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ID
25108
Beschrijving
GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Rash/Exanthem, Parotid swelling and febrile convulsion 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
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Versies (1)
- 26-08-17 26-08-17 -
Houder van rechten
glaxoSmithKline
Geüploaded op
26 augustus 2017
DOI
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Creative Commons BY-NC 3.0
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GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Rash, Parotid swelling, Febrile convulsion
GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Rash, Parotid swelling, Febrile convulsion
Similar models
GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Rash, Parotid swelling, Febrile convulsion
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
rash post-vaccination
Item
Has any rash/exanthem event occurred during 42 days post-vaccination ?
boolean
C0015230 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,2])
Rash number
Item
Rash No.
integer
C0015230 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
Description of rash
Item
Description
text
C0015230 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
Item
Description (Localisation)
integer
C0678257 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,2])
CL Item
Generalized (1)
CL Item
Localized (2)
Item
Localisation of rash
integer
C0015230 (UMLS CUI [1,1])
C0475264 (UMLS CUI [1,2])
C0475264 (UMLS CUI [1,2])
CL Item
Administration site (1)
CL Item
Other location : specify (2)
Other location specify
Item
Please specify 'other location'.
text
C1515974 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
CL Item
Measles / rubella-rash (1)
CL Item
Other (2)
specify other category
Item
Please specify 'other category'.
text
C0683312 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Start Date of rash
Item
Date started
date
C0015230 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
End Date of rash
Item
Date stopped
date
C0015230 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
CL Item
1-50 lesions (1)
CL Item
51-100 lesions (2)
CL Item
101-500 lesions (3)
CL Item
>500 lesions (4)
Relationship to investigational products
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0015230 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0085978 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
CL Item
Recovered / resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered with sequelae / resolved with sequelae (4)
Medically attended visit
Item
Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
If yes please specify type of visit.
text
C0281907 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
CL Item
Hospitalisation (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
Item Group
Parotid / Salivary gland swelling events
C0240925 (UMLS CUI-1)
C0240668 (UMLS CUI-3)
C0240668 (UMLS CUI-3)
Parotid / Salivary gland swelling events
Item
Has any parotid / salivary gland swelling event occurred during 42 days post-vaccination ?
boolean
C0240925 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0240668 (UMLS CUI [2,1])
C0042196 (UMLS CUI [2,2])
C0042196 (UMLS CUI [1,2])
C0240668 (UMLS CUI [2,1])
C0042196 (UMLS CUI [2,2])
Item Group
Parotid / Salivary gland swelling events
C0240925 (UMLS CUI-1)
C0240668 (UMLS CUI-2)
C0240668 (UMLS CUI-2)
Parotid Swelling number
Item
Parotid swelling No.
integer
C0240668 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
Description of parotid swelling
Item
Description
text
C0240668 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
Start date of parotid swelling
Item
Date started
date
C0240668 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
End date of parotid swelling
Item
Date stopped
text
C0240668 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Item
Intensity
integer
C0240668 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
CL Item
Swelling without difficulties to move the jaw. (1)
CL Item
Swelling with difficulties to move the jaw. (2)
CL Item
Swelling and additional general symptoms. (3)
Saliva sample
Item
Has a saliva sample been taken for mumps virus detection, strain identification and for viral culture?
boolean
C0438730 (UMLS CUI [1])
Date of saliva sample
Item
Date saliva sample was taken
date
C0438730 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Relationship to investigational products
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0240668 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0085978 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
CL Item
Recovered / resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered with sequelae / resolved with sequelae (4)
Medically attended visit
Item
Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
If yes, please specify type of visit.
text
C0281907 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
CL Item
Hospitalisation (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
Item Group
Febrile convulsions - Suspected signs of meningism events
C0009952 (UMLS CUI-1)
C0025287 (UMLS CUI-3)
C0025287 (UMLS CUI-3)
Febrile convulsions - Suspected signs of meningism events
Item
Have any febrile convulsion or any suspected signs of meningism occurred during 42 days post-vaccination ?
boolean
C0009952 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0025287 (UMLS CUI [2,1])
C0042196 (UMLS CUI [2,2])
C0042196 (UMLS CUI [1,2])
C0025287 (UMLS CUI [2,1])
C0042196 (UMLS CUI [2,2])
Item Group
Febrile convulsions - Suspected signs of meningism events
C0009952 (UMLS CUI-1)
C0025287 (UMLS CUI-2)
C0025287 (UMLS CUI-2)
Febrile convulsion number
Item
Febrile Convulsion No.
integer
C0009952 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
Description of febrile convulsion
Item
Description
text
C0009952 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
Start date of febrile convulsion
Item
Date started
date
C0009952 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
End date of febrile convulsion
Item
Date stopped
date
C0009952 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Item
Intensity
text
C0009952 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
Neurological examination
Item
Was a neurological examination performed?
boolean
C0027853 (UMLS CUI [1])
lumbar puncture
Item
If yes, was a lumbar puncture performed?
boolean
C0553794 (UMLS CUI [1])
Date of neurological examination
Item
Date of exam
date
C0027853 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
spinal fluid sample
Item
If yes, was a sample sent to GSK BIO?
boolean
C1973491 (UMLS CUI [1,1])
C0420724 (UMLS CUI [1,2])
C0420724 (UMLS CUI [1,2])
Item
Level of diagnostic certainty
integer
C0009952 (UMLS CUI [1,1])
C0332146 (UMLS CUI [1,2])
C0332146 (UMLS CUI [1,2])
CL Item
Level 1 (1)
CL Item
Level 2 (2)
CL Item
Level 3 (3)
CL Item
Level 4 (4)
CL Item
Level 5 (5)
Relationship to investigational products
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0009952 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0085978 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
CL Item
Recovered / resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered with sequelae / resolved with sequelae (4)
Medically attended visit
Item
Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
If yes please specify type of visit.
text
C0281907 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
CL Item
Hospitalisation (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
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