ID

2663

Description

E4A03 Treatment Form - Step 1 - Form 2059 Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DC861384-6E80-3EBD-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DC861384-6E80-3EBD-E034-0003BA12F5E7

Keywords

Versions (4)
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 7/5/15 7/5/15 -
Uploaded on

September 19, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Multiple Myeloma and Plasma Cell Neoplasm NCT00098475 Treatment - E4A03 Treatment Form - Step 1 - Form 2059 - 2283904v3.0

English

No Instruction available.

1 forms  
  1. StudyEvent: E4A03 Treatment Form - Step 1 - Form 2059
    1. No Instruction available.
Unnamed1
Description

Unnamed1

Registration Step
Description

RegistrationStepNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25646
UMLS 2011AA ObjectClass
C1514821
NCI Thesaurus Property
C16154
UMLS 2011AA Property
C1704379
NCI Thesaurus ValueDomain
C16154
UMLS 2011AA ValueDomain
C1704379
DCI Name (Place ID Label Here)
Description

CollectedDataFormName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C19464
UMLS 2011AA Property
C0376315
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus ObjectClass
C25452
Patient Initials
Description

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
ECOG Protocol Number
Description

ProtocolECOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25491
UMLS 2011AA Property
C1512162
ECOG Protocol Number
Description

ProtocolECOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25491
UMLS 2011AA Property
C1512162
ECOG Patient ID
Description

PatientECOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25491
UMLS 2011AA Property
C1512162
ECOG Patient ID
Description

PatientECOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25491
UMLS 2011AA Property
C1512162
Participating Group Protocol Number
Description

ProtocolParticipatingIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Participating Group Patient ID
Description

PatientParticipatingIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Institution/Affiliate
Description

CombinedInstitutionName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS 2011AA ObjectClass
C0205195
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ValueDomain
C21541
UMLS 2011AA ValueDomain
C0018704
On Treatment Report Period (1 cycle = 28 days)
Description

OnTreatmentTimePeriod

Data type

text

Unnamed2
Description

Unnamed2

Are data amended
Description

DataAmendedInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Section A: Vital Status
Description

Section A: Vital Status

Patient Vital Status
Description

PatientVitalStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C18003
UMLS 2011AA ValueDomain
C0442732
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Primary Cause of Death (if applicable)
Description

PatientDeathPrimaryReason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C28554
UMLS 2011AA Property
C0011065
NCI Thesaurus ValueDomain
C28554
UMLS 2011AA ValueDomain
C0011065
Describe cause of death
Description

PatientDeathSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C28554
UMLS 2011AA Property
C0011065
Date of Last Contact or Death
Description

PatientLastContactDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C25461
UMLS 2011AA Property
C0337611
Day 1 of this Report Period
Description

AssessmentFirstDayDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C25301
UMLS 2011AA Property
C0439228
ECOG Performance status (Day 1 of this report period)
Description

PerformanceStatusScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C25361
UMLS 2011AA ObjectClass
C0597198
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Weight (Day 1 of this report period)
Description

PatientWeightMeasurement

Data type

double

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

PatientInitialsName

Data type

text

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

TherapyCourseNumber

Data type

double

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
ECOG Patient ID
Description

PatientECOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25491
UMLS 2011AA Property
C1512162
Did patient receive pamidronate or zoledronic acid this report period?
Description

BisphosphonateSupportAdministeredInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C443
UMLS 2011AA ObjectClass
C0012544
NCI Thesaurus ObjectClass
C37902
UMLS 2011AA ObjectClass
C1521721
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Bisphosphanate type(s) received (If yes:)
Description

BisphosphonateSupportAdministeredType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C443
UMLS 2011AA ObjectClass
C0012544
NCI Thesaurus ObjectClass
C37902
UMLS 2011AA ObjectClass
C1521721
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Did the patient complete the Patient Diary?
Description

PatientDiaryCompleteInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Metathesaurus ObjectClass
C0030705
Section B: Therapy Administered During First Four Cycles Only
Description

Section B: Therapy Administered During First Four Cycles Only

Prescribed Dose (mg/day If dose is held, enter '0')
Description

PrescribedAgentDose

Data type

double

Alias
NCI Thesaurus ObjectClass
C28180
UMLS 2011AA ObjectClass
C1521941
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ValueDomain
C1708
UMLS 2011AA ValueDomain
C0450442
Agent Start Date
Description

AgentBeginDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Agent End Date
Description

AgentEndDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Total No. of Day at this Dose Level
Description

DoseTotalDayCount

Data type

double

Alias
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus Property
C25304
UMLS 2011AA Property
C0439810
NCI Thesaurus Property
C25301
UMLS 2011AA Property
C0439228
NCI Thesaurus ValueDomain
C25301
UMLS 2011AA ValueDomain
C0439228
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Patient Initials
Description

PatientInitialsName

Data type

text

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

TherapyCourseNumber

Data type

double

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
Total Dosage at this Dose Level
Description

AgentAdministeredTotalDose

Data type

double

Alias
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Cycle Number
Description

TherapyCourseNumber

Data type

double

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
Were there any dose modifications or additions/omissions to protocol treatment this report period?
Description

DoseModificationInd

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C25256
UMLS 2011AA ObjectClass
C1265611
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain
C25572
ECOG Patient ID
Description

PatientECOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25491
UMLS 2011AA Property
C1512162
Reason for dose modification
Description

TreatmentModificationReason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25572
Section C: Dexamethasone
Description

Section C: Dexamethasone

Prescribed Dose (mg/day If dose is held, enter '0')
Description

PrescribedAgentDose

Data type

double

Alias
NCI Thesaurus ObjectClass
C28180
UMLS 2011AA ObjectClass
C1521941
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ValueDomain
C1708
UMLS 2011AA ValueDomain
C0450442
Agent Start Date
Description

AgentBeginDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Agent End Date
Description

AgentEndDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Total No. of Day at this Dose Level
Description

DoseTotalDayCount

Data type

double

Alias
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus Property
C25304
UMLS 2011AA Property
C0439810
NCI Thesaurus Property
C25301
UMLS 2011AA Property
C0439228
NCI Thesaurus ValueDomain
C25301
UMLS 2011AA ValueDomain
C0439228
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Cycle Number
Description

TherapyCourseNumber

Data type

double

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
Total Dosage at this Dose Level
Description

AgentAdministeredTotalDose

Data type

double

Alias
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Were there any dose modifications or additions/omissions to protocol treatment this report period?
Description

DoseModificationInd

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C25256
UMLS 2011AA ObjectClass
C1265611
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain
C25572
Reason for dose modification
Description

TreatmentModificationReason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25572
Section D: Post Cycle 4 Treatment Summary
Description

Section D: Post Cycle 4 Treatment Summary

Total number of cycles (this report period)
Description

PriorTreatmentCourseCount

Data type

double

Alias
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
Agent(s) Modified (If yes:)
Description

AgentName

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ValueDomain
C1708
UMLS 2011AA ValueDomain
C0450442
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Agent(s) Modified (If yes:)
Description

AgentName

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ValueDomain
C1708
UMLS 2011AA ValueDomain
C0450442
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Cycle of dose modification
Description

ModifiedDoseCycleNumber

Data type

double

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C25472
UMLS 2011AA Property
C1511572
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
Cycle of dose modification
Description

ModifiedDoseCycleNumber

Data type

double

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C25472
UMLS 2011AA Property
C1511572
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
Patient Initials
Description

PatientInitialsName

Data type

text

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

TherapyCourseNumber

Data type

double

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
Were there any dose modifications or additions/omissions to protocol treatment this report period?
Description

DoseModificationInd

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C25256
UMLS 2011AA ObjectClass
C1265611
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain
C25572
ECOG Patient ID
Description

PatientECOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25491
UMLS 2011AA Property
C1512162
Reason for dose modification
Description

TreatmentModificationReason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25572
Reason for dose modification
Description

TreatmentModificationReason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25572
Modified dose (mg/day)
Description

DoseModificationAmount

Data type

double

Alias
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus ValueDomain
C25417
NCI Thesaurus Property
C25572
Modified dose (mg/day)
Description

DoseModificationAmount

Data type

double

Alias
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus ValueDomain
C25417
NCI Thesaurus Property
C25572
Date of dose modifications (Dexamethasone)
Description

DoseModificationDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus Property
C25572
Date of dose modifications (Dexamethasone)
Description

DoseModificationDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus Property
C25572
Section E: Non-protocol Therapy
Description

Section E: Non-protocol Therapy

Was any non-protocol therapy given during protocol treatment (not previously reported)?
Description

Non-protocolCancerTreatmentConcurrentClinicalTrialProtocolTherapeuticProcedureAdministeredInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus ObjectClass
C16212
UMLS 2011AA ObjectClass
C0920425
NCI Thesaurus Property
C25320
UMLS 2011AA Property
C1507394
NCI Thesaurus Property
C49236
UMLS 2011AA Property
C0087111
NCI Thesaurus Property
C25456
UMLS 2011AA Property
C0205420
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Section F: Related Forms
Description

Section F: Related Forms

Comments
Description

Comments

Comments
Description

ResearchCommentsText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411
Investigator Signature
Description

InvestigatorSignatureText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Investigator Signature Date
Description

InvestigatorSignatureDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
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1 forms
  1. StudyEvent: E4A03 Treatment Form - Step 1 - Form 2059
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Unnamed1
RegistrationStepNumber
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25646 (NCI Thesaurus ObjectClass)
C1514821 (UMLS 2011AA ObjectClass)
C16154 (NCI Thesaurus Property)
C1704379 (UMLS 2011AA Property)
C16154 (NCI Thesaurus ValueDomain)
C1704379 (UMLS 2011AA ValueDomain)
CollectedDataFormName
Item
DCI Name (Place ID Label Here)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus Property)
C0376315 (UMLS 2011AA Property)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus ObjectClass)
PatientInitialsName
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
ProtocolECOGIdentifierNumber
Item
ECOG Protocol 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)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
ProtocolECOGIdentifierNumber
Item
ECOG Protocol 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)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
PatientECOGIdentifierNumber
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
PatientECOGIdentifierNumber
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
ProtocolParticipatingIdentifierNumber
Item
Participating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientParticipatingIdentifierNumber
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CombinedInstitutionName
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
Item
On Treatment Report Period (1 cycle = 28 days)
text
CL.1
Code List
On Treatment Report Period (1 cycle = 28 days)
CL Item
Cycle 4 Step 1 (Cycle 4 step 1)
CL Item
Cycle 8 Step 1 (Cycle 8 step 1)
CL Item
Cycle 12 Step 1 (Cycle 12 step 1)
Item Group
Unnamed2
Item
Are data amended
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
CL.2
Code List
Are data amended
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Section A: Vital Status
Item
Patient Vital Status
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C18003 (NCI Thesaurus ValueDomain)
C0442732 (UMLS 2011AA ValueDomain)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.3
Code List
Patient Vital Status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
Item
Primary Cause of Death (if applicable)
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)
C28554 (NCI Thesaurus ValueDomain)
C0011065 (UMLS 2011AA ValueDomain)
CL.4
Code List
Primary Cause of Death (if applicable)
CL Item
Due To Protocol Treatment (Due to protocol treatment)
CL Item
Due To This Disease (Due to this disease)
CL Item
Due To Other Cause, Specify (Due to other cause)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
PatientDeathSpecify
Item
Describe cause of death
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)
PatientLastContactDate
Item
Date of Last Contact or Death
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C25461 (NCI Thesaurus Property)
C0337611 (UMLS 2011AA Property)
AssessmentFirstDayDate
Item
Day 1 of this Report Period
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25301 (NCI Thesaurus Property)
C0439228 (UMLS 2011AA Property)
Item
ECOG Performance status (Day 1 of this report period)
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25361 (NCI Thesaurus ObjectClass)
C0597198 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.5
Code List
ECOG Performance status (Day 1 of this report period)
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction (karnofsky 90 - 100) (ecog - 0 Asymptomatic) (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory (k70 - 80) (ecog - 1 Symptomatic - Fully Ambulatory) (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities (k 50 - 60) (ecog - 2 Symptomatic; In Bed , 50% Of The Day) (2)
CL Item
Capable Of Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (k 30 - 40) (ecog - 3 Symptomatic; In Bed > 50% Of The Day But Not Bedridden) (3)
CL Item
Completely Disabled (k10 - 20) (ecog - 4 Bedridden) (4)
PatientWeightMeasurement
Item
Weight (Day 1 of this report 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)
PatientInitialsName
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
TherapyCourseNumber
Item
Cycle Number
double
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
PatientECOGIdentifierNumber
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
Item
Did patient receive pamidronate or zoledronic acid this report period?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C443 (NCI Thesaurus ObjectClass)
C0012544 (UMLS 2011AA ObjectClass)
C37902 (NCI Thesaurus ObjectClass)
C1521721 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.6
Code List
Did patient receive pamidronate or zoledronic acid this report period?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Bisphosphanate type(s) received (If yes:)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C443 (NCI Thesaurus ObjectClass)
C0012544 (UMLS 2011AA ObjectClass)
C37902 (NCI Thesaurus ObjectClass)
C1521721 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.7
Code List
Bisphosphanate type(s) received (If yes:)
CL Item
Pamidronate (pamidronate)
CL Item
Zoledronic Acid (zoledronic acid)
CL Item
Both Pamidronate And Zoledronic Acid (both pamidronate and zoledronic acid)
Item
Did the patient complete the Patient Diary?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C0030705 (NCI Metathesaurus ObjectClass)
CL.8
Code List
Did the patient complete the Patient Diary?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Section B: Therapy Administered During First Four Cycles Only
PrescribedAgentDose
Item
Prescribed Dose (mg/day If dose is held, enter '0')
double
C28180 (NCI Thesaurus ObjectClass)
C1521941 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
AgentBeginDate
Item
Agent Start Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
AgentEndDate
Item
Agent End Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
DoseTotalDayCount
Item
Total No. of Day at this Dose Level
double
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25304 (NCI Thesaurus Property)
C0439810 (UMLS 2011AA Property)
C25301 (NCI Thesaurus Property)
C0439228 (UMLS 2011AA Property)
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
PatientInitialsName
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
TherapyCourseNumber
Item
Cycle Number
double
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
AgentAdministeredTotalDose
Item
Total Dosage at this Dose Level
double
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
TherapyCourseNumber
Item
Cycle Number
double
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
Item
Were there any dose modifications or additions/omissions to protocol treatment this report period?
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.11
Code List
Were there any dose modifications or additions/omissions to protocol treatment this report period?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (yes, planned)
CL Item
Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (yes, unplanned)
PatientECOGIdentifierNumber
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
TreatmentModificationReason
Item
Reason for dose modification
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
Item Group
Section C: Dexamethasone
PrescribedAgentDose
Item
Prescribed Dose (mg/day If dose is held, enter '0')
double
C28180 (NCI Thesaurus ObjectClass)
C1521941 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
AgentBeginDate
Item
Agent Start Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
AgentEndDate
Item
Agent End Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
DoseTotalDayCount
Item
Total No. of Day at this Dose Level
double
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25304 (NCI Thesaurus Property)
C0439810 (UMLS 2011AA Property)
C25301 (NCI Thesaurus Property)
C0439228 (UMLS 2011AA Property)
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
TherapyCourseNumber
Item
Cycle Number
double
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
AgentAdministeredTotalDose
Item
Total Dosage at this Dose Level
double
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Were there any dose modifications or additions/omissions to protocol treatment this report period?
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.11
Code List
Were there any dose modifications or additions/omissions to protocol treatment this report period?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (yes, planned)
CL Item
Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (yes, unplanned)
TreatmentModificationReason
Item
Reason for dose modification
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
Item Group
Section D: Post Cycle 4 Treatment Summary
PriorTreatmentCourseCount
Item
Total number of cycles (this report period)
double
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
Item
Agent(s) Modified (If yes:)
text
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
CL.13
Code List
Agent(s) Modified (If yes:)
CL Item
Dexamethasone (Dexamethasone)
Item
Agent(s) Modified (If yes:)
text
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
CL.13
Code List
Agent(s) Modified (If yes:)
CL Item
Dexamethasone (Dexamethasone)
ModifiedDoseCycleNumber
Item
Cycle of dose modification
double
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25472 (NCI Thesaurus Property)
C1511572 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
ModifiedDoseCycleNumber
Item
Cycle of dose modification
double
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25472 (NCI Thesaurus Property)
C1511572 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
PatientInitialsName
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
TherapyCourseNumber
Item
Cycle Number
double
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
Item
Were there any dose modifications or additions/omissions to protocol treatment this report period?
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.11
Code List
Were there any dose modifications or additions/omissions to protocol treatment this report period?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (yes, planned)
CL Item
Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (yes, unplanned)
PatientECOGIdentifierNumber
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
TreatmentModificationReason
Item
Reason for dose modification
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
TreatmentModificationReason
Item
Reason for dose modification
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
DoseModificationAmount
Item
Modified dose (mg/day)
double
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25417 (NCI Thesaurus ValueDomain)
C25572 (NCI Thesaurus Property)
DoseModificationAmount
Item
Modified dose (mg/day)
double
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25417 (NCI Thesaurus ValueDomain)
C25572 (NCI Thesaurus Property)
DoseModificationDate
Item
Date of dose modifications (Dexamethasone)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
DoseModificationDate
Item
Date of dose modifications (Dexamethasone)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
Item Group
Section E: Non-protocol Therapy
Item
Was any non-protocol therapy given during protocol treatment (not previously reported)?
text
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C16212 (NCI Thesaurus ObjectClass)
C0920425 (UMLS 2011AA ObjectClass)
C25320 (NCI Thesaurus Property)
C1507394 (UMLS 2011AA Property)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)
C25456 (NCI Thesaurus Property)
C0205420 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.14
Code List
Was any non-protocol therapy given during protocol treatment (not previously reported)?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Section F: Related Forms
Item Group
Comments
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
InvestigatorSignatureText
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignatureDate
Item
Investigator Signature Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
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