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Visit 1: Solicited Adverse Events - General Symptoms (All Groups)

1 forms  
Administrative data
Description

Administrative data

Visit Number
Description

Visit Number

Data type

text

Date of Visit
Description

Date of Visit

Data type

date

Subject Number
Description

Subject Number

Data type

integer

General Symptoms
Description

General Symptoms

Has the subject experienced any of the following signs/symptoms during the solicited period?
Description

Has the subject experienced any of the following signs/symptoms during the solicited period?

Data type

text

General Symptom 1
Description

General Symptom 1

Fever
Description

Fever

Data type

boolean

In any case, please complete the Temperature form
Description

In any case, please complete the Temperature form

Data type

text

Symptom 2
Description

Symptom 2

General rash/exanthema
Description

General rash/exanthema

Data type

boolean

If YES, please complete the Rash/Exanthema form
Description

If YES, please complete the Rash/Exanthema form

Data type

text

Symptom 3
Description

Symptom 3

Parotid/Salivary gland swelling
Description

Parotid/Salivary gland swelling

Data type

boolean

If YES, please complete the Parotid/Salivary Gland Swelling form
Description

If YES, please complete the Parotid/Salivary Gland Swelling form

Data type

text

Symptom 4
Description

Symptom 4

Febrile convulsions - suspected signs of meningitis
Description

Febrile convulsions - suspected signs of meningitis

Data type

boolean

If Yes, please complete the Febrile Convulsions - Suspected Signs of Meningitis form
Description

If Yes, please complete the Febrile Convulsions - Suspected Signs of Meningitis form

Data type

text

Please report serious adverse events to GSK by telephone within 24 hours
Description

Please report serious adverse events to GSK by telephone within 24 hours

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Visit 1: Solicited Adverse Events - General Symptoms (All Groups)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Item
Visit Number
text
Visit Number
Code List
Visit Number
CL Item
Visit 1 (1)
Date of Visit
Item
Date of Visit
date
Subject Number
Item
Subject Number
integer
Item Group
General Symptoms
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
Has the subject experienced any of the following signs/symptoms during the solicited period?
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (1)
CL Item
No vaccine administered (2)
CL Item
No (3)
CL Item
Yes, please tick YES for each symptom. If Yes is ticked, please complete all items. (4)
Item Group
General Symptom 1
Fever
Item
Fever
boolean
In any case, please complete the Temperature form
Item
In any case, please complete the Temperature form
text
Item Group
Symptom 2
General rash/exanthema
Item
General rash/exanthema
boolean
If YES, please complete the Rash/Exanthema form
Item
If YES, please complete the Rash/Exanthema form
text
Item Group
Symptom 3
Parotid/Salivary gland swelling
Item
Parotid/Salivary gland swelling
boolean
If YES, please complete the Parotid/Salivary Gland Swelling form
Item
If YES, please complete the Parotid/Salivary Gland Swelling form
text
Item Group
Symptom 4
Febrile convulsions - suspected signs of meningitis
Item
Febrile convulsions - suspected signs of meningitis
boolean
If Yes, please complete the Febrile Convulsions - Suspected Signs of Meningitis form
Item
If Yes, please complete the Febrile Convulsions - Suspected Signs of Meningitis form
text
Item Group
Please report serious adverse events to GSK by telephone within 24 hours
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