ID

9680

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 NCT00096278 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D7FA5174-1580-6420-E034-0003BA12F5E7

Lien

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

Mots-clés

Versions (5)
  1. 18/12/2014 18/12/2014 - Martin Dugas
  2. 09/01/2015 09/01/2015 - Martin Dugas
  3. 09/01/2015 09/01/2015 - Martin Dugas
  4. 10/01/2015 10/01/2015 - Martin Dugas
  5. 10/01/2015 10/01/2015 - Martin Dugas
Téléchargé le

10 janvier 2015

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy
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FORM ALERT Colorectal Cancer (NCT00096278)

Anglais

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

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

Header

Alias
UMLS CUI-1
C1320722
Date of this Report (Month Day Year)
Description

ReportCreatedDate

Type de données

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 Initials (Last, First Middle)
Description

Patient Initials

Type de données

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

Type de données

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
Institution Name
Description

Institution Name

Type de données

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

Type de données

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

Type de données

text

Treating MD First Name
Description

TreatingMDFirstName

Type de données

text

Treating MD Phone
Description

TreatingPhysicianPhoneNumber

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

boolean

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

Adverse event

Alias
UMLS CUI-1
C0877248
Patient's Age at Time of AE
Description

PatientAdverseEventAssessmentAgeYearCount

Type de données

integer

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C20989
NCI Thesaurus Property-2
C41331
NCI Thesaurus ValueDomain
C29848
NCI Thesaurus ValueDomain-2
C25463
UMLS CUI-1
C2981639
Notify Local IRB?
Description

LocalInstitutionalReviewBoardAdverseEventNotificationInd-2

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C25388
NCI Thesaurus ObjectClass-2
C16741
NCI Thesaurus Property
C41331
NCI Thesaurus Property-2
C25297
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0086911
UMLS CUI-2
C0422202
Was the patient hospitalized for 24 hours or more?
Description

PatientHospitalizationInd-2

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25179
UMLS CUI-1
C0019993
Specify Type of AE
Description

Adverse Event

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25284
NCI Thesaurus ObjectClass
C41331
NCI Thesaurus Property
C25365
UMLS CUI-1
C2985911
CTCAE v3.0 Short Name
Description

CommonToxicityCriteriaAdverseEventShortNameType

Type de données

text

Alias
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C49704
NCI Metathesaurus ValueDomain
C0332307
NCI Thesaurus Property-2
C25249
UMLS CUI-1
C1516728
UMLS CUI-2
C2826270
"Select" Term (when applicable)
Description

CTC Adverse Event Term

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C38024
NCI Thesaurus Property-2
C45559
Adverse Event Onset Date (Month Day Year)
Description

Adverse Event Onset Date

Type de données

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985916
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25279
Protocol Therapy
Description

Agent

Type de données

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
Description

DateofMostRecentTreatment

Type de données

text

Unités de mesure
  • Month Day Year
Alias
UMLS CUI-1
C3173313
UMLS CUI-2
C0332152
Month Day Year
CTC Adverse Event Attribution Code
Description

CTC Adverse Event Attribution Category

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1706735
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
Briefly describe the AE
Description

BrieflydescribetheAE (provide supporting documentation)

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2699044
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Similar models

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

1 Formulaires
  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)
Type de données
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
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)
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)
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
Adverse event
C0877248 (UMLS CUI-1)
Age at Time of Adverse Event
Item
Patient's Age at Time of AE
integer
C16960 (NCI Thesaurus ObjectClass)
C20989 (NCI Thesaurus Property)
C41331 (NCI Thesaurus Property-2)
C29848 (NCI Thesaurus ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C2981639 (UMLS CUI-1)
IRB notification
Item
Notify Local IRB?
boolean
C25388 (NCI Thesaurus ObjectClass)
C16741 (NCI Thesaurus ObjectClass-2)
C41331 (NCI Thesaurus Property)
C25297 (NCI Thesaurus Property-2)
C38147 (NCI Thesaurus ValueDomain)
C0086911 (UMLS CUI-1)
C0422202 (UMLS CUI-2)
Hospitalization
Item
Was the patient hospitalized for 24 hours or more?
boolean
C38147 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25179 (NCI Thesaurus Property)
C0019993 (UMLS CUI-1)
Item
Specify Type of AE
text
C25284 (NCI Thesaurus ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property)
C2985911 (UMLS CUI-1)
CL.4
Code List
Specify Type of AE
CL Item
Grade 4 Unexpected (Grade 4 unexpected)
CL Item
Grade 5 (Grade 5)
CL211380 (NCI Metathesaurus)
CTCAE Short Name
Item
CTCAE v3.0 Short Name
text
C25364 (NCI Thesaurus Property)
C49704 (NCI Thesaurus ObjectClass)
C0332307 (NCI Metathesaurus ValueDomain)
C25249 (NCI Thesaurus Property-2)
C1516728 (UMLS CUI-1)
C2826270 (UMLS CUI-2)
CTC Adverse Event Term
Item
"Select" Term (when applicable)
text
C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C38024 (NCI Thesaurus Property)
C45559 (NCI Thesaurus Property-2)
Adverse Event Onset Date
Item
Adverse Event Onset Date (Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C2985916 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C49704 (NCI Thesaurus ObjectClass)
C25279 (NCI Thesaurus 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)
CL.5
Code List
Protocol Therapy
CL Item
5FU (5FU)
CL Item
Leucovorin (Leucovorin)
CL Item
Oxaliplatin (Oxaliplatin)
CL Item
Bevacizumab (Bevacizumab)
Date of preceding treatment
Item
Date of Most Recent Treatment
text
C3173313 (UMLS CUI-1)
C0332152 (UMLS CUI-2)
Item
CTC Adverse Event Attribution Code
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
CL.6
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)
Adverse Event Description
Item
Briefly describe the AE
text
C25704 (NCI Thesaurus ValueDomain)
C2699044 (UMLS CUI-1)
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