ID

33061

Descrição

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 CRF Seiten: 268-336; 870-938

Palavras-chave

Versões (1)
  1. 26/11/2018 26/11/2018 -
Titular dos direitos

GSK group of companies

Transferido a

26 de novembro de 2018

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 3.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

  • Os mais recentes
  • Os mais antigos
  • Preferidos
  • Os mais recentes
    • Os mais recentes
    • Os mais antigos
    • Preferidos

Sem comentários

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

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

Inglês

Parotid / Salivary Gland Swelling AE Form

1 Formulários  
Administrative data
Descrição

Administrative data

Subject Number
Descrição

Subject Number

Tipo de dados

integer

Parotid/Salivary Gland Swelling Events
Descrição

Parotid/Salivary Gland Swelling Events

Event Number
Descrição

Please report any parotid / salivary gland swelling events occurring during the study period

Tipo de dados

integer

Description
Descrição

Description

Tipo de dados

text

Further Details (For GSK)
Descrição

Further Details (For GSK)

Event Number
Descrição

Event Number

Tipo de dados

integer

Date started
Descrição

Date started

Tipo de dados

date

Date stopped
Descrição

Date stopped

Tipo de dados

date

Intensity
Descrição

Intensity

Tipo de dados

text

Saliva Sample
Descrição

Saliva Sample

Event Number
Descrição

Event Number

Tipo de dados

integer

Has a saliva sample been taken for mumps virus detection, strain identification and for viral culture?
Descrição

Has a saliva sample been taken for mumps virus detection, strain identification and for viral culture?

Tipo de dados

boolean

If Yes, record date
Descrição

If Yes, record date

Tipo de dados

date

Relationship to Investigational products
Descrição

Relationship to Investigational products

Event Number
Descrição

Event Number

Tipo de dados

integer

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

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

Tipo de dados

boolean

Outcome
Descrição

Outcome

Event Number
Descrição

Event Number

Tipo de dados

integer

Outcome
Descrição

Outcome

Tipo de dados

text

Voltar ao início da página

Similar models

Parotid / Salivary Gland Swelling AE Form

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item Group
Parotid/Salivary Gland Swelling Events
Item
Event Number
integer
Event Number
Code List
Event Number
CL Item
PS. 1 (1)
CL Item
PS. 2 (2)
Description
Item
Description
text
Item Group
Further Details (For GSK)
Item
Event Number
integer
Event Number
Code List
Event Number
CL Item
PS. 1 (1)
CL Item
PS. 2 (2)
Date started
Item
Date started
date
Date stopped
Item
Date stopped
date
Item
Intensity
text
Intensity
Code List
Intensity
CL Item
Swelling without difficulties to move the jaw (1)
CL Item
Swelling with difficulties to move the jaw (2)
CL Item
Swelling and additional general symptoms (3)
Item Group
Saliva Sample
Item
Event Number
integer
Event Number
Code List
Event Number
CL Item
PS. 1 (1)
CL Item
PS. 2 (2)
Has a saliva sample been taken for mumps virus detection, strain identification and for viral culture?
Item
Has a saliva sample been taken for mumps virus detection, strain identification and for viral culture?
boolean
If Yes, record date
Item
If Yes, record date
date
Item Group
Relationship to Investigational products
Item
Event Number
integer
Event Number
Code List
Event Number
CL Item
PS. 1 (1)
CL Item
PS. 2 (2)
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
Item Group
Outcome
Item
Event Number
integer
Event Number
Code List
Event Number
CL Item
PS. 1 (1)
CL Item
PS. 2 (2)
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)
Voltar ao início da página 

Ajuda

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