ID

22071

Descripción

XELODA and Lapatinib Advanced or Metastatic Breast Cancer Study ID: 100151 Clinical Study ID: EGF100151 Study Title: A Phase III, Randomized, Open-label, Multicenter Study Comparing GW572016 and Capecitabine (XELODA) versus Capecitabine in Women with Refractory Advanced or Metastatic Breast Cancer Clinicaltrials.gov Identifier: NCT00078572 https://clinicaltrials.gov/ct2/show/NCT00078572 Procedure: Non-serious Adverse Events Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lapatinib Trade Name: Tyverb,Tykerb,Tycerb Study Indication: Breast Cancer; Neoplasms, Breast

Link

https://clinicaltrials.gov/ct2/show/NCT00078572

Palabras clave

Versiones (1)
  1. 18/5/17 18/5/17 -
Subido en

18 de mayo de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

XELODA and Lapatinib Advanced or Metastatic Breast Cancer Non-serious Adverse Events NCT00078572

Inglés

XELODA and Lapatinib Advanced or Metastatic Breast Cancer Non-serious Adverse Events NCT00078572

1 formularios  
Non-serious Adverse Events
Descripción

Non-serious Adverse Events

Alias
UMLS CUI-1
C1518404
Did the subject experience any non-serious adverse events during the study?
Descripción

If YES, indicate below:

Tipo de datos

text

Alias
UMLS CUI [1]
C1518404
Non-serious adverse events: Diagnosis only (if known) or signs / symptoms (list one per line)
Descripción

Non-serious adverse event

Tipo de datos

text

Alias
UMLS CUI [1]
C1518404
Date of onset
Descripción

Date of onset

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1518404
NCI-CTCAE toxicity
Descripción

NCI-CTCAE toxicity

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C3887242
UMLS CUI [1,2]
C1518404
Outcome
Descripción

Outcome

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1518404
Date of resolution
Descripción

Date of resolution

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1518404
Action taken with investigational product(s) as a result of the non-serious AE
Descripción

Action taken with investigational product

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1518404
Did subject withdraw from study as a result of this non-serious AE?
Descripción

Withdrawal

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
Descripción

Relationship to investigational product(s)

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1518404
Does the AE meet the definition of serious?
Descripción

Seriousness

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1518404
Volver a la parte superior de la página

Similar models

XELODA and Lapatinib Advanced or Metastatic Breast Cancer Non-serious Adverse Events NCT00078572

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Non-serious Adverse Events
C1518404 (UMLS CUI-1)
Item
Did the subject experience any non-serious adverse events during the study?
text
C1518404 (UMLS CUI [1])
Withdrawal
Code List
Did the subject experience any non-serious adverse events during the study?
CL Item
Yes (Y)
CL Item
No (N)
Non-serious adverse event
Item
Non-serious adverse events: Diagnosis only (if known) or signs / symptoms (list one per line)
text
C1518404 (UMLS CUI [1])
Date of onset
Item
Date of onset
text
C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
NCI-CTCAE toxicity
integer
C3887242 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
NCI-CTCAE toxicity
Code List
NCI-CTCAE toxicity
CL Item
Grade 1  (1)
CL Item
Grade 2  (2)
CL Item
Grade 3  (3)
CL Item
Not applicable (4)
Item
Outcome
text
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
Resolved  (R)
CL Item
Resolved with sequelae  (S)
CL Item
Not resolved (N)
Date of resolution
Item
Date of resolution
date
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Action taken with investigational product(s) as a result of the non-serious AE
integer
C1704758 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Action taken with investigational product
Code List
Action taken with investigational product(s) as a result of the non-serious AE
CL Item
None (0)
CL Item
Dose adjusted (1)
CL Item
Temporarily interrupted (2)
CL Item
Permanently discontinued (3)
CL Item
Not applicable (4)
Item
Did subject withdraw from study as a result of this non-serious AE?
text
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Withdrawal
Code List
Did subject withdraw from study as a result of this non-serious AE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Withdrawal
Code List
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the AE meet the definition of serious?
text
C1710056 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Withdrawal
Code List
Does the AE meet the definition of serious?
CL Item
Yes (Y)
CL Item
No (N)
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

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