ID

8543

Beskrivning

E2603 Adverse Event Form - (CTCAE v3) Carboplatin and Paclitaxel With or Without Sorafenib in Treating Patients With Unresectable Stage III or Stage IV Melanoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=E75AC780-DB8D-20A4-E034-0003BA3F9857

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=E75AC780-DB8D-20A4-E034-0003BA3F9857

Nyckelord

  1. 2012-09-19 2012-09-19 -
  2. 2015-01-08 2015-01-08 - Martin Dugas
  3. 2015-01-09 2015-01-09 - Martin Dugas
  4. 2015-01-09 2015-01-09 - Martin Dugas
  5. 2015-07-08 2015-07-08 -
Uppladdad den

9 januari 2015

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy

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Melanoma (Skin) NCT00110019 Toxicity - E2603 Adverse Event Form - (CTCAE v3) - 2296800v3.0

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
Beskrivning

Header

ECOG Protocol Number
Beskrivning

Protocol Number ECOG

Datatyp

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
Beskrivning

Patient ID ECOG

Datatyp

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
Beskrivning

Generic drug form

Datatyp

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
Beskrivning

Registration Number

Datatyp

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
Beskrivning

Unnamed2

ECOG Protocol Number
Beskrivning

Protocol Number ECOG

Datatyp

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
Patient Initials
Beskrivning

Patient Initials

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
ECOG Patient ID
Beskrivning

Patient ID ECOG

Datatyp

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
Beskrivning

Study Number Participating Group

Datatyp

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
Beskrivning

Institution Name

Datatyp

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
Beskrivning

Trial subject ID Participating Group

Datatyp

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
Unnamed3
Beskrivning

Unnamed3

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

Data amended

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Date data amended
Beskrivning

Data amended date

Datatyp

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
Beskrivning

On Treatment

On Treatment Report Period (Choose one)
Beskrivning

Cycle number

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2045829
NCI Thesaurus Property
C25214
NCI Thesaurus Property-2
C25616
NCI Thesaurus ObjectClass
C15368
cycle (specify)
Beskrivning

Chemotherapy cycle

Datatyp

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
Beskrivning

Off Treatment

Off Treatment Report Period (since registration)
Beskrivning

PersonOff-TreatmentTimePeriodType

Datatyp

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
Unnamed4
Beskrivning

Unnamed4

Were adverse events assessed during this report period (cycle)
Beskrivning

AdverseEventCurrentAssessmentInd

Datatyp

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
Beskrivning

CTCAdverseEventReportBeginDate

Datatyp

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
Beskrivning

CTCAdverseEventReportEndDate

Datatyp

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
Unnamed5
Beskrivning

Unnamed5

CTC Adverse Event Term Type
Beskrivning

CTC Adverse Event Term

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C45559
Investigator Term
Beskrivning

InvestigatorTermName

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C41331
UMLS 2011AA Property
C0877248
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
NCI Thesaurus Property-2
C45559
UMLS 2011AA Property-2
C1705313
CTC Adverse Event Grade (v3.0)
Beskrivning

CTC Adverse Event Grade

Datatyp

float

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

CTC Adverse Event Attribution Category

Datatyp

text

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

AdverseEventActionType

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25404
UMLS 2011AA Property
C0441472
Outcome of Adverse Event
Beskrivning

AdverseEventOutcomeType

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
Mark an 'X' if continuing from prior cycle.
Beskrivning

PriorAdverseEventContinuedText

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Metathesaurus Property
C0750536
CTC Adverse Event Start Date (Enter Day 1 of this report period if continuing from previous report period)
Beskrivning

Adverse Event Onset Date

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985916
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25279
CTC Adverse Event End Date (Leave blank if not resolved by end of report period)
Beskrivning

CTCAdverseEventResolutionDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25655
UMLS 2011AA Property
C1514893
Ii. Infections
Beskrivning

Ii. Infections

Unnamed question1 (Specify site for each event)
Beskrivning

CommonToxicityCriteriaAdverseEventShortNameType

Datatyp

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
Specify site
Beskrivning

CTCAdverseEventSpecifiedTermType

Datatyp

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
Investigator Term
Beskrivning

InvestigatorTermName

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C41331
UMLS 2011AA Property
C0877248
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
NCI Thesaurus Property-2
C45559
UMLS 2011AA Property-2
C1705313
CTC Adverse Event Grade (v3.0)
Beskrivning

CTC Adverse Event Grade

Datatyp

float

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

CTC Adverse Event Attribution Category

Datatyp

text

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

AdverseEventActionType

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25404
UMLS 2011AA Property
C0441472
Outcome of Adverse Event
Beskrivning

AdverseEventOutcomeType

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
Other Adverse Events
Beskrivning

Other Adverse Events

Other CTC Adverse Event Term not listed
Beskrivning

CTCAdverseEventTermSpecify

Datatyp

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/sub-term)
Beskrivning

CTC Adverse Event Reported Term

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2699044
NCI Thesaurus Property
C25161
Investigator Term
Beskrivning

InvestigatorTermName

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C41331
UMLS 2011AA Property
C0877248
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
NCI Thesaurus Property-2
C45559
UMLS 2011AA Property-2
C1705313
CTC Adverse Event Grade (v3.0)
Beskrivning

CTC Adverse Event Grade

Datatyp

float

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

CTC Adverse Event Attribution Category

Datatyp

text

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

AdverseEventActionType

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25404
UMLS 2011AA Property
C0441472
Outcome of Adverse Event
Beskrivning

AdverseEventOutcomeType

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
Comments
Beskrivning

Comments

Comments
Beskrivning

Research Comments

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Investigator Signature
Beskrivning

Investigator Signature

Datatyp

text

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

Investigator Signature Date

Datatyp

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
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
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 Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
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)
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
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 (Choose one)
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 (Choose one)
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 10 (> Cycle 10)
Chemotherapy cycle
Item
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 (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 Group
Unnamed4
Item
Were adverse events assessed during this report period (cycle)
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 (cycle)
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
Unnamed5
Item
CTC Adverse Event Term Type
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 Type
CL Item
Anorexia (Anorexia)
C2875 (NCI Thesaurus)
C0003123 (UMLS 2011AA)
CL Item
Diarrhoea Nos (Diarrhea)
CL Item
Fatigue (Fatigue)
C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)
CL Item
Hypertension Nos (Hypertension)
CL Item
Mucositis/stomatitis (functional/symptomatic) (Mucositis/Stomatitis, Stomach)
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
Arthralgia (Pain, Joint)
C0003862 (NCI Metathesaurus)
CL Item
Myalgia (Pain, Muscle)
C27009 (NCI Thesaurus)
C0231528 (UMLS 2011AA)
CL Item
Pruritus Nos (Pruritus/itching)
CL Item
Dermatitis Exfoliative Nos (Rash/desquamation)
CL Item
Localised Exfoliation (Rash: hand-foot skin reaction)
CL Item
Rigors (Rigors/chills)
C0424790 (NCI Metathesaurus)
CL Item
Vomiting Nos (Vomiting)
InvestigatorTermName
Item
Investigator Term
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
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 Scale
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
Code List
CTC Adverse Event Attribution Scale
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
Action Taken at Time of Adverse Event
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25404 (NCI Thesaurus Property)
C0441472 (UMLS 2011AA Property)
Code List
Action Taken at Time of Adverse Event
CL Item
There Was No Action Taken Based On The Adverse Event (none)
CL Item
Study Dose Was Reduced As A Result Of The Adverse Event (study dose reduced)
CL Item
Protocol Treatment Was Delayed As A Result Of The Adverse Event (protocol treatment delayed)
CL Item
Protocol Treatment Was Discontinued As A Result Of The Adverse Event (protocol treatment discontinued)
CL Item
Other Treatment Was Required As A Result Of The Adverse Event (other treatment required)
Item
Outcome of Adverse Event
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
Code List
Outcome of Adverse Event
CL Item
Adverse Event Is Resolved (resolved)
CL Item
Adverse Event Has Improved (improved)
CL Item
Adverse Event Is Unchanged (unchanged)
CL Item
Adverse Event Is Worse (worsened)
CL Item
Adverse Event Was Fatal (death/fatal)
CL Item
Adverse Event Is Ongoing (ongoing)
PriorAdverseEventContinuedText
Item
Mark an 'X' if continuing from prior cycle.
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C0750536 (NCI Metathesaurus Property)
Adverse Event Onset Date
Item
CTC Adverse Event Start Date (Enter Day 1 of this report period if continuing from previous report period)
date
C25164 (NCI Thesaurus ValueDomain)
C2985916 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C49704 (NCI Thesaurus ObjectClass)
C25279 (NCI Thesaurus Property)
CTCAdverseEventResolutionDate
Item
CTC Adverse Event End Date (Leave blank if not resolved by end of report period)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25655 (NCI Thesaurus Property)
C1514893 (UMLS 2011AA Property)
Item Group
Ii. Infections
Item
Unnamed question1 (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
Unnamed question1 (Specify site for each event)
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
Specify site
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)
InvestigatorTermName
Item
Investigator Term
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
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 Scale
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
Code List
CTC Adverse Event Attribution Scale
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
Action Taken at Time of Adverse Event
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25404 (NCI Thesaurus Property)
C0441472 (UMLS 2011AA Property)
Code List
Action Taken at Time of Adverse Event
CL Item
There Was No Action Taken Based On The Adverse Event (none)
CL Item
Study Dose Was Reduced As A Result Of The Adverse Event (study dose reduced)
CL Item
Protocol Treatment Was Delayed As A Result Of The Adverse Event (protocol treatment delayed)
CL Item
Protocol Treatment Was Discontinued As A Result Of The Adverse Event (protocol treatment discontinued)
CL Item
Other Treatment Was Required As A Result Of The Adverse Event (other treatment required)
Item
Outcome of Adverse Event
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
Code List
Outcome of Adverse Event
CL Item
Adverse Event Is Resolved (resolved)
CL Item
Adverse Event Has Improved (improved)
CL Item
Adverse Event Is Unchanged (unchanged)
CL Item
Adverse Event Is Worse (worsened)
CL Item
Adverse Event Was Fatal (death/fatal)
CL Item
Adverse Event Is Ongoing (ongoing)
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/sub-term)
text
C25685 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2699044 (UMLS CUI-2)
C25161 (NCI Thesaurus Property)
InvestigatorTermName
Item
Investigator Term
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
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 Scale
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
Code List
CTC Adverse Event Attribution Scale
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
Action Taken at Time of Adverse Event
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25404 (NCI Thesaurus Property)
C0441472 (UMLS 2011AA Property)
Code List
Action Taken at Time of Adverse Event
CL Item
There Was No Action Taken Based On The Adverse Event (none)
CL Item
Study Dose Was Reduced As A Result Of The Adverse Event (study dose reduced)
CL Item
Protocol Treatment Was Delayed As A Result Of The Adverse Event (protocol treatment delayed)
CL Item
Protocol Treatment Was Discontinued As A Result Of The Adverse Event (protocol treatment discontinued)
CL Item
Other Treatment Was Required As A Result Of The Adverse Event (other treatment required)
Item
Outcome of Adverse Event
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
Code List
Outcome of Adverse Event
CL Item
Adverse Event Is Resolved (resolved)
CL Item
Adverse Event Has Improved (improved)
CL Item
Adverse Event Is Unchanged (unchanged)
CL Item
Adverse Event Is Worse (worsened)
CL Item
Adverse Event Was Fatal (death/fatal)
CL Item
Adverse Event Is Ongoing (ongoing)
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
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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