ID

42973

Beschreibung

NCIC MA.32 Serious Adverse Event Folder A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=81E4E526-5F38-E26A-E040-BB89AD43175C

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=81E4E526-5F38-E26A-E040-BB89AD43175C

Stichworte

  1. 08.08.14 08.08.14 - Martin Dugas
  2. 09.01.15 09.01.15 - Martin Dugas
  3. 09.01.15 09.01.15 - Martin Dugas
  4. 17.09.21 17.09.21 -
Hochgeladen am

17. September 2021

DOI

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Breast Cancer NCT01101438 Toxicity - NCIC MA.32 Serious Adverse Event Folder - 3027655v1.0

No Instruction available.

  1. StudyEvent: NCIC MA.32 Serious Adverse Event Folder
    1. No Instruction available.
Date Of Event/reporting Period
Beschreibung

Date Of Event/reporting Period

Start Date of Primary AE
Beschreibung

PrimaryAdverseEventBeginDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C25251
UMLS 2011AA ObjectClass
C0205225
NCI Thesaurus ObjectClass-2
C41331
UMLS 2011AA ObjectClass-2
C0877248
NCI Thesaurus Property
C25431
UMLS 2011AA Property
C0439659
NCI Thesaurus Property-2
C25275
UMLS 2011AA Property-2
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
SAE Reported to Investigator Date
Beschreibung

SeriousAdverseEventReportedtoInvestigatorDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Metathesaurus Property
CL124429
Temporal relation to SAE to protocol treatment
Beschreibung

ReportSeriousAdverseEventPeriodType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ObjectClass
C25375
UMLS 2011AA ObjectClass
C0684224
NCI Thesaurus Property-2
C41335
UMLS 2011AA Property-2
C1519255
Reporting period at which SAE occurred
Beschreibung

ReportSeriousAdverseEventPeriodText

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ObjectClass
C25375
UMLS 2011AA ObjectClass
C0684224
NCI Thesaurus Property-2
C41335
UMLS 2011AA Property-2
C1519255
Event Description
Beschreibung

Event Description

Event Description
Beschreibung

AdverseEventTreatingDescriptionText

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25705
UMLS 2011AA Property
C1522326
NCI Thesaurus Property-2
C25365
UMLS 2011AA Property-2
C0678257
Serious Adverse Events
Beschreibung

Serious Adverse Events

CTC Adverse Event Term
Beschreibung

AdverseEventCommonTerminologyforAdverseEventsVersion4TermName

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C49704
UMLS 2011AA Property
C1516728
NCI Thesaurus Property-2
C45559
UMLS 2011AA Property-2
C1705313
NCI Thesaurus ValueDomain
C45255
UMLS 2011AA ValueDomain
C1708523
NCI Thesaurus ValueDomain-2
C49704
UMLS 2011AA ValueDomain-2
C1516728
NCI Thesaurus ValueDomain-3
C42614
UMLS 2011AA ValueDomain-3
C0027365
NCI Thesaurus ValueDomain-4
C45559
UMLS 2011AA ValueDomain-4
C1705313
NCI Thesaurus ValueDomain-5
C25714
UMLS 2011AA ValueDomain-5
C0333052
Event Onset Time
Beschreibung

AdverseEventOnsetTime

Datentyp

time

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ValueDomain
C25207
UMLS 2011AA ValueDomain
C0040223
NCI Thesaurus Property
C25279
UMLS 2011AA Property
C0332162
Event End Time
Beschreibung

AdverseEventEndTime

Datentyp

time

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ValueDomain
C25207
UMLS 2011AA ValueDomain
C0040223
NCI Thesaurus Property
C25496
UMLS 2011AA Property
C2746065
Grade
Beschreibung

AdverseEventSeverityGrade

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C48309
UMLS 2011AA Property
C0441800
NCI Thesaurus Property-2
C49705
UMLS 2011AA Property-2
C1710065
NCI Thesaurus Property-3
C25676
UMLS 2011AA Property-3
C0439793
NCI Thesaurus ValueDomain
C41331
UMLS 2011AA ValueDomain
C0877248
NCI Thesaurus ValueDomain-2
C48309
UMLS 2011AA ValueDomain-2
C0441800
NCI Thesaurus ValueDomain-3
C25676
UMLS 2011AA ValueDomain-3
C0439793
Attribution (to Metformin/Placebo)
Beschreibung

CTC Adverse Event Attribution Category

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1706735
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
Action Taken at Time of Adverse Event
Beschreibung

AdverseEventActionType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25404
UMLS 2011AA Property
C0441472
AE Outcome
Beschreibung

Adverse Event Outcome

Datentyp

text

Alias
NCI Thesaurus Property
C25626
UMLS CUI-1
C1705586
NCI Thesaurus ObjectClass
C41331
NCI Thesaurus ValueDomain
C25688
Seriousness Attributed to Adverse Event
Beschreibung

AdverseEventSeriousnessAttributionScale

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
Laboratory Tests - Question
Beschreibung

Laboratory Tests - Question

Are there any relevant laboratory or physical exam tests to report
Beschreibung

AbnormalPhysicalExaminationLaboratoryProcedureOutcomeInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus ObjectClass-2
C25401
UMLS 2011AA ObjectClass-2
C0205161
NCI Thesaurus ObjectClass-3
C25294
UMLS 2011AA ObjectClass-3
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Laboratory Test
Beschreibung

Laboratory Test

Diagnostic Test
Beschreibung

LaboratoryProcedurePhysicalExaminationAssessmentType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C25367
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Specify
Beschreibung

LaboratoryProcedurePerformedSpecify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Nadir/Worst Value
Beschreibung

AdverseEventWorstSymptomValue

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C4876
UMLS 2011AA Property
C1457887
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property-2
C25719
UMLS 2011AA Property-2
C1522166
Nadir/Worst Date (at Time of SAE)
Beschreibung

AdverseEventWorstSymptomDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C4876
UMLS 2011AA Property
C1457887
NCI Thesaurus Property-2
C25719
UMLS 2011AA Property-2
C1522166
Nadir/Worst Unit of Measure
Beschreibung

AdverseEventWorstSymptomUOM

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C4876
UMLS 2011AA Property
C1457887
NCI Thesaurus ValueDomain
C25709
UMLS 2011AA ValueDomain
C1519795
NCI Thesaurus Property-2
C25719
UMLS 2011AA Property-2
C1522166
LLN
Beschreibung

LaboratoryProcedurePerformedLowerLimitofNormalValue

Datentyp

float

Alias
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25555
UMLS 2011AA ValueDomain-2
C1518030
ULN
Beschreibung

LaboratoryProcedurePerformedUpperLimitofNormalValue

Datentyp

float

Alias
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
Has the patient recovered
Beschreibung

LaboratoryFindingRecoveryInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C38470
NCI Thesaurus Property
C70827
UMLS 2011AA Property
C0237820
Recovery or Latest Value
Beschreibung

AdverseEventMostRecentRecoveryValue

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25746
UMLS 2011AA Property
C2004454
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property-2
C25577
UMLS 2011AA Property-2
C1513491
Date of Recovery or Death
Beschreibung

AdverseEventMostRecentRecoveryDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25746
UMLS 2011AA Property
C2004454
NCI Thesaurus Property-2
C25577
UMLS 2011AA Property-2
C1513491
Name of Laboratory (where tests were completed)
Beschreibung

PathologyCoreFacilityLaboratoryIdentifierName

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C37984
UMLS 2011AA ObjectClass
C0022877
NCI Thesaurus ObjectClass-2
C18189
UMLS 2011AA ObjectClass-2
C0030664
NCI Thesaurus ObjectClass-3
C15896
UMLS 2011AA ObjectClass-3
C1511521
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Blood Pressure - Question
Beschreibung

Blood Pressure - Question

Are there any relevant blood pressure results to report
Beschreibung

AbnormalBloodPressureLaboratoryProcedureOutcomeInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C25401
UMLS 2011AA ObjectClass
C0205161
NCI Thesaurus ObjectClass-2
C25294
UMLS 2011AA ObjectClass-2
C0022885
NCI Thesaurus ObjectClass-3
C54706
UMLS 2011AA ObjectClass-3
C0005823
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Blood Pressure
Beschreibung

Blood Pressure

Nadir/Worst Date (at Time of SAE)
Beschreibung

AdverseEventWorstSymptomDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C4876
UMLS 2011AA Property
C1457887
NCI Thesaurus Property-2
C25719
UMLS 2011AA Property-2
C1522166
Blood Pressure, Systolic (mmHg, Recovery Value)
Beschreibung

Systolic blood pressure

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0871470
NCI Thesaurus Property
C25214
NCI Thesaurus ObjectClass
C25298
Blood Pressure, Systolic (mmHg, Recovery Value)
Beschreibung

Systolic blood pressure

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0871470
NCI Thesaurus Property
C25214
NCI Thesaurus ObjectClass
C25298
Blood pressure, Diastolic (mmHg, Recovery Value)
Beschreibung

Diastolic blood pressure

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0428883
NCI Thesaurus Property
C25214
NCI Thesaurus ObjectClass
C25299
Blood pressure, Diastolic (mmHg, Recovery Value)
Beschreibung

Diastolic blood pressure

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0428883
NCI Thesaurus Property
C25214
NCI Thesaurus ObjectClass
C25299
Has the patient recovered
Beschreibung

LaboratoryFindingRecoveryInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C38470
NCI Thesaurus Property
C70827
UMLS 2011AA Property
C0237820
Date of Recovery or Death
Beschreibung

AdverseEventMostRecentRecoveryDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25746
UMLS 2011AA Property
C2004454
NCI Thesaurus Property-2
C25577
UMLS 2011AA Property-2
C1513491
Other Investigations - Question
Beschreibung

Other Investigations - Question

Are there any other relevant investigations to report
Beschreibung

AbnormalOtherLaboratoryProcedureOutcomeInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C17649
UMLS 2011AA ObjectClass
C0205394
NCI Thesaurus ObjectClass-2
C25401
UMLS 2011AA ObjectClass-2
C0205161
NCI Thesaurus ObjectClass-3
C25294
UMLS 2011AA ObjectClass-3
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Other Investigations - Question
Beschreibung

Other Investigations - Question

Diagnostic Test
Beschreibung

LaboratoryProcedurePhysicalExaminationAssessmentType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C25367
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Specify
Beschreibung

LaboratoryProcedurePerformedSpecify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Date
Beschreibung

Laboratory Procedure Date

Datentyp

date

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

AdverseEventAssessmentText

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
Protocol Treatment
Beschreibung

Protocol Treatment

Treatment Assignment Code
Beschreibung

TreatmentAssignmentCode

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25426
UMLS 2011AA Property
C1516050
Actual dose
Beschreibung

Medication Dose

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25488
UMLS CUI-1
C3174092
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain-2
C1708
NCI Thesaurus Property
C25382
Units
Beschreibung

UnitsText

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ObjectClass
C25709
UMLS 2011AA ObjectClass
C1519795
Route of Administration
Beschreibung

Drug administration method

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C0449311
NCI Metathesaurus ObjectClass
CL111054
NCI Thesaurus Property
C25409
Schedule
Beschreibung

Medication frequency

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS CUI-1
C3476109
NCI Thesaurus ValueDomain
C25515
NCI Thesaurus Property
C25382
Randomization Date
Beschreibung

PatientRandomizationDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25196
UMLS 2011AA Property
C0034656
Last Administered Date (Prior to SAE)
Beschreibung

TreatmentLastAdministeredDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25551
UMLS 2011AA Property
C1517741
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
Agent Source
Beschreibung

AgentSourceText

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25683
UMLS 2011AA Property
C0449416
Patient rechallenged with agent
Beschreibung

PatientRetreatmentInd

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C54055
UMLS 2011AA Property
C0376495
Did event reoccur
Beschreibung

SeriousAdverseEventRepeatOccurrenceInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass-2
C54035
UMLS 2011AA ObjectClass-2
C0205404
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus Property-2
C47886
UMLS 2011AA Property-2
C0205341
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Prior Systemic Therapy - Question
Beschreibung

Prior Systemic Therapy - Question

Has the patient received systemic therapy?
Beschreibung

SystemicTherapyAdministeredInd-3

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15698
UMLS 2011AA ObjectClass
C1515119
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Prior Radiation Therapy - Question
Beschreibung

Prior Radiation Therapy - Question

Has the patient received adjuvant RT
Beschreibung

AdjuvantRadiationTherapyAdministeredInd-3

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus ObjectClass-2
C2140
UMLS 2011AA ObjectClass-2
C0001552
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Relevant Major Medical Problems - Question
Beschreibung

Relevant Major Medical Problems - Question

Significant Medical History, Concomitant Diseases and/or Relevant Medical Conditions
Beschreibung

ConcomitantDiseasePersonalMedicalHistoryInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass-2
C25730
UMLS 2011AA ObjectClass-2
C0521115
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
Relevant Major Medical Problems
Beschreibung

Relevant Major Medical Problems

Date Documented
Beschreibung

PatientMedicalConditionDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25261
UMLS 2011AA Property
C0205476
NCI Thesaurus Property-2
C25457
UMLS 2011AA Property-2
C0348080
Relevant major medical problems
Beschreibung

ConcomitantDiseaseOrganSystemPersonalMedicalHistoryType

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass-2
C25730
UMLS 2011AA ObjectClass-2
C0521115
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
NCI Thesaurus Property-2
C12919
UMLS 2011AA Property-2
C0460002
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Specify other disease/condition
Beschreibung

ConcomitantDiseaseOrganSystemPersonalMedicalHistorySpecify

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass-2
C25730
UMLS 2011AA ObjectClass-2
C0521115
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
NCI Thesaurus Property-2
C12919
UMLS 2011AA Property-2
C0460002
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Other Relevant Details
Beschreibung

PatientHistoryText

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
Concomitant Medications - Question
Beschreibung

Concomitant Medications - Question

Did the participant report taking any concomitant medication
Beschreibung

ConcomitantMedicationUseInd-3

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
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
Concomitant Medications
Beschreibung

Concomitant Medications

Concomitant Medication (335 permissible values)
Beschreibung

Concomitant Medication

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2347852
NCI Thesaurus ObjectClass
C459
NCI Thesaurus Property
C25639
NCI Thesaurus ObjectClass-2
C25730
Agent Type (116 permissible values not coded)
Beschreibung

Concomitant Medication Use Indication

Datentyp

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
Was this medication used to treat the SAE
Beschreibung

SeriousAdverseEventTherapyInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C15368
NCI Thesaurus ObjectClass
C41335
UMLS 2011AA ObjectClass
C1519255
Start date
Beschreibung

Medication Start Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1521826
NCI Thesaurus ValueDomain-2
C25431
UMLS CUI-2
C0808070
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property
C25275
Stop date
Beschreibung

Medication End Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C0806020
NCI Thesaurus Property
C25275
Sae Notification Form
Beschreibung

Sae Notification Form

Ähnliche Modelle

No Instruction available.

  1. StudyEvent: NCIC MA.32 Serious Adverse Event Folder
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Date Of Event/reporting Period
PrimaryAdverseEventBeginDate
Item
Start Date of Primary AE
date
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass-2)
C0877248 (UMLS 2011AA ObjectClass-2)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
SeriousAdverseEventReportedtoInvestigatorDate
Item
SAE Reported to Investigator Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
CL124429 (NCI Metathesaurus Property)
Item
Temporal relation to SAE to protocol treatment
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25375 (NCI Thesaurus ObjectClass)
C0684224 (UMLS 2011AA ObjectClass)
C41335 (NCI Thesaurus Property-2)
C1519255 (UMLS 2011AA Property-2)
Code List
Temporal relation to SAE to protocol treatment
CL Item
During Protocol Treatment (during protocol treatment)
CL Item
Within 30 Days After Completion Of Protocol Treatment (within 30 days after completion of protocol treatment)
CL Item
More Than 30 Days After Completion Of Protocol Treatment (more than 30 days after completion of protocol treatment)
ReportSeriousAdverseEventPeriodText
Item
Reporting period at which SAE occurred
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25375 (NCI Thesaurus ObjectClass)
C0684224 (UMLS 2011AA ObjectClass)
C41335 (NCI Thesaurus Property-2)
C1519255 (UMLS 2011AA Property-2)
Item Group
Event Description
AdverseEventTreatingDescriptionText
Item
Event Description
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus Property)
C1522326 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
Item Group
Serious Adverse Events
AdverseEventCommonTerminologyforAdverseEventsVersion4TermName
Item
CTC Adverse Event Term
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C49704 (NCI Thesaurus Property)
C1516728 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property-2)
C1705313 (UMLS 2011AA Property-2)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain-2)
C1516728 (UMLS 2011AA ValueDomain-2)
C42614 (NCI Thesaurus ValueDomain-3)
C0027365 (UMLS 2011AA ValueDomain-3)
C45559 (NCI Thesaurus ValueDomain-4)
C1705313 (UMLS 2011AA ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)
C0333052 (UMLS 2011AA ValueDomain-5)
AdverseEventOnsetTime
Item
Event Onset Time
time
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25207 (NCI Thesaurus ValueDomain)
C0040223 (UMLS 2011AA ValueDomain)
C25279 (NCI Thesaurus Property)
C0332162 (UMLS 2011AA Property)
AdverseEventEndTime
Item
Event End Time
time
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25207 (NCI Thesaurus ValueDomain)
C0040223 (UMLS 2011AA ValueDomain)
C25496 (NCI Thesaurus Property)
C2746065 (UMLS 2011AA Property)
Item
Grade
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C48309 (NCI Thesaurus Property)
C0441800 (UMLS 2011AA Property)
C49705 (NCI Thesaurus Property-2)
C1710065 (UMLS 2011AA Property-2)
C25676 (NCI Thesaurus Property-3)
C0439793 (UMLS 2011AA Property-3)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C48309 (NCI Thesaurus ValueDomain-2)
C0441800 (UMLS 2011AA ValueDomain-2)
C25676 (NCI Thesaurus ValueDomain-3)
C0439793 (UMLS 2011AA ValueDomain-3)
Code List
Grade
CL Item
Absent Adverse Event (0)
C75533 (NCI Thesaurus)
C2699517 (UMLS 2011AA)
CL Item
Mild Adverse Event (1)
C84263 (NCI Thesaurus)
C1513302 (UMLS 2011AA)
CL Item
Moderate Adverse Event (2)
C84264 (NCI Thesaurus)
C1513374 (UMLS 2011AA)
CL Item
Severe Adverse Event (3)
C84265 (NCI Thesaurus)
C2919019 (UMLS 2011AA)
CL Item
Life Threatening Adverse Event (4)
C84266 (NCI Thesaurus)
C1517874 (UMLS 2011AA)
CL Item
Death Related To Adverse Event (5)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)
Item
Attribution (to Metformin/Placebo)
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
Code List
Attribution (to Metformin/Placebo)
CL Item
Definite (Definite)
CL209464 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
Item
Action Taken at Time of Adverse Event
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25404 (NCI Thesaurus Property)
C0441472 (UMLS 2011AA Property)
Code List
Action Taken at Time of Adverse Event
CL Item
There Was No Action Taken Based On The Adverse Event (none)
CL Item
Study Dose Was Reduced As A Result Of The Adverse Event (study dose reduced)
CL Item
Protocol Treatment Was Delayed As A Result Of The Adverse Event (protocol treatment delayed)
CL Item
Protocol Treatment Was Discontinued As A Result Of The Adverse Event (protocol treatment discontinued)
Item
AE Outcome
text
C25626 (NCI Thesaurus Property)
C1705586 (UMLS CUI-1)
C41331 (NCI Thesaurus ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
Code List
AE Outcome
CL Item
Recovered Or Resolved Without Sequelae (Recovered/Resolved without Sequelae)
C85257 (NCI Thesaurus)
C2827606 (UMLS 2011AA)
CL Item
Not Recovered Or Not Resolved (Not recovered/Not resolved)
C49494 (NCI Thesaurus)
C1709277 (UMLS 2011AA)
CL Item
Recovered Or Resolved With Sequelae (Recovered/Resolved with Sequelae)
C49495 (NCI Thesaurus)
C1709862 (UMLS 2011AA)
CL Item
Fatal Or Died (Fatal/Died)
Item
Seriousness Attributed to Adverse Event
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
Code List
Seriousness Attributed to Adverse Event
CL Item
Not Serious (Not serious)
CL Item
Death (Death)
C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)
CL Item
Life Threatening (Life threatening)
CL Item
Hospitalized (Hospitalization, initial or prolonged)
CL Item
Disability (Disability/incapacity)
C21007 (NCI Thesaurus)
C0231170 (UMLS 2011AA)
CL Item
Congenital Anomaly (Congenital anomaly)
CL Item
Intervention Required (Required intervention to prevent permanent impairment/damage)
Item Group
Laboratory Tests - Question
AbnormalPhysicalExaminationLaboratoryProcedureOutcomeInd-2
Item
Are there any relevant laboratory or physical exam tests to report
boolean
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25401 (NCI Thesaurus ObjectClass-2)
C0205161 (UMLS 2011AA ObjectClass-2)
C25294 (NCI Thesaurus ObjectClass-3)
C0022885 (UMLS 2011AA ObjectClass-3)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Laboratory Test
Item
Diagnostic Test
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Code List
Diagnostic Test
CL Item
Activated Partial Thromboplastin Time (Activated partial thromboplastin time (APTT))
CL Item
Albumin (Albumin - blood)
C214 (NCI Thesaurus)
C0001924 (UMLS 2011AA)
CL Item
Alkaline Phosphatase (Alkaline phosphatase NOS)
CL Item
Alkaline Phosphatase (Alkaline phosphates NOS)
CL Item
Amylase (Amylase - blood)
CL Item
Absolute Neutrophil Count (ANC)
CL Item
Bacterial Infection (Bacterial infection NOS)
CL Item
Direct Bilirubin (Bilirubin direct - blood)
CL Item
Total Bilirubin (Bilirubin total - blood)
C38037 (NCI Thesaurus)
C0201913 (UMLS 2011AA)
CL Item
Blood Bicarbonate (Blood bicarbonate)
CL Item
Blood Carbon Dioxide (Blood carbon dioxide)
CL Item
Anc (Blood neutrophils (ANC))
CL Item
Bun (Blood urea nitrogen (BUN))
CL Item
Bone Marrow Blasts (Bone Marrow Blasts)
CL Item
Bone Marrow Cellularity (Bone Marrow Cellularity)
C12431 (NCI Thesaurus)
C0005953 (UMLS 2011AA)
C37923 (NCI Thesaurus-3)
C1516377 (UMLS 2011AA-4)
CL Item
Calcium (Calcium - blood (Ca))
CL Item
Blood Carbon Dioxide (Carbon dioxide - blood (CO2))
CL Item
Chloride (Chloride - blood)
CL Item
Cholesterol (Cholesterol - blood)
CL Item
Creatine Phosphokinase (Creatine phosphokinase - blood (CK))
CL Item
Creatinine (Creatinine - serum (Cr))
CL Item
Creatinine Clearance (Creatinine clearance (CrCl))
CL Item
Fibrin D-dimer (Fibrin D-dimer)
CL Item
Fibrin Degradation Products (Fibrin degradation products (FDP))
CL Item
Fibrinogen (Fibrinogen - blood)
C25736 (NCI Thesaurus)
C0016006 (UMLS 2011AA)
CL Item
Fungal Infection (Fungal infection NOS)
CL Item
Glucose (Glucose - blood)
CL Item
Glutamic-oxaloacetic Transferase (ast, Sgot) (Glutamic-oxaloacetic transferase (AST, SGOT))
CL Item
Glutamic-pyruvate Transferase (alt, Sgpt) (Glutamic-pyruvate transferase (ALT, SGPT))
CL Item
Hematocrit (Hematocrit (Hct))
CL Item
Hemoglobin (hgb) (Hemoglobin (Hb))
CL Item
International Normalized Ratio (International normalised ratio (INR))
CL Item
Ldh (Lactate dehydrogenase - blood (LDH))
CL Item
Lipase (Lipase)
C37988 (NCI Thesaurus)
C0023764 (UMLS 2011AA)
CL Item
Magnesium (Magnesium - blood (Mg))
CL Item
Oxygen Saturation (Oxygen saturation)
C0483415 (NCI Metathesaurus)
CL Item
Peripheral Blasts (Peripheral Blasts)
CL Item
Ph Nos (pH NOS)
CL Item
Phosphorus (Phosphorus)
CL Item
Platelet Count (Platelet count (PLT))
C0032181 (NCI Metathesaurus)
CL Item
Po2 (pO2)
C0483414 (NCI Metathesaurus)
CL Item
Potassium (Potassium - blood (K))
CL Item
Total Protein (Protein NOS (Total))
CL Item
Prothrombin Time (Prothrombin time (PT))
C0033707 (NCI Metathesaurus)
CL Item
Sodium (Sodium - blood)
C830 (NCI Thesaurus)
C0037473 (UMLS 2011AA)
CL Item
Triglycerides (Triglycerides)
C906 (NCI Thesaurus)
C0041004 (UMLS 2011AA)
CL Item
Urinalysis (Urine analysis)
C17241 (NCI Thesaurus)
C0042014 (UMLS 2011AA)
CL Item
Viral Infection (Viral infection NOS)
CL Item
Wbc (White blood cell count (WBC))
LaboratoryProcedurePerformedSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
AdverseEventWorstSymptomValue
Item
Nadir/Worst Value
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25719 (NCI Thesaurus Property-2)
C1522166 (UMLS 2011AA Property-2)
AdverseEventWorstSymptomDate
Item
Nadir/Worst Date (at Time of SAE)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)
C25719 (NCI Thesaurus Property-2)
C1522166 (UMLS 2011AA Property-2)
Item
Nadir/Worst Unit of Measure
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS 2011AA ValueDomain)
C25719 (NCI Thesaurus Property-2)
C1522166 (UMLS 2011AA Property-2)
Code List
Nadir/Worst Unit of Measure
CL Item
Percent (%)
C48570 (NCI Thesaurus)
C0439165 (UMLS 2011AA)
CL Item
1000 Per Cubic Millimiter (1000/mm3)
CL Item
1000 Per Microliter (1000/uL)
CL Item
Cubic Centimeters Per Minute (cc/min)
CL Item
Cells Per Liter (cells/L)
CL Item
Grams Per Deciliter (g/dL)
CL Item
Grams Per Liter (g/L)
CL Item
Gram (gm)
C0439208 (NCI Metathesaurus)
CL Item
Grams Per Deciliter (gm/dl)
CL Item
International Units Per Liter (iU/L)
CL Item
Kilopascals (kPa)
CL Item
Milliequivalents Per Liter (mEq/L)
CL Item
Milligrams Per Deciliter (mg/dL)
CL Item
Milligrams Per Liter (mg/L)
CL Item
Minutes (min)
CL Item
Ml/min/1.73m^2 (mL/min/1.73m2)
CL Item
Cubic Millimeters (mm3)
CL Item
Millimeters Of Mercury (mmHg)
CL Item
Millimole Per Liter (mmol/L)
CL Item
Not Applicable (n/a)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
CL Item
Number (number)
C25337 (NCI Thesaurus)
C0237753 (UMLS 2011AA)
CL Item
Seconds (seconds)
CL Item
Units Per Liter (U/L)
CL Item
Micrograms Per Milliliter (ug/mL)
CL Item
Microliter (ul)
C48153 (NCI Thesaurus)
C0439243 (UMLS 2011AA)
CL Item
Micromole Per Liter (umol/L)
CL Item
Volume Fraction (Vol Frac)
C67469 (NCI Thesaurus)
C0560268 (UMLS 2011AA)
LaboratoryProcedurePerformedLowerLimitofNormalValue
Item
LLN
float
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedurePerformedUpperLimitofNormalValue
Item
ULN
float
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
LaboratoryFindingRecoveryInd-2
Item
Has the patient recovered
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38470 (NCI Thesaurus ObjectClass)
C70827 (NCI Thesaurus Property)
C0237820 (UMLS 2011AA Property)
AdverseEventMostRecentRecoveryValue
Item
Recovery or Latest Value
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25746 (NCI Thesaurus Property)
C2004454 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25577 (NCI Thesaurus Property-2)
C1513491 (UMLS 2011AA Property-2)
AdverseEventMostRecentRecoveryDate
Item
Date of Recovery or Death
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25746 (NCI Thesaurus Property)
C2004454 (UMLS 2011AA Property)
C25577 (NCI Thesaurus Property-2)
C1513491 (UMLS 2011AA Property-2)
PathologyCoreFacilityLaboratoryIdentifierName
Item
Name of Laboratory (where tests were completed)
text
C37984 (NCI Thesaurus ObjectClass)
C0022877 (UMLS 2011AA ObjectClass)
C18189 (NCI Thesaurus ObjectClass-2)
C0030664 (UMLS 2011AA ObjectClass-2)
C15896 (NCI Thesaurus ObjectClass-3)
C1511521 (UMLS 2011AA ObjectClass-3)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
Item Group
Blood Pressure - Question
AbnormalBloodPressureLaboratoryProcedureOutcomeInd-2
Item
Are there any relevant blood pressure results to report
boolean
C25401 (NCI Thesaurus ObjectClass)
C0205161 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
C54706 (NCI Thesaurus ObjectClass-3)
C0005823 (UMLS 2011AA ObjectClass-3)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Blood Pressure
AdverseEventWorstSymptomDate
Item
Nadir/Worst Date (at Time of SAE)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)
C25719 (NCI Thesaurus Property-2)
C1522166 (UMLS 2011AA Property-2)
Systolic blood pressure
Item
Blood Pressure, Systolic (mmHg, Recovery Value)
float
C25209 (NCI Thesaurus ValueDomain)
C0871470 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25298 (NCI Thesaurus ObjectClass)
Systolic blood pressure
Item
Blood Pressure, Systolic (mmHg, Recovery Value)
float
C25209 (NCI Thesaurus ValueDomain)
C0871470 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25298 (NCI Thesaurus ObjectClass)
Diastolic blood pressure
Item
Blood pressure, Diastolic (mmHg, Recovery Value)
float
C25209 (NCI Thesaurus ValueDomain)
C0428883 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25299 (NCI Thesaurus ObjectClass)
Diastolic blood pressure
Item
Blood pressure, Diastolic (mmHg, Recovery Value)
float
C25209 (NCI Thesaurus ValueDomain)
C0428883 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25299 (NCI Thesaurus ObjectClass)
LaboratoryFindingRecoveryInd-2
Item
Has the patient recovered
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38470 (NCI Thesaurus ObjectClass)
C70827 (NCI Thesaurus Property)
C0237820 (UMLS 2011AA Property)
AdverseEventMostRecentRecoveryDate
Item
Date of Recovery or Death
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25746 (NCI Thesaurus Property)
C2004454 (UMLS 2011AA Property)
C25577 (NCI Thesaurus Property-2)
C1513491 (UMLS 2011AA Property-2)
Item Group
Other Investigations - Question
AbnormalOtherLaboratoryProcedureOutcomeInd-2
Item
Are there any other relevant investigations to report
boolean
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C25401 (NCI Thesaurus ObjectClass-2)
C0205161 (UMLS 2011AA ObjectClass-2)
C25294 (NCI Thesaurus ObjectClass-3)
C0022885 (UMLS 2011AA ObjectClass-3)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Other Investigations - Question
Item
Diagnostic Test
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Code List
Diagnostic Test
CL Item
Activated Partial Thromboplastin Time (Activated partial thromboplastin time (APTT))
CL Item
Albumin (Albumin - blood)
C214 (NCI Thesaurus)
C0001924 (UMLS 2011AA)
CL Item
Alkaline Phosphatase (Alkaline phosphatase NOS)
CL Item
Alkaline Phosphatase (Alkaline phosphates NOS)
CL Item
Amylase (Amylase - blood)
CL Item
Absolute Neutrophil Count (ANC)
CL Item
Bacterial Infection (Bacterial infection NOS)
CL Item
Direct Bilirubin (Bilirubin direct - blood)
CL Item
Total Bilirubin (Bilirubin total - blood)
C38037 (NCI Thesaurus)
C0201913 (UMLS 2011AA)
CL Item
Blood Bicarbonate (Blood bicarbonate)
CL Item
Blood Carbon Dioxide (Blood carbon dioxide)
CL Item
Anc (Blood neutrophils (ANC))
CL Item
Bun (Blood urea nitrogen (BUN))
CL Item
Bone Marrow Blasts (Bone Marrow Blasts)
CL Item
Bone Marrow Cellularity (Bone Marrow Cellularity)
C12431 (NCI Thesaurus)
C0005953 (UMLS 2011AA)
C37923 (NCI Thesaurus-3)
C1516377 (UMLS 2011AA-4)
CL Item
Calcium (Calcium - blood (Ca))
CL Item
Blood Carbon Dioxide (Carbon dioxide - blood (CO2))
CL Item
Chloride (Chloride - blood)
CL Item
Cholesterol (Cholesterol - blood)
CL Item
Creatine Phosphokinase (Creatine phosphokinase - blood (CK))
CL Item
Creatinine (Creatinine - serum (Cr))
CL Item
Creatinine Clearance (Creatinine clearance (CrCl))
CL Item
Fibrin D-dimer (Fibrin D-dimer)
CL Item
Fibrin Degradation Products (Fibrin degradation products (FDP))
CL Item
Fibrinogen (Fibrinogen - blood)
C25736 (NCI Thesaurus)
C0016006 (UMLS 2011AA)
CL Item
Fungal Infection (Fungal infection NOS)
CL Item
Glucose (Glucose - blood)
CL Item
Glutamic-oxaloacetic Transferase (ast, Sgot) (Glutamic-oxaloacetic transferase (AST, SGOT))
CL Item
Glutamic-pyruvate Transferase (alt, Sgpt) (Glutamic-pyruvate transferase (ALT, SGPT))
CL Item
Hematocrit (Hematocrit (Hct))
CL Item
Hemoglobin (hgb) (Hemoglobin (Hb))
CL Item
International Normalized Ratio (International normalised ratio (INR))
CL Item
Ldh (Lactate dehydrogenase - blood (LDH))
CL Item
Lipase (Lipase)
C37988 (NCI Thesaurus)
C0023764 (UMLS 2011AA)
CL Item
Magnesium (Magnesium - blood (Mg))
CL Item
Oxygen Saturation (Oxygen saturation)
C0483415 (NCI Metathesaurus)
CL Item
Peripheral Blasts (Peripheral Blasts)
CL Item
Ph Nos (pH NOS)
CL Item
Phosphorus (Phosphorus)
CL Item
Platelet Count (Platelet count (PLT))
C0032181 (NCI Metathesaurus)
CL Item
Po2 (pO2)
C0483414 (NCI Metathesaurus)
CL Item
Potassium (Potassium - blood (K))
CL Item
Total Protein (Protein NOS (Total))
CL Item
Prothrombin Time (Prothrombin time (PT))
C0033707 (NCI Metathesaurus)
CL Item
Sodium (Sodium - blood)
C830 (NCI Thesaurus)
C0037473 (UMLS 2011AA)
CL Item
Triglycerides (Triglycerides)
C906 (NCI Thesaurus)
C0041004 (UMLS 2011AA)
CL Item
Urinalysis (Urine analysis)
C17241 (NCI Thesaurus)
C0042014 (UMLS 2011AA)
CL Item
Viral Infection (Viral infection NOS)
CL Item
Wbc (White blood cell count (WBC))
LaboratoryProcedurePerformedSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Laboratory Procedure Date
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
AdverseEventAssessmentText
Item
Results
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
Item Group
Protocol Treatment
TreatmentAssignmentCode
Item
Treatment Assignment Code
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25426 (NCI Thesaurus Property)
C1516050 (UMLS 2011AA Property)
Medication Dose
Item
Actual dose
float
C25488 (NCI Thesaurus ValueDomain)
C3174092 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)
UnitsText
Item
Units
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25709 (NCI Thesaurus ObjectClass)
C1519795 (UMLS 2011AA ObjectClass)
Item
Route of Administration
text
C25284 (NCI Thesaurus ValueDomain)
C0449311 (UMLS CUI-1)
CL111054 (NCI Metathesaurus ObjectClass)
C25409 (NCI Thesaurus Property)
Code List
Route of Administration
CL Item
Oral Administration Of Drug (PO)
Item
Schedule
text
C1708 (NCI Thesaurus ObjectClass)
C3476109 (UMLS CUI-1)
C25515 (NCI Thesaurus ValueDomain)
C25382 (NCI Thesaurus Property)
Code List
Schedule
CL Item
Daily (Daily)
C25473 (NCI Thesaurus)
C0332173 (UMLS 2011AA)
PatientRandomizationDate
Item
Randomization Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
TreatmentLastAdministeredDate
Item
Last Administered Date (Prior to SAE)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
AgentSourceText
Item
Agent Source
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25683 (NCI Thesaurus Property)
C0449416 (UMLS 2011AA Property)
Item
Patient rechallenged with agent
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C54055 (NCI Thesaurus Property)
C0376495 (UMLS 2011AA Property)
Code List
Patient rechallenged with agent
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Decision Pending (Decision Pending)
SeriousAdverseEventRepeatOccurrenceInd-2
Item
Did event reoccur
boolean
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C54035 (NCI Thesaurus ObjectClass-2)
C0205404 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C47886 (NCI Thesaurus Property-2)
C0205341 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Prior Systemic Therapy - Question
SystemicTherapyAdministeredInd-3
Item
Has the patient received systemic therapy?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15698 (NCI Thesaurus ObjectClass)
C1515119 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item Group
Prior Radiation Therapy - Question
AdjuvantRadiationTherapyAdministeredInd-3
Item
Has the patient received adjuvant RT
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item Group
Relevant Major Medical Problems - Question
ConcomitantDiseasePersonalMedicalHistoryInd-2
Item
Significant Medical History, Concomitant Diseases and/or Relevant Medical Conditions
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
Item Group
Relevant Major Medical Problems
PatientMedicalConditionDate
Item
Date Documented
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25457 (NCI Thesaurus Property-2)
C0348080 (UMLS 2011AA Property-2)
Item
Relevant major medical problems
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C12919 (NCI Thesaurus Property-2)
C0460002 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Relevant major medical problems
CL Item
Acquired Immunodeficiency Syndrome (AIDS)
C2851 (NCI Thesaurus)
C0001175 (UMLS 2011AA)
CL Item
Immunology Hypersensitivity (Allergy/Immunology)
C3114 (NCI Thesaurus)
C0020517 (UMLS 2011AA)
C18011 (NCI Thesaurus-3)
C0152036 (UMLS 2011AA-4)
CL Item
Auditory (Auditory/Ear)
C37915 (NCI Thesaurus)
C0439825 (UMLS 2011AA)
CL Item
Bone Marrow Blood (Blood/Bone Marrow)
C12431 (NCI Thesaurus)
C0005953 (UMLS 2011AA)
C12434 (NCI Thesaurus-3)
C0229664 (UMLS 2011AA-4)
CL Item
Cardiac (Cardiac)
C13306 (NCI Thesaurus)
C1522601 (UMLS 2011AA)
CL Item
Coagulation (Coagulation)
C20812 (NCI Thesaurus)
C0005778 (UMLS 2011AA)
CL Item
Dermatologic (Dermatology/Skin)
C41128 (NCI Thesaurus)
C0205489 (UMLS 2011AA)
CL Item
Endocrine (Endocrine)
C41064 (NCI Thesaurus)
C0521425 (UMLS 2011AA)
CL Item
Gastrointestinal (Gastrointestinal)
C13359 (NCI Thesaurus)
C0521362 (UMLS 2011AA)
CL Item
Hepatobiliary System (Hepatobiliary/Pancreas)
C43612 (NCI Thesaurus)
C1711359 (UMLS 2011AA)
CL Item
Infection (Infection)
C26726 (NCI Thesaurus)
C0009450 (UMLS 2011AA)
CL Item
Metabolic (Metabolic/Laboratory)
C28240 (NCI Thesaurus)
C0311400 (UMLS 2011AA)
CL Item
Soft Tissue Musculoskeletal (Musculoskeletal/Soft Tissue)
C25348 (NCI Thesaurus)
C0497254 (UMLS 2011AA)
C12471 (NCI Thesaurus-3)
C0225317 (UMLS 2011AA-4)
CL Item
Neurology (Neurology)
C16908 (NCI Thesaurus)
C0027855 (UMLS 2011AA)
CL Item
Ocular (Ocular)
C87163 (NCI Thesaurus)
C1299003 (UMLS 2011AA)
C87163 (NCI Thesaurus-3)
C1299003 (UMLS 2011AA-4)
CL Item
Ocular (Ocular/Eye)
C87163 (NCI Thesaurus)
C1299003 (UMLS 2011AA)
C87163 (NCI Thesaurus-3)
C1299003 (UMLS 2011AA-4)
CL Item
Other (Other)
CL Item
Other Malignant Neoplasm (Other Malignancy)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C9305 (NCI Thesaurus-3)
C0006826 (UMLS 2011AA-4)
CL Item
Pulmonary (Pulmonary/Upper Respiratory)
C13304 (NCI Thesaurus)
C2709248 (UMLS 2011AA)
CL Item
Genitourinary Renal (Renal/Genitourinary)
C25225 (NCI Thesaurus)
C0022646 (UMLS 2011AA)
C25350 (NCI Thesaurus-3)
C0042066 (UMLS 2011AA-4)
CL Item
Surgical Procedure (Surgical Procedure)
C15329 (NCI Thesaurus)
C0543467 (UMLS 2011AA)
ConcomitantDiseaseOrganSystemPersonalMedicalHistorySpecify
Item
Specify other disease/condition
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C12919 (NCI Thesaurus Property-2)
C0460002 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
PatientHistoryText
Item
Other Relevant Details
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
Item Group
Concomitant Medications - Question
ConcomitantMedicationUseInd-3
Item
Did the participant report taking any concomitant medication
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (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)
Item Group
Concomitant Medications
Concomitant Medication
Item
Concomitant Medication (335 permissible values)
text
C25704 (NCI Thesaurus ValueDomain)
C2347852 (UMLS CUI-1)
C459 (NCI Thesaurus ObjectClass)
C25639 (NCI Thesaurus Property)
C25730 (NCI Thesaurus ObjectClass-2)
Concomitant Medication Use Indication
Item
Agent Type (116 permissible values not coded)
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)
SeriousAdverseEventTherapyInd-2
Item
Was this medication used to treat the SAE
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus Property)
C41335 (NCI Thesaurus ObjectClass)
C1519255 (UMLS 2011AA ObjectClass)
Medication Start Date
Item
Start date
date
C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C25431 (NCI Thesaurus ValueDomain-2)
C0808070 (UMLS CUI-2)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
Medication End Date
Item
Stop date
date
C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C0806020 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)
Item Group
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