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Visit 2: Unsolicited Adverse Events

1 Formulär  
Administrative data
Beskrivning

Administrative data

Visit Number
Beskrivning

Visit Number

Datatyp

text

Date of Visit
Beskrivning

Date of Visit

Datatyp

date

Subject Number
Beskrivning

Subject Number

Datatyp

integer

Unsolicited Adverse Events
Beskrivning

Unsolicited Adverse Events

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

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

Datatyp

text

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Visit 2: Unsolicited Adverse Events

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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