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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

1 Formulär  
Expert - Independent data monitoring committee
Beskrivning

Expert - Independent data monitoring committee

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

1-5

Datatyp

integer

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

Rash Start Date

Datatyp

date

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

Episode number rash

Datatyp

integer

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

Number of lesions

Datatyp

integer

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

Maximum intensity: Macular < Papular < Mostly vesicular < Hemorrhagic

Datatyp

integer

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

Fever

Datatyp

integer

Alias
UMLS CUI [1]
C0015967
Systemic signs
Beskrivning

Systemic signs

Datatyp

boolean

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

Back pain or Pain in abdomen

Datatyp

boolean

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

Interstitial pneumonia

Datatyp

boolean

Alias
UMLS CUI [1]
C0206061
Encephalitis
Beskrivning

Encephalitis

Datatyp

boolean

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

Subjective assessment of the illness by investigator

Datatyp

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?
Beskrivning

photographs

Datatyp

integer

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

photographs case decision

Datatyp

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?
Beskrivning

Serious adverse event varicella

Datatyp

boolean

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

Serious adverse event review

Datatyp

boolean

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

Varicella Clinical Case

Datatyp

boolean

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

Herpes Zoster case

Datatyp

boolean

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

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.

Datatyp

text

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

Printed expert's name

Datatyp

text

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

Date of expert's signature

Datatyp

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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