ID

11038

Description

NSABP PROTOCOL C-08: BEVACIZUMAB TREATMENT FORM NCT00096278 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=D7F6B84C-2C3E-4583-E034-0003BA12F5E7

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D7F6B84C-2C3E-4583-E034-0003BA12F5E7

Mots-clés

Versions (3)
  1. 27/08/2012 27/08/2012 -
  2. 09/01/2015 09/01/2015 - Martin Dugas
  3. 16/06/2015 16/06/2015 -
Téléchargé le

16 juin 2015

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy
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NSABP PROTOCOL C-08: BEVACIZUMAB TREATMENT FORM NCT00096278

Anglais

Submit this form when a patient falls to start bevacizumab or when bevacizumab treatment has ended.

1 Formulaires  
Header
Description

Header

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
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
BEVACIZUMAB TREATMENT
Description

BEVACIZUMAB TREATMENT

Begin Date (if patient failed to start, code=00 00 0000)
Description

Agent Start Date

Type de données

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1521826
NCI Thesaurus ValueDomain-2
C25431
UMLS CUI-2
C0808070
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property
C25275
End Date (if patient failed to start, code=00 00 0000)
Description

DoseEndDate

Type de données

date

Alias
NCI Thesaurus Property
C25164
UMLS 2011AA Property
C0011008
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus ObjectClass-2
C25551
UMLS 2011AA ObjectClass-2
C1517741
Total Number of Doses Received (enter "0" if never started)
Description

Number of Doses, Total

Type de données

float

Alias
NCI Thesaurus Property
C25304
UMLS CUI-1
C0178602
NCI Thesaurus ValueDomain
C25463
UMLS CUI-2
C0750480
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property-2
C25256
Treatment Discontinued Type (select primary reason)
Description

TreatmentDiscontinuedType

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
Other reason, specify
Description

Other,specify(reasontreatmentended)

Type de données

text

Adverse events which require discontinuation of bevacizumab
Description

AdverseEventEndTreatmentType

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C15368
Comments
Description

Comments

Comments
Description

Research Comments

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
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Similar models

Submit this form when a patient falls to start bevacizumab or when bevacizumab treatment has ended.

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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)
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)
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
BEVACIZUMAB TREATMENT
Agent Start Date
Item
Begin Date (if patient failed to start, code=00 00 0000)
date
C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C25431 (NCI Thesaurus ValueDomain-2)
C0808070 (UMLS CUI-2)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
DoseEndDate
Item
End Date (if patient failed to start, code=00 00 0000)
date
C25164 (NCI Thesaurus Property)
C0011008 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25551 (NCI Thesaurus ObjectClass-2)
C1517741 (UMLS 2011AA ObjectClass-2)
Number of Doses, Total
Item
Total Number of Doses Received (enter "0" if never started)
float
C25304 (NCI Thesaurus Property)
C0178602 (UMLS CUI-1)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS CUI-2)
C1708 (NCI Thesaurus ObjectClass)
C25256 (NCI Thesaurus Property-2)
Item
Treatment Discontinued Type (select primary reason)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
CL.2
Code List
Treatment Discontinued Type (select primary reason)
CL Item
Protocol Mandated Discontinuation (Protocol Mandated Discontinuation)
CL Item
Completed Per Protocol (Completed per protocol)
CL Item
Alternative Therapy (Alternative Therapy)
CL Item
Physician Withdrawal (Physician withdrawal)
CL Item
Patient Withdrawal Or Refusal (Patient withdrawal or refusal)
CL Item
Death, Recurrence, Or Second Primary Cancer (Death, recurrence, or second primary cancer)
CL Item
Other Adverse Event/side Effects/complications (Other Adverse Event/Side Effects/Complications)
CL Item
Other, Specify (Other, specify)
CL Item
Adverse Event/side Effects/complications (Toxicity/Side effects)
CL Item
Death, Recurrence, Or Second Primary Cancer (Death, recurrence, or second primary cancer)
CL Item
Patient Withdrawal Or Refusal (Patient withdrawal or refusal)
CL Item
Physician Withdrawal (Physician withdrawal)
CL Item
Alternative Therapy (Alternative Therapy)
CL Item
Treatment Completed Per Protocol Criteria (Completed per protocol)
CL Item
Other (Other reason, specify)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Other,specify(reasontreatmentended)
Item
Other reason, specify
text
Item
Adverse events which require discontinuation of bevacizumab
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
CL.3
Code List
Adverse events which require discontinuation of bevacizumab
CL Item
Grade 4 Acute Infusion Reaction Or Allergic Reaction/hypersensitivity (Grade 4 Acute infusion reaction or Allergic reaction/hypersensitivity)
CL Item
Grade 3 Or 4 Hemorrhage (Grade 3 or 4 Hemorrhage)
CL Item
Grade 2, 3, Or 4 Visceral Or Peripheral Arterial Ischemia (Grade 2, 3, or 4 Visceral or peripheral arterial ischemia)
CL Item
Grade 2, 3, Or 4 Cardiac Ischemia/infarction (Grade 2, 3, or 4 Cardiac ischemia/infarction)
CL Item
Grade 2, 3, Or 4 Cns Cerebrovascular Ischemia (Grade 2, 3, or 4 CNS cerebrovascular ischemia)
CL Item
Grade 4 Thrombosis/thrombus/embolism (Grade 4 Thrombosis/Thrombus/Embolism)
CL Item
Grade 4 Intra-abdominal Abscess/infection (Grade 4 Intra-abdominal abscess/Infection)
CL Item
Grade 2, 3, Or 4 Wound Complication, Non-infectious (Grade 2, 3, or 4 Wound complication, non-infectious)
CL Item
Grade 4 Proteinuria (Grade 4 Proteinuria)
CL Item
Grade 4 Hypertension (Grade 4 Hypertension)
CL Item
Other Clinically Significant Grade 4 Ae Related To Bevacizumab (Other clinically significant Grade 4 AE related to Bevacizumab)
CL Item
Grade 1, 2, 3, Or 4 Gi Perforation, Gi Leak, Or Gi Fistula (Grade 1, 2, 3, or 4 GI perforation, GI leak, or GI fistula)
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
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