ID

10740

Description

E2805 Treatment Form NCT00326898 Sunitinib or Sorafenib in Treating Patients With Kidney Cancer That Was Removed By Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=054B80EC-08C8-3374-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=054B80EC-08C8-3374-E044-0003BA3F9857

Keywords

Versions (4)
  1. 9/19/12 9/19/12 -
  2. 8/8/14 8/8/14 - Martin Dugas
  3. 1/8/15 1/8/15 - Martin Dugas
  4. 6/8/15 6/8/15 -
Uploaded on

June 8, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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E2805 Treatment Form NCT00326898

English

INSTRUCTIONS: Complete this form at the end of each cycle (1 cycle = 3 weeks), and at required follow-ups if specified by the Long-Term Follow-Up Form (to report late adverse events).

1 forms  
Header
Description

Header

ECOG Protocol Number
Description

Protocol Number ECOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Patient ID
Description

Patient ID ECOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
DCI Name
Description

Generic drug form

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C3242750
NCI Thesaurus Property
C19464
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus ObjectClass-2
C25452
Registration Step
Description

Registration Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
On Treatment Report Period (1 cycle = 6 weeks Choose one X)
Description

Cycle number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2045829
NCI Thesaurus Property
C25214
NCI Thesaurus Property-2
C25616
NCI Thesaurus ObjectClass
C15368
Patient demographics
Description

Patient demographics

ECOG Protocol Number
Description

Protocol Number ECOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Patient ID
Description

Patient ID ECOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
Patient Initials (Last, First)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Participating Group Protocol Number
Description

Study Number Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Institution/Affiliate
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Participating Group Patient ID
Description

Trial subject ID Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Data amendment
Description

Data amendment

Please mark an 'X' if data have been amended.
Description

Data amended

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Date data amended (s)
Description

Data amended date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
UMLS CUI-2
C0011008
NCI Thesaurus Property
C25416
NCI Thesaurus ValueDomain-2
C25367
Section I - Vital Status
Description

Section I - Vital Status

Vital Status
Description

Patient Status

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C3846084
NCI Thesaurus ValueDomain
C18003
NCI Thesaurus ValueDomain-2
C25688
NCI Thesaurus Property
C25717
Date of Last Contact or Death (M D Y)
Description

Date last contact

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C0805839
NCI Thesaurus Property
C25461
NCI Thesaurus Property-2
C25551
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Primary Cause of Death (if applicable)
Description

Primary Cause of Death

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C0007465
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C28554
NCI Thesaurus ValueDomain-2
C25251
Describe cause of death
Description

Cause of Death, specify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C0007465
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1521902
NCI Thesaurus Property
C28554
Section Ii - Patient Characteristics
Description

Section Ii - Patient Characteristics

Reporting Period Start Date (M D Y)
Description

Reporting Period Start Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25616
UMLS CUI-1
C2361257
NCI Thesaurus Property-2
C25651
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
Reporting Period End Date (M D Y)
Description

Reporting Period End Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2361259
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25651
ECOG Performance Status (Day 1 of this cycle)
Description

ECOG Performance Status

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1520224
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
Agent Name: Sorafenib/placebo
Description

Agent Name: Sorafenib/placebo

Did the patient complete and return the Patient Pill Calendar this cycle
Description

Patient Diary complete

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C3259162
NCI Thesaurus Property
C25250
NCI Thesaurus ObjectClass
C25394
NCI Thesaurus Property-2
C19459
Agent Name (Sorafenib/Placebo)
Description

Agent

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
Did the patient return their BAYER bottle this cycle
Description

PatientSorafenibPlaceboBottleMedicationInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C753
UMLS 2011AA Property
C0032042
NCI Thesaurus Property-2
C459
UMLS 2011AA Property-2
C0013227
NCI Thesaurus Property-3
C43169
UMLS 2011AA Property-3
C0179376
NCI Thesaurus Property-4
C61948
UMLS 2011AA Property-4
C1174389
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Total number of tablets remaining ([hand count required])
Description

PillsRemainingCount

Data type

float

Alias
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ObjectClass
C25394
UMLS 2011AA ObjectClass
C0994475
NCI Thesaurus Property
C25649
UMLS 2011AA Property
C1527428
Prescribed dose (number of capsules per day - on Day 1 of this cycle)
Description

Agent dose prescribed

Data type

float

Alias
NCI Thesaurus ObjectClass
C28180
UMLS CUI-1
C0678766
NCI Thesaurus ObjectClass-2
C1708
UMLS CUI-2
C0278329
NCI Thesaurus Property
C25256
NCI Thesaurus ValueDomain
C25488
NCI Thesaurus ValueDomain-2
C1708
Expected number of tablets taken ([Prescribed dosenumber of tablets per day *42])
Description

PillTakenCount

Data type

float

Alias
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ObjectClass
C25394
UMLS 2011AA ObjectClass
C0994475
NCI Thesaurus ValueDomain-2
C25394
UMLS 2011AA ValueDomain-2
C0994475
NCI Thesaurus Property
C25701
UMLS 2011AA Property
C1883727
Actual number of capsules taken (by hand count, if available, otherwise by pill diary)
Description

PillsTakenTotalCount

Data type

text

Alias
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus ValueDomain-2
C25463
UMLS 2011AA ValueDomain-2
C0750480
NCI Thesaurus ObjectClass
C25394
UMLS 2011AA ObjectClass
C0994475
NCI Thesaurus Property
C25701
UMLS 2011AA Property
C1883727
What was the source of the pill count
Description

PatientPillsDescriptionType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C25394
UMLS 2011AA ObjectClass-2
C0994475
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
If pill count was not done, please explain
Description

PillsNotAssessmentPerformedText

Data type

text

Alias
NCI Thesaurus ObjectClass
C25394
UMLS 2011AA ObjectClass
C0994475
NCI Thesaurus Property
C25367
NCI Thesaurus Property-2
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property-3
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Dose Modifications
Description

Dose Modifications

Agent Name (Sorafenib/Placebo)
Description

Agent

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
Were there any dose modifications or additions/omissions to protocol treatment (this report period)
Description

ECOGAgentQuantityModificationInd

Data type

text

Alias
NCI Thesaurus ObjectClass
C25491
UMLS 2011AA ObjectClass
C1512162
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
NCI Thesaurus Property-2
C25572
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Start Date of Dose Modification (M D Y)
Description

Dose modification begin date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1707811
NCI Thesaurus ValueDomain-2
C25431
UMLS CUI-2
C0808070
NCI Thesaurus ObjectClass
C25488
NCI Thesaurus Property
C25572
End Date of Dose Modification (M D Y)
Description

Dose modification end date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25488
UMLS CUI-2
C0806020
NCI Thesaurus Property
C25572
Modified Dose (mg)
Description

DoseModificationAmount

Data type

float

Alias
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus ValueDomain
C25417
NCI Thesaurus Property
C25572
Reason for therapy modification
Description

Dose Modification Reason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25488
UMLS CUI-2
C0392360
NCI Thesaurus Property
C25572
Other, specify
Description

Dose Modification Reason, other

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25488
UMLS CUI-2
C3840932
NCI Thesaurus Property
C25572
Assessment of medication
Description

Assessment of medication

Agent Name (Sorafenib/Placebo)
Description

Agent

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
Did the patient return their Pfizer bottle this cycle
Description

PatientSunitinibPlaceboBottleMedicationInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C753
UMLS 2011AA Property
C0032042
NCI Thesaurus Property-2
C459
UMLS 2011AA Property-2
C0013227
NCI Thesaurus Property-3
C43169
UMLS 2011AA Property-3
C0179376
NCI Thesaurus Property-4
C26673
UMLS 2011AA Property-4
C1698963
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Total number capsules remaining (if yes by hand count)
Description

CapsuleAgentRemainingTotalNumber

Data type

float

Alias
NCI Thesaurus ObjectClass
C25158
UMLS 2011AA ObjectClass
C0006935
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25649
UMLS 2011AA Property
C1527428
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus ValueDomain-2
C25463
UMLS 2011AA ValueDomain-2
C0750480
Prescribed dose (number of capsules per day - on Day 1 of this cycle)
Description

Agent dose prescribed

Data type

float

Alias
NCI Thesaurus ObjectClass
C28180
UMLS CUI-1
C0678766
NCI Thesaurus ObjectClass-2
C1708
UMLS CUI-2
C0278329
NCI Thesaurus Property
C25256
NCI Thesaurus ValueDomain
C25488
NCI Thesaurus ValueDomain-2
C1708
Expected number of capsules taken ([Prescribed dose number of capsules per day *28])
Description

CapsuleAgentTakenExpectedCount

Data type

float

Alias
NCI Thesaurus ObjectClass
C25158
UMLS 2011AA ObjectClass
C0006935
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25701
UMLS 2011AA Property
C1883727
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ValueDomain-2
C25501
UMLS 2011AA ValueDomain-2
C1517001
Actual number of capsules taken (by hand count, if available, otherwise by pill diary)
Description

PillsTakenTotalCount

Data type

text

Alias
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus ValueDomain-2
C25463
UMLS 2011AA ValueDomain-2
C0750480
NCI Thesaurus ObjectClass
C25394
UMLS 2011AA ObjectClass
C0994475
NCI Thesaurus Property
C25701
UMLS 2011AA Property
C1883727
What was the source of the pill count
Description

PatientPillsDescriptionType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C25394
UMLS 2011AA ObjectClass-2
C0994475
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
If pill count was not done, please explain
Description

PillsNotAssessmentPerformedText

Data type

text

Alias
NCI Thesaurus ObjectClass
C25394
UMLS 2011AA ObjectClass
C0994475
NCI Thesaurus Property
C25367
NCI Thesaurus Property-2
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property-3
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Dose Modifications
Description

Dose Modifications

Agent Name (Sorafenib/Placebo)
Description

Agent

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
Were there any dose modifications or additions/omissions to protocol treatment (this report period)
Description

ECOGAgentQuantityModificationInd

Data type

text

Alias
NCI Thesaurus ObjectClass
C25491
UMLS 2011AA ObjectClass
C1512162
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
NCI Thesaurus Property-2
C25572
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Start Date of Dose Modification (M D Y)
Description

Dose modification begin date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1707811
NCI Thesaurus ValueDomain-2
C25431
UMLS CUI-2
C0808070
NCI Thesaurus ObjectClass
C25488
NCI Thesaurus Property
C25572
End Date of Dose Modification (M D Y)
Description

Dose modification end date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25488
UMLS CUI-2
C0806020
NCI Thesaurus Property
C25572
Modified Dose (mg)
Description

DoseModificationAmount

Data type

float

Alias
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus ValueDomain
C25417
NCI Thesaurus Property
C25572
Reason for therapy modification
Description

Dose Modification Reason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25488
UMLS CUI-2
C0392360
NCI Thesaurus Property
C25572
Other, specify
Description

Dose Modification Reason, other

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25488
UMLS CUI-2
C3840932
NCI Thesaurus Property
C25572
Section Iv - Blood Pressure
Description

Section Iv - Blood Pressure

Systolic (mm/Hg)
Description

Systolic blood pressure

Data type

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0871470
NCI Thesaurus Property
C25214
NCI Thesaurus ObjectClass
C25298
Diastolic (mm/Hg)
Description

Diastolic blood pressure

Data type

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0428883
NCI Thesaurus Property
C25214
NCI Thesaurus ObjectClass
C25299
Mark an 'X' if not done
Description

LaboratoryProcedureNotPerformedText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Section V - Last Cycle Of Protocol Therapy
Description

Section V - Last Cycle Of Protocol Therapy

Date of MUGA
Description

HeartMUGATestDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus Property
C38073
UMLS 2011AA Property
C0521317
NCI Thesaurus Property-2
C25294
UMLS 2011AA Property-2
C0022885
Mark an 'X' if not done
Description

DataUnknownText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C17998
UMLS 2011AA Property
C0439673
Date of assessment (Note: If patient was originally registered to the protocol using an ECHO scan at baseline, an ECHO must be used in lieu of the - MUGA scan for the entirety of the study. In this case, fill in the section below.)
Description

EchocardiogramDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C37945
UMLS 2011AA ObjectClass
C2243117
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Mark an 'X' if not done
Description

LaboratoryProcedureNotPerformedText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Left Ventricular Ejection Fraction at Rest
Description

HeartLVEFTestPercentageValue

Data type

float

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property-2
C37946
UMLS 2011AA Property-2
C2700377
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
%
Left Ventricular Ejection Fraction at Rest
Description

HeartLVEFTestPercentageValue

Data type

float

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property-2
C37946
UMLS 2011AA Property-2
C2700377
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
%
LVEF Institutional Lower Limit of Normal
Description

HeartLVEFTestPercentageLowerLimitofNormalValue

Data type

float

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property-2
C37946
UMLS 2011AA Property-2
C2700377
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
NCI Thesaurus ValueDomain-3
C25555
UMLS 2011AA ValueDomain-3
C1518030
%
LVEF Institutional Lower Limit of Normal
Description

HeartLVEFTestPercentageLowerLimitofNormalValue

Data type

float

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property-2
C37946
UMLS 2011AA Property-2
C2700377
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
NCI Thesaurus ValueDomain-3
C25555
UMLS 2011AA ValueDomain-3
C1518030
%
Section Vi - Non-protocol Therapy
Description

Section Vi - Non-protocol Therapy

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

Non-protocol therapy

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25590
UMLS CUI-1
C1518384
NCI Thesaurus ObjectClass-2
C16212
UMLS CUI-2
C0087111
NCI Thesaurus Property
C25320
NCI Thesaurus Property-2
C49236
NCI Thesaurus Property-3
C25456
NCI Thesaurus Property-4
C25382
NCI Thesaurus ValueDomain
C38148
Investigator Signature
Description

Investigator Signature

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
NCI Thesaurus ObjectClass
C17089
Investigator Signature Date
Description

Investigator Signature Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
UMLS CUI-2
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C17089
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INSTRUCTIONS: Complete this form at the end of each cycle (1 cycle = 3 weeks), and at required follow-ups if specified by the Long-Term Follow-Up Form (to report late adverse events).

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Generic drug form
Item
DCI Name
text
C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)
Registration Number
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Item
On Treatment Report Period (1 cycle = 6 weeks Choose one X)
text
C25284 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25616 (NCI Thesaurus Property-2)
C15368 (NCI Thesaurus ObjectClass)
CL.1
Code List
On Treatment Report Period (1 cycle = 6 weeks Choose one X)
CL Item
Cycle 1 (Cycle 1)
CL Item
Cycle 2 (Cycle 2)
CL Item
Cycle 3 (Cycle 3)
CL Item
Cycle 4 (cycle 4)
CL Item
Cycle 5 (Cycle 5)
CL Item
Cycle 6 (Cycle 6)
CL Item
Cycle 7 (Cycle 7)
CL Item
Cycle 8 (cycle 8)
CL Item
Cycle 9 (Cycle 9)
Item Group
Patient demographics
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient Initials
Item
Patient Initials (Last, First)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Item Group
Data amendment
Data amended
Item
Please mark an 'X' if data have been amended.
text
C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Data amended date
Item
Date data amended (s)
date
C25164 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Section I - Vital Status
Item
Vital Status
text
C16960 (NCI Thesaurus ObjectClass)
C3846084 (UMLS CUI-1)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25717 (NCI Thesaurus Property)
CL.2
Code List
Vital Status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
Date last contact
Item
Date of Last Contact or Death (M D Y)
date
C16960 (NCI Thesaurus ObjectClass)
C0805839 (UMLS CUI-1)
C25461 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Primary Cause of Death (if applicable)
text
C25638 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C28554 (NCI Thesaurus Property)
C25251 (NCI Thesaurus ValueDomain-2)
CL.3
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 (Due to other cause)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Cause of Death, specify
Item
Describe cause of death
text
C25685 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C28554 (NCI Thesaurus Property)
Item Group
Section Ii - Patient Characteristics
Reporting Period Start Date
Item
Reporting Period Start Date (M D Y)
date
C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C2361257 (UMLS CUI-1)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Reporting Period End Date
Item
Reporting Period End Date (M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
Item
ECOG Performance Status (Day 1 of this cycle)
text
C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
CL.4
Code List
ECOG Performance Status (Day 1 of this cycle)
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
Item Group
Agent Name: Sorafenib/placebo
Patient Diary complete
Item
Did the patient complete and return the Patient Pill Calendar this cycle
boolean
C38147 (NCI Thesaurus ValueDomain)
C3259162 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C25394 (NCI Thesaurus ObjectClass)
C19459 (NCI Thesaurus Property-2)
Agent
Item
Agent Name (Sorafenib/Placebo)
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
PatientSorafenibPlaceboBottleMedicationInd-3
Item
Did the patient return their BAYER bottle this cycle
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C753 (NCI Thesaurus Property)
C0032042 (UMLS 2011AA Property)
C459 (NCI Thesaurus Property-2)
C0013227 (UMLS 2011AA Property-2)
C43169 (NCI Thesaurus Property-3)
C0179376 (UMLS 2011AA Property-3)
C61948 (NCI Thesaurus Property-4)
C1174389 (UMLS 2011AA Property-4)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PillsRemainingCount
Item
Total number of tablets remaining ([hand count required])
float
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25394 (NCI Thesaurus ObjectClass)
C0994475 (UMLS 2011AA ObjectClass)
C25649 (NCI Thesaurus Property)
C1527428 (UMLS 2011AA Property)
Agent dose prescribed
Item
Prescribed dose (number of capsules per day - on Day 1 of this cycle)
float
C28180 (NCI Thesaurus ObjectClass)
C0678766 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass-2)
C0278329 (UMLS CUI-2)
C25256 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus ValueDomain-2)
PillTakenCount
Item
Expected number of tablets taken ([Prescribed dosenumber of tablets per day *42])
float
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25394 (NCI Thesaurus ObjectClass)
C0994475 (UMLS 2011AA ObjectClass)
C25394 (NCI Thesaurus ValueDomain-2)
C0994475 (UMLS 2011AA ValueDomain-2)
C25701 (NCI Thesaurus Property)
C1883727 (UMLS 2011AA Property)
PillsTakenTotalCount
Item
Actual number of capsules taken (by hand count, if available, otherwise by pill diary)
text
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
C25394 (NCI Thesaurus ObjectClass)
C0994475 (UMLS 2011AA ObjectClass)
C25701 (NCI Thesaurus Property)
C1883727 (UMLS 2011AA Property)
Item
What was the source of the pill count
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25394 (NCI Thesaurus ObjectClass-2)
C0994475 (UMLS 2011AA ObjectClass-2)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.11
Code List
What was the source of the pill count
CL Item
Patient Pill Diary (Patient pill diary)
CL Item
Hand Count (Hand count)
CL Item
Pill Count Not Done (Pill count not done)
PillsNotAssessmentPerformedText
Item
If pill count was not done, please explain
text
C25394 (NCI Thesaurus ObjectClass)
C0994475 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus Property)
C25594 (NCI Thesaurus Property-2)
C1518422 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-3)
C0884358 (UMLS 2011AA Property-2)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
Item Group
Dose Modifications
Agent
Item
Agent Name (Sorafenib/Placebo)
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Item
Were there any dose modifications or additions/omissions to protocol treatment (this report period)
text
C25491 (NCI Thesaurus ObjectClass)
C1512162 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25572 (NCI Thesaurus Property-2)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.12
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 (Yes, planned)
CL Item
Yes, Unplanned (Yes, unplanned)
CL Item
Yes, Both Planned And Unplanned (Yes, both planned and unplanned)
Dose modification begin date
Item
Start Date of Dose Modification (M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25431 (NCI Thesaurus ValueDomain-2)
C0808070 (UMLS CUI-2)
C25488 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
Dose modification end date
Item
End Date of Dose Modification (M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C0806020 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
DoseModificationAmount
Item
Modified Dose (mg)
float
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25417 (NCI Thesaurus ValueDomain)
C25572 (NCI Thesaurus Property)
Item
Reason for therapy modification
text
C25638 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C0392360 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
CL.13
Code List
Reason for therapy modification
CL Item
Adverse Event (Adverse event)
C41331 (NCI Thesaurus)
C0877248 (UMLS 2011AA)
CL Item
Agent Discontinued (Agent discontinued)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Dose Modification Reason, other
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C3840932 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
Item Group
Assessment of medication
Agent
Item
Agent Name (Sorafenib/Placebo)
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
PatientSunitinibPlaceboBottleMedicationInd-3
Item
Did the patient return their Pfizer bottle this cycle
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C753 (NCI Thesaurus Property)
C0032042 (UMLS 2011AA Property)
C459 (NCI Thesaurus Property-2)
C0013227 (UMLS 2011AA Property-2)
C43169 (NCI Thesaurus Property-3)
C0179376 (UMLS 2011AA Property-3)
C26673 (NCI Thesaurus Property-4)
C1698963 (UMLS 2011AA Property-4)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CapsuleAgentRemainingTotalNumber
Item
Total number capsules remaining (if yes by hand count)
float
C25158 (NCI Thesaurus ObjectClass)
C0006935 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25649 (NCI Thesaurus Property)
C1527428 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
Agent dose prescribed
Item
Prescribed dose (number of capsules per day - on Day 1 of this cycle)
float
C28180 (NCI Thesaurus ObjectClass)
C0678766 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass-2)
C0278329 (UMLS CUI-2)
C25256 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus ValueDomain-2)
CapsuleAgentTakenExpectedCount
Item
Expected number of capsules taken ([Prescribed dose number of capsules per day *28])
float
C25158 (NCI Thesaurus ObjectClass)
C0006935 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25701 (NCI Thesaurus Property)
C1883727 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25501 (NCI Thesaurus ValueDomain-2)
C1517001 (UMLS 2011AA ValueDomain-2)
PillsTakenTotalCount
Item
Actual number of capsules taken (by hand count, if available, otherwise by pill diary)
text
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
C25394 (NCI Thesaurus ObjectClass)
C0994475 (UMLS 2011AA ObjectClass)
C25701 (NCI Thesaurus Property)
C1883727 (UMLS 2011AA Property)
Item
What was the source of the pill count
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25394 (NCI Thesaurus ObjectClass-2)
C0994475 (UMLS 2011AA ObjectClass-2)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.11
Code List
What was the source of the pill count
CL Item
Patient Pill Diary (Patient pill diary)
CL Item
Hand Count (Hand count)
CL Item
Pill Count Not Done (Pill count not done)
PillsNotAssessmentPerformedText
Item
If pill count was not done, please explain
text
C25394 (NCI Thesaurus ObjectClass)
C0994475 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus Property)
C25594 (NCI Thesaurus Property-2)
C1518422 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-3)
C0884358 (UMLS 2011AA Property-2)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
Item Group
Dose Modifications
Agent
Item
Agent Name (Sorafenib/Placebo)
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Item
Were there any dose modifications or additions/omissions to protocol treatment (this report period)
text
C25491 (NCI Thesaurus ObjectClass)
C1512162 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25572 (NCI Thesaurus Property-2)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.12
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 (Yes, planned)
CL Item
Yes, Unplanned (Yes, unplanned)
CL Item
Yes, Both Planned And Unplanned (Yes, both planned and unplanned)
Dose modification begin date
Item
Start Date of Dose Modification (M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25431 (NCI Thesaurus ValueDomain-2)
C0808070 (UMLS CUI-2)
C25488 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
Dose modification end date
Item
End Date of Dose Modification (M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C0806020 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
DoseModificationAmount
Item
Modified Dose (mg)
float
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25417 (NCI Thesaurus ValueDomain)
C25572 (NCI Thesaurus Property)
Item
Reason for therapy modification
text
C25638 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C0392360 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
CL.13
Code List
Reason for therapy modification
CL Item
Adverse Event (Adverse event)
C41331 (NCI Thesaurus)
C0877248 (UMLS 2011AA)
CL Item
Agent Discontinued (Agent discontinued)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Dose Modification Reason, other
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C3840932 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
Item Group
Section Iv - Blood Pressure
Systolic blood pressure
Item
Systolic (mm/Hg)
float
C25209 (NCI Thesaurus ValueDomain)
C0871470 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25298 (NCI Thesaurus ObjectClass)
Diastolic blood pressure
Item
Diastolic (mm/Hg)
float
C25209 (NCI Thesaurus ValueDomain)
C0428883 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25299 (NCI Thesaurus ObjectClass)
LaboratoryProcedureNotPerformedText
Item
Mark an 'X' if not done
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Item Group
Section V - Last Cycle Of Protocol Therapy
HeartMUGATestDate
Item
Date of MUGA
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C38073 (NCI Thesaurus Property)
C0521317 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
DataUnknownText
Item
Mark an 'X' if not done
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C17998 (NCI Thesaurus Property)
C0439673 (UMLS 2011AA Property)
EchocardiogramDate
Item
Date of assessment (Note: If patient was originally registered to the protocol using an ECHO scan at baseline, an ECHO must be used in lieu of the - MUGA scan for the entirety of the study. In this case, fill in the section below.)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C37945 (NCI Thesaurus ObjectClass)
C2243117 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
LaboratoryProcedureNotPerformedText
Item
Mark an 'X' if not done
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
HeartLVEFTestPercentageValue
Item
Left Ventricular Ejection Fraction at Rest
float
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property-2)
C2700377 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
HeartLVEFTestPercentageValue
Item
Left Ventricular Ejection Fraction at Rest
float
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property-2)
C2700377 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
HeartLVEFTestPercentageLowerLimitofNormalValue
Item
LVEF Institutional Lower Limit of Normal
float
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property-2)
C2700377 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)
C1518030 (UMLS 2011AA ValueDomain-3)
HeartLVEFTestPercentageLowerLimitofNormalValue
Item
LVEF Institutional Lower Limit of Normal
float
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property-2)
C2700377 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)
C1518030 (UMLS 2011AA ValueDomain-3)
Item Group
Section Vi - Non-protocol Therapy
Non-protocol therapy
Item
Was any non-protocol cancer therapy given during protocol treatment (not previously reported)
boolean
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS CUI-1)
C16212 (NCI Thesaurus ObjectClass-2)
C0087111 (UMLS CUI-2)
C25320 (NCI Thesaurus Property)
C49236 (NCI Thesaurus Property-2)
C25456 (NCI Thesaurus Property-3)
C25382 (NCI Thesaurus Property-4)
C38148 (NCI Thesaurus ValueDomain)
Investigator Signature
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
Investigator Signature Date
Item
Investigator Signature Date
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)
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