Englisch

Rash / Exanthem AE Form

1 Formulare  
Administrative data
Beschreibung

Administrative data

Subject Number
Beschreibung

Subject Number

Datentyp

integer

Rash/Exanthem
Beschreibung

Rash/Exanthem

Event Number
Beschreibung

Please report any rash event that occurred during the study period

Datentyp

integer

Description
Beschreibung

Description

Datentyp

text

Administration sites
Beschreibung

Administration sites

Datentyp

text

Non-administration site
Beschreibung

Non-administration site

Datentyp

text

Further Event Details (For GSK)
Beschreibung

Further Event Details (For GSK)

Event Number
Beschreibung

Event Number

Datentyp

integer

Category
Beschreibung

Category

Datentyp

text

If Other, specify
Beschreibung

If Other, specify

Datentyp

text

Date started
Beschreibung

Date started

Datentyp

date

Date stopped
Beschreibung

Date stopped

Datentyp

date

Intensity
Beschreibung

Intensity

Datentyp

text

Has a vesicular fluid sample been taken?
Beschreibung

Has a vesicular fluid sample been taken?

Datentyp

boolean

If Yes, record date
Beschreibung

If Yes, record date

Datentyp

date

Relationship to investigational products
Beschreibung

is there a reasonable possibility that the AE may have been caused by the investigational product?

Datentyp

boolean

Outcome
Beschreibung

Outcome

Datentyp

text

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Ähnliche Modelle

Rash / Exanthem AE Form

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item Group
Rash/Exanthem
Item
Event Number
integer
Event Number
Code List
Event Number
CL Item
RA. 1 (1)
CL Item
RA. 2 (2)
Description
Item
Description
text
Item
Administration sites
text
Administration sites
Code List
Administration sites
CL Item
MemURu-OKA vaccine (1)
CL Item
Priorix vaccine (2)
CL Item
Varilirix vaccine (3)
Item
Non-administration site
text
Non-administration site
Code List
Non-administration site
CL Item
Generalized (1)
CL Item
Localized (2)
Item Group
Further Event Details (For GSK)
Item
Event Number
integer
Event Number
Code List
Event Number
CL Item
RA. 1 (1)
CL Item
RA. 2 (2)
Item
Category
text
Category
Code List
Category
CL Item
Varicella rash (1)
CL Item
Measles / rubella-rash (2)
CL Item
Other (3)
If Other, specify
Item
If Other, specify
text
Date started
Item
Date started
date
Date stopped
Item
Date stopped
date
Item
Intensity
text
Intensity
Code List
Intensity
CL Item
1 - 50 lesions (1)
CL Item
51 - 150 lesions (2)
CL Item
> 150 lesions (3)
Has a vesicular fluid sample been taken?
Item
Has a vesicular fluid sample been taken?
boolean
If Yes, record date
Item
If Yes, record date
date
Relationship to investigational products
Item
Relationship to investigational products
boolean
Item
Outcome
text
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)
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