Inglés

Rash / Exanthem AE Form

1 formularios  
Administrative data
Descripción

Administrative data

Subject Number
Descripción

Subject Number

Tipo de datos

integer

Rash/Exanthem
Descripción

Rash/Exanthem

Event Number
Descripción

Please report any rash event that occurred during the study period

Tipo de datos

integer

Description
Descripción

Description

Tipo de datos

text

Administration sites
Descripción

Administration sites

Tipo de datos

text

Non-administration site
Descripción

Non-administration site

Tipo de datos

text

Further Event Details (For GSK)
Descripción

Further Event Details (For GSK)

Event Number
Descripción

Event Number

Tipo de datos

integer

Category
Descripción

Category

Tipo de datos

text

If Other, specify
Descripción

If Other, specify

Tipo de datos

text

Date started
Descripción

Date started

Tipo de datos

date

Date stopped
Descripción

Date stopped

Tipo de datos

date

Intensity
Descripción

Intensity

Tipo de datos

text

Has a vesicular fluid sample been taken?
Descripción

Has a vesicular fluid sample been taken?

Tipo de datos

boolean

If Yes, record date
Descripción

If Yes, record date

Tipo de datos

date

Relationship to investigational products
Descripción

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

Tipo de datos

boolean

Outcome
Descripción

Outcome

Tipo de datos

text

Volver a la parte superior de la página

Similar models

Rash / Exanthem AE Form

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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)
Volver a la parte superior de la página