Febrile Convulsions AE Form

Administrative data
Beskrivning

Administrative data

Subject Number
Beskrivning

Subject Number

Datatyp

integer

Febrile Convulsions - Suspected Signs of Meningitis
Beskrivning

Febrile Convulsions - Suspected Signs of Meningitis

Event Number
Beskrivning

Please report any febrile convulsion and any suspected signs of meningitis occurring during the study period

Datatyp

integer

Description
Beskrivning

Description

Datatyp

text

Further Details (For GSK)
Beskrivning

Further Details (For GSK)

Event Number
Beskrivning

Event Number

Datatyp

text

Date started
Beskrivning

Date started

Datatyp

date

Date stopped
Beskrivning

Date stopped

Datatyp

date

Intensity
Beskrivning

Intensity

Datatyp

text

Was a neurological examination performed?
Beskrivning

Was a neurological examination performed?

Datatyp

boolean

If Yes, was a lumbar puncture performed?
Beskrivning

If Yes, was a lumbar puncture performed?

Datatyp

boolean

If Yes, date of exam
Beskrivning

If Yes, date of exam

Datatyp

date

Relationship to investigational products
Beskrivning

Relationship to investigational products

Datatyp

boolean

Outcome
Beskrivning

Outcome

Datatyp

text

Similar models

Febrile Convulsions AE Form

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item Group
Febrile Convulsions - Suspected Signs of Meningitis
Item
Event Number
integer
Code List
Event Number
CL Item
FC. 1 (1)
CL Item
FC. 2 (2)
Description
Item
Description
text
Item Group
Further Details (For GSK)
Item
Event Number
text
Code List
Event Number
CL Item
FC. 1 (1)
CL Item
FC. 2 (2)
Date started
Item
Date started
date
Date stopped
Item
Date stopped
date
Item
Intensity
text
Code List
Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Was a neurological examination performed?
Item
Was a neurological examination performed?
boolean
If Yes, was a lumbar puncture performed?
Item
If Yes, was a lumbar puncture performed?
boolean
If Yes, date of exam
Item
If Yes, date of exam
date
Relationship to investigational products
Item
Relationship to investigational products
boolean
Item
Outcome
text
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)