Febrile Convulsions AE Form

Administrative data
Beschreibung

Administrative data

Subject Number
Beschreibung

Subject Number

Datentyp

integer

Febrile Convulsions - Suspected Signs of Meningitis
Beschreibung

Febrile Convulsions - Suspected Signs of Meningitis

Event Number
Beschreibung

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

Datentyp

integer

Description
Beschreibung

Description

Datentyp

text

Further Details (For GSK)
Beschreibung

Further Details (For GSK)

Event Number
Beschreibung

Event Number

Datentyp

text

Date started
Beschreibung

Date started

Datentyp

date

Date stopped
Beschreibung

Date stopped

Datentyp

date

Intensity
Beschreibung

Intensity

Datentyp

text

Was a neurological examination performed?
Beschreibung

Was a neurological examination performed?

Datentyp

boolean

If Yes, was a lumbar puncture performed?
Beschreibung

If Yes, was a lumbar puncture performed?

Datentyp

boolean

If Yes, date of exam
Beschreibung

If Yes, date of exam

Datentyp

date

Relationship to investigational products
Beschreibung

Relationship to investigational products

Datentyp

boolean

Outcome
Beschreibung

Outcome

Datentyp

text

Ähnliche Modelle

Febrile Convulsions AE Form

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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)