ID

8442

Description

E1105 Adverse Event Form (CTCAE v3) First-Line Chemotherapy and Trastuzumab With or Without Bevacizumab in Treating Patients With Metastatic Breast Cancer That Overexpresses HER-2/NEU Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1722503D-5400-666B-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1722503D-5400-666B-E044-0003BA3F9857

Keywords

  1. 8/26/12 8/26/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 1/9/15 1/9/15 - Martin Dugas
  5. 7/8/15 7/8/15 -
Uploaded on

January 9, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT00520975 Toxicity - E1105 Adverse Event Form (CTCAE v3) - 2491129v1.0

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).

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
Unnamed2
Description

Unnamed2

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
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
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
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
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
Unnamed3
Description

Unnamed3

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
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
On Treatment
Description

On Treatment

On Treatment Report Period (since start of treatment)
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
On Treatment Report Period (since start of treatment)
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
Specify Cycle (specify)
Description

Chemotherapy cycle

Data type

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25214
UMLS CUI-1
C1302181
NCI Thesaurus Property-2
C25616
NCI Thesaurus ValueDomain
C25685
NCI Thesaurus ValueDomain-2
C25472
NCI Thesaurus ValueDomain-3
C25275
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-2
C25601
UMLS 2011AA Property-2
C1518544
NCI Thesaurus Property-3
C25207
UMLS 2011AA Property-3
C0040223
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Unnamed2
Description

Unnamed2

Were adverse events assessed during this report period
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-2
C25471
UMLS 2011AA Property-2
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-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
CTC Adverse Event Report End Date
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
Blood/bone Marrow - Labs
Description

Blood/bone Marrow - Labs

CTC Adverse Event Term
Description

CTC Adverse Event Term

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C45559
CTC Adverse Event Grade (v3.0)
Description

CTC Adverse Event Grade

Data type

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS CUI-1
C2985911
NCI Thesaurus ValueDomain
C18000
NCI Thesaurus Property
C25365
CTC Adverse Event Attribution Code
Description

CTC Adverse Event Attribution Category

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1706735
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
Was this attributed to investigational protocol treatment
Description

AdverseEventInvestigationalClinicalStudyTherapyAttributionind-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C15368
NCI Thesaurus Property-2
C28041
UMLS 2011AA Property
C1517586
NCI Thesaurus Property-3
C15206
UMLS 2011AA Property-2
C0008972
NCI Thesaurus Property-4
C25358
UMLS 2011AA Property-3
C0596130
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Unnamed5
Description

Unnamed5

CTC Adverse Event Term
Description

CTC Adverse Event Term

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C45559
CTC Adverse Event Short Name (Specify site for each event)
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-2
C25249
UMLS 2011AA Property-2
C1806781
CTC Select AE
Description

CTCAdverseEventSpecifiedTermType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C38024
UMLS 2011AA Property
C0205369
NCI Thesaurus Property-2
C45559
UMLS 2011AA Property-2
C1705313
CTC Adverse Event Grade (v3.0)
Description

CTC Adverse Event Grade

Data type

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS CUI-1
C2985911
NCI Thesaurus ValueDomain
C18000
NCI Thesaurus Property
C25365
CTC Adverse Event Grade (v3.0)
Description

CTC Adverse Event Grade

Data type

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS CUI-1
C2985911
NCI Thesaurus ValueDomain
C18000
NCI Thesaurus Property
C25365
CTC Adverse Event Attribution Code
Description

CTC Adverse Event Attribution Category

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1706735
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
CTC Adverse Event Attribution Code
Description

CTC Adverse Event Attribution Category

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1706735
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
Was this attributed to investigational protocol treatment
Description

AdverseEventInvestigationalClinicalStudyTherapyAttributionind-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C15368
NCI Thesaurus Property-2
C28041
UMLS 2011AA Property
C1517586
NCI Thesaurus Property-3
C15206
UMLS 2011AA Property-2
C0008972
NCI Thesaurus Property-4
C25358
UMLS 2011AA Property-3
C0596130
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Was this attributed to investigational protocol treatment
Description

AdverseEventInvestigationalClinicalStudyTherapyAttributionind-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C15368
NCI Thesaurus Property-2
C28041
UMLS 2011AA Property
C1517586
NCI Thesaurus Property-3
C15206
UMLS 2011AA Property-2
C0008972
NCI Thesaurus Property-4
C25358
UMLS 2011AA Property-3
C0596130
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Unnamed5
Description

Unnamed5

CTC Adverse Event Term
Description

CTC Adverse Event Term

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C45559
CTC Adverse Event Grade (v3.0)
Description

CTC Adverse Event Grade

Data type

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS CUI-1
C2985911
NCI Thesaurus ValueDomain
C18000
NCI Thesaurus Property
C25365
CTC Adverse Event Attribution Code
Description

CTC Adverse Event Attribution Category

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1706735
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
Was this attributed to investigational protocol treatment
Description

AdverseEventInvestigationalClinicalStudyTherapyAttributionind-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C15368
NCI Thesaurus Property-2
C28041
UMLS 2011AA Property
C1517586
NCI Thesaurus Property-3
C15206
UMLS 2011AA Property-2
C0008972
NCI Thesaurus Property-4
C25358
UMLS 2011AA Property-3
C0596130
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Other Adverse Events
Description

Other Adverse Events

Other CTC Adverse Event Term not listed
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
Other, Specify (site or subterm)
Description

CTC Adverse Event Reported Term

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2699044
NCI Thesaurus Property
C25161
CTC Adverse Event Grade (v3.0)
Description

CTC Adverse Event Grade

Data type

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS CUI-1
C2985911
NCI Thesaurus ValueDomain
C18000
NCI Thesaurus Property
C25365
CTC Adverse Event Attribution Code
Description

CTC Adverse Event Attribution Category

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1706735
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
Was this attributed to investigational protocol treatment
Description

AdverseEventInvestigationalClinicalStudyTherapyAttributionind-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C15368
NCI Thesaurus Property-2
C28041
UMLS 2011AA Property
C1517586
NCI Thesaurus Property-3
C15206
UMLS 2011AA Property-2
C0008972
NCI Thesaurus Property-4
C25358
UMLS 2011AA Property-3
C0596130
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Iii. Infections
Description

Iii. Infections

CTC Adverse Event Short Name (Specify site for each event)
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-2
C25249
UMLS 2011AA Property-2
C1806781
CTC Select AE
Description

CTCAdverseEventSpecifiedTermType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C38024
UMLS 2011AA Property
C0205369
NCI Thesaurus Property-2
C45559
UMLS 2011AA Property-2
C1705313
CTC Adverse Event Grade (v3.0)
Description

CTC Adverse Event Grade

Data type

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS CUI-1
C2985911
NCI Thesaurus ValueDomain
C18000
NCI Thesaurus Property
C25365
CTC Adverse Event Attribution Code
Description

CTC Adverse Event Attribution Category

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1706735
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
Was this attributed to investigational protocol treatment
Description

AdverseEventInvestigationalClinicalStudyTherapyAttributionind-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C15368
NCI Thesaurus Property-2
C28041
UMLS 2011AA Property
C1517586
NCI Thesaurus Property-3
C15206
UMLS 2011AA Property-2
C0008972
NCI Thesaurus Property-4
C25358
UMLS 2011AA Property-3
C0596130
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Comments
Description

Comments

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

Similar models

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).

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 Group
Unnamed2
Patient Initials
Item
Patient Initials (Last, First)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
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)
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)
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)
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)
Item Group
Unnamed3
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
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
On Treatment
Item
On Treatment Report Period (since start of treatment)
text
C25284 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25616 (NCI Thesaurus Property-2)
C15368 (NCI Thesaurus ObjectClass)
Code List
On Treatment Report Period (since start of treatment)
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)
CL Item
Cycle 10 (Cycle 10)
CL Item
Cycle 11 (Cycle 11)
CL Item
> Cycle 11 (> Cycle 11)
Item
On Treatment Report Period (since start of treatment)
text
C25284 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25616 (NCI Thesaurus Property-2)
C15368 (NCI Thesaurus ObjectClass)
Code List
On Treatment Report Period (since start of treatment)
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)
CL Item
Cycle 10 (Cycle 10)
CL Item
Cycle 11 (Cycle 11)
CL Item
> Cycle 11 (> Cycle 11)
Chemotherapy cycle
Item
Specify Cycle (specify)
text
C15368 (NCI Thesaurus ObjectClass)
C25214 (NCI Thesaurus Property)
C1302181 (UMLS CUI-1)
C25616 (NCI Thesaurus Property-2)
C25685 (NCI Thesaurus ValueDomain)
C25472 (NCI Thesaurus ValueDomain-2)
C25275 (NCI Thesaurus ValueDomain-3)
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-2)
C1518544 (UMLS 2011AA Property-2)
C25207 (NCI Thesaurus Property-3)
C0040223 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Off Treatment Report Period (since registration)
CL Item
3 Months Post Randomization (3 Months Post Randomization)
CL Item
6 Months Post Randomization (6 Months Post Randomization)
CL Item
9 Months Post Randomization (9 Months Post Randomization)
CL Item
12 Months Post Randomization (12 Months Post Randomization)
CL Item
18 Months Post Randomization (18 Months Post Randomization)
CL Item
21 Months Post Randomization (21 Months Post Randomization)
CL Item
24 Months Post Randomization (24 Months Post Randomization)
CL Item
30 Months Post Randomization (30 Months Post Randomization)
CL Item
36 Months Post Randomization (36 Months Post Randomization)
CL Item
42 Months Post Randomization (42 Months Post Randomization)
CL Item
48 Months Post Randomization (48 Months Post Randomization)
CL Item
54 Months Post Randomization (54 Months Post Randomization)
CL Item
60 Months Post Randomization (60 Months Post Randomization)
CL Item
6 Years (72 months post registration)
CL Item
84 Months Post Registration (84 months post registration)
CL Item
8 Years (96 months post registration)
CL Item
9 Years (108 months post registration)
CL Item
10 Years (120 months post registration)
Item Group
Unnamed2
Item
Were adverse events assessed during this report period
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
Code List
Were adverse events assessed during this report period
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-2)
C0439659 (UMLS 2011AA ValueDomain-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
CTCAdverseEventReportEndDate
Item
CTC Adverse Event Report End Date
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
Blood/bone Marrow - Labs
Item
CTC Adverse Event Term
text
C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)
Code List
CTC Adverse Event Term
CL Item
Anorexia (Anorexia)
C2875 (NCI Thesaurus)
C0003123 (UMLS 2011AA)
CL Item
Constipation (Constipation)
C37930 (NCI Thesaurus)
C0009806 (UMLS 2011AA)
CL Item
Cough (Cough)
C37935 (NCI Thesaurus)
C0010200 (UMLS 2011AA)
CL Item
Cytokine Release Syndrome/acute Infusion Reaction (Cytokine release syndrome/acute infusion reaction)
CL Item
Fatigue (Fatigue (asthenia, lethargy, malaise))
C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)
CL Item
Pyrexia (Fever (in absence of neutropenia, where neutropenia is defined as ANC <1000))
CL Item
Hypertension Nos (Hypertension)
CL Item
Mucositis/stomatitis (functional/symptomatic) (Mucositis/stomatitis (functional/symptomatic) - Oral cavity)
CL Item
Muscle Weakness Nos (Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized)
C0151786 (NCI Metathesaurus)
CL Item
Myocarditis Nos (Myocarditis)
CL Item
Nausea (Nausea)
C3258 (NCI Thesaurus)
C0027497 (UMLS 2011AA)
CL Item
Chest Pain (Pain - Chest/thorax NOS)
C38665 (NCI Thesaurus)
C0008031 (UMLS 2011AA)
CL Item
Headache Nos (Pain - Head/headache)
CL Item
Arthralgia (Pain - Joint)
C0003862 (NCI Metathesaurus)
CL Item
Pneumonitis Nos (Pneumonitis/pulmonary infiltrates)
CL Item
Dermatitis Exfoliative Nos (Rash/desquamation)
CL Item
Restrictive Cardiomyopathy (Restrictive cardiomyopathy)
C0007196 (NCI Metathesaurus)
CL Item
Rigors (Rigors/chills)
C0424790 (NCI Metathesaurus)
CL Item
Urticaria Nos (Urticaria (hives, welts, wheals))
CL Item
Dysphonia (Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis))
C0935979 (NCI Metathesaurus)
CL Item
Vomiting Nos (Vomiting)
CL Item
Culture Wound Negative (Wound complication, non-infectious)
CL040841 (NCI Metathesaurus)
CTC Adverse Event Grade
Item
CTC Adverse Event Grade (v3.0)
float
C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
Item
CTC Adverse Event Attribution Code
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
Code List
CTC Adverse Event Attribution Code
CL Item
Unrelated (unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (unlikely)
CL Item
Possible (possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (probable)
C0332148 (NCI Metathesaurus)
CL Item
Definite (definite)
CL209464 (NCI Metathesaurus)
AdverseEventInvestigationalClinicalStudyTherapyAttributionind-2
Item
Was this attributed to investigational protocol treatment
boolean
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C28041 (NCI Thesaurus Property-2)
C1517586 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-2)
C25358 (NCI Thesaurus Property-4)
C0596130 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Unnamed5
Item
CTC Adverse Event Term
text
C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)
Code List
CTC Adverse Event Term
CL Item
Anorexia (Anorexia)
C2875 (NCI Thesaurus)
C0003123 (UMLS 2011AA)
CL Item
Constipation (Constipation)
C37930 (NCI Thesaurus)
C0009806 (UMLS 2011AA)
CL Item
Cough (Cough)
C37935 (NCI Thesaurus)
C0010200 (UMLS 2011AA)
CL Item
Cytokine Release Syndrome/acute Infusion Reaction (Cytokine release syndrome/acute infusion reaction)
CL Item
Fatigue (Fatigue (asthenia, lethargy, malaise))
C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)
CL Item
Pyrexia (Fever (in absence of neutropenia, where neutropenia is defined as ANC <1000))
CL Item
Hypertension Nos (Hypertension)
CL Item
Mucositis/stomatitis (functional/symptomatic) (Mucositis/stomatitis (functional/symptomatic) - Oral cavity)
CL Item
Muscle Weakness Nos (Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized)
C0151786 (NCI Metathesaurus)
CL Item
Myocarditis Nos (Myocarditis)
CL Item
Nausea (Nausea)
C3258 (NCI Thesaurus)
C0027497 (UMLS 2011AA)
CL Item
Chest Pain (Pain - Chest/thorax NOS)
C38665 (NCI Thesaurus)
C0008031 (UMLS 2011AA)
CL Item
Headache Nos (Pain - Head/headache)
CL Item
Arthralgia (Pain - Joint)
C0003862 (NCI Metathesaurus)
CL Item
Pneumonitis Nos (Pneumonitis/pulmonary infiltrates)
CL Item
Dermatitis Exfoliative Nos (Rash/desquamation)
CL Item
Restrictive Cardiomyopathy (Restrictive cardiomyopathy)
C0007196 (NCI Metathesaurus)
CL Item
Rigors (Rigors/chills)
C0424790 (NCI Metathesaurus)
CL Item
Urticaria Nos (Urticaria (hives, welts, wheals))
CL Item
Dysphonia (Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis))
C0935979 (NCI Metathesaurus)
CL Item
Vomiting Nos (Vomiting)
CL Item
Culture Wound Negative (Wound complication, non-infectious)
CL040841 (NCI Metathesaurus)
Item
CTC Adverse Event Short Name (Specify site for each event)
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-2)
C1806781 (UMLS 2011AA Property-2)
Code List
CTC Adverse Event Short Name (Specify site for each event)
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)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically) - Select)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC - Select)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Select)
CTCAdverseEventSpecifiedTermType
Item
CTC Select AE
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C38024 (NCI Thesaurus Property)
C0205369 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property-2)
C1705313 (UMLS 2011AA Property-2)
CTC Adverse Event Grade
Item
CTC Adverse Event Grade (v3.0)
float
C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
CTC Adverse Event Grade
Item
CTC Adverse Event Grade (v3.0)
float
C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
Item
CTC Adverse Event Attribution Code
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
Code List
CTC Adverse Event Attribution Code
CL Item
Unrelated (unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (unlikely)
CL Item
Possible (possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (probable)
C0332148 (NCI Metathesaurus)
CL Item
Definite (definite)
CL209464 (NCI Metathesaurus)
Item
CTC Adverse Event Attribution Code
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
Code List
CTC Adverse Event Attribution Code
CL Item
Unrelated (unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (unlikely)
CL Item
Possible (possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (probable)
C0332148 (NCI Metathesaurus)
CL Item
Definite (definite)
CL209464 (NCI Metathesaurus)
AdverseEventInvestigationalClinicalStudyTherapyAttributionind-2
Item
Was this attributed to investigational protocol treatment
boolean
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C28041 (NCI Thesaurus Property-2)
C1517586 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-2)
C25358 (NCI Thesaurus Property-4)
C0596130 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
AdverseEventInvestigationalClinicalStudyTherapyAttributionind-2
Item
Was this attributed to investigational protocol treatment
boolean
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C28041 (NCI Thesaurus Property-2)
C1517586 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-2)
C25358 (NCI Thesaurus Property-4)
C0596130 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Unnamed5
Item
CTC Adverse Event Term
text
C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)
Code List
CTC Adverse Event Term
CL Item
Anorexia (Anorexia)
C2875 (NCI Thesaurus)
C0003123 (UMLS 2011AA)
CL Item
Constipation (Constipation)
C37930 (NCI Thesaurus)
C0009806 (UMLS 2011AA)
CL Item
Cough (Cough)
C37935 (NCI Thesaurus)
C0010200 (UMLS 2011AA)
CL Item
Cytokine Release Syndrome/acute Infusion Reaction (Cytokine release syndrome/acute infusion reaction)
CL Item
Fatigue (Fatigue (asthenia, lethargy, malaise))
C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)
CL Item
Pyrexia (Fever (in absence of neutropenia, where neutropenia is defined as ANC <1000))
CL Item
Hypertension Nos (Hypertension)
CL Item
Mucositis/stomatitis (functional/symptomatic) (Mucositis/stomatitis (functional/symptomatic) - Oral cavity)
CL Item
Muscle Weakness Nos (Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized)
C0151786 (NCI Metathesaurus)
CL Item
Myocarditis Nos (Myocarditis)
CL Item
Nausea (Nausea)
C3258 (NCI Thesaurus)
C0027497 (UMLS 2011AA)
CL Item
Chest Pain (Pain - Chest/thorax NOS)
C38665 (NCI Thesaurus)
C0008031 (UMLS 2011AA)
CL Item
Headache Nos (Pain - Head/headache)
CL Item
Arthralgia (Pain - Joint)
C0003862 (NCI Metathesaurus)
CL Item
Pneumonitis Nos (Pneumonitis/pulmonary infiltrates)
CL Item
Dermatitis Exfoliative Nos (Rash/desquamation)
CL Item
Restrictive Cardiomyopathy (Restrictive cardiomyopathy)
C0007196 (NCI Metathesaurus)
CL Item
Rigors (Rigors/chills)
C0424790 (NCI Metathesaurus)
CL Item
Urticaria Nos (Urticaria (hives, welts, wheals))
CL Item
Dysphonia (Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis))
C0935979 (NCI Metathesaurus)
CL Item
Vomiting Nos (Vomiting)
CL Item
Culture Wound Negative (Wound complication, non-infectious)
CL040841 (NCI Metathesaurus)
CTC Adverse Event Grade
Item
CTC Adverse Event Grade (v3.0)
float
C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
Item
CTC Adverse Event Attribution Code
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
Code List
CTC Adverse Event Attribution Code
CL Item
Unrelated (unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (unlikely)
CL Item
Possible (possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (probable)
C0332148 (NCI Metathesaurus)
CL Item
Definite (definite)
CL209464 (NCI Metathesaurus)
AdverseEventInvestigationalClinicalStudyTherapyAttributionind-2
Item
Was this attributed to investigational protocol treatment
boolean
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C28041 (NCI Thesaurus Property-2)
C1517586 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-2)
C25358 (NCI Thesaurus Property-4)
C0596130 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Other Adverse Events
CTCAdverseEventTermSpecify
Item
Other CTC Adverse Event Term not listed
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)
CTC Adverse Event Reported Term
Item
Other, Specify (site or subterm)
text
C25685 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2699044 (UMLS CUI-2)
C25161 (NCI Thesaurus Property)
CTC Adverse Event Grade
Item
CTC Adverse Event Grade (v3.0)
float
C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
Item
CTC Adverse Event Attribution Code
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
Code List
CTC Adverse Event Attribution Code
CL Item
Unrelated (unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (unlikely)
CL Item
Possible (possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (probable)
C0332148 (NCI Metathesaurus)
CL Item
Definite (definite)
CL209464 (NCI Metathesaurus)
AdverseEventInvestigationalClinicalStudyTherapyAttributionind-2
Item
Was this attributed to investigational protocol treatment
boolean
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C28041 (NCI Thesaurus Property-2)
C1517586 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-2)
C25358 (NCI Thesaurus Property-4)
C0596130 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Iii. Infections
Item
CTC Adverse Event Short Name (Specify site for each event)
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-2)
C1806781 (UMLS 2011AA Property-2)
Code List
CTC Adverse Event Short Name (Specify site for each event)
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)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically) - Select)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC - Select)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Select)
CTCAdverseEventSpecifiedTermType
Item
CTC Select AE
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C38024 (NCI Thesaurus Property)
C0205369 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property-2)
C1705313 (UMLS 2011AA Property-2)
CTC Adverse Event Grade
Item
CTC Adverse Event Grade (v3.0)
float
C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
Item
CTC Adverse Event Attribution Code
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
Code List
CTC Adverse Event Attribution Code
CL Item
Unrelated (unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (unlikely)
CL Item
Possible (possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (probable)
C0332148 (NCI Metathesaurus)
CL Item
Definite (definite)
CL209464 (NCI Metathesaurus)
AdverseEventInvestigationalClinicalStudyTherapyAttributionind-2
Item
Was this attributed to investigational protocol treatment
boolean
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C28041 (NCI Thesaurus Property-2)
C1517586 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-2)
C25358 (NCI Thesaurus Property-4)
C0596130 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Comments
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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