ID

25400

Descripción

Expert 1-5 - Independent data monitoring committee - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

Palabras clave

Versiones (1)
  1. 3/9/17 3/9/17 -
Titular de derechos de autor

glaxoSmithKline

Subido en

3 de septiembre de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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Expert 1-5 - Independent data monitoring committee - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

Inglés

Expert 1-5 - Independent data monitoring committee - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

1 formularios  
Expert - Independent data monitoring committee
Descripción

Expert - Independent data monitoring committee

Alias
UMLS CUI-1
C0600219
UMLS CUI-2
C0949757
Expert number
Descripción

1-5

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0600219
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C0949757
Rash Start Date
Descripción

Rash Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0808070
Episode number
Descripción

Episode number rash

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C4086638
Number of lesions
Descripción

Number of lesions

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0008049
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0449788
Character of most lesions:
Descripción

Maximum intensity: Macular < Papular < Mostly vesicular < Hemorrhagic

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0008049
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0332307
Fever
Descripción

Fever

Tipo de datos

integer

Alias
UMLS CUI [1]
C0015967
Systemic signs
Descripción

Systemic signs

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0205373
Pain in back or abdomen
Descripción

Back pain or Pain in abdomen

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004604
UMLS CUI [2]
C0000737
Interstitial pneumonia
Descripción

Interstitial pneumonia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0206061
Encephalitis
Descripción

Encephalitis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0596773
Subjective assessment of the illness by investigator
Descripción

Subjective assessment of the illness by investigator

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C0035173
Did you see any photograph related to the case?
Descripción

photographs

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0441468
UMLS CUI [1,2]
C0008049
Did the photographs contribute to your case adjudication?
Descripción

photographs case decision

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0008049
UMLS CUI [1,2]
C0441468
UMLS CUI [1,3]
C0011109
Did an SAE occur during this VZ case?
Descripción

Serious adverse event varicella

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0008049
UMLS CUI [1,2]
C1519255
Did you review the case narrative for this SAE?
Descripción

Serious adverse event review

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0699752
Varicella Clinical Case?
Descripción

Varicella Clinical Case

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0008049
UMLS CUI [1,2]
C0205210
Herpes Zoster case?
Descripción

Herpes Zoster case

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0740380
UMLS CUI [1,2]
C0205210
Expert's signature
Descripción

I confirm that I have reviewed the data for this episode. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C0600219
Printed expert's name
Descripción

Printed expert's name

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C0600219
Date
Descripción

Date of expert's signature

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1519316
UMLS CUI [1,3]
C0600219
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Similar models

Expert 1-5 - Independent data monitoring committee - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Expert - Independent data monitoring committee
C0600219 (UMLS CUI-1)
C0949757 (UMLS CUI-2)
Expert number
Item
Expert number
integer
C0600219 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0949757 (UMLS CUI [1,3])
Rash Start Date
Item
Rash Start Date
date
C0015230 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Episode number rash
Item
Episode number
integer
C0015230 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Number of lesions
integer
C0008049 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Number of lesions
Code List
Number of lesions
CL Item
1-50 (1)
CL Item
51-100 (2)
CL Item
101 - 500 (3)
CL Item
>500 (4)
CL Item
Information not available (5)
Item
Character of most lesions:
integer
C0008049 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Character of lesions
Code List
Character of most lesions:
CL Item
Macular (1)
CL Item
Papular (2)
CL Item
Mostly vesicular (3)
CL Item
Hemorrhagic (4)
CL Item
Information not available (5)
Item
Fever
integer
C0015967 (UMLS CUI [1])
Fever
Code List
Fever
CL Item
Temperature < 38.8°C (Rectally) or < 38.3°C (Axillary) (1)
CL Item
Temperature 38.8°C - 39.9°C (Rectally) or 38.3°C - 39.4°C (Axillary) (2)
CL Item
Temperature > 40.0°C (Rectally) or > 39.5°C (Axillary) (3)
CL Item
Temperature not taken (4)
Systemic signs
Item
Systemic signs
boolean
C0037088 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Back pain or Pain in abdomen
Item
Pain in back or abdomen
boolean
C0004604 (UMLS CUI [1])
C0000737 (UMLS CUI [2])
Interstitial pneumonia
Item
Interstitial pneumonia
boolean
C0206061 (UMLS CUI [1])
Encephalitis
Item
Encephalitis
boolean
C0596773 (UMLS CUI [1])
Item
Subjective assessment of the illness by investigator
integer
C0221423 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0035173 (UMLS CUI [1,3])
Subjective assessment of the illness by investigator
Code List
Subjective assessment of the illness by investigator
CL Item
Subject does not appear ill (1)
CL Item
Subject appears moderately ill (2)
CL Item
Subject appears severely ill (3)
CL Item
Information not available (4)
Item
Did you see any photograph related to the case?
integer
C0441468 (UMLS CUI [1,1])
C0008049 (UMLS CUI [1,2])
photographs
Code List
Did you see any photograph related to the case?
CL Item
Yes (1)
CL Item
No, as no pictures were available. (2)
photographs case decision
Item
Did the photographs contribute to your case adjudication?
boolean
C0008049 (UMLS CUI [1,1])
C0441468 (UMLS CUI [1,2])
C0011109 (UMLS CUI [1,3])
Serious adverse event varicella
Item
Did an SAE occur during this VZ case?
boolean
C0008049 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Serious adverse event review
Item
Did you review the case narrative for this SAE?
boolean
C1519255 (UMLS CUI [1,1])
C0699752 (UMLS CUI [1,2])
Varicella Clinical Case
Item
Varicella Clinical Case?
boolean
C0008049 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
Herpes Zoster case
Item
Herpes Zoster case?
boolean
C0740380 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
Expert's signature
Item
Expert's signature
text
C1519316 (UMLS CUI [1,1])
C0600219 (UMLS CUI [1,2])
Printed expert's name
Item
Printed expert's name
text
C1519316 (UMLS CUI [1,1])
C0600219 (UMLS CUI [1,2])
Date of expert's signature
Item
Date
date
C0011008 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
C0600219 (UMLS CUI [1,3])
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