ID

7705

Description

NSABP PROTOCOL C-08: FORM ALERT Fluorouracil, Leucovorin, and Oxaliplatin With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II or Stage III Colon Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D7FA5174-1580-6420-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D7FA5174-1580-6420-E034-0003BA12F5E7

Keywords

  1. 12/18/14 12/18/14 - Martin Dugas
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 1/10/15 1/10/15 - Martin Dugas
  5. 1/10/15 1/10/15 - Martin Dugas
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January 9, 2015

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License

Creative Commons BY-NC 3.0 Legacy

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Colorectal Cancer NCT00096278 Toxicity - NSABP PROTOCOL C-08: FORM ALERT - 2277144v3.0

If not submitted online, fax Form ALERT to 412-622-2113.

  1. StudyEvent: NSABP PROTOCOL C-08: FORM ALERT
    1. If not submitted online, fax Form ALERT to 412-622-2113.
Header
Description

Header

Patient Initials (Last, First Middle)
Description

Patient Initials

Data type

text

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

Patient ID NSABP

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1513905
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C15818
Unnamed2
Description

Unnamed2

Institution Name
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Affiliate Name
Description

Affiliate Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C21541
UMLS CUI-1
C1510825
NCI Thesaurus ObjectClass-2
C25413
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Treating MD Last Name
Description

TreatingMDLastName

Data type

text

Treating MD First Name
Description

TreatingMDFirstName

Data type

text

Treating MD Phone
Description

TreatingPhysicianPhoneNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25741
UMLS 2011AA ObjectClass
C0031831
NCI Thesaurus Property
C25395
UMLS 2011AA Property
C0039457
Person Completing Form Last Name
Description

Person Completing Form Last Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass-2
C25657
UMLS CUI-2
C1301584
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25551
NCI Thesaurus ValueDomain
C25191
Person Completing Form First Name
Description

Person Completing Form First Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass-2
C25657
UMLS CUI-2
C1443235
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25509
NCI Thesaurus ValueDomain
C25191
Person Completing Form Phone
Description

Person Completing Form Phone

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25190
UMLS CUI-2
C1515258
NCI Thesaurus ObjectClass-2
C25657
NCI Thesaurus Property
C25395
Are data amended? (check box if yes, and circle amended items)
Description

Data amended

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Unnamed3
Description

Unnamed3

Date of this Report (Month Day Year)
Description

ReportCreatedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25375
UMLS 2011AA ObjectClass
C0684224
NCI Thesaurus Property
C42620
UMLS 2011AA Property
C1706214
Patient's Age at Time of AE
Description

PatientAdverseEventAssessmentAgeYearCount

Data type

float

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C41331
UMLS 2011AA Property-2
C0877248
NCI Thesaurus ValueDomain
C29848
UMLS 2011AA ValueDomain
C0439234
NCI Thesaurus ValueDomain-2
C25463
UMLS 2011AA ValueDomain-2
C0750480
Notify Local IRB?
Description

LocalInstitutionalReviewBoardAdverseEventNotificationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25388
UMLS 2011AA ObjectClass
C1947913
NCI Thesaurus ObjectClass-2
C16741
UMLS 2011AA ObjectClass-2
C0086911
NCI Thesaurus Property
C41331
UMLS 2011AA Property
C0877248
NCI Thesaurus Property-2
C25297
UMLS 2011AA Property-2
C0422202
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Was the patient hospitalized for 24 hours or more?
Description

PatientHospitalizationInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25179
UMLS 2011AA Property
C0019993
Specify Type of AE
Description

AdverseEventType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
CTCAE v3.0 Short Name
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
"Select" Term (when applicable)
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
Adverse Event Onset Date (Month Day Year)
Description

CTCAdverseEventOnsetDate

Data type

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
C25279
UMLS 2011AA Property
C0332162
Protocol Therapy
Description

Agent

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
Date of Most Recent Treatment (Month Day Year)
Description

DateofMostRecentTreatment

Data type

text

CTC Adverse Event Attribution Code
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
Briefly describe the AE (provide supporting documentation)
Description

BrieflydescribetheAE

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021

Similar models

If not submitted online, fax Form ALERT to 412-622-2113.

  1. StudyEvent: NSABP PROTOCOL C-08: FORM ALERT
    1. If not submitted online, fax Form ALERT to 412-622-2113.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Patient Initials
Item
Patient Initials (Last, First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Patient ID NSABP
Item
NSABP Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1513905 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C15818 (NCI Thesaurus Property-2)
Item Group
Unnamed2
Institution Name
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Affiliate Name
Item
Affiliate Name
text
C21541 (NCI Thesaurus ObjectClass)
C1510825 (UMLS CUI-1)
C25413 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
TreatingMDLastName
Item
Treating MD Last Name
text
TreatingMDFirstName
Item
Treating MD First Name
text
TreatingPhysicianPhoneNumber
Item
Treating MD Phone
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25395 (NCI Thesaurus Property)
C0039457 (UMLS 2011AA Property)
Person Completing Form Last Name
Item
Person Completing Form Last Name
text
C25190 (NCI Thesaurus ObjectClass)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass-2)
C1301584 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25191 (NCI Thesaurus ValueDomain)
Person Completing Form First Name
Item
Person Completing Form First Name
text
C25190 (NCI Thesaurus ObjectClass)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass-2)
C1443235 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C25191 (NCI Thesaurus ValueDomain)
Person Completing Form Phone
Item
Person Completing Form Phone
text
C25337 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C1515258 (UMLS CUI-2)
C25657 (NCI Thesaurus ObjectClass-2)
C25395 (NCI Thesaurus Property)
Data amended
Item
Are data amended? (check box if yes, and circle amended items)
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Unnamed3
ReportCreatedDate
Item
Date of this Report (Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25375 (NCI Thesaurus ObjectClass)
C0684224 (UMLS 2011AA ObjectClass)
C42620 (NCI Thesaurus Property)
C1706214 (UMLS 2011AA Property)
PatientAdverseEventAssessmentAgeYearCount
Item
Patient's Age at Time of AE
float
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C41331 (NCI Thesaurus Property-2)
C0877248 (UMLS 2011AA Property-2)
C29848 (NCI Thesaurus ValueDomain)
C0439234 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
LocalInstitutionalReviewBoardAdverseEventNotificationInd-2
Item
Notify Local IRB?
boolean
C25388 (NCI Thesaurus ObjectClass)
C1947913 (UMLS 2011AA ObjectClass)
C16741 (NCI Thesaurus ObjectClass-2)
C0086911 (UMLS 2011AA ObjectClass-2)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C25297 (NCI Thesaurus Property-2)
C0422202 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientHospitalizationInd-2
Item
Was the patient hospitalized for 24 hours or more?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25179 (NCI Thesaurus Property)
C0019993 (UMLS 2011AA Property)
Item
Specify Type of AE
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
Specify Type of AE
CL Item
Grade 4 Unexpected (Grade 4 unexpected)
CL Item
Grade 5 (Grade 5)
CL211380 (NCI Metathesaurus)
CommonToxicityCriteriaAdverseEventShortNameType
Item
CTCAE v3.0 Short Name
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)
CTCAdverseEventSpecifiedTermType
Item
"Select" Term (when applicable)
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)
CTCAdverseEventOnsetDate
Item
Adverse Event Onset Date (Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25279 (NCI Thesaurus Property)
C0332162 (UMLS 2011AA Property)
Item
Protocol Therapy
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Code List
Protocol Therapy
CL Item
5FU (5FU)
CL Item
Leucovorin (Leucovorin)
CL Item
Oxaliplatin (Oxaliplatin)
CL Item
Bevacizumab (Bevacizumab)
DateofMostRecentTreatment
Item
Date of Most Recent Treatment (Month Day Year)
text
Item
CTC Adverse Event Attribution Code
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)
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)
BrieflydescribetheAE
Item
Briefly describe the AE (provide supporting documentation)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)

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