ID

9674

Beschrijving

NSABP PROTOCOL R-04: FORM ALERT Radiation Therapy and Either Capecitabine or Fluorouracil With or Without Oxaliplatin Before Surgery in Treating Patients With Resectable Rectal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B7822CF5-8853-24F1-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B7822CF5-8853-24F1-E034-0003BA12F5E7

Trefwoorden

  1. 18-12-14 18-12-14 - Martin Dugas
  2. 09-01-15 09-01-15 - Martin Dugas
  3. 09-01-15 09-01-15 - Martin Dugas
  4. 09-01-15 09-01-15 - Martin Dugas
Geüploaded op

9 januari 2015

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0 Legacy

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Colorectal Cancer NCT00058474 Toxicity - NSABP PROTOCOL R-04: FORM ALERT - 2082606v3.0

*Unexpected: AE not listed in drug package insert (5FU and Epoetin alfa) or in the Investigator's Brochure (Capecitabine).

Ccrr Module For Nsabp Protocol R-04: Form Alert
Beschrijving

Ccrr Module For Nsabp Protocol R-04: Form Alert

First Three Letters of Patient's Last Name
Beschrijving

FirstThreeLettersofPatient'sLastName

Datatype

text

Patient Study ID
Beschrijving

Patient ID NSABP

Datatype

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 / Affiliate Name
Beschrijving

Affiliate Name

Datatype

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
Beschrijving

TreatingMDLastName

Datatype

text

Treating MD, First Name
Beschrijving

TreatingMDFirstName

Datatype

text

Treating MD, Phone
Beschrijving

TreatingMDPhone

Datatype

text

Person Completing Form, Last Name
Beschrijving

Person Completing Form Last Name

Datatype

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
Beschrijving

Person Completing Form First Name

Datatype

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
Phone
Beschrijving

Person Completing Form Phone

Datatype

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
Phone
Beschrijving

Person Completing Form Phone

Datatype

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?
Beschrijving

Data amended

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Date of this Report (Month Day Year)
Beschrijving

ReportCreatedDate

Datatype

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
Beschrijving

PatientAdverseEventAssessmentAgeYearCount

Datatype

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?
Beschrijving

LocalInstitutionalReviewBoardAdverseEventNotificationInd-2

Datatype

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?
Beschrijving

PatientHospitalizationInd-2

Datatype

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
CTC Adverse Event Type
Beschrijving

CTCAdverseEventType

Datatype

text

CTC Adverse Event Term
Beschrijving

CTC Adverse Event Term

Datatype

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS CUI-1
C1516728
NCI Thesaurus Property
C25703
UMLS CUI-2
C2826934
4-Character NSABP Code
Beschrijving

4-CharacterNSABPCode

Datatype

text

CTC Adverse Event Date (Month Day Year)
Beschrijving

CTCAdverseEventOnsetDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25279
UMLS 2011AA Property
C0332162
Protocol Therapy
Beschrijving

Agent

Datatype

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)
Beschrijving

DateofMostRecentTreatment

Datatype

text

CTC Adverse Event Attribution Code
Beschrijving

CTC Adverse Event Attribution Category

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1706735
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
Briefly describe the AE (provide supporting documentation)
Beschrijving

BrieflydescribetheAE

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021

Similar models

*Unexpected: AE not listed in drug package insert (5FU and Epoetin alfa) or in the Investigator's Brochure (Capecitabine).

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Ccrr Module For Nsabp Protocol R-04: Form Alert
FirstThreeLettersofPatient'sLastName
Item
First Three Letters of Patient's Last Name
text
Patient ID NSABP
Item
Patient Study 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)
Affiliate Name
Item
Institution Name / 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
TreatingMDPhone
Item
Treating MD, Phone
text
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
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)
Person Completing Form Phone
Item
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?
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
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
CTC Adverse Event Type
text
Code List
CTC Adverse Event Type
CL Item
Grade 3 Unexpected* (Grade 3 unexpected*)
CL Item
Grade 4 Unexpected* (Grade 4 unexpected*)
CL Item
Grade 4 Expected (Grade 4 expected)
CL Item
Grade 5**unexpected* (Grade 5**unexpected*)
CL Item
Grade 5** Expected (Grade 5** expected)
CTC Adverse Event Term
Item
CTC Adverse Event Term
text
C41331 (NCI Thesaurus ObjectClass)
C1516728 (UMLS CUI-1)
C25703 (NCI Thesaurus Property)
C2826934 (UMLS CUI-2)
4-CharacterNSABPCode
Item
4-Character NSABP Code
text
CTCAdverseEventOnsetDate
Item
CTC Adverse Event Date (Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (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
Capecitabine (Capecitabine)
CL Item
5FU (5FU)
CL Item
Epoetin Alfa (Epoetin Alfa)
DateofMostRecentTreatment
Item
Date of Most Recent Treatment (Month Day Year)
text
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 (Possibly)
C0332149 (NCI Metathesaurus)
CL Item
Probable (Probably)
C0332148 (NCI Metathesaurus)
CL Item
Definite (Definitely)
CL209464 (NCI Metathesaurus)
BrieflydescribetheAE
Item
Briefly describe the AE (provide supporting documentation)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial