ID

33073

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. 22/11/18 22/11/18 -
  2. 26/11/18 26/11/18 -
Titular de derechos de autor

GSK group of companies

Subido en

26 de noviembre de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

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

Inglés

Medical History

1 formularios  
  1. StudyEvent: ODM
    1. Medical History
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

General Medical History / Physical Examination
Descripción

General Medical History / Physical Examination

Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
Descripción

Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?

Tipo de datos

text

Cutaneous
Descripción

Cutaneous

Tipo de datos

text

Diagnosis
Descripción

Diagnosis

Tipo de datos

text

Eyes
Descripción

Eyes

Tipo de datos

text

Diagnosis
Descripción

Diagnosis

Tipo de datos

text

Ears-Nose-Throat
Descripción

Ears-Nose-Throat

Tipo de datos

text

Diagnosis
Descripción

Diagnosis

Tipo de datos

text

Cardiovascular
Descripción

Cardiovascular

Tipo de datos

text

Diagnosis
Descripción

Diagnosis

Tipo de datos

text

Respiratory
Descripción

Respiratory

Tipo de datos

text

Gastrointestinal
Descripción

Gastrointestinal

Tipo de datos

text

Muskuloskeletal
Descripción

Muskuloskeletal

Tipo de datos

text

Neurological
Descripción

Neurological

Tipo de datos

text

Genitourinary
Descripción

Genitourinary

Tipo de datos

text

Haematology
Descripción

Haematology

Tipo de datos

text

Allergies
Descripción

Allergies

Tipo de datos

text

Endocrine
Descripción

Endocrine

Tipo de datos

text

Other, specify
Descripción

Other, specify

Tipo de datos

text

Concomitant Medications
Descripción

Concomitant Medications

Please report medication(s) as specified in the protocol and fill in the Medication section
Descripción

Please report medication(s) as specified in the protocol and fill in the Medication section

Tipo de datos

text

Volver a la parte superior de la página

Similar models

Medical History

1 formularios
  1. StudyEvent: ODM
    1. Medical History
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 1 (1)
Date of Visit
Item
Date of Visit
date
Subject Number
Item
Subject Number
integer
Item Group
General Medical History / Physical Examination
Item
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
text
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
Code List
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
CL Item
No (1)
CL Item
Yes -> please tick appropriate box(es) and give diagnosis (2)
Item
Cutaneous
text
Cutaneous
Code List
Cutaneous
CL Item
Current (1)
CL Item
Past (2)
Diagnosis
Item
Diagnosis
text
Item
Eyes
text
Eyes
Code List
Eyes
CL Item
Current (1)
CL Item
Past (2)
Diagnosis
Item
Diagnosis
text
Item
Ears-Nose-Throat
text
Ears-Nose-Throat
Code List
Ears-Nose-Throat
CL Item
Current (1)
CL Item
Past (2)
Diagnosis
Item
Diagnosis
text
Item
Cardiovascular
text
Cardiovascular
Code List
Cardiovascular
CL Item
Current (1)
CL Item
Past (2)
Diagnosis
Item
Diagnosis
text
Item
Respiratory
text
Respiratory
Code List
Respiratory
CL Item
Current (1)
CL Item
Past (2)
Item
Gastrointestinal
text
Gastrointestinal
Code List
Gastrointestinal
CL Item
Current (1)
CL Item
Past (2)
Item
Muskuloskeletal
text
Muskuloskeletal
Code List
Muskuloskeletal
CL Item
Current (1)
CL Item
Past (2)
Item
Neurological
text
Neurological
Code List
Neurological
CL Item
Current (1)
CL Item
Past (2)
Item
Genitourinary
text
Genitourinary
Code List
Genitourinary
CL Item
Current (1)
CL Item
Past (2)
Item
Haematology
text
Haematology
Code List
Haematology
CL Item
Current (1)
CL Item
Past (2)
Item
Allergies
text
Allergies
Code List
Allergies
CL Item
Current (1)
CL Item
Past (2)
Item
Endocrine
text
Endocrine
Code List
Endocrine
CL Item
Current (1)
CL Item
Past (2)
Other, specify
Item
Other, specify
text
Item Group
Concomitant Medications
Please report medication(s) as specified in the protocol and fill in the Medication section
Item
Please report medication(s) as specified in the protocol and fill in the Medication section
text
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

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