ID

25400

Description

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

Keywords

Versions (1)
  1. 9/3/17 9/3/17 -
Copyright Holder

glaxoSmithKline

Uploaded on

September 3, 2017

DOI

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License

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

English

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 forms  
Expert - Independent data monitoring committee
Description

Expert - Independent data monitoring committee

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

1-5

Data type

integer

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

Rash Start Date

Data type

date

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

Episode number rash

Data type

integer

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

Number of lesions

Data type

integer

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

Maximum intensity: Macular < Papular < Mostly vesicular < Hemorrhagic

Data type

integer

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

Fever

Data type

integer

Alias
UMLS CUI [1]
C0015967
Systemic signs
Description

Systemic signs

Data type

boolean

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

Back pain or Pain in abdomen

Data type

boolean

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

Interstitial pneumonia

Data type

boolean

Alias
UMLS CUI [1]
C0206061
Encephalitis
Description

Encephalitis

Data type

boolean

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

Subjective assessment of the illness by investigator

Data type

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?
Description

photographs

Data type

integer

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

photographs case decision

Data type

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?
Description

Serious adverse event varicella

Data type

boolean

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

Serious adverse event review

Data type

boolean

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

Varicella Clinical Case

Data type

boolean

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

Herpes Zoster case

Data type

boolean

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

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.

Data type

text

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

Printed expert's name

Data type

text

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

Date of expert's signature

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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