ID

1867

Description

E2902 Adverse Event Form - (CTCAE v3) Tipifarnib in Treating Patients With Acute Myeloid Leukemia in Remission Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DBCDA63A-8A39-2CC7-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DBCDA63A-8A39-2CC7-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. 7/8/15 7/8/15 -
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September 19, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Leukemia NCT00093470 Toxicity - E2902 Adverse Event Form - (CTCAE v3) - 2282572v3.0

English

No Instruction available.

1 forms  
  1. StudyEvent: E2902 Adverse Event Form - (CTCAE v3)
    1. No Instruction available.
Unnamed1
Description

Unnamed1

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 (Last, First)
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
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
Unnamed 2
Description

Unnamed 2

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
On Treatment Or Observation
Description

On Treatment Or Observation

On Treatment Report Period (Choose one)
Description

OnTreatmentTimePeriod

Data type

text

Cycle (specify)
Description

TreatmentEvaluationPeriodCycleSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ValueDomain
C25472
UMLS 2011AA ValueDomain
C1511572
NCI Thesaurus ValueDomain
C25275
UMLS 2011AA ValueDomain
C2745955
Off Treatment
Description

Off Treatment

Off Treatment Report Period (since registration)
Description

PersonOff-TreatmentTimePeriodType

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25601
UMLS 2011AA Property
C1518544
NCI Thesaurus Property
C25207
UMLS 2011AA Property
C0040223
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Were adverse events assessed during this report period? (For the dates below, record the start and end dates of the time period within current report period in which patient was assessed for adverse events.)
Description

AdverseEventCurrentAssessmentInd

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
CTC Adverse Event Report Begin Date
Description

CTCAdverseEventReportBeginDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
CTC Adverse Event Report End Date (BL104)
Description

CTCAdverseEventReportEndDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
Unnamed 3
Description

Unnamed 3

CTC Adverse Event (v3.0) Grade (this cycle/report period)
Description

CommonToxicityCriteriaAdverseEventGrade

Data type

double

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
CTC Adverse Event (v3.0) Grade (this cycle/report period)
Description

CommonToxicityCriteriaAdverseEventGrade

Data type

double

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
CTC Adverse Event (v3.0) Grade (this cycle/report period)
Description

CommonToxicityCriteriaAdverseEventGrade

Data type

double

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
CTC Adverse Event Attribution Scale
Description

CTCAdverseEventAttributionScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
CTC Adverse Event Attribution Scale
Description

CTCAdverseEventAttributionScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
CTC Adverse Event Attribution Scale
Description

CTCAdverseEventAttributionScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
CTC Adverse Event Term Type
Description

CommonToxicityCriteriaAdverseEventTermType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
CTC Adverse Event Term Type
Description

CommonToxicityCriteriaAdverseEventTermType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
CTC Adverse Event Term Type
Description

CommonToxicityCriteriaAdverseEventShortNameType

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Metathesaurus ValueDomain
C0332307
NCI Thesaurus Property
C25249
UMLS 2011AA Property
C1806781
Specify site (Other CTC Adverse Event Terms not listed)
Description

CTCAdverseEventSiteSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
Other Adverse Events
Description

Other Adverse Events

AE Term
Description

CTCAdverseEventTermSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
Specify site/sub-term (if applicable)
Description

CTCAdverseEventClassificationSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25161
UMLS 2011AA Property
C0008902
CTC Adverse Event (v3.0) Grade (this cycle/report period)
Description

CommonToxicityCriteriaAdverseEventGrade

Data type

double

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
CTC Adverse Event Attribution Scale
Description

CTCAdverseEventAttributionScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
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: E2902 Adverse Event Form - (CTCAE v3)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Unnamed1
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 (Last, First)
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)
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)
Item Group
Unnamed 2
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.1
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
On Treatment Or Observation
Item
On Treatment Report Period (Choose one)
text
CL.2
Code List
On Treatment Report Period (Choose one)
CL Item
Cycle 3 (Cycle 3)
CL Item
Cycle 6 (Cycle 6)
CL Item
Cycle 9 (Cycle 9)
CL Item
Cycle 1 (Cycle 12)
CL Item
Cycle 15 (Cycle 15)
CL Item
Cycle 18 (Cycle 18)
CL Item
Cycle 2 (Cycle 21)
CL Item
Cycle 24 (Cycle 24)
CL Item
Cycle 27 (Cycle 27)
CL Item
Cycle 30 (Cycle 30)
CL Item
Cycle 33 (Cycle 33)
CL Item
> Cycle 33 (> Cycle 33)
TreatmentEvaluationPeriodCycleSpecify
Item
Cycle (specify)
text
C15368 (NCI Thesaurus ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25472 (NCI Thesaurus ValueDomain)
C1511572 (UMLS 2011AA ValueDomain)
C25275 (NCI Thesaurus ValueDomain)
C2745955 (UMLS 2011AA ValueDomain)
Item Group
Off Treatment
Item
Off Treatment Report Period (since registration)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25601 (NCI Thesaurus Property)
C1518544 (UMLS 2011AA Property)
C25207 (NCI Thesaurus Property)
C0040223 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.3
Code List
Off Treatment Report Period (since registration)
CL Item
3 Months (3 Months Post Registration)
CL Item
6 Months (6 Months Post Registration)
CL Item
9 Months (9 Months Post Registration)
CL Item
12 Months (12 Months Post Registration)
CL Item
15 Months (15 Months Post Registration)
CL Item
18 Months (18 Months Post Registration)
CL Item
21 Months Post Registration (21 Months Post Registration)
CL Item
2 Years (24 Months Post Registration)
CL Item
30 Months (30 Months Post Registration)
CL Item
3 Years (36 Months Post Registration)
CL Item
42 Months (42 Months Post Registration)
CL Item
4 Years (48 Months Post Registration)
CL Item
54 Months (54 Months Post Registration)
CL Item
5 Years (60 Months Post Registration)
Item
Were adverse events assessed during this report period? (For the dates below, record the start and end dates of the time period within current report period in which patient was assessed for adverse events.)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
CL.4
Code List
Were adverse events assessed during this report period? (For the dates below, record the start and end dates of the time period within current report period in which patient was assessed for adverse events.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, But No Reportable Adverse Events Occurred (Yes, but no reportable adverse events occurred)
CL Item
Yes, And Reportable Adverse Events Occurred (Yes, and reportable adverse events occurred)
CTCAdverseEventReportBeginDate
Item
CTC Adverse Event Report Begin Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
CTCAdverseEventReportEndDate
Item
CTC Adverse Event Report End Date (BL104)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
Item Group
Unnamed 3
CommonToxicityCriteriaAdverseEventGrade
Item
CTC Adverse Event (v3.0) Grade (this cycle/report period)
double
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CommonToxicityCriteriaAdverseEventGrade
Item
CTC Adverse Event (v3.0) Grade (this cycle/report period)
double
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CommonToxicityCriteriaAdverseEventGrade
Item
CTC Adverse Event (v3.0) Grade (this cycle/report period)
double
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CTCAdverseEventAttributionScale
Item
CTC Adverse Event Attribution Scale
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
CTCAdverseEventAttributionScale
Item
CTC Adverse Event Attribution Scale
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
CTCAdverseEventAttributionScale
Item
CTC Adverse Event Attribution Scale
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
Item
CTC Adverse Event Term Type
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
CL.7
Code List
CTC Adverse Event Term Type
CL Item
Anorexia (Anorexia)
C2875 (NCI Thesaurus)
C0003123 (UMLS 2011AA)
CL Item
Ataxia Nec (Ataxia (incoordination))
CL Item
Confusion (Confusion)
C37928 (NCI Thesaurus)
C0009676 (UMLS 2011AA)
CL Item
Constipation (Constipation)
C37930 (NCI Thesaurus)
C0009806 (UMLS 2011AA)
CL Item
Diarrhoea Nos (Diarrhea)
CL Item
Dyspnoea Nos (Dyspnea (shortness of breath))
CL Item
Fatigue (Fatigue (asthenia, lethargy, malaise))
C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)
CL Item
Febrile Neutropenia (fever Of Unknown Origin Without Clinically Or Microbiologically Documented Infection) (anc <1.0 X 10^9/l, Fever >=38.5 Degrees C) (Febrile neutropenia (fever of unknown origin without infection))
CL Item
Mood Alteration - Agitation (Mood Alteration-agitation)
CL Item
Anxiety Nec (Mood Alteration-anxiety)
CL Item
Nausea (Nausea)
C3258 (NCI Thesaurus)
C0027497 (UMLS 2011AA)
CL Item
Peripheral Sensory Neuropathy (Neuropathy: sensory)
C3501 (NCI Thesaurus)
C0151313 (UMLS 2011AA)
CL Item
Abdominal Pain Nos (Pain - Abdomen NOS)
CL Item
Arthralgia (Pain - Joint)
C0003862 (NCI Metathesaurus)
CL Item
Myalgia (Pain - Muscle)
C27009 (NCI Thesaurus)
C0231528 (UMLS 2011AA)
CL Item
Dermatitis Exfoliative Nos (Rash/desquamation)
CL Item
Thrombosis Nos (Thrombosis/thrombus/embolism)
CL Item
Vomiting Nos (Vomiting)
Item
CTC Adverse Event Term Type
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
CL.7
Code List
CTC Adverse Event Term Type
CL Item
Anorexia (Anorexia)
C2875 (NCI Thesaurus)
C0003123 (UMLS 2011AA)
CL Item
Ataxia Nec (Ataxia (incoordination))
CL Item
Confusion (Confusion)
C37928 (NCI Thesaurus)
C0009676 (UMLS 2011AA)
CL Item
Constipation (Constipation)
C37930 (NCI Thesaurus)
C0009806 (UMLS 2011AA)
CL Item
Diarrhoea Nos (Diarrhea)
CL Item
Dyspnoea Nos (Dyspnea (shortness of breath))
CL Item
Fatigue (Fatigue (asthenia, lethargy, malaise))
C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)
CL Item
Febrile Neutropenia (fever Of Unknown Origin Without Clinically Or Microbiologically Documented Infection) (anc <1.0 X 10^9/l, Fever >=38.5 Degrees C) (Febrile neutropenia (fever of unknown origin without infection))
CL Item
Mood Alteration - Agitation (Mood Alteration-agitation)
CL Item
Anxiety Nec (Mood Alteration-anxiety)
CL Item
Nausea (Nausea)
C3258 (NCI Thesaurus)
C0027497 (UMLS 2011AA)
CL Item
Peripheral Sensory Neuropathy (Neuropathy: sensory)
C3501 (NCI Thesaurus)
C0151313 (UMLS 2011AA)
CL Item
Abdominal Pain Nos (Pain - Abdomen NOS)
CL Item
Arthralgia (Pain - Joint)
C0003862 (NCI Metathesaurus)
CL Item
Myalgia (Pain - Muscle)
C27009 (NCI Thesaurus)
C0231528 (UMLS 2011AA)
CL Item
Dermatitis Exfoliative Nos (Rash/desquamation)
CL Item
Thrombosis Nos (Thrombosis/thrombus/embolism)
CL Item
Vomiting Nos (Vomiting)
Item
CTC Adverse Event Term Type
text
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C0332307 (NCI Metathesaurus ValueDomain)
C25249 (NCI Thesaurus Property)
C1806781 (UMLS 2011AA Property)
CL.8
Code List
CTC Adverse Event Term Type
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection with Grade 3 or 4 neutrophils)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils)
CL Item
Infection With Unknown Anc (Infection with unknown ANC)
CTCAdverseEventSiteSpecify
Item
Specify site (Other CTC Adverse Event Terms not listed)
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
Item Group
Other Adverse Events
CTCAdverseEventTermSpecify
Item
AE Term
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
CTCAdverseEventClassificationSpecify
Item
Specify site/sub-term (if applicable)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
CommonToxicityCriteriaAdverseEventGrade
Item
CTC Adverse Event (v3.0) Grade (this cycle/report period)
double
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CTCAdverseEventAttributionScale
Item
CTC Adverse Event Attribution Scale
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
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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