ID

33082

Beschreibung

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

Stichworte

  1. 26.11.18 26.11.18 -
Rechteinhaber

GSK group of companies

Hochgeladen am

26. November 2018

DOI

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Lizenz

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

Non-Serious Adverse Event Form

Administrative data
Beschreibung

Administrative data

Subject Number
Beschreibung

Subject Number

Datentyp

integer

Non-Serious Adverse Events
Beschreibung

Non-Serious Adverse Events

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

Please exclude those recorded on the SAE form

Datentyp

boolean

If Yes, please complete the following table
Beschreibung

If Yes, please complete the following table

Datentyp

text

AE Details
Beschreibung

AE Details

AE Number
Beschreibung

AE Number

Datentyp

integer

Description
Beschreibung

Description

Datentyp

text

Administration sites
Beschreibung

Administration sites

Datentyp

text

Date started
Beschreibung

Date started

Datentyp

date

Date stopped
Beschreibung

Date stopped

Datentyp

date

Intensity
Beschreibung

Intensity

Datentyp

text

Relationship to investigational products
Beschreibung

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

Datentyp

boolean

Outcome
Beschreibung

Outcome

Datentyp

text

Ähnliche Modelle

Non-Serious Adverse Event Form

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
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
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
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
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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