ID

10639

Descrizione

CALGB: 49903 ADVERSE EVENT FORM NCT00053339 Trastuzumab With or Without Tamoxifen in Treating Women With Progressive Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A73D2363-5625-477E-E034-0003BA0B1A09

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A73D2363-5625-477E-E034-0003BA0B1A09

Keywords

versioni (2)
  1. 18/12/14 18/12/14 - Martin Dugas
  2. 03/06/15 03/06/15 -
Caricato su

3 giugno 2015

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0 Legacy
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

CALGB: 49903 ADVERSE EVENT FORM NCT00053339

Inglese

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice. Print text in capital letters. Avoid contact with the edges of the boxes. Circle amended items and check "Amended data" box to the right. If submitting by mail, retain a copy for your records and send the original to the CALGB Data Management Center. If faxing, use an original form for maximum clarity in transmission and fax to 919-416-4990. If submitting electronically, click the Send button when you have completed the PDF version of the form.

1 moduli  
CALGB clinical trial administrative data
Descrizione

CALGB clinical trial administrative data

CALGB Form
Descrizione

CALGBForm

Tipo di dati

text

CALGB Study No
Descrizione

CALGBStudyNo

Tipo di dati

text

CALGB Patient ID
Descrizione

CALGBPatientID

Tipo di dati

text

From
Descrizione

CTCAdverseEventReportBeginDate

Tipo di dati

date

To (M)
Descrizione

CTCAdverseEventReportEndDate

Tipo di dati

date

Amended data?
Descrizione

AmendedDataInd

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Patient demographics
Descrizione

Patient demographics

Patient's Name
Descrizione

Patient'sName

Tipo di dati

text

Participating Group
Descrizione

ParticipatingGroup

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C17005
UMLS 2011AA ObjectClass
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Patient Hospital Number
Descrizione

PatientHospitalNumber

Tipo di dati

text

Participating Group Protocol No.
Descrizione

ParticipatingGroupProtocolNo.

Tipo di dati

text

Main Member Institution/Adjunct
Descrizione

AffiliateName

Tipo di dati

text

Participating Group Patient No.
Descrizione

ParticipatingGroupPatientID

Tipo di dati

text

ADR Report
Descrizione

ADR Report

Was an ADR Report filed based on an event reported below?
Descrizione

ADRFiledInd

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C25410
UMLS 2011AA ObjectClass
C1521800
NCI Thesaurus Property
C25175
UMLS 2011AA Property
C1522646
Expected Adverse Events
Descrizione

Expected Adverse Events

IMT Code
Descrizione

IMTCodeduplicate

Tipo di dati

text

CTC Adverse Event Term
Descrizione

CTCAdverseEventTerm

Tipo di dati

text

CTC Grade (Coding Instructions: Use the most current version of the NCI Common Toxicity Criteria CTC to determine the grade for each event with the exception of Hand-foot syndrome see protocol section 12.8. If no adverse event is reported for a specific category, code grade = 0. DO NOT USE THE CALGB EXPANDED COMMON TOXICITY CRITERIA.)
Descrizione

CTCAdverseEventGrade

Tipo di dati

text

Attribution (Attribution Codes)
Descrizione

CTCAdverseEventAttributionCode

Tipo di dati

text

Person Completing Form
Descrizione

Person Completing Form

Completed By (Print or Type Name)
Descrizione

PersonCompletingForm,FirstName

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Date Completed
Descrizione

FormCompletionDate,Original

Tipo di dati

date

Ccrr Module For Calgb: 49903 Adverse Event Form
Descrizione

Ccrr Module For Calgb: 49903 Adverse Event Form

Ritorna all'inizio della pagina

Similar models

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice. Print text in capital letters. Avoid contact with the edges of the boxes. Circle amended items and check "Amended data" box to the right. If submitting by mail, retain a copy for your records and send the original to the CALGB Data Management Center. If faxing, use an original form for maximum clarity in transmission and fax to 919-416-4990. If submitting electronically, click the Send button when you have completed the PDF version of the form.

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
CALGB clinical trial administrative data
CALGBForm
Item
CALGB Form
text
CALGBStudyNo
Item
CALGB Study No
text
CALGBPatientID
Item
CALGB Patient ID
text
CTCAdverseEventReportBeginDate
Item
From
date
CTCAdverseEventReportEndDate
Item
To (M)
date
Item
Amended data?
text
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
CL.1
Code List
Amended data?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Patient demographics
Patient'sName
Item
Patient's Name
text
ParticipatingGroup
Item
Participating Group
text
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientHospitalNumber
Item
Patient Hospital Number
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
AffiliateName
Item
Main Member Institution/Adjunct
text
ParticipatingGroupPatientID
Item
Participating Group Patient No.
text
Item Group
ADR Report
Item
Was an ADR Report filed based on an event reported below?
text
C25410 (NCI Thesaurus ObjectClass)
C1521800 (UMLS 2011AA ObjectClass)
C25175 (NCI Thesaurus Property)
C1522646 (UMLS 2011AA Property)
CL.2
Code List
Was an ADR Report filed based on an event reported below?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Expected Adverse Events
IMTCodeduplicate
Item
IMT Code
text
CTCAdverseEventTerm
Item
CTC Adverse Event Term
text
CTCAdverseEventGrade
Item
CTC Grade (Coding Instructions: Use the most current version of the NCI Common Toxicity Criteria CTC to determine the grade for each event with the exception of Hand-foot syndrome see protocol section 12.8. If no adverse event is reported for a specific category, code grade = 0. DO NOT USE THE CALGB EXPANDED COMMON TOXICITY CRITERIA.)
text
Item
Attribution (Attribution Codes)
text
CL.3
Code List
Attribution (Attribution Codes)
CL Item
Unrelated (unrelated to treatment)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (unlikely to be related to treatment)
CL Item
Possibly (possible related to treatment)
CL Item
Probably (probably related to treatment)
CL Item
Definitely (definitely related to treatment)
Item Group
Person Completing Form
PersonCompletingForm,FirstName
Item
Completed By (Print or Type Name)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
FormCompletionDate,Original
Item
Date Completed
date
Item Group
Ccrr Module For Calgb: 49903 Adverse Event Form
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

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