ID

8605

Beschreibung

BIG 2-06 / NCCTG N063D / EGF106708 - Treatment Completion ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=314FE254-F5BC-36C0-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=314FE254-F5BC-36C0-E044-0003BA3F9857

Stichworte

Versionen (2)
  1. 19.09.12 19.09.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
Hochgeladen am

9. Januar 2015

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0 Legacy
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Neoplasms, Breast DRKS00003651 NCT00490139 Follow-Up - BIG 2-06 / NCCTG N063D / EGF106708 - Treatment Completion - 2644342v1.0

Englisch

No Instruction available.

1 Formulare  
  1. StudyEvent: BIG 2-06 / NCCTG N063D / EGF106708 - Treatment Completion
    1. No Instruction available.
Header Module
Beschreibung

Header Module

Centre No.
Beschreibung

Institution Number

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
UMLS CUI-2
C0805701
NCI Thesaurus Property
C25364
Subject No.
Beschreibung

Patient Study ID

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25462
NCI Thesaurus Property-2
C25364
Treatment Completion
Beschreibung

Treatment Completion

Did the patient complete Lapatinib as per protocol
Beschreibung

LapatinibTherapyCompleteIndicator

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus ObjectClass
C26653
UMLS 2011AA ObjectClass
C1173538
NCI Thesaurus ObjectClass-2
C15368
Did the patient complete Trastuzumab as per protocol
Beschreibung

TrastuzumabTherapyCompleteIndicator

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus ObjectClass
C1647
UMLS 2011AA ObjectClass
C0338204
NCI Thesaurus ObjectClass-2
C15368
Did the patient complete Paclitaxel as per protocol
Beschreibung

PaclitaxelTherapyCompleteIndicator

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus ObjectClass
C1411
UMLS 2011AA ObjectClass
C0144576
NCI Thesaurus ObjectClass-2
C15368
Reasons for treatment discontinuation
Beschreibung

TherapyDiscontinueReason

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
Date of last contact within treatment period
Beschreibung

PatientLastClinicalStudyPeriodContactDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25461
UMLS 2011AA Property-2
C0337611
NCI Thesaurus Property-3
C15206
UMLS 2011AA Property-3
C0008972
NCI Thesaurus Property-4
C25551
UMLS 2011AA Property-4
C1517741
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Additional Comments And Investigator's Signature
Beschreibung

Additional Comments And Investigator's Signature

CRF page number
Beschreibung

CaseReportFormSubmissionPageNumber

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C40988
UMLS 2011AA ObjectClass
C1516308
NCI Thesaurus Property
C25694
UMLS 2011AA Property
C1515022
Comments
Beschreibung

Research Comments

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Investigator Signature
Beschreibung

Investigator Signature

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
NCI Thesaurus ObjectClass
C17089
Date
Beschreibung

Investigator Signature Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
UMLS CUI-2
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C17089
Zum Seitenanfang zurückkehren

Ähnliche Modelle

No Instruction available.

1 Formulare
  1. StudyEvent: BIG 2-06 / NCCTG N063D / EGF106708 - Treatment Completion
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Header Module
Institution Number
Item
Centre No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
Patient Study ID
Item
Subject No.
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Item Group
Treatment Completion
Item
Did the patient complete Lapatinib as per protocol
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C26653 (NCI Thesaurus ObjectClass)
C1173538 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
CL.1
Code List
Did the patient complete Lapatinib as per protocol
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
Item
Did the patient complete Trastuzumab as per protocol
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C1647 (NCI Thesaurus ObjectClass)
C0338204 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
CL.2
Code List
Did the patient complete Trastuzumab as per protocol
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
Item
Did the patient complete Paclitaxel as per protocol
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C1411 (NCI Thesaurus ObjectClass)
C0144576 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
CL.3
Code List
Did the patient complete Paclitaxel as per protocol
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
Item
Reasons for treatment discontinuation
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
CL.4
Code List
Reasons for treatment discontinuation
CL Item
Adverse Event (Adverse Event)
C41331 (NCI Thesaurus)
C0877248 (UMLS 2011AA)
CL Item
Protocol Violation (Protocol violation)
C48251 (NCI Thesaurus)
C1709750 (UMLS 2011AA)
CL Item
Subject Decided To Withdraw From Investigational Product But Is Continuing To Be Followed Per Protocol (Subject decided to withdraw from investigational product but is continuing to be followed per protocol)
CL Item
Subject Decided To Withdraw From The Study (Subject decided to withdraw from the study)
CL Item
Recurrence Of Disease Or Second Primary Malignancy Or Contralateral Breast Cancer (Recurrence of disease or second primary malignancy or contralateral breast cancer)
CL Item
Death (Death)
C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)
CL Item
Lost To Follow-up: C48227 (Lost to follow-up)
C48227 (NCI Thesaurus)
C1302313 (UMLS 2011AA)
PatientLastClinicalStudyPeriodContactDate
Item
Date of last contact within treatment period
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25461 (NCI Thesaurus Property-2)
C0337611 (UMLS 2011AA Property-2)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-3)
C25551 (NCI Thesaurus Property-4)
C1517741 (UMLS 2011AA Property-4)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Additional Comments And Investigator's Signature
CaseReportFormSubmissionPageNumber
Item
CRF page number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25694 (NCI Thesaurus Property)
C1515022 (UMLS 2011AA Property)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Investigator Signature
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
Investigator Signature Date
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video