ID

33060

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2018-11-26 2018-11-26 -
Rättsinnehavare

GSK group of companies

Uppladdad den

26 november 2018

DOI

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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

Engelsk

Rash / Exanthem AE Form

1 Formulär  
Administrative data
Beskrivning

Administrative data

Subject Number
Beskrivning

Subject Number

Datatyp

integer

Rash/Exanthem
Beskrivning

Rash/Exanthem

Event Number
Beskrivning

Please report any rash event that occurred during the study period

Datatyp

integer

Description
Beskrivning

Description

Datatyp

text

Administration sites
Beskrivning

Administration sites

Datatyp

text

Non-administration site
Beskrivning

Non-administration site

Datatyp

text

Further Event Details (For GSK)
Beskrivning

Further Event Details (For GSK)

Event Number
Beskrivning

Event Number

Datatyp

integer

Category
Beskrivning

Category

Datatyp

text

If Other, specify
Beskrivning

If Other, specify

Datatyp

text

Date started
Beskrivning

Date started

Datatyp

date

Date stopped
Beskrivning

Date stopped

Datatyp

date

Intensity
Beskrivning

Intensity

Datatyp

text

Has a vesicular fluid sample been taken?
Beskrivning

Has a vesicular fluid sample been taken?

Datatyp

boolean

If Yes, record date
Beskrivning

If Yes, record date

Datatyp

date

Relationship to investigational products
Beskrivning

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

Datatyp

boolean

Outcome
Beskrivning

Outcome

Datatyp

text

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Similar models

Rash / Exanthem AE Form

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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