ID

33060

Beschrijving

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

Trefwoorden

Versies (1)
  1. 26-11-18 26-11-18 -
Houder van rechten

GSK group of companies

Geüploaded op

26 november 2018

DOI

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Licentie

Creative Commons BY-NC 3.0
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Immunogenicity of Combined Measles, Mumps, Rubella, Varicella Vaccine for healthy 2 y.o children - 104020

Engels

Rash / Exanthem AE Form

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Subject Number
Beschrijving

Subject Number

Datatype

integer

Rash/Exanthem
Beschrijving

Rash/Exanthem

Event Number
Beschrijving

Please report any rash event that occurred during the study period

Datatype

integer

Description
Beschrijving

Description

Datatype

text

Administration sites
Beschrijving

Administration sites

Datatype

text

Non-administration site
Beschrijving

Non-administration site

Datatype

text

Further Event Details (For GSK)
Beschrijving

Further Event Details (For GSK)

Event Number
Beschrijving

Event Number

Datatype

integer

Category
Beschrijving

Category

Datatype

text

If Other, specify
Beschrijving

If Other, specify

Datatype

text

Date started
Beschrijving

Date started

Datatype

date

Date stopped
Beschrijving

Date stopped

Datatype

date

Intensity
Beschrijving

Intensity

Datatype

text

Has a vesicular fluid sample been taken?
Beschrijving

Has a vesicular fluid sample been taken?

Datatype

boolean

If Yes, record date
Beschrijving

If Yes, record date

Datatype

date

Relationship to investigational products
Beschrijving

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

Datatype

boolean

Outcome
Beschrijving

Outcome

Datatype

text

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Similar models

Rash / Exanthem AE Form

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item Group
Rash/Exanthem
Item
Event Number
integer
Event Number
Code List
Event Number
CL Item
RA. 1 (1)
CL Item
RA. 2 (2)
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
Varilirix vaccine (3)
Item
Non-administration site
text
Non-administration site
Code List
Non-administration site
CL Item
Generalized (1)
CL Item
Localized (2)
Item Group
Further Event Details (For GSK)
Item
Event Number
integer
Event Number
Code List
Event Number
CL Item
RA. 1 (1)
CL Item
RA. 2 (2)
Item
Category
text
Category
Code List
Category
CL Item
Varicella rash (1)
CL Item
Measles / rubella-rash (2)
CL Item
Other (3)
If Other, specify
Item
If Other, specify
text
Date started
Item
Date started
date
Date stopped
Item
Date stopped
date
Item
Intensity
text
Intensity
Code List
Intensity
CL Item
1 - 50 lesions (1)
CL Item
51 - 150 lesions (2)
CL Item
> 150 lesions (3)
Has a vesicular fluid sample been taken?
Item
Has a vesicular fluid sample been taken?
boolean
If Yes, record date
Item
If Yes, record date
date
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)
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