ID

25108

Beschreibung

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

Stichworte

Versionen (1)
  1. 8/26/17 8/26/17 -
Rechteinhaber

glaxoSmithKline

Hochgeladen am

August 26, 2017

DOI

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Lizenz

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

Englisch

GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Rash, Parotid swelling, Febrile convulsion

1 Formulare  
Rash / Exanthem
Beschreibung

Rash / Exanthem

Alias
UMLS CUI-1
C0015230
Has any rash/exanthem event occurred during 42 days post-vaccination ?
Beschreibung

Do not report here Varicella or Zoster but report in the Varicella or Zoster Case section. If yes, please complete the following table.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0042196
Rash / Exanthem
Beschreibung

Rash / Exanthem

Alias
UMLS CUI-1
C0015230
Rash No.
Beschreibung

Rash number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0449788
Description
Beschreibung

Description of rash

Datentyp

text

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0678257
Description (Localisation)
Beschreibung

Localisation of rash

Datentyp

integer

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1515974
Localisation of rash
Beschreibung

Only answer if you chose "localized".

Datentyp

integer

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0475264
Please specify 'other location'.
Beschreibung

Other location specify

Datentyp

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1521902
Category
Beschreibung

Category of rash

Datentyp

integer

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0683312
Please specify 'other category'.
Beschreibung

specify other category

Datentyp

text

Alias
UMLS CUI [1,1]
C0683312
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1521902
Date started
Beschreibung

Start Date of rash

Datentyp

date

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0808070
Date stopped
Beschreibung

End Date of rash

Datentyp

date

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0806020
Intensity
Beschreibung

Intensity of rash

Datentyp

integer

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0518690
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschreibung

Relationship to investigational products

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0042210
Outcome
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1]
C1547647
Medically attended visit?
Beschreibung

Medically attended visit

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
If yes please specify type of visit.
Beschreibung

Specify type of visit

Datentyp

text

Alias
UMLS CUI [1,1]
C0281907
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1521902
Parotid / Salivary gland swelling events
Beschreibung

Parotid / Salivary gland swelling events

Alias
UMLS CUI-1
C0240925
UMLS CUI-3
C0240668
Has any parotid / salivary gland swelling event occurred during 42 days post-vaccination ?
Beschreibung

If yes, please complete the following table.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0240925
UMLS CUI [1,2]
C0042196
UMLS CUI [2,1]
C0240668
UMLS CUI [2,2]
C0042196
Parotid / Salivary gland swelling events
Beschreibung

Parotid / Salivary gland swelling events

Alias
UMLS CUI-1
C0240925
UMLS CUI-2
C0240668
Parotid swelling No.
Beschreibung

Parotid Swelling number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0240668
UMLS CUI [1,2]
C0449788
Description
Beschreibung

Description of parotid swelling

Datentyp

text

Alias
UMLS CUI [1,1]
C0240668
UMLS CUI [1,2]
C0678257
Date started
Beschreibung

Start date of parotid swelling

Datentyp

date

Alias
UMLS CUI [1,1]
C0240668
UMLS CUI [1,2]
C0808070
Date stopped
Beschreibung

End date of parotid swelling

Datentyp

text

Alias
UMLS CUI [1,1]
C0240668
UMLS CUI [1,2]
C0806020
Intensity
Beschreibung

Intensity of parotid swelling

Datentyp

integer

Alias
UMLS CUI [1,1]
C0240668
UMLS CUI [1,2]
C0518690
Has a saliva sample been taken for mumps virus detection, strain identification and for viral culture?
Beschreibung

Saliva sample

Datentyp

boolean

Alias
UMLS CUI [1]
C0438730
Date saliva sample was taken
Beschreibung

Only answer if you choose 'yes' in previous question.

Datentyp

date

Alias
UMLS CUI [1,1]
C0438730
UMLS CUI [1,2]
C0011008
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschreibung

Relationship to investigational products

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0240668
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0042210
Outcome
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1]
C1547647
Medically attended visit?
Beschreibung

Medically attended visit

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
If yes, please specify type of visit.
Beschreibung

Specify type of visit

Datentyp

text

Alias
UMLS CUI [1,1]
C0281907
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1521902
Febrile convulsions - Suspected signs of meningism events
Beschreibung

Febrile convulsions - Suspected signs of meningism events

Alias
UMLS CUI-1
C0009952
UMLS CUI-3
C0025287
Have any febrile convulsion or any suspected signs of meningism occurred during 42 days post-vaccination ?
Beschreibung

Febrile convulsions - Suspected signs of meningism events

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009952
UMLS CUI [1,2]
C0042196
UMLS CUI [2,1]
C0025287
UMLS CUI [2,2]
C0042196
Febrile convulsions - Suspected signs of meningism events
Beschreibung

Febrile convulsions - Suspected signs of meningism events

Alias
UMLS CUI-1
C0009952
UMLS CUI-2
C0025287
Febrile Convulsion No.
Beschreibung

Febrile convulsion number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0009952
UMLS CUI [1,2]
C0449788
Description
Beschreibung

Description of febrile convulsion

Datentyp

text

Alias
UMLS CUI [1,1]
C0009952
UMLS CUI [1,2]
C0678257
Date started
Beschreibung

Start date of febrile convulsion

Datentyp

date

Alias
UMLS CUI [1,1]
C0009952
UMLS CUI [1,2]
C0808070
Date stopped
Beschreibung

End date of febrile convulsion

Datentyp

date

Alias
UMLS CUI [1,1]
C0009952
UMLS CUI [1,2]
C0806020
Intensity
Beschreibung

Intensity of febrile convulsion

Datentyp

text

Alias
UMLS CUI [1,1]
C0009952
UMLS CUI [1,2]
C0518690
Was a neurological examination performed?
Beschreibung

Neurological examination

Datentyp

boolean

Alias
UMLS CUI [1]
C0027853
If yes, was a lumbar puncture performed?
Beschreibung

Only answer if you answered previous question with 'yes'.

Datentyp

boolean

Alias
UMLS CUI [1]
C0553794
Date of exam
Beschreibung

Only answer if neurological examination was performed.

Datentyp

date

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0011008
If yes, was a sample sent to GSK BIO?
Beschreibung

spinal fluid sample

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1973491
UMLS CUI [1,2]
C0420724
Level of diagnostic certainty
Beschreibung

Level 1 of diagnostic certainty: witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Level 2 of diagnostic certainty: history of unconsciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Level 3 of diagnostic certainty: history of unconsciousness AND other generalized motor manifestations Level 4 of diagnostic certainty: reported generalized convulsive seizure with insufficient evidence to meet the case definitions for Level 1, 2 or 3 of diagnostic certainty above Level 5 of diagnostic certainty: Not a case of generalized convulsive seizure

Datentyp

integer

Alias
UMLS CUI [1,1]
C0009952
UMLS CUI [1,2]
C0332146
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschreibung

Relationship to investigational products

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009952
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C0042210
Outcome
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1]
C1547647
Medically attended visit?
Beschreibung

Medically attended visit

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
If yes please specify type of visit.
Beschreibung

Specify type of visit

Datentyp

text

Alias
UMLS CUI [1,1]
C0281907
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1521902
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Ähnliche Modelle

GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Rash, Parotid swelling, Febrile convulsion

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Rash / Exanthem
C0015230 (UMLS CUI-1)
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])
Item Group
Rash / Exanthem
C0015230 (UMLS CUI-1)
Rash number
Item
Rash No.
integer
C0015230 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Description of rash
Item
Description
text
C0015230 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
Description (Localisation)
integer
C0678257 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Localisation of rash
Code List
Description (Localisation)
CL Item
Generalized (1)
CL Item
Localized (2)
Item
Localisation of rash
integer
C0015230 (UMLS CUI [1,1])
C0475264 (UMLS CUI [1,2])
Localisation rash
Code List
Localisation of rash
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])
Item
Category
integer
C0015230 (UMLS CUI [1,1])
C0683312 (UMLS CUI [1,2])
Category of rash
Code List
Category
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])
Start Date of rash
Item
Date started
date
C0015230 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End Date of rash
Item
Date stopped
date
C0015230 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Intensity
integer
C0015230 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Intensity of rash
Code List
Intensity
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])
Item
Outcome
integer
C1547647 (UMLS CUI [1])
Outcome
Code List
Outcome
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])
Item
If yes please specify type of visit.
text
C0281907 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Specify type of visit
Code List
If yes please specify type of visit.
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)
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])
Item Group
Parotid / Salivary gland swelling events
C0240925 (UMLS CUI-1)
C0240668 (UMLS CUI-2)
Parotid Swelling number
Item
Parotid swelling No.
integer
C0240668 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Description of parotid swelling
Item
Description
text
C0240668 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Start date of parotid swelling
Item
Date started
date
C0240668 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End date of parotid swelling
Item
Date stopped
text
C0240668 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Intensity
integer
C0240668 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Intensity of parotid swelling
Code List
Intensity
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])
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])
Item
Outcome
integer
C1547647 (UMLS CUI [1])
Outcome
Code List
Outcome
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])
Item
If yes, please specify type of visit.
text
C0281907 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Specify type of visit
Code List
If yes, please specify type of visit.
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)
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])
Item Group
Febrile convulsions - Suspected signs of meningism events
C0009952 (UMLS CUI-1)
C0025287 (UMLS CUI-2)
Febrile convulsion number
Item
Febrile Convulsion No.
integer
C0009952 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Description of febrile convulsion
Item
Description
text
C0009952 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Start date of febrile convulsion
Item
Date started
date
C0009952 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End date of febrile convulsion
Item
Date stopped
date
C0009952 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Intensity
text
C0009952 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Intensity of febrile convulsion
Code List
Intensity
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])
spinal fluid sample
Item
If yes, was a sample sent to GSK BIO?
boolean
C1973491 (UMLS CUI [1,1])
C0420724 (UMLS CUI [1,2])
Item
Level of diagnostic certainty
integer
C0009952 (UMLS CUI [1,1])
C0332146 (UMLS CUI [1,2])
Diagnostic certainty
Code List
Level of diagnostic certainty
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])
Item
Outcome
integer
C1547647 (UMLS CUI [1])
Outcome
Code List
Outcome
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])
Item
If yes please specify type of visit.
text
C0281907 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Specify type of visit
Code List
If yes please specify type of visit.
CL Item
Hospitalisation  (HO)
CL Item
Emergency Room  (ER)
CL Item
Medical Personnel (MD)
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