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Visit 2: Unsolicited Adverse Events

1 Formulários  
Administrative data
Descrição

Administrative data

Visit Number
Descrição

Visit Number

Tipo de dados

text

Date of Visit
Descrição

Date of Visit

Tipo de dados

date

Subject Number
Descrição

Subject Number

Tipo de dados

integer

Unsolicited Adverse Events
Descrição

Unsolicited Adverse Events

Has the subject experienced any serious or non-serious unsolicited adverse events within minimum 43 days post-vaccination?
Descrição

Has the subject experienced any serious or non-serious unsolicited adverse events within minimum 43 days post-vaccination?

Tipo de dados

text

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Visit 2: Unsolicited Adverse Events

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative data
Item
Visit Number
text
Visit Number
Code List
Visit Number
CL Item
Visit 2 (1)
Date of Visit
Item
Date of Visit
date
Subject Number
Item
Subject Number
integer
Item Group
Unsolicited Adverse Events
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within minimum 43 days post-vaccination?
text
Has the subject experienced any serious or non-serious unsolicited adverse events within minimum 43 days post-vaccination?
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within minimum 43 days post-vaccination?
CL Item
Information not availble (1)
CL Item
No vaccine administered (2)
CL Item
No (3)
CL Item
Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event Form (4)
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