ID

33082

Descripción

Study ID: 104020 Clinical Study ID: 104020 Study Title: Blinded, randomised study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ live attenuated measles-mumps-rubella-varicella candidate vaccine when given to healthy children in their second year of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00126997 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Combined Measles, Mumps, Rubella, Varicella Vaccine Trade Name: Priorix Tetra Study Indication: Measles; Mumps; Rubella; Varicella

Palabras clave

Versiones (1)
  1. 26/11/18 26/11/18 -
Titular de derechos de autor

GSK group of companies

Subido en

26 de noviembre de 2018

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.

Immunogenicity of Combined Measles, Mumps, Rubella, Varicella Vaccine for healthy 2 y.o children - 104020

Inglés

Non-Serious Adverse Event Form

1 formularios  
Administrative data
Descripción

Administrative data

Subject Number
Descripción

Subject Number

Tipo de datos

integer

Non-Serious Adverse Events
Descripción

Non-Serious Adverse Events

Has any non-serious adverse events occurred within minimum 43 days post-vaccination?
Descripción

Please exclude those recorded on the SAE form

Tipo de datos

boolean

If Yes, please complete the following table
Descripción

If Yes, please complete the following table

Tipo de datos

text

AE Details
Descripción

AE Details

AE Number
Descripción

AE Number

Tipo de datos

integer

Description
Descripción

Description

Tipo de datos

text

Administration sites
Descripción

Administration sites

Tipo de datos

text

Date started
Descripción

Date started

Tipo de datos

date

Date stopped
Descripción

Date stopped

Tipo de datos

date

Intensity
Descripción

Intensity

Tipo de datos

text

Relationship to investigational products
Descripción

Is there a reasonable possibility that the AE may have been caused by the investigational product?

Tipo de datos

boolean

Outcome
Descripción

Outcome

Tipo de datos

text

Volver a la parte superior de la página

Similar models

Non-Serious Adverse Event Form

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item Group
Non-Serious Adverse Events
Has any non-serious adverse events occurred within minimum 43 days post-vaccination?
Item
Has any non-serious adverse events occurred within minimum 43 days post-vaccination?
boolean
If Yes, please complete the following table
Item
If Yes, please complete the following table
text
Item Group
AE Details
Item
AE Number
integer
AE Number
Code List
AE Number
CL Item
Event 1 (1)
CL Item
Event 2 (2)
CL Item
Event 3 (3)
CL Item
Event 4 (4)
Description
Item
Description
text
Item
Administration sites
text
Administration sites
Code List
Administration sites
CL Item
MeMuRu-OKA vaccine (1)
CL Item
Priorix vaccine (2)
CL Item
Varilrix vaccine (3)
CL Item
Non-administration site (4)
Date started
Item
Date started
date
Date stopped
Item
Date stopped
date
Item
Intensity
text
Intensity
Code List
Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Relationship to investigational products
Item
Relationship to investigational products
boolean
Item
Outcome
text
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/ Resolving (2)
CL Item
Not recovered/ Not resolved (3)
CL Item
Recovered with sequelae/ Resolved with sequelae (4)
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