ID

33015

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 CRF Seiten: 268-336; 870-938

Palabras clave

Versiones (2)
  1. 23/11/2018 23/11/2018 -
  2. 26/11/2018 26/11/2018 -
Titular de derechos de autor

GSK group of companies

Subido en

23 novembre 2018

DOI

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Licencia

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

Inglés

Visit 2: Solicited Adverse Events (All Groups)

1 formularios  
Administrative data
Descripción

Administrative data

Visit Number
Descripción

Visit Number

Tipo de datos

text

Date of Visit
Descripción

Date of Visit

Tipo de datos

date

Subject Number
Descripción

Subject Number

Tipo de datos

integer

Local Symptoms
Descripción

Local Symptoms

Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Descripción

Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?

Tipo de datos

text

Local Symptoms
Descripción

Local Symptoms

Redness
Descripción

If YES is ticked, please complete all items

Tipo de datos

boolean

Size - Day 0
Descripción

Size - Day 0

Tipo de datos

float

Unidades de medida
  • mm
mm
Size - Day 1
Descripción

Size - Day 1

Tipo de datos

float

Unidades de medida
  • mm
mm
Size - Day 2
Descripción

Size - Day 2

Tipo de datos

float

Unidades de medida
  • mm
mm
Size - Day 3
Descripción

Size - Day 3

Tipo de datos

float

Unidades de medida
  • mm
mm
Ongoing after Day 3?
Descripción

Ongoing after Day 3?

Tipo de datos

boolean

If YES, record date of last day of symptoms
Descripción

If YES, record date of last day of symptoms

Tipo de datos

date

Local Symptoms
Descripción

Local Symptoms

Swelling
Descripción

If YES is ticked, please complete all items

Tipo de datos

boolean

Size - Day 0
Descripción

Size - Day 0

Tipo de datos

float

Unidades de medida
  • mm
mm
Size - Day 1
Descripción

Size - Day 1

Tipo de datos

float

Unidades de medida
  • mm
mm
Size - Day 2
Descripción

Size - Day 2

Tipo de datos

float

Unidades de medida
  • mm
mm
Size - Day 3
Descripción

Size - Day 3

Tipo de datos

float

Unidades de medida
  • mm
mm
Ongoing after Day 3?
Descripción

Ongoing after Day 3?

Tipo de datos

boolean

If YES, record date of last day of symptoms
Descripción

If YES, record date of last day of symptoms

Tipo de datos

date

Local Symptoms
Descripción

Local Symptoms

Pain
Descripción

If YES is ticked, please complete all items

Tipo de datos

boolean

Intensity - Day 0
Descripción

Intensity - Day 0

Tipo de datos

integer

Intensity - Day 1
Descripción

Intensity - Day 1

Tipo de datos

integer

Intensity - Day 2
Descripción

Intensity - Day 2

Tipo de datos

integer

Intensity - Day 3
Descripción

Intensity - Day 3

Tipo de datos

integer

Ongoing after Day 3?
Descripción

Ongoing after Day 3?

Tipo de datos

boolean

If YES, record date of last day of symptoms
Descripción

If YES, record date of last day of symptoms

Tipo de datos

date

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Similar models

Visit 2: Solicited Adverse Events (All Groups)

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative data
Item
Visit Number
text
Visit Number
Code List
Visit Number
CL Item
Visit 2 (1)
Date of Visit
Item
Date of Visit
date
Subject Number
Item
Subject Number
integer
Item Group
Local Symptoms
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
Has the subject experienced any serious or non-serious unsolicited adverse events within minimum 43 days post-vaccination?
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Information not available (1)
CL Item
No vaccine administered (2)
CL Item
No (3)
CL Item
Yes, please tick NO/YES for each symptom.  (4)
Item Group
Local Symptoms
Redness
Item
Redness
boolean
Size - Day 0
Item
Size - Day 0
float
Size - Day 1
Item
Size - Day 1
float
Size - Day 2
Item
Size - Day 2
float
Size - Day 3
Item
Size - Day 3
float
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
If YES, record date of last day of symptoms
Item
If YES, record date of last day of symptoms
date
Item Group
Local Symptoms
Swelling
Item
Swelling
boolean
Size - Day 0
Item
Size - Day 0
float
Size - Day 1
Item
Size - Day 1
float
Size - Day 2
Item
Size - Day 2
float
Size - Day 3
Item
Size - Day 3
float
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
If YES, record date of last day of symptoms
Item
If YES, record date of last day of symptoms
date
Item Group
Local Symptoms
Pain
Item
Pain
boolean
Item
Intensity - Day 0
integer
Intensity - Day 0
Code List
Intensity - Day 0
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Intensity - Day 1
integer
Intensity - Day 1
Code List
Intensity - Day 1
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Intensity - Day 2
integer
Intensity - Day 2
Code List
Intensity - Day 2
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Intensity - Day 3
integer
Intensity - Day 3
Code List
Intensity - Day 3
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
If YES, record date of last day of symptoms
Item
If YES, record date of last day of symptoms
date
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