeriodEndDate
Item
Reporting Period end date (MM/DD/YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
PatientHeightMeasurement
Item
Patient's Height (in cm at beginning of Reporting Period)
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS 2011AA Property)
PatientWeightMeasurement
Item
Patient's Weight (in kg at beginning of Reporting Period)
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 Group
Unnamed3
Item
Did patient have a bone marrow evaluation during this reporting interval? (1. Required field)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
CL.1
Code List
Did patient have a bone marrow evaluation during this reporting interval? (1. Required field)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
BoneMarrowEvaluationDate
Item
what was the date of exam? (MM/DD/YYYY)
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)
Item
does patient have bone marrow involvement? (Reset)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
CL.2
Code List
does patient have bone marrow involvement? (Reset)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Was patient's shortening fraction determined by echocardiogram?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25217 (NCI Thesaurus Property)
C1516048 (UMLS 2011AA Property)
CL.3
Code List
Was patient's shortening fraction determined by echocardiogram?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
ShorteningFractionResultPercentageValue
Item
what is the percentage? (1. Required field)
double
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38020 (NCI Thesaurus ObjectClass)
C1335957 (UMLS 2011AA ObjectClass)
Item
Was patient's ejection fraction as determined by MUGA?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25217 (NCI Thesaurus Property)
C1516048 (UMLS 2011AA Property)
C38073 (NCI Thesaurus Property)
C0521317 (UMLS 2011AA Property)
C37946 (NCI Thesaurus ObjectClass)
C2700377 (UMLS 2011AA ObjectClass)
CL.4
Code List
Was patient's ejection fraction as determined by MUGA?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
EjectionFractionResultPercentageValue
Item
what is the percentage? (1. Required field)
double
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item
Is patient off protocol therapy at the end of this reporting period? (1. Required field)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25601 (NCI Thesaurus Property)
C1518544 (UMLS 2011AA Property)
CL.5
Code List
Is patient off protocol therapy at the end of this reporting period? (1. Required field)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
TreatmentLastDoseEndDate
Item
date last drug or other protocol defined treatment was received (1. Must be between DT1 and DT2 or entry is prevented)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
Item
reason off protocol therapy (Off Study is defined as lost to follow-up, death, entry onto another COG therapeutic protocol)
text
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.6
Code List
reason off protocol therapy (Off Study is defined as lost to follow-up, death, entry onto another COG therapeutic protocol)
CL Item
Relapse/Progressive disease (Relapse/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
Death On Study (Death on study)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal or refusal after beginning protocol therapy)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
CL Item
Disease Progression Before Active Treatment (Disease Progression before Active Treatment)
CL Item
Patient Withdrawal Or Refusal Before Beginning Protocol Therapy (Patient withdrawal or refusal before beginning protocol therapy)
CL Item
Lost To Follow-up (Lost to follow-up)
CL310949 (NCI Metathesaurus)
CL Item
Cytogenetic Resistance (Cytogenetic Resistance)
Item Group
Unnamed4
Item
Was patient's disease status evaluated during this reporting interval? (1. Required field)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
CL.7
Code List
Was patient's disease status evaluated during this reporting interval? (1. Required field)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
what was the patient's response? (1. If CR or PR, a request for submission of the response assessment form is generated if the form has not been filled out.)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
CL.8
Code List
what was the patient's response? (1. If CR or PR, a request for submission of the response assessment form is generated if the form has not been filled out.)
CL Item
Complete Response (Complete Response)
CL Item
Partial Response (Partial Response)
C18212 (NCI Thesaurus)
CL Item
Stable Disease (Stable disease)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
CL Item
Progressive Disease (Progressive Disease)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
CL Item
Insufficient Evaluation (Not evaluable)
AgentCourseTotalDose
Item
Total mg dose of Depsipeptide received during this reporting period (1. Required field)
double
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
Item
Were any of the infusions of Depsipeptide interrupted for any reason? (1. Required field)
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)
CL.9
Code List
Were any of the infusions of Depsipeptide interrupted for any reason? (1. Required field)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
DoseModificationText
Item
please describe. (1. Text field)
text
C25256 (NCI Thesaurus ObjectClass)
C1265611 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
Item
Was there a deviation from protocol therapy? (1. Required field)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25256 (NCI Thesaurus ObjectClass)
C1265611 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain)
CL.12
Code List
Was there a deviation from protocol therapy? (1. Required field)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, protocol specified modification for toxicity)
CL Item
Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes non-protocol specified modification for toxicity)
CL Item
Yes, other reason for deviation (Yes, other reason for deviation)
Item
Did the patient receive radiation therapy during this reporting period? (1. Required field)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
CL.10
Code List
Did the patient receive radiation therapy during this reporting period? (1. Required field)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
RTSiteName
Item
Specify sites (1. If the field is reported as "Yes" above, some text must be filled in for the "specify sites" question. If above is no, this question must not be answered.)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
Item
Was tumor tissue surgically obtained for biology studies (e.g. biopsy, resection, fine needle aspiration)? (1. Required field)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C25683 (NCI Thesaurus Property)
C0449416 (UMLS 2011AA Property)
CL.11
Code List
Was tumor tissue surgically obtained for biology studies (e.g. biopsy, resection, fine needle aspiration)? (1. Required field)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Unnamed5
DoseModificationText
Item
please describe. (1. Text field)
text
C25256 (NCI Thesaurus ObjectClass)
C1265611 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
Item
Was there a deviation from protocol therapy? (1. Required field)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25256 (NCI Thesaurus ObjectClass)
C1265611 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain)
CL.12
Code List
Was there a deviation from protocol therapy? (1. Required field)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, protocol specified modification for toxicity)
CL Item
Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes non-protocol specified modification for toxicity)
CL Item
Yes, other reason for deviation (Yes, other reason for deviation)
Item Group
Unnamed6
Item
Did patient receive concomitant medications while on protocol therapy? (1. Required field)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
CL.13
Code List
Did patient receive concomitant medications while on protocol therapy? (1. Required field)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Type (Type of drugs)
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)
CL.14
Code List
Type (Type of drugs)
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 field)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass)
C0521115 (UMLS 2011AA ObjectClass)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
TreatmentBeginDate
Item
Start Date
date
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
TreatmentEndDate
Item
End Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
ConcomitantMedicationReceivedText
Item
Description (agent, dose, etc.)
text
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
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 Group
Unnamed7
Item
Did a second malignant neoplasm (SMN) occur during this Reporting Period? (If SMN is acute myelogenous leukemia or myelodysplastic syndrome MDS, submit the NCI secondary AML/MDS form, cytogenetics and pathology reports.)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
CL.15
Code List
Did a second malignant neoplasm (SMN) occur during this Reporting Period? (If SMN is acute myelogenous leukemia or myelodysplastic syndrome MDS, submit the NCI secondary AML/MDS form, cytogenetics and pathology reports.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
NewCancerDiagnosisDate
Item
Date SMN diagnosed (1. If the answer to SMN is yes, this field must be supplied. The date must be between the start and end date of this reporting period.)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
Item Group
Unnamed8
Item
Life status at end of this reporting period (1. Required field)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C18003 (NCI Thesaurus ValueDomain)
C0442732 (UMLS 2011AA ValueDomain)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.16
Code List
Life status at end of this reporting period (1. Required field)
CL Item
Alive (Alive)
CL Item
Dead (Dead)
Item
Was patient confirmed lost to follow up at the end of this reporting period? (1. Required field)
text
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)
C1522577 (UMLS 2011AA Property)
CL.17
Code List
Was patient confirmed lost to follow up at the end of this reporting period? (1. Required field)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Was patient enrolled on another COG therapeutic study at the end of this reporting period? (1. Required field)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
CL.18
Code List
Was patient enrolled on another COG therapeutic study at the end of this reporting period? (1. Required field)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Was patient's consent withdrawn? (1. Required field)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38061 (NCI Thesaurus Property)
C2349954 (UMLS 2011AA Property)
CL.19
Code List
Was patient's consent withdrawn? (1. Required field)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Did patient relapse or experience disease progression during this reporting period? (1. Required field)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
CL.20
Code List
Did patient relapse or experience disease progression during this reporting period? (1. Required field)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
DiseaseProgressionDate
Item
date of relapse or progression (MM/DD/YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
Item Group
Unnamed9
Item
Category
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
CL.21
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)
CL.22
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
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)
CL.23
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]
double
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
Item
Grade
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.24
Code List
Grade
CL Item
No Adverse Event Or Within Normal Limits (0)
CL Item
Mild Adverse Event (1)
C41338 (NCI Thesaurus)
C1513302 (UMLS 2011AA)
CL Item
Moderate Adverse Event (2)
C41339 (NCI Thesaurus)
C1513374 (UMLS 2011AA)
CL Item
Severe And Undesirable Adverse Event (3)
CL Item
Life-threatening Or Disabling Adverse Event (4)
CL Item
Death Related To Adverse Event (5)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)
CL Item
Unknown (9)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Attribution (Code only for grade 2 or higher or for any toxicity for which an AdEERS Report is filed)
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.25
Code List
Attribution (Code only for grade 2 or higher or for any toxicity for which an AdEERS Report is filed)
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)
Item
Adverse Drug Experience? (Code only for grade 2 or higher or for any toxicity for which an AdEERS Report is filed)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25410 (NCI Thesaurus ObjectClass)
C1521800 (UMLS 2011AA ObjectClass)
C25175 (NCI Thesaurus Property)
C1522646 (UMLS 2011AA Property)
CL.26
Code List
Adverse Drug Experience? (Code only for grade 2 or higher or for any toxicity for which an AdEERS Report is filed)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Dose Limiting Toxicity? (Reset)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C27990 (NCI Thesaurus ObjectClass)
C0600688 (UMLS 2011AA ObjectClass)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
CL.27
Code List
Dose Limiting Toxicity? (Reset)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CTCAdverseEventOnsetDate
Item
Date Onset
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
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)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25655 (NCI Thesaurus Property)
C1514893 (UMLS 2011AA Property)
CTCAdverseEventResolutionInd
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)
Item Group
Unnamed10
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
Ccrr Module For Advl0212: Reporting Period Worksheet
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